Monday, March 31, 2025

Alvotech Reveals Ramp-Up In Development As Sales Explode In 2024

(3/28, Dave Wallace, Generics Bulletin) ...With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years... Global Sub. Full

BoFA Says Novo Nordisk May Miss Q1 Expectations as Wegovy, Ozempic Sales Lag

(3/28, Greta Fondahn, Maggie Fick, Reuters) ...Bank of America analysts on Friday said Novo Nordisk may miss first-quarter expectations, as sales of its blockbuster Wegovy and Ozempic drugs lag, which could prompt the Danish drugmaker to cut its 2025 guidance in its quarterly results. BofA global research predicted in a note a 2% cut to the company's full-year sales guidance and expects a new sales growth range for the year of between 14% and 22%... Full

Celltrion Plans Multiple US Biosimilar Launches In An ‘Exciting And Momentous' Year

(3/28, Dave Wallace, Generics Bulletin) ...In an exclusive Q&A interview with Generics Bulletin, the Celltrion executive talked about the firm's recently-approved Avtozma (tocilizumab-anoh) rival to Actemra and discussed the company's expectations around Stelara (ustekinumab) biosimilar competition following its recent launch of Steqeyma (ustekinumab-stba), which the company recently revealed had been added to Costco's Member Prescription Program from April 1... Global Sub. Full

Celltrion Receives European Approval Recommendation for Omlyclo Autoinjector

(3/31, Yeom Hyun-a, Chosun Biz) ...This recommendation for approval is an amendment to add the 75 mg and 150 mg AI formulations following those of the previously approved 75 mg and 150 mg prefilled syringe (PFS) formulation, with the aim of expanding patient self-injection options and enhancing treatment convenience. Celltrion confirmed the efficacy and safety of Omlyclo in a global Phase 3 clinical trial involving 619 patients with chronic idiopathic urticaria compared to Xolair... Full

Exclusive: SV Health Debuts Parkinson's Biotech with Backing from AbbVie and Others

(3/31, Kyle LaHucik, Endpoints News) ...The London-based healthcare investor launched Endlyz Therapeutics on Monday morning. The small biotech, which has quietly been in the works for nearly four years, is working on Parkinson's disease and other neurodegenerative disorders by revamping the body's cellular recycling function. The startup has raised $16 million to date from SV's Dementia Discovery Fund, Oxford Science Enterprises, AbbVie Ventures, Parkinson's UK and the Centre for Drug Design and Discovery at KU Leuven, according to a source familiar with the biotech's fundraising... Full

J&J Beats Viatris in Patent Fight Over its Antipsychotic Drug, Staving Off Competition

(3/28, Alexis Kramer, Endpoints News) ...The US Court of Appeals for the Federal Circuit on Friday affirmed a lower court ruling which had said that a generic from Mylan Laboratories (now part of Viatris) would induce healthcare providers to infringe claims in J&J's dosing patent for the drug, called Invega Trinza. The claims cover a missed-dose regimen for a three-month paliperidone palmitate injection (PP3M), an antipsychotic used to treat schizophrenia. Invega Trinza's dosing instructions track the patent claims and lay out a regimen for patients who had their last dose between four and nine months earlier, according to the decision... Full

Novo Nordisk's Diabetes Pill Slashes Risk of Cardiovascular Complications by 14% After Four Years

(3/29, Annika Kim Constantino, CNBC) ...Novo Nordisk on Saturday said its diabetes pill Rybelsus showed cardiovascular benefits in a late-stage trial, paving the way for it to become a new treatment option for people living with diabetes and heart disease. The pill lowered the risk of cardiovascular-related death, heart attack and stroke by 14% compared to a placebo after four years on average in patients with diabetes and established heart disease, with or without chronic kidney disease... Full

FDA Finds Data Integrity Problems in Recent Warning Letters

(3/28, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices related to the production of sterile drugs and over-the-counter products. Two of the warning letters identified data integrity issues, and failures in component testing were a recurring theme in the others. One warning letter was issued following a records request, and another was sent to an outsourcing facility. The FDA published the letters on March 25... Full

FDA to Pharmaceutical Companies: Certain Studies Conducted by Raptim Research Pvt. Ltd. Are Unacceptable

(3/28, U.S. Food & Drug Administration) ...FDA has identified significant data integrity and study conduct concerns with bioequivalence studies conducted by Raptim Research Pvt. Ltd., a contract research organization based in Navi Mumbai, India...The agency has notified sponsors of new drug applications and abbreviated new drug applications that in vitro studies conducted by Raptim are not acceptable, and when those studies are essential for approval, they must be repeated at study sites that do not have data integrity concerns... Full

Generic Tofacitinib: Will It Be a Bellwether for the Future of Expensive Generics?

(3/28, Madelaine A. Feldman, MD, Medscape) ...When tofacitinib (Xeljanz), the first Food and Drug Administration-approved Janus kinase inhibitor, comes off patent exclusivity in the United States in 2026, the accessibility and affordability of its generic versions may serve as an important test for efforts to counter exorbitant pricing of "specialty" generic drugs by pharmacy benefit managers (PBMs), which often make these drugs available only through their own specialty pharmacies... Full

Trump Open to Tariff Negotiations, Will Hit Drug Imports ‘Soon'

(3/31, Skylar Woodhouse, Bloomberg) ...Trump said Friday he would be announcing pharmaceutical tariffs "soon" but sidestepped a question on whether life-saving medications would be exempted and what the rate of those taxes would be. "It'll be a certain number that will be enough to get the drugs and the pharmaceutical companies to bring in their product into our country. We never want to have to rely on other countries for that, like we did in COVID," Trump said... Full

Trump Undecided On Structure Of Potential Pharma Tariffs, WH Says

(3/28, Maaisha Osman, Inside Health Policy) ...Pfizer CEO Albert Bourla warned that U.S. tariffs on Chinese imports pose a greater threat to U.S.-China relations than to Pfizer itself. While acknowledging that China remains a key growth market for his company, Bourla emphasized that the country is swiftly becoming a biotech powerhouse and urged U.S. policymakers to foster innovation to maintain global competitiveness rather than attempting to curb China's rise in the sector... Sub. Req’d

OMB Weighs Whether CMS AOM Coverage Rule Could Spur Shortages

(3/28, Luke Zarzecki, Inside Health Policy) ...The source told Inside Health Policy that one of the government officials asked whether there was any concern about shortages of anti-obesity medications (AOMs) that would impact the diabetes community if the drugs were covered for a broader population...In a statement to Inside Health Policy, a spokesperson for Eli Lilly, the maker of GLP-1 active ingredient tirzepatide, said the company told OMB in its meeting with the office the reinterpretation to allow coverage of AOMs aligns with the original intent of the statute, today's science and CMS policy precedent... Sub. Req’d

The Silent Emergency: Jay Bhaumik On the Drug Shortage Crisis

(3/28, William Jones, USA Today) ...Today, drug shortages are a constant threat to patient care and a significant strain on exhausted medical teams. Whether it's a patient's cancer treatment or critical care medication, the unpredictable availability of life-saving drugs has challenged healthcare providers around the world. The global drug shortage crisis continues to impact healthcare systems worldwide. With expertise in pharmaceutical supply chains and medical technology, healthcare CEO and entrepreneur Dr. Jay Bhaumik has examined the factors contributing to the crisis... Full

Medicare's Recent Actions to Promote Access to Lower Cost Drugs

(3/28, Christen Linke Young, Brookings) ...Conversely, the trade associations for brand, generic, and biosimilar manufacturers all supported CMS's efforts. Unsurprisingly, the brand manufacturers argued that a CMS review was important to protect access to drugs with negotiated prices—an issue that has been critically important to them—and underscored the importance of focusing on net prices to determine lower cost products. Generic and biosimilar manufacturers pointed to evidence that biosimilar adoption remained slow and generic adoption has shown signs of slowing, and argued that the Part D plan continued to exclude lower cost products, so CMS reviews were necessary. CMS will decide whether to finalize the proposal in the months ahead... Full

Top FDA Vaccine Regulator Peter Marks Pushed Out

(3/28, David Lim, Adam Cancryn and Lauren Gardner, Politico) ...Marks was pushed out under pressure from HHS Secretary Robert F. Kennedy Jr., said two people familiar with the matter granted anonymity to discuss the resignation — a development that sent shockwaves across the nation's capital and prompted concern among some pharmaceutical companies...Marks' final day at the FDA is April 5... Full

Ouster of FDA's Peter Marks Alarms a Biopharma Industry that Saw Him as an Ally

(3/29, Jason Mast and Adam Feuerstein, STAT+) ..."This letter should shake us all," Jeremy Levin, CEO of Ovid Therapeutics wrote on LinkedIn, about Marks' resignation letter. "It signals that the very infrastructure we rely on to evaluate, approve, and monitor life-saving medicines — and to protect patients from harm — is at risk of collapse. The implications are vast. The consequences for biomedical innovation, public trust, and America's role as a global health leader are profound."..."This hurts. It's really hurtful."... Sub. Req’d

‘Pipeline In A Pill' Or Pipe Dream? US FDA's April Goal Dates Test Expansion Strategies

(3/29, Bridget Silverman, Pink Sheet) ...Six novel agents are due for FDA decisions in April 2025, stemming from different disease areas such as ophthalmology, immunology, vaccines, cancer imaging, and cardio-metabolic disease. Sanofi seeks a big population indication for Dupixent, which is on its second review cycle for chronic spontaneous urticaria, along with Aldeyra's reproxalap for dry eye, also on its second review cycle, and Novavax/Sanofi's COVID-19 vaccine. Stealth's elamipretide is hoping for approval for Barth syndrome after a rocky history with the FDA and close advisory committee vote... Global Sub. Full

Amgen Loses its Battle Against Colorado Over a Prescription Drug Affordability Board

(3/28, Ed Silverman, STAT+) ...An Amgen spokeswoman sent a statement saying the company continues to have "significant concerns with the board's flawed policy and procedures during the rulemaking process to set an upper payment limit for Enbrel. Not only is the law unconstitutional, but price controls will not meaningfully address affordability at the pharmacy counter and will instead create new access barriers for many patients." A spokesman for the Colorado Division of Insurance, which oversees the affordability board, said that officials are still evaluating the decision and there is no comment for the moment... Sub. Req’d

Gallego Backs Bill to Lower Drug Costs and Hold Big Pharma Accountable for Price Hikes

(3/28, Senator Ruben Gallego) ...The bill, which Senator Gallego also championed in the House, would punish drug companies for raising prescription drug prices in the commercial market faster than inflation...The legislation builds on the success of the Gallego-backed Inflation Reduction Act, which lowered drug prices for seniors on Medicare. The Lower Drug Costs for Families Act would extend these protections to all Americans, including those with private insurance and employer-sponsored plans... Full

Montana's Small Pharmacies Behind Bill to Corral Pharmacy Benefit Managers

(3/31, Mike Dennison, KFF Health News) ...The bill, which sailed through the Montana House 98-1 in early March and is now before the state Senate, would set a price floor that PBMs must pay pharmacies for each prescription. Currently, there is no mandated minimum rate in contracts with pharmacies, and independent drugstores said the rates are often below what they paid for the drugs. The measure includes a half-dozen restrictions on other PBM practices the smaller pharmacies call anticompetitive... Full

Q&A: Root Out Drug Company Abuses to Lower Rx Prices

(3/28, U.S. Senator Chuck Grassley) ...I've teamed up with Sen. Dick Durbin of Illinois to introduce the Drug-Price Transparency for Consumers Act. It would require price disclosures on prescription drug advertisements to empower consumer choice and reduce bloated drug prices. As chairman of the Senate Judiciary Committee, I'm laser-focused on boosting competition and rooting out anticompetitive practices that game the system to pad profits at the expense of taxpayers and patients. For example, brand-name companies producing prescription drugs under patent or exclusivity protection essentially are able to name their price by distorting marketplace competition... Full

AstraZeneca, Sanofi, Lilly, Pfizer CEOs Meet with Xi Jinping Amid US-China Trade Tensions

(3/28, Angus Liu, Fierce Pharma) ...As U.S. President Donald Trump threatens a new round of tariffs as part of an onshoring push, Chinese President Xi Jinping is courting foreign investment as well, including from drugmakers. CEOs from large pharma companies AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GSK, Merck KGaA, Pfizer and Sanofi were among more than 40 international business leaders who met with Xi in Beijing on Friday. Their presence gave pharmaceuticals the largest representation of a single industry sector at the meeting, according to Reuters... Full

China's Xi Calls On Top Executives to Help ‘Uphold Global Order' as Trade Tensions with U.S. Rise

(3/28, Evelyn Cheng, CBNC) ... hinese President Xi Jinping on Friday met with global executives and made a case for investing in the country, as Beijing focuses on reaching out to businesses amid escalating trade tensions with the U.S. He said multinational companies had a big responsibility to "uphold global order" and that they needed to work hand in hand with China. Xi emphasized that China was a safe and stable place for foreign companies. "To invest in China is to invest in tomorrow," he said in Mandarin translated by CNBC... Full

US Pharmaceutical Giant Opens R&D Center in Beijing

(3/31, China Daily) ...US pharmaceutical giant Pfizer's new research and development (R&D) center officially opened at BioPark in the Beijing Economic-Technological Development Area (BDA) on Saturday. As the company's third R&D center in China, the new facility aims to enhance its existing drug development network in the country, integrating China into Pfizer's global early-stage clinical trials and all pivotal phase III studies... Full

IGBA Warns Of Harmful Impact Of Tariffs On Generic Drug Supply

(3/28, Adam Zamecnik, Generics Bulletin) ...According to the IGBA, one of the association's key priorities is to ensure patient access to generic and biosimilar drugs, which are threatened by trade instruments such as tariffs that affect the "efficient supply and distribution of medicines across regional and international markets." Since generic and biosimilar drugs are dependent on the supply of active pharmaceutical ingredients sourced from across the world, any disruptions to this globalized supply chains can harm the availability of such medicines for the patients who need them... Global Sub. Full

Donohoe 'Extremely Concerned' Over Potential Impact of Tariffs

(3/28, RTE) ...The Chief Executive of the Irish Pharmaceutical Healthcare Association has said that the pharmaceutical industry does not want to see tariffs, or retaliatory tariffs, on medicines introduced. Speaking on RTÉ's Drivetime programme, Oliver O'Connor described the situation as "very challenging" for pharmaceutical companies across the European Union, which export to the United States. Responding to Mr Trump's comments, Mr O'Connor said: "There are very challenging times ahead, challenging issues for companies to address, and challenging issues for policymakers to address across the Atlantic in that relationship."... Full

Reshoring EU Pharma Production? Start with Critical Medicines, Says Belgian MEP

(3/29, Nicole Verbeeck, Euractiv) ...Growing geopolitical tensions, persistent medicine shortages, and increasing global competition have quickened Europe's ambitions to secure its pharmaceutical supply chains. For Belgian MEP Yvan Verougstraete (Renew Europe Group), relocating pharmaceutical production to Europe is a realistic goal. "But it won't happen on its own," he said in an interview with Euractiv...According to Verougstrate, the priority should be to begin with critical medicines, where vulnerabilities in the supply chain are already well known... Full

No Clear Benefits of Generic Prescribing, Says Denmark's Lif

(3/31, The Pharma Letter) ...The Danish Medicines Agency's new analysis of generic prescribing confirms that the current model for generic substitution works extremely effectively in Denmark, despite a perception that generic prescribing can lower the regions' costs for subsidized medicines. The analysis indicates that a possible introduction of generic prescribing will lead to a complex two-tier prescribing system, which may limit the potential benefits of generic prescribing and it cannot certainly lead to financial savings for society or citizens. These conclusions are recognized by Lif, which supports generic substitution, where pharmacies dispense the cheapest drug within a substitution group... Sub. Req’d

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