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  31. <title>ALMAC SCIENCES AWARDED LIFE SCIENCES INNOVATIVE MANUFACTURING FUND GRANT</title>
  32. <link>https://journalforclinicalstudies.com/almac-sciences-awarded-life-sciences-innovative-manufacturing-fund-grant/</link>
  33. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  34. <pubDate>Thu, 14 Mar 2024 10:29:35 +0000</pubDate>
  35. <category><![CDATA[Regional News]]></category>
  36. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23946</guid>
  37.  
  38. <description><![CDATA[<p>Grant awarded to support the expansion of Almac’s small molecule API manufacturing plant Almac Sciences, a member of the&#160;Almac Group, has been awarded a Life Sciences Innovative Manufacturing Fund (LSIMF) Grant to support the expansion of its small molecule active pharmaceutical ingredients (API) manufacturing facility at its Global Headquarters in Craigavon, UK. The grant will [&#8230;]</p>
  39. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/almac-sciences-awarded-life-sciences-innovative-manufacturing-fund-grant/">ALMAC SCIENCES AWARDED LIFE SCIENCES INNOVATIVE MANUFACTURING FUND GRANT</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  40. ]]></description>
  41. <content:encoded><![CDATA[
  42. <p><em>Grant awarded to support the expansion of Almac’s small molecule API manufacturing plant</em></p>
  43.  
  44.  
  45. <div class="wp-block-image">
  46. <figure class="aligncenter size-large"><img fetchpriority="high" decoding="async" width="1024" height="576" src="https://journalforclinicalstudies.com/wp-content/uploads/2024/03/Almac_Expansion-1-1024x576.jpg" alt="" class="wp-image-23947" srcset="https://journalforclinicalstudies.com/wp-content/uploads/2024/03/Almac_Expansion-1-1024x576.jpg 1024w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/Almac_Expansion-1-300x169.jpg 300w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/Almac_Expansion-1-768x432.jpg 768w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/Almac_Expansion-1-1536x864.jpg 1536w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/Almac_Expansion-1.jpg 2000w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></div>
  47.  
  48.  
  49. <p></p>
  50.  
  51.  
  52.  
  53. <p><a href="https://www.almacgroup.com/analytical-solid-state/" target="_blank" rel="noreferrer noopener">Almac Sciences</a>, a member of the&nbsp;<a href="https://www.almacgroup.com/" target="_blank" rel="noreferrer noopener">Almac Group</a>, has been awarded a Life Sciences Innovative Manufacturing Fund (LSIMF) Grant to support the expansion of its small molecule active pharmaceutical ingredients (API) manufacturing facility at its Global Headquarters in Craigavon, UK.</p>
  54.  
  55.  
  56.  
  57. <p>The grant will support the installation of the expanded facility, already under construction, which is due for completion in Summer 2025. Once complete, the 30,000 sq ft facility will support small molecule API production at 100s kg to metric tonne scale.</p>
  58.  
  59.  
  60.  
  61. <p>As&nbsp;<a href="https://www.gov.uk/government/news/360-million-to-boost-british-manufacturing-and-rd" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;by Jeremy Hunt, UK Chancellor, Almac was one of two UK pharmaceutical companies awarded the grant to support manufacturing expansion projects.&nbsp; The Department for Science Innovation and Technology (DSIT) reopened the LSIMF in 2023 to support businesses investing in manufacturing projects in the UK. Over its lifetime, the fund will provide capital grants for investments in the manufacture of human medicines (drug substance and drug product), medical diagnostics and MedTech products.</p>
  62.  
  63.  
  64.  
  65. <p>Almac Sciences has grown rapidly over the last five years and this expansion is part of a multi-million-pound investment programme to support increased client manufacturing demands.&nbsp; The first stage of Almac’s GMP facility expansion was announced late 2022 with an extension to its current GMP manufacturing facility, and warehouse expansion opened Summer 2023.&nbsp; Increased capacity for peptide API production has just been&nbsp;<a href="https://www.almacgroup.com/news/almac-group-expands-commercial-manufacturing-and-packaging-as-well-as-peptide-production-capacity/?utm_campaign=CM_Trusted_CDMO_Mar2024&amp;utm_source=CM_Trusted_CDMO_GroupHP_Banner_Mar2024&amp;utm_medium=CM_Trusted_CDMO_GroupHP_Banner_Mar2024&amp;utm_term=CM_Trusted_CDMO_GroupHP_Banner_Mar2024&amp;utm_content=CM_Trusted_CDMO_GroupHP_Banner_Mar2024" target="_blank" rel="noreferrer noopener">announced</a>, &nbsp;creating another manufacturing centre of excellence and further supporting the business’ ongoing growth plans.</p>
  66.  
  67.  
  68.  
  69. <p>Dr Daniel Bayston, VP Small Molecule API, said:&nbsp;<em>“</em><em>As a privately-owned and independent company, we are committed to&nbsp;</em><em>re-investing all our profit back into the business, allowing us to continuously innovate and expand.&nbsp;&nbsp;</em><em>We are delighted and grateful to be awarded this grant, assisting us with our ongoing expansion plans.&nbsp;</em></p>
  70.  
  71.  
  72.  
  73. <p><em>“</em><em>Almac has a strong, global reputation, built over the last 55 years as a trusted and stable CDMO partner for the world’s leading biopharma companies</em>.&nbsp;&nbsp;<em>This new manufacturing facility is critical to support the increased demand from our clients and provides us with a stronger ability to serve our global customer base advancing human health.”</em></p>
  74.  
  75.  
  76.  
  77. <p>Almac has a proven track record and expertise in small molecule and peptide API manufacturing from pre-clinical to commercial scale and has developed long-established relationships from pharma and biotech clients offering comprehensive end-to-end development and manufacturing solutions.</p>
  78.  
  79.  
  80.  
  81. <p><strong>About Almac Sciences</strong></p>
  82.  
  83.  
  84.  
  85. <p>Almac delivers services from development to commercial scale of advanced intermediates &amp; Active Pharmaceutical Ingredients (API) for small molecules (including highly potent) and peptides. We have a proven track record of saving time &amp; costs through the integration of our services &amp; application of innovative biocatalysis &amp; technology solutions. Supported by our radiolabelling, physical sciences and global analytical services teams, think Almac for drug development outsourcing solutions.</p>
  86.  
  87.  
  88.  
  89. <p><strong>About Almac Group</strong></p>
  90.  
  91.  
  92.  
  93. <p>A unique culture delivering exceptional solutions</p>
  94.  
  95.  
  96.  
  97. <p>The Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle to the life sciences sector.</p>
  98.  
  99.  
  100.  
  101. <p>These innovative services range from diagnostic services, drug product manufacture, formulation development, clinical trial supply services and technologies through to commercial-scale manufacture and distribution.</p>
  102.  
  103.  
  104.  
  105. <p>The international company is a privately owned organisation which has grown organically, now employing over 7,000 highly skilled personnel across 18 facilities including Europe, the USA and Asia.&nbsp;&nbsp;</p>
  106. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/almac-sciences-awarded-life-sciences-innovative-manufacturing-fund-grant/">ALMAC SCIENCES AWARDED LIFE SCIENCES INNOVATIVE MANUFACTURING FUND GRANT</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  107. ]]></content:encoded>
  108. </item>
  109. <item>
  110. <title>Mirum scores second FDA nod for rare liver disease drug Livmarli, this one to treat PFIC</title>
  111. <link>https://journalforclinicalstudies.com/mirum-scores-second-fda-nod-for-rare-liver-disease-drug-livmarli-this-one-to-treat-pfic/</link>
  112. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  113. <pubDate>Thu, 14 Mar 2024 09:42:12 +0000</pubDate>
  114. <category><![CDATA[Regional News]]></category>
  115. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23942</guid>
  116.  
  117. <description><![CDATA[<p>With Livmarli sales reaching $142 million during its second full year on the market, Mirum Pharmaceuticals’ rare liver disease treatment is off to a solid start in fulfilling its blockbuster potential. On Wednesday, the company took another step toward reaching that goal as it secured an FDA approval for Livmarli to treat cholestatic pruritus in patients ages 5 and older with [&#8230;]</p>
  118. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/mirum-scores-second-fda-nod-for-rare-liver-disease-drug-livmarli-this-one-to-treat-pfic/">Mirum scores second FDA nod for rare liver disease drug Livmarli, this one to treat PFIC</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  119. ]]></description>
  120. <content:encoded><![CDATA[
  121. <p>With Livmarli sales reaching $142 million during its second full year on the market, Mirum Pharmaceuticals’ rare liver disease treatment is off to a solid start in fulfilling its blockbuster potential.</p>
  122.  
  123.  
  124.  
  125. <p>On Wednesday, the company took another step toward reaching that goal as it secured an FDA approval for Livmarli to treat cholestatic pruritus in patients ages 5 and older with progressive familial intrahepatic cholestasis (PFIC).</p>
  126.  
  127.  
  128.  
  129. <p>Combined with an FDA green light in 2021 to treat cholestatic pruritus in patients ages 3 months and older with Alagille syndrome (ALGS), Livmarli (maralixibat) is now available to patients with two of the three rare pediatric liver diseases that cause pruritus, the intense itch that accompanies the genetic disorders.</p>
  130.  
  131.  
  132.  
  133. <p>“When we started out, we had this really intriguing data on PFIC with some kids that did really well,” CEO Chris Peetz said in an interview with Fierce Pharma. “It feels good to get to the finish line for one of the key things we set out to do when we founded and started Mirum.”</p>
  134.  
  135.  
  136.  
  137. <p>Founded in 2018, Mirum acquired the rights to maralixibat from Shire that same year. Shire, for its part, acquired the drug through its Lumena buyout in 2014. A decade ago, the drug was tipped as a potential blockbuster when Shire paid $260 million up front for the medicine.</p>
  138.  
  139.  
  140.  
  141. <p>Now, the FDA approval gives Foster City, California-based Mirum a potential edge in its PFIC market rivalry with Ipsen. While Ipsen’s drug Bylvay (odevixibat) was approved in 2021 for PFIC and can be given to children as young as 3 months old, Livmarli’s approval is for a higher dose, which provides superior itch relief and bile acid clearance from the liver.</p>
  142.  
  143.  
  144.  
  145. <p>“(It) comes with a great response rate and depth of response for PFIC patients,” Peetz said. “It’s a great new treatment alternative for patients that either aren’t responding or aren’t being fully controlled with current therapies.&#8221;</p>
  146.  
  147.  
  148.  
  149. <p>The next order of business for Mirum is to secure a label expansion to treat younger PFIC patients with Livmarli. The company has submitted a supplemental new drug application (sNDA) to introduce a higher concentration formula of Livmarli, which was used on some patients during the phase 3 MARCH study that paved the way for the PFIC approval. Peetz expects that green light to come later this year.</p>
  150.  
  151.  
  152.  
  153. <p>PFIC and ALGS cause a buildup of bile acid in the liver, requiring patients to undergo transplants to stay alive. Life expectancy is shorter with PFIC, with only 50% of patients making it past age 10.</p>
  154.  
  155.  
  156.  
  157. <p>Livmarli and Bylvay are both ileal bile acid transporter (iBAT) inhibitors which are taken orally. They are the only treatments approved for PFIC and ALGS, and that&#8217;s&nbsp;expected to remain the case for years. Products in the works by potential competitors remain in early stages of development.</p>
  158.  
  159.  
  160.  
  161. <p>Bylvay was developed by AstraZeneca spinout Albireo, which was bought out by Ipsen for $952 million in January of last year. Bylvay sales reached $73.8 million for the final 10 months of the year, after the Ipsen acquisition was closed.</p>
  162.  
  163.  
  164.  
  165. <p>As for competition in the third pediatric liver disease which causes pruritis, biliary atresia (BA), Ipsen is in phase 3 testing while Mirum has struggled in phase 2. In December, the company revealed the failure of the EMBARK trial in which Livmarli came up short in all primary and secondary endpoints following Kasai surgery in babies between the ages of 21 and 90 days old.</p>
  166.  
  167.  
  168.  
  169. <p>The procedure for BA patients removes diseased bile ducts at the base of the liver and re-establishes bile flow using a portion of the intestine.</p>
  170.  
  171.  
  172.  
  173. <p>“What the study showed in both groups (Livmarli and placebo) is the surgery works really well when it works, so you’re not really adding much,” Peetz explained.</p>
  174.  
  175.  
  176.  
  177. <p>Mirum has another iBAT inhibitor in the early stages of development in volixibat. The drug&nbsp;has shown “great precedent data,” in reducing bile acid&nbsp;Peetz said.</p>
  178.  
  179.  
  180.  
  181. <p>In July of last year, Mirum acquired two approved bile acid drugs from Travere Therapeutics, ponying up $210 million up front and $235 million in potential milestones for Cholbam and Chenodal. The drugs combined for sales of $103 million in 2022.</p>
  182. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/mirum-scores-second-fda-nod-for-rare-liver-disease-drug-livmarli-this-one-to-treat-pfic/">Mirum scores second FDA nod for rare liver disease drug Livmarli, this one to treat PFIC</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  183. ]]></content:encoded>
  184. </item>
  185. <item>
  186. <title>Coherus again axes staff, with 30% of roles on chopping block amid ‘sharpened focus’ on cancer drugs</title>
  187. <link>https://journalforclinicalstudies.com/coherus-again-axes-staff-with-30-of-roles-on-chopping-block-amid-sharpened-focus-on-cancer-drugs/</link>
  188. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  189. <pubDate>Thu, 14 Mar 2024 09:39:52 +0000</pubDate>
  190. <category><![CDATA[Regional News]]></category>
  191. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23940</guid>
  192.  
  193. <description><![CDATA[<p>About a year after launching a prior round of layoffs, Coherus BioSciences is again reducing its head count, this time by 30%. Coherus unveiled the latest job cuts Wednesday alongside its full-year 2023 financial results. The company was previously left with about 300 employees after a reduction last March forced 60 staffers out of the door. The latest round [&#8230;]</p>
  194. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/coherus-again-axes-staff-with-30-of-roles-on-chopping-block-amid-sharpened-focus-on-cancer-drugs/">Coherus again axes staff, with 30% of roles on chopping block amid ‘sharpened focus’ on cancer drugs</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  195. ]]></description>
  196. <content:encoded><![CDATA[
  197. <p>About a year after launching a prior round of layoffs, Coherus BioSciences is again reducing its head count, this time by 30%.</p>
  198.  
  199.  
  200.  
  201. <p>Coherus unveiled the latest job cuts Wednesday alongside its full-year 2023 financial results. The company was previously left with about 300 employees after a reduction last March forced 60 staffers out of the door.</p>
  202.  
  203.  
  204.  
  205. <p>The latest round of cuts started on March 7. Coherus aims to complete the reductions by the end of the year and save more than $25 million in annual costs.</p>
  206.  
  207.  
  208.  
  209. <p>The layoffs come as a result of a “sharpened focus” in oncology and a subsequent restructuring, Coherus said. The company in January announced that it will sell its ophthalmology franchise surrounding its Lucentis biosimilar to Sandoz for $170 million in cash. The latest job cuts include 35 employees as part of the ophthalmology divestiture.</p>
  210.  
  211.  
  212.  
  213. <p>The Lucentis copycat, branded as Cimerli, generated $52 million in fourth-quarter sales for Coherus, bringing its full-year total to $125 million.</p>
  214.  
  215.  
  216.  
  217. <p>Udenyca, the other biosimilar product in Coherus’ portfolio, references Amgen’s Neulasta. The biosim generated $36 million in the fourth quarter, down from $38 million in the same period last year, but up sequentially.</p>
  218.  
  219.  
  220.  
  221. <p>An on-body autoinjector presentation of Udenyca was approved by the FDA toward the end of 2023, and Coherus just launched that version in February. In just a few weeks, 138 accounts have already orded the on-body product, Coherus chief commerical officer&nbsp;Paul Reider&nbsp;said during a call Wednesday. Citing IQVIA data,&nbsp;Coherus said Udenyca held about 26% of the U.S. market share as of March 1.</p>
  222.  
  223.  
  224.  
  225. <p>Coherus is rebranding itself from a biosimilar developer to an innovative cancer drug player. The Junshi Biosciences-partnered PD-1 inhibitor Loqtorzi is leading that charge. After a first-in-class FDA approval in nasopharyngeal carcinoma in October, Coherus launched Loqtorzi at the beginning of 2024.</p>
  226.  
  227.  
  228.  
  229. <p>Still, the company recorded $600,000 Loqtorzi sales in the fourth quarter from wholesaler stockpiling, Reider said. The PD-1 latecomer has received payer coverage under its label for about 95% targeted patients, he added.</p>
  230.  
  231.  
  232.  
  233. <p>In the first few weeks of its launch, Coherus saw 59 targeted nasopharyngeal cancer accounts ordering Loqtorzi, and the company described the uptake as “tracking to expectations.”</p>
  234.  
  235.  
  236.  
  237. <p>To further help strengthen Coherus’ capital position, the California company has agreed with Junshi to delay and potentially reduce a $25 million milestone payment that was previously due in the first quarter.</p>
  238.  
  239.  
  240.  
  241. <p>Now, Coherus is slated to pay its Chinese partner $12.5 million by June and the rest in the first quarter of 2025, with the possibility to cut back on the second tranche by selling the drug’s Canadian rights, the company said.</p>
  242. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/coherus-again-axes-staff-with-30-of-roles-on-chopping-block-amid-sharpened-focus-on-cancer-drugs/">Coherus again axes staff, with 30% of roles on chopping block amid ‘sharpened focus’ on cancer drugs</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  243. ]]></content:encoded>
  244. </item>
  245. <item>
  246. <title>Skincare products maker Galderma gears up for long-awaited $2.6B IPO</title>
  247. <link>https://journalforclinicalstudies.com/skincare-products-maker-galderma-gears-up-for-long-awaited-2-6b-ipo/</link>
  248. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  249. <pubDate>Thu, 14 Mar 2024 09:37:56 +0000</pubDate>
  250. <category><![CDATA[Regional News]]></category>
  251. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23938</guid>
  252.  
  253. <description><![CDATA[<p>After a few holdups, Swiss skincare company Galderma is finally going public in a highly anticipated market debut that could make for one of Europe’s largest listings this year. The company is offering more than 40 million shares at a price between 49 to 53 Swiss francs, Galderma said in a release. The offer period begins today and [&#8230;]</p>
  254. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/skincare-products-maker-galderma-gears-up-for-long-awaited-2-6b-ipo/">Skincare products maker Galderma gears up for long-awaited $2.6B IPO</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  255. ]]></description>
  256. <content:encoded><![CDATA[
  257. <p>After a few holdups, Swiss skincare company Galderma is finally going public in a highly anticipated market debut that could make for one of Europe’s largest listings this year.</p>
  258.  
  259.  
  260.  
  261. <p>The company is offering more than 40 million shares at a price between 49 to 53 Swiss francs, Galderma said in a release. The offer period begins today and runs through March 20, with the first day of trading on the SIX Swiss Exchange expected on March 22.</p>
  262.  
  263.  
  264.  
  265. <p>That price range adds up to an initial public offering (IPO) size of 2.3 billion Swiss francs ($2.6 billion). Including debt, Galderma’s total market value should come out in the range of 16.4 billion francs to 17.3 billion francs ($18.69 billion to $19.72 billion), Bloomberg reports, citing people familiar with the matter.</p>
  266.  
  267.  
  268.  
  269. <p>The Wednesday offering quickly garnered demand in excess of the full deal size, according to Bloomberg. The company is backed by European private equity firm EQT, among other investors.</p>
  270.  
  271.  
  272.  
  273. <p>Last summer, Galderma picked up around $1 billion in private placement funding for newly issued private shares. At the time, the company said a public offering was the “likely next step” in its efforts to become the world’s leading dermatology company, it said at the time.</p>
  274.  
  275.  
  276.  
  277. <p>An IPO has been in the works ever since EQT bought the company, formally known as Nestle Skin Health, in 2019 for $10 billion. Galderma was formed back in 1981 as a joint venture between cosmetics maker L’Oréal and food and beverage company Nestlé upon the invention of the first Cetaphil formulation.</p>
  278.  
  279.  
  280.  
  281. <p>In 2022, volatile market conditions derailed the company’s listing plans, which were delayed again in 2023 due to a “crisis of confidence” in the banking sector, a source close to the matter told Reuters at the time.</p>
  282.  
  283.  
  284.  
  285. <p>Galderma’s IPO is reportedly expected to be one of Europe’s largest in 2024. It seems that timing could be crucial, with UBS’ global co-head of equity capital markets on Tuesday calling the current IPO market a “critical window” in an interview with CNBC.  </p>
  286.  
  287.  
  288.  
  289. <p>Led by its injectable aesthetics portfolio, the company generated more than $4 million in 2023 sales. Galderma is largely known for its leading skincare brand Cetaphil. In 2021, it made its first U.S. buy, purchasing California-based skincare company Alastin and its anti-aging products for an undisclosed price.</p>
  290.  
  291.  
  292.  
  293. <p>Last month, the FDA granted priority review to the drugmaker’s nemolizumab for prurigo nodularis. The agency previously designated the candidate as a breakthrough therapy in 2019.</p>
  294.  
  295.  
  296.  
  297. <p>Nemolizumab is a first-in-class investigational monoclonal antibody that’s meant to inhibit IL-31 signaling to relieve itching in both prurigo nodularis patients and those with moderate to severe atopic dermatitis. Regulators in Europe have also accepted the company’s filing.</p>
  298.  
  299.  
  300.  
  301. <p>Meanwhile, the company’s FDA approval bid for its injectable aesthetic RelabotulinumtoxinA was shot down late last year due to manufacturing issues.</p>
  302. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/skincare-products-maker-galderma-gears-up-for-long-awaited-2-6b-ipo/">Skincare products maker Galderma gears up for long-awaited $2.6B IPO</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  303. ]]></content:encoded>
  304. </item>
  305. <item>
  306. <title>Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec</title>
  307. <link>https://journalforclinicalstudies.com/biotech-trade-group-pledges-support-for-biosecure-act-plans-to-boot-member-wuxi-apptec/</link>
  308. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  309. <pubDate>Thu, 14 Mar 2024 09:36:10 +0000</pubDate>
  310. <category><![CDATA[Regional News]]></category>
  311. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23936</guid>
  312.  
  313. <description><![CDATA[<p>As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C. Wednesday, the Biotechnology Industry Organization (BIO) said it&#8217;s taking &#8220;important steps&#8221; to support U.S. national security. Those steps include supporting the BIOSECURE Act, which looks to prevent &#8220;adversary biotech companies&#8221; [&#8230;]</p>
  314. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/biotech-trade-group-pledges-support-for-biosecure-act-plans-to-boot-member-wuxi-apptec/">Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  315. ]]></description>
  316. <content:encoded><![CDATA[
  317. <p>As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C.</p>
  318.  
  319.  
  320.  
  321. <p>Wednesday, the Biotechnology Industry Organization (BIO) said it&#8217;s taking &#8220;important steps&#8221; to support U.S. national security. Those steps include supporting the BIOSECURE Act, which looks to prevent &#8220;adversary biotech companies&#8221; from obtaining federal funding.</p>
  322.  
  323.  
  324.  
  325. <p>BIO also plans to take steps to remove WuXi AppTec from its membership roster, the trade group said.</p>
  326.  
  327.  
  328.  
  329. <p>&#8220;Our adversaries abroad have stated that they intend to become the biotechnology center of excellence in the world,&#8221; BIO CEO John Crowley said in a statement. &#8220;America and our allies cannot let this happen. Securing and advancing our preeminence in biomanufacturing will be one key component of a multi-prong approach to secure and advance this strategic imperative in biotechnology.”</p>
  330.  
  331.  
  332.  
  333. <p>BIO&#8217;s decision comes shortly after the chairman of the House&nbsp;Select Committee on the Chinese Communist Party,&nbsp;Mike Gallagher (R-Wisc.), began raising questions about whether the group should be forced to register as a foreign agent.</p>
  334.  
  335.  
  336.  
  337. <p>Gallagher recently asked U.S. Attorney General Merrick Garland to start a review of BIO&#8217;s lobbying against the BIOSECURE Act, according to the publication.</p>
  338.  
  339.  
  340.  
  341. <p>Back in January, a bipartisan group of lawmakers began advancing legislative efforts to crack down on certain Chinese biopharma companies because of alleged ties to government officials and the Chinese military. The U.S. Senate&#8217;s homeland security committee last week voted to advance a version of the BIOSECURE Act.</p>
  342.  
  343.  
  344.  
  345. <p>As WuXi Biologics&#8217; stock price crashed in late January, the company defended itself and said the lawmakers had mischaracterized its CEO, Zhisheng Chen. More recently, WuXi AppTec said it strongly objects to &#8220;blanket allegations and preemptive actions against our company without due process.&#8221;</p>
  346.  
  347.  
  348.  
  349. <p>WuXi Biologics and WuXi AppTec are separate but associated “sister companies,” according to The Wall Street Journal.  </p>
  350.  
  351.  
  352.  
  353. <p>Besides the two CDMO giants, the BIOSECURE Act targets Chinese genomics companies BGI Group, MGI and Complete Genomics.</p>
  354. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/biotech-trade-group-pledges-support-for-biosecure-act-plans-to-boot-member-wuxi-apptec/">Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  355. ]]></content:encoded>
  356. </item>
  357. <item>
  358. <title>Evonik, looking to cut costs, shrinks workforce by 2,000 in structural overhaul</title>
  359. <link>https://journalforclinicalstudies.com/evonik-looking-to-cut-costs-shrinks-workforce-by-2000-in-structural-overhaul/</link>
  360. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  361. <pubDate>Thu, 07 Mar 2024 09:35:27 +0000</pubDate>
  362. <category><![CDATA[Regional News]]></category>
  363. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23929</guid>
  364.  
  365. <description><![CDATA[<p>Up to 2,000 Evonik workers worldwide will be laid off as the German chemicals company and contract drug manufacturer looks to cut costs. Over the last few months, the company has been “extensively” analyzing its operations, culminating in a move to a new operating structure that’s projected to be up and running by the end [&#8230;]</p>
  366. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/evonik-looking-to-cut-costs-shrinks-workforce-by-2000-in-structural-overhaul/">Evonik, looking to cut costs, shrinks workforce by 2,000 in structural overhaul</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  367. ]]></description>
  368. <content:encoded><![CDATA[
  369. <p>Up to 2,000 Evonik workers worldwide will be laid off as the German chemicals company and contract drug manufacturer looks to cut costs.</p>
  370.  
  371.  
  372.  
  373. <p>Over the last few months, the company has been “extensively” analyzing its operations, culminating in a move to a new operating structure that’s projected to be up and running by the end of 2026, it said in a press release.  The multi-year reorganization program is dubbed “Evonik Tailor Made.”</p>
  374.  
  375.  
  376.  
  377. <p>A key aspect of the redesign is aimed at trimming administrative roles that “do not directly support” Evonik’s operating business. The new “tailor made” company will have a maximum of six layers of staffers beneath the executive board.</p>
  378.  
  379.  
  380.  
  381. <p>The bulk of the 2,000 layoffs will come from the management ranks, Evonik said. Some 1,500 of the job cuts will be in the company’s home country of Germany.</p>
  382.  
  383.  
  384.  
  385. <p>All of this is designed to cut costs to the tune of around €400 million annually by 2026. </p>
  386.  
  387.  
  388.  
  389. <p>Evonik recently reported a 17% drop in full-year sales. In 2023, the company generated €15.2 billion, while 2022 saw a total haul of €18.4 billion, according to the recent financial report.</p>
  390.  
  391.  
  392.  
  393. <p>The decline is not the result of “cyclical fluctuations,” but instead can be chalked up to “massive, consequential changes of our economic environment,” CEO Christian Kullmann said in Evonik’s release. &#8220;We are addressing this challenge with the &#8216;Evonik Tailor Made&#8217; program which will change our organizational structure for good.&#8221;</p>
  394.  
  395.  
  396.  
  397. <p>Evonik&#8217;s healthcare arm offers CDMO services ranging from early development to commercial manufacturing, according to its website. The company also works with medical device manufacturers.</p>
  398.  
  399.  
  400.  
  401. <p>In recent years, Evonik has opened a new lipid manufacturing plant in Hanau, Germany, and announced plans to build another in Lafayette, Indiana.</p>
  402. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/evonik-looking-to-cut-costs-shrinks-workforce-by-2000-in-structural-overhaul/">Evonik, looking to cut costs, shrinks workforce by 2,000 in structural overhaul</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  403. ]]></content:encoded>
  404. </item>
  405. <item>
  406. <title>WHO flags increasing resistance to GSK&#8217;s HIV med Tivicay in some countries</title>
  407. <link>https://journalforclinicalstudies.com/who-flags-increasing-resistance-to-gsks-hiv-med-tivicay-in-some-countries/</link>
  408. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  409. <pubDate>Thu, 07 Mar 2024 09:33:36 +0000</pubDate>
  410. <category><![CDATA[Regional News]]></category>
  411. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23927</guid>
  412.  
  413. <description><![CDATA[<p>GSK&#8217;s antiretroviral HIV medicine Tivicay (dolutegravir) has been recommended by the World Health Organization (WHO) since 2018 as a preferred treatment for the virus. Now, the same agency is flagging increasing resistance to the drug in some countries. WHO regularly tracks the good and bad news in HIV drug resistance through its HIV Drug Resistance [&#8230;]</p>
  414. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/who-flags-increasing-resistance-to-gsks-hiv-med-tivicay-in-some-countries/">WHO flags increasing resistance to GSK&#8217;s HIV med Tivicay in some countries</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  415. ]]></description>
  416. <content:encoded><![CDATA[
  417. <p>GSK&#8217;s antiretroviral HIV medicine Tivicay (dolutegravir) has been recommended by the World Health Organization (WHO) since 2018 as a preferred treatment for the virus. Now, the same agency is flagging increasing resistance to the drug in some countries.</p>
  418.  
  419.  
  420.  
  421. <p>WHO regularly tracks the good and bad news in HIV drug resistance through its HIV Drug Resistance report. This year’s report showed high levels of HIV viral load suppression in populations receiving Tivicay-based therapy, but it’s not all good news.</p>
  422.  
  423.  
  424.  
  425. <p>The organization cited surveys from four countries that suggest rates of resistance to Tivicay are “exceeding levels observed in clinical trials,” according to a WHO press release.</p>
  426.  
  427.  
  428.  
  429. <p>The surveys showed the rate of resistance to the drug at 3.9% to 8.6% among patients with uncontrolled viral loads in Uganda, Ukraine and Malawi. Another survey from Mozambique&nbsp;showed a&nbsp;whopping&nbsp;19.6% rate of resistance in people with prior treatment experience who switched to a Tivicay-containing therapy while still having high viral loads.</p>
  430.  
  431.  
  432.  
  433. <p>Importantly, the analysis focuses on &#8220;subgroups whose virus was not suppressed and the data does not indicate that resistance was prevalent in the overall population,&#8221; a GSK spokesperson said in an emailed statement.</p>
  434.  
  435.  
  436.  
  437. <p>In addition, the data are not fully reflective of the global situation; only a few countries have reported survey data to WHO, the agency said.</p>
  438.  
  439.  
  440.  
  441. <p>“This medicine has demonstrated strong efficacy, safety and a high barrier to resistance in treating people living with HIV-1,” GSK&#8217;s spokesperson added.</p>
  442.  
  443.  
  444.  
  445. <p>Still, the evidence &#8220;underscores the necessity for increased vigilance and intensified efforts to optimize the quality of HIV care delivery,” WHO&#8217;s global HIV, hepatitis and STI program head, Meg Doherty, M.D., Ph.D., said in a statement.</p>
  446.  
  447.  
  448.  
  449. <p>Tivicay earned its WHO endorsement due to its effectiveness, easiness to take and lack of side effects compared with other drugs.</p>
  450. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/who-flags-increasing-resistance-to-gsks-hiv-med-tivicay-in-some-countries/">WHO flags increasing resistance to GSK&#8217;s HIV med Tivicay in some countries</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  451. ]]></content:encoded>
  452. </item>
  453. <item>
  454. <title>Growing Almac boosts capacity for manufacturing peptides and packaging commercial products</title>
  455. <link>https://journalforclinicalstudies.com/growing-almac-boosts-capacity-for-manufacturing-peptides-and-packaging-commercial-products/</link>
  456. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  457. <pubDate>Thu, 07 Mar 2024 09:32:09 +0000</pubDate>
  458. <category><![CDATA[Regional News]]></category>
  459. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23925</guid>
  460.  
  461. <description><![CDATA[<p>In its continuing expansion blitz, Almac has completed new two facilities at its headquarters in Craigavon, Northern Ireland, which will expand the capacity of the CDMO to package commercial products and to manufacture peptides. In one expansion project, the 55-year-old private company has finished a 32,000-square-foot facility that increases its ability to manufacture and package sachet drug [&#8230;]</p>
  462. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/growing-almac-boosts-capacity-for-manufacturing-peptides-and-packaging-commercial-products/">Growing Almac boosts capacity for manufacturing peptides and packaging commercial products</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  463. ]]></description>
  464. <content:encoded><![CDATA[
  465. <p>In its continuing expansion blitz, Almac has completed new two facilities at its headquarters in Craigavon, Northern Ireland, which will expand the capacity of the CDMO to package commercial products and to manufacture peptides.</p>
  466.  
  467.  
  468.  
  469. <p>In one expansion project, the 55-year-old private company has finished a 32,000-square-foot facility that increases its ability to manufacture and package sachet drug products, Almac said in a Wednesday release. The site features large-scale manufacturing suites and quality control lab testing.&nbsp;&nbsp;</p>
  470.  
  471.  
  472.  
  473. <p>Sachet drugs are precisely packaged to enable accurate dosing while allowing portability.</p>
  474.  
  475.  
  476.  
  477. <p>Almac also has built a 28,000-square-foot facility that will more than double its peptide API manufacturing capacity to meet the growing demand for clinical development and commercial products.&nbsp;</p>
  478.  
  479.  
  480.  
  481. <p>“Our new peptide API manufacturing facility will significantly grow our portfolio of client APIs and is the latest stage of a wider development and manufacturing expansion initiative for Almac Sciences,” Graeme McBurney, Almac’s chief operating officer, said in a release.</p>
  482.  
  483.  
  484.  
  485. <p>In 2022, the company announced an investment of 200 million pounds ($247 million) to “meet increased client demand” worldwide over the next three years.</p>
  486.  
  487.  
  488.  
  489. <p>Then, five months ago, the company declared that 80 million pounds ($102 million) was designated to add 140,000 square feet at headquarters and house an additional 550 employees. The company&#8217;s head count totals more than 7,000.</p>
  490.  
  491.  
  492.  
  493. <p>Almac also is growing its presence in the U.S. In 2022, the company pegged $93.5 million for expansion of its North American headquarters in Souderton, Pennsylvania. The expansion is adding 100,000 square feet to the 246,000-square-foot facility, paving the way for the addition of 355 new staffers.</p>
  494.  
  495.  
  496.  
  497. <p>Among the products Almac has helped launch over the last two years are Agios’ Pyrukynd, Sanofi&#8217;s Tzield and PTC’s gene therapy Upstaza. The company also has a partnership with AstraZeneca.</p>
  498. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/growing-almac-boosts-capacity-for-manufacturing-peptides-and-packaging-commercial-products/">Growing Almac boosts capacity for manufacturing peptides and packaging commercial products</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  499. ]]></content:encoded>
  500. </item>
  501. <item>
  502. <title>AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ</title>
  503. <link>https://journalforclinicalstudies.com/astrazeneca-pledges-650m-in-uk-investments-to-boost-vaccine-capabilities-expand-near-hq/</link>
  504. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  505. <pubDate>Thu, 07 Mar 2024 09:30:24 +0000</pubDate>
  506. <category><![CDATA[Regional News]]></category>
  507. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23923</guid>
  508.  
  509. <description><![CDATA[<p>AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. AZ plans to invest £650 million ($827 million) in the U.K., Chancellor Jeremy Hunt announced Wednesday. The money will be divided into two tranches. About £450 [&#8230;]</p>
  510. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/astrazeneca-pledges-650m-in-uk-investments-to-boost-vaccine-capabilities-expand-near-hq/">AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  511. ]]></description>
  512. <content:encoded><![CDATA[
  513. <p>AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country.</p>
  514.  
  515.  
  516.  
  517. <p>AZ plans to invest £650 million ($827 million) in the U.K., Chancellor Jeremy Hunt announced Wednesday.</p>
  518.  
  519.  
  520.  
  521. <p>The money will be divided into two tranches. About £450 million will go to AZ’s manufacturing site in Speke, Liverpool, to build out the company’s R&amp;D and manufacturing capabilities for vaccines.</p>
  522.  
  523.  
  524.  
  525. <p>The remaining £200 million will be used to expand AZ’s presence near its global headquarters in Cambridge. The plan includes a facility that will house around 1,000 employees.</p>
  526.  
  527.  
  528.  
  529. <p>AZ’s spending is contingent upon a mutual agreement&nbsp;with the U.K. government and undisclosed&nbsp;&#8220;third parties,&#8221; as well as the clearance of regulatory hurdles, according to&nbsp;Wednesday’s press release.&nbsp;</p>
  530.  
  531.  
  532.  
  533. <p>“AstraZeneca’s planned investment would enhance the U.K.’s pandemic preparedness and demonstrates our ongoing confidence in U.K. life sciences,” Soriot said in a statement.</p>
  534.  
  535.  
  536.  
  537. <p>The investment will help the Liverpool site&nbsp;respond to the threat of future pandemics and meet the growing demand for vaccines, an AZ spokesperson told Fierce Pharma. The exact vaccines to be made there will be determined as the company’s pipeline progresses, the spokesperson added.</p>
  538.  
  539.  
  540.  
  541. <p>As for the Cambridge site, the facility was already included in development plans for AZ’s newly opened innovation center. The site will primarily support commercial and regular business operations, the spokesperson said.&nbsp;</p>
  542.  
  543.  
  544.  
  545. <p>AZ’s refreshed commitment to the U.K. comes about a year after Soriot blamed the country’s “discouraging” tax rate for his company’s decision to build a $400 million active pharmaceutical ingredient facility in Ireland at the Alexion campus in Dublin.</p>
  546.  
  547.  
  548.  
  549. <p>“We’re very committed [to the U.K.], but we need to see also supporting policies for the whole industry,” Soriot said at the time.</p>
  550.  
  551.  
  552.  
  553. <p>In his statement Wednesday, U.K. Chancellor Hunt touted the U.K. as “one of the most competitive business tax regimes of any major economy.”</p>
  554.  
  555.  
  556.  
  557. <p>“AstraZeneca’s investment plans are a vote of confidence in the attractiveness of U.K. as a life sciences superpower and strengthen our resilience for future health emergencies,” Hunt added.</p>
  558.  
  559.  
  560.  
  561. <p>Late last year, amid tensions between the industry and government, U.K. officials and industry representatives reached an accord on a voluntary drug rebate scheme. Soon after, though, the Association of the British Pharmaceutical Industry (ABPI) lashed out at a separate statutory scheme that’s designed to control drug costs.</p>
  562.  
  563.  
  564.  
  565. <p>At that time, the ABPI said the rebate levels included in the statutory program “have damaged the U.K.’s international standing with global life science companies.&#8221;</p>
  566.  
  567.  
  568.  
  569. <p>Nevertheless, the U.K. remains AZ’s home base. The drugmaker last year opened its flagship £1 billion&nbsp;R&amp;D site in Cambridge, Soriot noted during a press briefing in February. The chief executive also pointed to the work the British government has done to facilitate clinical trials, as well as tax policies that are “helping incentivize companies to invest.”</p>
  570.  
  571.  
  572.  
  573. <p>There’s still more to do, but the U.K. is moving in the right direction toward offering a better environment for the life sciences field, he said.</p>
  574.  
  575.  
  576.  
  577. <p>In addition to Liverpool, AZ will also open a new manufacturing facility to make a cancer drug at its Macclesfield manufacturing and development campus later this year as part of a £380 million investment, according to the U.K. government.</p>
  578.  
  579.  
  580.  
  581. <p>For a global company like AZ, manufacturing investments are certainly bound to be scattered in different parts of the world. Last month, AZ announced it will plow $300 million into a new facility in Rockville, Maryland, for its cell therapy programs.</p>
  582.  
  583.  
  584.  
  585. <p>At the same time, the firm is investing in a facility in the Chinese city of Qingdao to manufacture inhaled medicines.</p>
  586.  
  587.  
  588.  
  589. <p>“We continue to invest in manufacturing around the world, and each time we look at, what is the environment,” Soriot said during the February press conference.</p>
  590.  
  591.  
  592.  
  593. <p>“More often it’s more general environment in terms of, is the ecosystem attractive for investment in innovation?” Soriot explained. “Is it a country where there is clearly an understanding that incentives have to be created through appropriate tax policies, but also importantly, access to innovation?”</p>
  594. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/astrazeneca-pledges-650m-in-uk-investments-to-boost-vaccine-capabilities-expand-near-hq/">AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  595. ]]></content:encoded>
  596. </item>
  597. <item>
  598. <title>SGS LABORATORY IN FAIRFIELD, NJ, USA DEMONSTRATES ITS COMMITMENT TO TESTING AND CALIBRATION EXCELLENCE WITH NEW ISO/IEC 17025:2017 CERTIFICATION</title>
  599. <link>https://journalforclinicalstudies.com/sgs-laboratory-in-fairfield-nj-usa-demonstrates-its-commitment-to-testing-and-calibration-excellence-with-new-iso-iec-170252017-certification/</link>
  600. <dc:creator><![CDATA[Mark Barker]]></dc:creator>
  601. <pubDate>Wed, 06 Mar 2024 11:50:10 +0000</pubDate>
  602. <category><![CDATA[Regional News]]></category>
  603. <guid isPermaLink="false">https://journalforclinicalstudies.com/?p=23920</guid>
  604.  
  605. <description><![CDATA[<p>The world’s leading testing, inspection and certification company announced today that its Fairfield laboratory has earned its ISO/IEC 17025:2017 certification. The globally recognized accreditation, together with Fairfield’s extensive experience as a GMP FDA approved laboratory, allows SGS to clearly demonstrate the reliability of its drug development testing results, as well as the integrity, competence and [&#8230;]</p>
  606. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sgs-laboratory-in-fairfield-nj-usa-demonstrates-its-commitment-to-testing-and-calibration-excellence-with-new-iso-iec-170252017-certification/">SGS LABORATORY IN FAIRFIELD, NJ, USA DEMONSTRATES ITS COMMITMENT TO TESTING AND CALIBRATION EXCELLENCE WITH NEW ISO/IEC 17025:2017 CERTIFICATION</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
  607. ]]></description>
  608. <content:encoded><![CDATA[
  609. <p><strong>The world’s leading testing, inspection and certification company announced today that its Fairfield laboratory has earned its ISO/IEC 17025:2017 certification.</strong></p>
  610.  
  611.  
  612.  
  613. <p></p>
  614.  
  615.  
  616. <div class="wp-block-image">
  617. <figure class="aligncenter size-large"><img decoding="async" width="1024" height="768" src="https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Laboratory-1024x768.jpg" alt="" class="wp-image-23918" srcset="https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Laboratory-1024x768.jpg 1024w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Laboratory-300x225.jpg 300w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Laboratory-768x576.jpg 768w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Laboratory-1536x1152.jpg 1536w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Laboratory-2048x1536.jpg 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></div>
  618.  
  619.  
  620. <p></p>
  621.  
  622.  
  623.  
  624. <p>The globally recognized accreditation, together with Fairfield’s extensive experience as a GMP FDA approved laboratory, allows SGS to clearly demonstrate the reliability of its drug development testing results, as well as the integrity, competence and overall quality of the Fairfield laboratory’s practices.<br><br><strong>A highly respected quality certification</strong></p>
  625.  
  626.  
  627.  
  628. <p>ISO/IEC 17025:2017 is a globally recognized quality management standard for testing and calibration laboratories. ISO 17025 certifies technical competence in lab testing and calibration services.</p>
  629.  
  630.  
  631.  
  632. <p>The accreditation covers a wide range of chemical testing and in vitro cytotoxicity (IVT) testing for finished medical devices, medical device components, drugs and packaging.</p>
  633.  
  634.  
  635.  
  636. <p>The chemical testing includes a wide range of tests, namely:&nbsp;</p>
  637.  
  638.  
  639.  
  640. <ul>
  641. <li>Extractables and Leachables (E&amp;L);</li>
  642.  
  643.  
  644.  
  645. <li>Analysis of medical devices through Non-Volatile Residue (NVR) analysis;</li>
  646.  
  647.  
  648.  
  649. <li>Liquid chromatography (LC-MS/UV), headspace (HS) or direct-injection gas chromatography (GC-FID/MS) and inductively coupled plasma mass spectrometry (ICPMS).</li>
  650. </ul>
  651.  
  652.  
  653.  
  654. <p>All of these tests are assessed per ISO 10993-18 and ISO 10993-12, except for the IVT test which is performed per ISO 10993-5 and USP &lt;87>.</p>
  655.  
  656.  
  657.  
  658. <p></p>
  659.  
  660.  
  661. <div class="wp-block-image">
  662. <figure class="aligncenter size-full"><img decoding="async" width="800" height="800" src="https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Niveen-Head-Shot.jpg" alt="" class="wp-image-23919" srcset="https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Niveen-Head-Shot.jpg 800w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Niveen-Head-Shot-300x300.jpg 300w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Niveen-Head-Shot-150x150.jpg 150w, https://journalforclinicalstudies.com/wp-content/uploads/2024/03/SGS_Niveen-Head-Shot-768x768.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /></figure></div>
  663.  
  664.  
  665. <p></p>
  666.  
  667.  
  668.  
  669. <p>“This certification is a testament to the expertise, attention to detail and dedicated support that our Fairfield laboratory offers SGS customers every day,” said Dr. Niveen Mulholland, Vice President, Life Science North America at SGS. “We’re delighted to see their outstanding work recognized in this way. This third-party accreditation provides customers with a level of comfort that certified laboratories produce the highest level of accurate and reliable results.”</p>
  670.  
  671.  
  672.  
  673. <p>For more information on the ISO/IEC 17025:2017 certification and its role in ensuring quality service for drug development teams, visit the&nbsp;<a href="https://www.iso.org/standard/66912.html" target="_blank" rel="noreferrer noopener">ISO website</a>.</p>
  674.  
  675.  
  676.  
  677. <p>To find out more about the Fairfield laboratory and its offerings for SGS customers, please contact:</p>
  678.  
  679.  
  680.  
  681. <p>Patrick Kelley<br>Sr. Director, Business Development, SGS Health Science<br>805-405-5272</p>
  682.  
  683.  
  684.  
  685. <h3 class="wp-block-heading"><a></a>About SGS Health Science</h3>
  686.  
  687.  
  688.  
  689. <h3 class="wp-block-heading"><strong>SGS Health Science is a division of SGS, the world’s leading testing, inspection and certification company. Its global network of analytical testing, formulation, clinical research and clinical manufacturing solutions offer a wide range of integrated services and expertise across America, Europe and Asia-Pacific.</strong></h3>
  690.  
  691.  
  692.  
  693. <p>SGS Health Science experts are ready to support customers throughout the development and commercial manufacture of their drug products, helping ensure the delivery of safe, effective and compliant medicines to global markets.<br><br><strong>About SGS</strong></p>
  694.  
  695.  
  696.  
  697. <p>We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.</p>
  698. <p>The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sgs-laboratory-in-fairfield-nj-usa-demonstrates-its-commitment-to-testing-and-calibration-excellence-with-new-iso-iec-170252017-certification/">SGS LABORATORY IN FAIRFIELD, NJ, USA DEMONSTRATES ITS COMMITMENT TO TESTING AND CALIBRATION EXCELLENCE WITH NEW ISO/IEC 17025:2017 CERTIFICATION</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.</p>
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