Tuesday, March 31, 2026

 

 

FDA Gives Teva OK for Prolia Biosimilar, Alongside Xolair Biosimilar Review

(3/30, Sandra Levy, Drug Store News) ...Teva announced three milestones in its biosimilar portfolio, which the company said demonstrates continued momentum in the advancement of its Pivot to Growth strategy. The Food and Drug Administration has approved Ponlimsi (denosumab-adet), which is a biosimilar to Amgen's Prolia. Additionally, Teva's applications for a proposed biosimilar candidate to Novartis AG's Xolair (omalizumab) have been accepted by both the FDA and the European Medicines Agency... Full | Seeking Alpha

 

FDA Approves Denosumab-Adet as Biosimilar to Prolia

(3/30, Ashley Gallagher, MA, Drug Topics) ..."Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we're building a highly competitive portfolio," Steffen Nock, PhD, head of biosimilars research and development and chief science officer at Teva, said in a news release... Full | MPR

 

Teva Receives FDA Approval for Prolia Biosimilar

(3/31, Salong Debbarma, Pharmaceutical Technology) ...Teva biosimilars R&D head and chief science officer Steffen Nock said..."With a strong early-stage pipeline and a suite of advancing programmes, we see significant potential to address patient needs and fuel Teva's long-term growth."... Full

 

FDA vs. EMA Biosimilar Approvals, an Update

(3/30, Stanton Mehr, Biosimilars Review & Report) ...In other Teva news, the company also announced that the FDA has accepted its 351(k) application for TEV-45779, its omalizumab biosimilar. An FDA decision is expected in Q1 2027 on this third Xolair biosimilar product... Full

 

Blackstone Closes Record $6.3b Life Sciences Fund

(3/30, Will Maddox, Fierce Biotech) ...Blackstone reported that BLXS investments have achieved an 86% approval success rate for phase 3 assets. Over the past 12 months, the platform has made $2 billion in new investments, including $400 million to support Teva's Sanofi-partnered IBD drug duvakitug and $700 million for Merck's antibody-drug conjugate sacituzumab tirumotecan... Full

 

Blackstone Raises $6.3b Life Sciences Fund in Record Fundraising Haul

(3/30, Kyle LaHucik, Endpoints News) ...Its larger pool of capital means Blackstone can commit hundreds of millions of dollars to the development of assets, such as Moderna's influenza work, Merck's antibody-drug conjugate known as sac-TMT, or Teva and Sanofi's anti-TL1A. Merck licensed that drug from China-based Kelun-Biotech, and Blackstone Life Sciences' investment there was its first China deal, [Nick Galakatos, global head of Blackstone Life Sciences,] said... Sub. Req’d

 

 

White House Overtures to Pharma on New Pricing Talks Met With Frosty Reception

(3/30, Max Bayer, Endpoints News) ...Attempts by the White House to curry industry support for legislation that would codify last year's voluntary drug pricing deals are being ignored by some drugmakers who believe there's little to negotiate...Multiple large drugmakers told Endpoints News on condition of anonymity that they weren't supportive of the effort and have held off from engaging with the administration... Sub. Req'd

 

Bristol Myers Squibb Adding 3 Medications on TrumpRx

(3/30, Edward Lawrence, Fox Business) ...Bristol Myers Squibb is launching three medications on TrumpRx.gov on Monday, FOX Business has learned...The three prescription drugs will each be offered at deep discounts that range from 40% to 90% off the retail price. The Princeton, New Jersey-based company's drug Sotyktu retails for $7,135.55 and will be offered through TrumpRx.gov for $743. That represents a 90% discount off what patients have been paying... Full

 

FOCUS-Drugmakers Delay Some European Launches With a Wary Eye on Trump's Pricing Policies

(3/31, Maggie Fick, Bhanvi Satija, Dominique Patton, Reuters) ...Drugmakers are delaying launches of some new medicines in Europe as the industry grapples with U.S. pressure and pricing policy shifts from President Donald Trump, according to executives, an industry trade group and data shared with Reuters... Sub. Req'd

 

US Urges Court to Toss AstraZeneca's Drug Price Negotiation Suit

(3/30, Nyah Phengsitthy, Bloomberg Law) ...As a threshold matter, the US District Court for the District of Maryland "lacks statutory subject-matter jurisdiction over this suit," the Department of Justice, representing the CMS, said in a March 27 motion. "Both the plain text of the IRA and case law analyzing similar bars to judicial review in other parts of the Medicare statute confirm that this Court cannot ignore Congress's choice to explicitly preclude judicial review," the DOJ said... Sub. Req’d

 

US Supply Chain Challenges Increase In Shadow Of Iran War

(3/31, Dave Wallace, Generics Bulletin) ...Speaking to Generics Bulletin, the US Association for Accessible Medicines has warned that supply-chain challenges are on the rise, adding that while so far the off-patent industry has been working hard to deliver medicines and avoid supply shortages, availability could become compromised if the war continues... Global Sub. Full

 

Policymakers Shouldn't Double Down on The IRA's Flaws With MFN

(3/30, Matthew Norawong, PhRMA Blog) ...Spoiler alert: it's not going well. Investments are dropping, clinical trials are slowing and patients aren't seeing the benefits they were promised. Three takeaways from the IRA that show price setting doesn't work... Full

 

The Likely Evolution of Generic Players in The U.S. Life Sciences Market

(3/30, Rahul Mittal, PharmaLive) ...The next phase of generics will look very different from the last. The defining question is no longer how quickly manufacturers can match patents with filings, but how reliably they can convert market entry into sustained access and economic viability... Full

 

The FDA's Shame Game

(3/30, Kelly Bilodeau, PharmaVoice) ...FDA's ramped up pressure on pharma companies is being greeted with similar caution. Pharma giants generally support transparency but want the option to redact sensitive commercial details, Abrams said... Full

 

MedShadow's Investigating Generics Series Selected as a Finalist at the 18th Annual Shorty Awards

(3/30, Lisa Jaycox, MedShadow Foundation) ...MedShadow Foundation has been shortlisted for the 18th Annual Shorty Awards for Investigating Generics in the Strategy and Engagement: On a Shoestring category, showcasing the creativity and effectiveness of its work in digital media... Full

 

Investigating Generics: FDA Records Show Drug Companies Are Skipping Safety Checks

(3/30, Emma Yasinski, MedShadow Foundation) ...Current inspection data suggests that relying solely on manufacturers to police themselves leaves critical gaps in oversight. MedShadow has called for reforms to improve drug quality and safety. One possible solution is to require an independent third party, such as an academic lab, government lab, or private company, to chemically analyze a sample from each batch of drug before it is released to consumers... Full

 

Scott Presses FDA On Expedited Review Of China-Linked Biotech

(3/30, James Jarvis, Inside Health Policy) ...Sen. Rick Scott (R-FL) is pressing HHS Secretary Robert F. Kennedy Jr. and top FDA officials for answers about the agency's decision to grant expedited regulatory designations to a China-based biotech firm with alleged ties to the Chinese government, warning the move could pose risks to patient data, clinical trial oversight and national security... Sub. Req'd

 

IU Research Informs Federal Drug Safety Bill to Clearly Label Drugs With Manufacturing Details

(3/31, Georga Vlahakis, Indiana University) ...Ball and his colleague's research found that generic drugs made in India were linked to significantly more "severe adverse events" than equivalent generic drugs produced in the U.S. These adverse events included hospitalization, disability and, in a few cases, death... A remedy for the increased offshoring of drug manufacturing - and associated quality risk - that Ball and his co-authors proposed in their upcoming paper is to provide country of origin and a quality rating on the drug's label. This is what the CLEAR LABELS Act would require... Full

 

FDA Agrees To Craft Ad Comm Conflict-Of-Interest Guide After GAO Press

(3/30, James Jarvis, Inside Health Policy) ...FDA told Congress' oversight arm it will craft final guidance laying out its conflict-of-interest policies for agency advisory committees, responding to pressure from the Government Accountability Office. FDA's agreement, albeit with no timeline attached, comes as the agency faces criticism for its lack of transparency on the issue... Sub. Req'd

 

AbbVie, Novartis Sue Over New WA 340B Law That Blocks Pharma Claims Reqs

(3/30, Jessica Karins, Inside Health Policy) ...Novartis and AbbVie are suing the state of Washington over a new law that would block manufacturers from restricting pharmacy access or requiring claims access as conditions for hospitals to benefit from 340B drug discounts. The lawsuits were filed last week the same day Gov. Bob Ferguson, a Democrat, signed the bill... Sub. Req'd

 

 

Sandoz Partners With Samsung Bioepis to Develop Up to Five Biosimilars

(3/31, Lucy Batizovszky, PMLiVE) ...Sandoz has partnered with Samsung Bioepis to broaden patient access to high-quality biosimilar medicines worldwide. The agreement allows the companies to work together on up to five biosimilar assets. The first will be a vedolizumab biosimilar, which is in early-stage development... Full

 

Celltrion Launches Omalizumab Biosimilar Omlyclo in Brazil, Secures Early Tender Win

(3/31, Lee Han-soo, Korea Biomedical Review) ...Celltrion has launched its omalizumab biosimilar Omlyclo in Brazil, securing an early state government tender as it pushes into Latin America's largest pharmaceutical market. The company said Tuesday it recently held a launch event for Omlyclo in Brazil, where it has already won a state tender in Santa Catarina, positioning the product for initial market penetration... Full

 

Regulatory Hold For China's Most Advanced Domestic Semaglutide Biosimilar Over 'Data Protection'

(3/31, Dexter Jie Yan, Pink Sheet) ...China's most advanced biosimilar referencing Novo Nordisk's blockbuster GLP-1 receptor agonist drugs Ozempic/Wegovy (semaglutide) has been suspended from regulatory review and approval in the country, due to "data protection provisions under agreements with governments of other countries," developer Hangzhou Jiuyuan Genetic Biopharmaceutical (Jiuyuan Gene) disclosed in its annual results on Mar. 30... Global Sub. Full

 

Lupin Gets Tentative Nod From USFDA for Generic Sugammadex Injection

(3/31, PTI) ...Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of Sugammadex injection used for reversing the effects of muscle relaxants given during surgery. The tentative approval by the US [FDA] is for the abbreviated new drug application for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing... Full

 

Alembic Pharmaceuticals Receives USFDA Final Approval For Paroxetine Extended Release Tablets

(3/31, BWHealthcareworld.com) ...Alembic Pharmaceuticals (Alembic) has received final approval from the US [FDA] for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg... Full

 

 

Eli Lilly to Buy Centessa for $6.3B to Get Sleep Disorder Drug

(3/31, Kyle LaHucik, Endpoints News) ...The pharma giant will devote $6.3 billion upfront and up to $1.5 billion in contingent value rights to acquire Centessa and its orexin receptor 2 (OX2R) agonists. The deal is for $38 per share $CNTA upfront in cash. It also includes multiple CVRs upon certain regulatory approvals. Centessa's lead drug, called cleminorexton (ORX750), is in Phase 2a testing for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia... Sub. Req’d

 

Biogen to Acquire Apellis for $5.6B

(3/31, Elizabeth Cairns, Endpoints News) ...The deal will allow Biogen to get hold of the kidney disease drug Empaveli and the eye disease therapy Syfovre, both of which are forecast to grow rapidly. Biogen said the deal will begin to add to its earnings starting in 2027... Sub. Req’d

 

Lupin Takes a Bigger Bite of Innovation

(3/30, PT Jyothi Datta, The Hindu BusinessLine) ...It's Friday the 13th — a day some consider ominous, but not Lupin Managing Director Nilesh Gupta. Dressed in a traditional black kurta, he walks in for our meeting on the ninth floor of the company's Mumbai headquarters — where he and his sister Vinita, the Chief Executive Officer, have their offices — to discuss the road ahead for the home-grown estimated Rs. 22,707-crore multinational drugmaker... Full

 

Viatris Bets On Value-Added Medicines To Boost Growth

(3/30, Dean Rudge, Generics Bulletin) ...Management described growth as being driven by both a consistent base of $450m-$550m in annual revenue from its generics and R&D engine, alongside incremental upside from value-added and innovative products...The company's generics and established brands platform continues to serve as a "powerful cash-generating engine," according to the firm, with management expecting stable performance supported by portfolio renewal, complex generics expansion and targeted commercial execution... Global Sub. Full

 

Canadian Generic Drugmaker Apotex Switches CEO

(3/31, Tim Kiladze, The Globe and Mail) ...Jeff Watson, who led Apotex from 2018 to 2023 and was named the company's leader in the wake of founder Barry Sherman's death, will replace Allan Oberman, who is departing from the role. Mr. Watson has been on the company's board of directors since Mr. Oberman became CEO in 2023... Full

 

Merck’s Cholesterol Drug Meets Main Goal in Head-to-Head Trial

(3/30, Christy Santhosh, Reuters) ...The eight-week trial compared enlicitide directly with existing oral non-statin therapies, bempedoic acid and ezetimibe, in patients receiving background statin treatment. In the head-to-head trial, the drug reduced LDL cholesterol by up to 64.6% from baseline when added to background treatment with a statin... Full

 

Novo Bets Subscriptions Will Offer an Edge in Obesity Drug Sales

(3/31, Madison Muller, Bloomberg) ...Starting on Tuesday, patients who pay in cash can sign up for a three-, six- or 12-month subscription through select telehealth partners, including Ro, Weight Watchers and LifeMD Inc. Patients who sign up for a 12-month subscription will pay just $249 a month for the Wegovy pen, undercutting Lilly's lowest monthly price by about $50... Sub. Req’d

 

The Top 10 Pharma R&D Budgets of 2025

(3/30, Darren Incorvaia, Fierce Biotech) ...Every company in the business, whether small, large or in-between, has had to think hard about how to respond to this swirling turmoil. For most of the Big Pharmas that made our list of the top 10 R&D budgets of 2025, that meant taking a hard look at the very spending that earned them their spot... Full

 

 

Regulatory Hold For China's Most Advanced Domestic Semaglutide Biosimilar Over ‘Data Protection'

(3/31, Dexter Jie Yan, Pink Sheet) ...China's most advanced biosimilar referencing Novo Nordisk's blockbuster GLP-1 receptor agonist drugs Ozempic/Wegovy (semaglutide) has been suspended from regulatory review and approval in the country, due to "data protection provisions under agreements with governments of other countries," developer Hangzhou Jiuyuan Genetic Biopharmaceutical (Jiuyuan Gene) disclosed in its annual results on Mar. 30... Global Sub. Full

 

UK Patients Told 'Not to Worry' Over Medicine Supply Amid Iran War

(3/31, Ella Pickover, Independent) ...A Government spokesperson said: "There are currently no reported medicine shortages as a result of conflict in the Middle East...We continue to monitor the situation closely for any impacts on the medical supply chain..."... Full

 

EMA Details Data Quality Considerations When Using RWD

(3/30, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) has finalized a document with recommendations on using the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) when submitting premarket applications that include real-world data. The agency said the recommendations in the document are intended to help regulators evaluate the quality of data used to assess real-world evidence supporting marketing applications... Full

 

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