Friday, February 7, 2025

Cipla Maintains Core Growth Despite US Challenges

(2/6, Adam Zamecnik, Generics Bulletin) ...While meeting and even exceeding some revenue estimates, Cipla's results for the third quarter of its 2025 fiscal year were met with some questions in the industry over delays in its upcoming drug launches. In its third quarter, Cipla reported income from operations of INR70.7bn ($807m), which marked an 8% year-over-year increase. This figure either beat or was in line with the estimates of select industry analysts... Global Sub. Full

India's Aurobindo Pharma Posts Third-Quarter Profit Drop On Higher Expenses

(2/6, Kashish Tandon, Reuters) ...The company's consolidated net profit fell 10% to 8.46 billion rupees ($96.6 million) in the quarter ended Dec. 31...Significant revenue at most of India's generic drugmakers comes from the U.S. and fierce competition in North America's generic drugs market has been weighing on the firms' margins... Full

Wockhardt Swings to Profit in Q3, Reports Multifold Growth in EBITDA

(2/7, Sheersh Kapoor, CNBC TV-18) ...Wockhardt Ltd. swung to a net profit of 20 crore in Q3FY25, a sharp recovery from the 86 crore loss reported in the same period last year. The pharmaceutical and biotechnology company, which manufactures drugs, vaccines, and other healthcare products, also posted steady revenue growth during the quarter... Full

Bristol Myers Prunes Pipeline Amid New Round of Cost Cuts

(2/6, Max Bayer, Endpoints News) ...Bristol Myers Squibb is ending work on a handful of assets, including an immunology medication that was in two Phase 3 trials. The pipeline cuts disclosed Thursday follow news of a wider $2 billion cost-saving initiative, the pharma's second large restructuring in less than a year. Those reductions are set to impact the workforce and operating costs involving marketing, clinical trials and supply chains...The changes, and select explanations by execs, further demonstrate BMS' effort to double down on its existing portfolio — and invest in and maximize revenue from those medicines... Full

Bristol Myers Backs Out of Dupixent Fight, Axing Allergy Asset Despite Phase 3 Win

(2/7, Nick Paul Taylor, Fierce Biotech) ...Adam Lenkowsky, chief commercialization officer at BMS, explained the removal on an earnings call with analysts Thursday. "Given the data that we have seen, we've made the decision not to commercialize cendakimab," Lenkowsky said. "We're going to continue to prioritize investments and opportunities where we have a competitive advantage. We can deliver the highest return for the company in areas where we believe that we have an opportunity to deliver potentially transformational outcomes for patients."... Full

Henlius And Reddy's Shake Hands On $130M Darzalex Biosimilar Deal

(2/6, Dean Rudge, Generics Bulletin) ...Fresh from filing its proposed biosimilar to Perjeta with the US FDA, Henlius has brought in Dr Reddy's Laboratories as its US and European commercial partner for its proposed biosimilar to Darzalex, which has already succeeded in Phase I trials... Global Sub. Full

AstraZeneca Takes $753M Charge On Abandoned Complement Drug from Alexion Deal

(2/6, Elizabeth Cairns, Endpoints News) ...Development of vemircopan for paroxysmal nocturnal hemoglobinuria was halted in November 2023, but now the drug is being abandoned completely. A Phase 2 trial in lupus nephritis or IgA nephropathy, and an early-stage trial in impaired hepatic function, have also been discontinued for lack of efficacy. Marc Dunoyer, the CEO of AstraZeneca's rare disease unit, said it "is not immune to the odds of the industry, where not all of the pioneering work that you do is going to work."... Full

Eli Lilly's Next R&D Focus: Testing Incretin Meds in Neuro, Immunology Fields

(2/6, Gabrielle Masson, Fierce Biotech) ..."A new focus area first in 2025 will be to study potential new applications of incretin biology across diseases in neuroscience and immunology," Lilly's chief scientific officer Daniel Skovronsky, M.D., Ph.D., said during a Feb. 6 investor call. "With a pipeline of incretins in clinical development and deep scientific expertise in this space, Lilly is well positioned to match the biologic properties of specific molecules to the desired indications being studied."... Full

The Obesity Market Is Growing Just Fine. But Investors Want to Know What's Next

(2/6, David Wainer, The Wall Street Journal) ...Building out the GLP-1 market is no small feat, involving supply-chain expansion and reimbursement hurdles. Both companies are executing well, but their high valuations -- making them the two most valuable pharma companies globally -- reflect a lot of built-in optimism. That makes their pipelines important... Sub. Req’d

Interchangeable Aflibercept Biosimilar, Enzeevu, Comparable With Eylea for nAMD

(2/6, Cameron Santoro, The Center For Biosimilars) ...Enzeevu (aflibercept-abzv), a proposed biosimilar from Sandoz, matched reference aflibercept (Eylea) in efficacy, safety, and pharmacokinetics among patients with neovascular age-related macular degeneration (nAMD), according to a study published in Retina... Full

Viatris, Pfizer Cut Jobs in Korea As Drug Pricing Overhaul Threatens Margin

(2/7, Kim Ji-hye, Korea Biomedical Review) ...Viatris Korea and Pfizer Korea were offering employees a choice—take a severance package and leave, or wait for what came next. Vantive Korea followed with its own early retirement program...Behind it all looms a government policy set to take effect in late 2025—one that will systematically lower drug prices by benchmarking them against international standards. The first wave of price reductions will hit hypertension drugs. Next, cholesterol medications. Then, pain relievers... Full

Cencora Reinforces Efforts to Strengthen Pharmaceutical Supply Chain with Expansion of Drug Shortages Mitigation Program

(2/6, Cencora) ...Cencora, a global healthcare company, has significantly expanded the number and type of medications available in its sure supply program, a drug shortage mitigation initiative designed to provide health systems with reliable access to critical medications, including those at risk of going on shortage. Nearly 200 medications – including several oncology treatments – are now available through the program, which represents an increase of more than 350% since the program launched in 2021... Full

Trump Faces Pressure from US Industry Over China Tariff On Medicines

(2/6, Michael Erman, Patrick Wingrove, Reuters) ...The American Hospital Association wrote in a letter to Trump on Tuesday that the tariffs will affect cancer and heart medicines as well as antibiotics like amoxicillin from China...In the weeks leading up to the sanctions announcement, four lobbyists and one pharmaceutical executive who spoke to Reuters on the condition of anonymity said they had pressed the Trump administration for assurances that their products would be excluded from any tariffs. The White House did not immediately respond to a request for comment... Full

US Medicare Agency Brings Back Familiar Faces For Trump 2.0

(2/6, Michael McCaughan and Cathy Kelly, Pink Sheet) ...The Trump Administration has placed several CMS veterans from its first administration into agency leadership positions. Several also have worked in the Medicare space as consultants, as well as on Capitol Hill. But so far no one has been named director of the Medicare Drug Rebate and Negotiations Group, which is in charge of implementing the IRA drug pricing provisions... Global Sub. Full

Gottlieb Sees Policymaking Difficulties Ahead For FDA Under Trump

(2/6, Jessica Karins, Inside Health Policy) ...Former FDA Commissioner Scott Gottlieb said the agency faces several major challenges to implementing policy in the second Trump administration, including a new White House requirement to retract 10 regulations or guidance documents for every new one that he said could not only bring new rules to a halt but also stifle use of guidance for deregulatory purposes... Sub. Req’d

Cassidy: Upcoming Bill Will Realign 340B Program To Mitigate Misuse

(2/6, Gabrielle Wanneh, Dorothy Mills-Gregg, Inside Health Policy) ...Reforming the 340B drug discount program is among the top priorities for Senate health committee chair Bill Cassidy (R-LA), who said he plans to soon introduce long-awaited legislation aimed at maintaining the program's mission while stemming safety net hospitals' misuse of drug discounts. He said the reforms are also needed to prevent drug prices from rising... Sub. Req’d

Updated: Hospital Group Blasts Proposed 340B Rebate Models, Requests to Join Lawsuits with HHS

(2/6, Nicole DeFeudis, Endpoints News) ...340B Health and two of its member hospitals said Wednesday that they would be "harmed by the time and expenses incurred" if they are forced to comply with proposed new models from Eli Lilly, Sanofi, Novartis and Bristol Myers Squibb, which would require hospitals to purchase 340B drugs at market price and recoup the discounts later via rebates. UMass Memorial Medical Center and Genesis HealthCare System also joined the motions... Full

Access! 2025 Recap: A Call to Action for the Future of Generics and Biosimilars

(2/6, AAM) ...With PBMs under heightened scrutiny for their role in prescription drug costs, the fireside chat featuring Craig Burton, Executive Director of the Biosimilars Council, and Joshua Fredell, Senior Vice President at CVS Health, provided insight into biosimilar adoption strategies from a PBM perspective. Fredell discussed how PBMs must balance the needs of employers, government payers, and health plans while managing cost pressures. He pointed to CVS Caremark's private-label strategy for adalimumab as a major development in the biosimilar space, demonstrating how vertically integrated models can create price competition and ensure continuity of supply... Full

FDA – Everybody Is Guessing! AAM Meeting Presenters Just Don't Know and Can Only Guess!

(2/6, Bob Pollock, Lachman Consultants) ..."Disruption" was the common theme expressed by many panel members at this year's Access 2025 meeting of the Association for Accessible Medicines in Amelia Island, Florida. In speaking to attendees, "I just don't know what to expect" seemed to be the mantra of the day. The absence of FDA attendees also seemed to shake the crowd somewhat as the temporary communications "pause" lingers on... Full

Stakeholders Seek More In-Person Meetings and Faster Guidance Development from FDA

(2/6, Ferdous Al-Faruque, Regulatory Focus) ...Stakeholders want the US Food and Drug Administration (FDA) to hold more in-person meetings, provide transcripts and meeting minutes of all public meetings, and to be more expedient in finalizing guidances..."Meetings provide a unique opportunity to have an open dialogue with the agency," said AAM. "Although meetings may necessitate additional resources, a meaningful substantive discussion can often reduce or, at times, eliminate the need for further follow-up, ultimately conserving resources."... Full

 

Arizona Attorney General Sues Drug Company for Endangering Asthma Patients, Skirting Medicaid Payments

(2/6, Matt Simons, Courthouse News Service) ...Arizona Attorney General Kris Mayes sued drug manufacturer GlaxoSmithKline Thursday over claims the company engaged in "deceptive and unfair" practices that endangered consumers' lives and enabled the company's attempts to game the medical system. The lawsuit accuses the pharmaceutical firm of discontinuing its widely used asthma medication Flovent and replacing it with an identical product in a scheme to avoid paying rebates to Medicaid tied to the drug's high price, which is required under federal law... Full

Governor Lamont Announces 2025 Legislative Proposal: Reduce Prescription Drug Costs

(2/6, Governor Ned Lamont) ..."It's nearly impossible for someone to follow their healthcare provider's treatment plan if they can't afford the out-of-pocket cost for the prescriptions they need," Dr. Deidre Gifford, commissioner of the Connecticut Office of Health Strategy and Governor Lamont's senior advisor for health and human services, said. "This proposal focuses on making prescription drugs more affordable for Connecticut residents. It's good healthcare and it's good public policy... Full

Maryland Senate, House Hear Arguments On Limiting Prescription Drug Costs

(2/6, Rachel Sawicki, WBAL) ...Senate and House committees both heard hours long arguments on bills to give the Prescription Drug Affordability Board more authority over the private sector. The move would allow the board to set Upper Payment Limits on certain prescription drugs it deems a cost burden for Marylanders...The board can't set Upper Payment Limits on drugs for the entire state until they do so for state and local governments. State Policy VP for PhRMA Kristin Parde said they'll make it harder for providers to secure medications and also argued there's a different problem... Full

EU Launches Biotech Hub With ‘Critical Information' About Regulations & Funding

(2/6, Eliza Slawther, Pink Sheet) ...The European Commission has launched a hub for biotech innovators, which directs companies to resources about EU funding opportunities, regulatory requirements and other important information. The hub is part of the commission's strategy to boost biotechnology and biomanufacturing. It also forms part of the wider EU vision to improve growth and competitiveness across the bloc, according to lawyers from Van Bael & Bellis... Global Sub. Full

EU Platform Trial To Fast-Track Developing & Testing Depression Treatments

(2/6, Vibha Sharma, Pink Sheet) ...A new depression trial taking place across six European countries to test the safety and efficacy of multiple treatments will initially focus on repurposed drugs approved for other indications. There are plans to expand to Phase III settings and include additional treatments based on stakeholder input... Global Sub. Full

No SPCs In The UK For New Therapeutic Uses As Appeal Court Aligns With EU Ruling

(2/6, Neena Brizmohun, Pink Sheet) ...While the UK Court of Appeal's decision in Merck Serono v Comptroller-General will be unwelcome by innovators, it provides much-needed certainty for companies seeking – or seeking to invalidate – supplementary protection certificates based on marketing authorizations for new uses of known active ingredients... Global Sub. Full

Swedish SANT-MEP Wants Pharma Package Compromise This Spring

(2/7, Monica Kleja, Euractiv) ...The Polish presidency's willingness to find a compromise to untie knots the Pharmaceutical Package negotiations has raised hopes of a deal, Swedish MEP Jessica Polfjärd tells Euractiv...According to the committee's approved powers and responsibilities, it will address public health issues in seven areas, including pharmaceuticals, public health programmes and actions, and health crisis preparedness and response... Full

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