Monday, March 24, 2025

Amneal Digs Deeper Into GLP-1 Aspirations Following Metsera's IPO

(3/21, Dean Rudge, Generics Bulletin) ...Months on from penning a landmark commercial and manufacturing agreement for GLP-1 assets with Metsera, Amneal says it is happy with how the partnership is shaping up. Amneal says the planned portfolio of its glucagon-like peptide-1 (GLP-1) agonist collaboration partner Metsera is "moving swiftly through the drug development phase," as the US-based firm noted that the capital expenditure needed to bring its ambitions in the obesity and diabetes space to life was manageable based on current projections... Global Sub. Full

Novo Nordisk Secures License to Weight-Loss Drug Candidate from China's United Labs

(3/24, Mariam Sunny, Reuters) ...China-based United Laboratories International said on Monday it will license its weight-loss drug candidate to Danish drugmaker Novo Nordisk in a deal worth up to $2 billion. The Chinese investment holding company said on Monday that as part of the licensing agreement with a United Labs unit, Novo will make an upfront payment of $200 million and up to $1.8 billion upon the completion of certain development and sales milestones... Full

Brazil's Hypera to Launch An Ozempic Generic in 2026, CEO Says

(3/21, Alberto Alerigi, Reuters) ...Brazilian drugmaker Hypera plans to launch next year a generic version of semaglutide, the active ingredient of Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic, Hypera's chief executive said on Friday. The patent protection for semaglutide, which is also the key ingredient of injectable obesity treatment Wegovy and the oral diabetes drug Rybelsus, expires in Latin America's largest country in March 2026, allowing companies there to produce their own versions... Full

Biocon Unit Gets USFDA Nod for Blood Pressure Treatment Drug

(3/24, CNBC TV-18) ...Biocon on Monday, March 24, said its subsidiary Biocon Pharma, has received approval from the US and Drug Administration (FDA) for the norepinephrine bitartrate injection. The approval of norepinephrine bitartrate injection 4 mg/4 mL (1 mg/mL) single-dose vial adds to Biocon Pharma's expanding portfolio of complex injectable products, Biocon said in a stock exchange filing... Full

European Regulators to Review GSK's Asthma Drug Nucala to Treat COPD

(3/24, Anandita Mehrotra, Reuters) ...The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, the British drugmaker said on Monday... Full

Generic Drug Maker Can Deduct Costs of Patent Infringement Suits

(3/21, Tristan Navera, Bloomberg Law) ...Legal fees that Actavis Laboratories FL Inc. incurred while defending its generic drug applications from patent infringement lawsuits are tax deductible, the US Court of Appeals for the Federal Circuit said Friday. A three-judge panel affirmed the conclusion of the US Court of Federal Claims from 2022. Judge Leonard P. Stark wrote that that the lawsuits the generic drug maker defended involving Hatch-Waxman Act patent infringement claims were a "parallel" process to the approval it was seeking from the US Food and Drug Administration, and qualified as deductible "ordinary and necessary business expenses."... Sub. Req’d

White House Narrows April 2 Tariffs

(3/23, Gavin Bade, Josh Dawsey and Meridith McGraw, The Wall Street Journal) ...President Trump has declared his April 2 deadline to be "Liberation Day" for the U.S., when he will put in place what is called reciprocal tariffs that seek to equalize U.S. tariffs with the duties charged by trading partners, as well as tariffs on sectors like automobiles, pharmaceuticals and semiconductors he repeatedly said would be enacted on that day. Those sector-specific tariffs, however, are now not likely to be announced on April 2, said an administration official, who said the White House is still planning to unveil the reciprocal -tariff action on that day, though planning remains fluid... Sub. Req’d

Xi Must Stop Fentanyl Flow Before Tariff Talks, Trump Ally Says

(3/24, Jenni Marsh, Bloomberg) ...Steve Daines, a close ally of President Donald Trump, laid out the condition in meetings with Chinese officials in Beijing over the weekend. The Republican lawmaker said he hopes a leadership meeting will take place before the end of the year, although Trump previously said it would happen soon...China's Vice Premier He Lifeng met on Sunday with heads of multinational corporations including Apple Inc., Brookfield Corp, Medtronic Plc, Mastercard Inc., Eli Lilly & Co, and Corning Inc., according to a statement. The Chinese official said his country welcomes the company to expand investment and vowed to improve the business environment. In addition to fentanyl, Daines said he also raised the issue of expired export licenses for US beef producers that require renewal... Sub. Req’d

Trump Allies Aim to Slash Drug Prices. The Pharma Industry Is in a Bind.

(3/21, Josh Nathan-Kazis, Barron's) ...Asked for comment on the new position paper, PhRMA spokeswoman Sarah Ryan did not outright condemn the proposal. "We've highlighted for years that some countries are not paying their fair share today for innovation, which impacts the development of future treatments and cures," Ryan said. "We are also the only country where over half of every dollar spent on medicines goes to others in the supply chain that do not even make medicines, like PBMs, insurers, hospitals and others."... Full

FTC Turmoil Raises PBM Probe Questions

(3/21, Lauren Gardner, Politico) ...By dismissing commissioners Alvaro Bedoya and Rebecca Kelly Slaughter on Tuesday night, Trump overturned decades of precedent at the consumer protection and competition regulator, POLITICO's Nate Robson writes. The move also raises practical questions about the future of the PBM case, which has attracted bipartisan plaudits as lawmakers struggle to advance legislation to overhaul some industry practices... Full

Lawmakers Are Pushing the HALT Fentanyl Act as the Solution to the Overdose Crisis. Experts Warn it Will Fall Short

(3/24, Samanta Habashy, STAT) ...Now, in an effort to address the public health crisis, the Senate recently passed the HALT Fentanyl Act in an 84-16 vote...However, experts question whether the bill truly addresses the roots of the epidemic, for two main reasons. For one, the bill focuses on increasing penalties for fentanyl-related substances, a version of the drug that's far less prevalent than fentanyl itself. Plus, the critics say the bill extends the punitive approach of the War on Drugs without addressing systemic factors driving the crisis... Full

Evolving Litigation Tactics Emerge in JPMorgan Drug Cost Case

(3/24, Lauren Clason, Bloomberg Law) ...Employees filing pioneering suits against companies like JPMorgan Chase & Co. and Johnson & Johnson over prescription drug spending in their health plans are adapting litigation tactics in a renewed effort to show they suffered harm. Plaintiffs, who also recently sued Wells Fargo & Co., are seeking to prove that employers are overpaying their pharmacy benefit managers and passing those costs along to workers through inflated drug costs and insurance premiums... Sub. Req’d

APC: FDA's GLP-1 Compounding Concerns Based On Shaky Data

(3/21, Jessica Karins, Inside Health Policy) ...The Alliance for Pharmacy Compounding (APC) is "protest(ing) in the strongest terms" FDA's assertion it has received hundreds of reports of adverse events linked to compounding of GLP-1 weight loss and diabetes drugs, alleging the agency is casing doubt on the integrity and quality of compounding pharmacies based on unverified reports from consumers. The compounding group's protest comes as FDA prepares to enforce its limitations on compounding following the end of GLP-1 shortages... Sub. Req’d

Florida Gets Nothing from Plan for Drug Importation

(3/22, Sally C. Pipes, The Palm Beach Post) ...Canadians "free-ride" off American investments in research and development. If the United States adopts Canada's drug pricing policies, then there will be many fewer innovative drugs on which to place price controls. Florida's leaders sold prescription drug importation as a way to save the state money – perhaps as part of an effort to attract seniors' votes. A little over a year on, it has failed to do so – in spectacular fashion... Full

Virginia Veteran with Daughter Who Has Rare Disease Requiring Expensive Medication: Youngkin Should "Choose Hardworking Virginia Families and Sign the Prescription Drug Affordability Board Bill into Law."

(3/20, Hermionne G. Johnson, MSN RN, Bsc., Blue Virginia) ...We must put people over profits and lower the cost of medicine for Virginians by establishing a Prescription Drug Affordability Board. Governor Youngkin can set an example for the future and make Virginia a leader in affordability. I urge the governor to choose hardworking Virginia families and sign the Prescription Drug Affordability Board bill into law... Full

Pharmacy Reimbursement Bill Passes Senate

(3/21, Mary Sell, Alabama Daily News) ...On Thursday, the Alabama Senate voted unanimously for Senate Bill 252. It prohibits pharmacy benefit managers, third-party groups that negotiate drug prices for insurers and enter into contracts with pharmacies, from paying independent pharmacies less than their costs for medications. "If we don't pass this legislation, it's going to get worse," Sen. Billy Beasley, D-Clayton, said on the Senate floor Thursday about the financial struggle community pharmacies are facing... Full

New Policy Changes the Way Texans Get Asthma Medication

(3/21, Brayel Brown, News Channel 6 Now) ...Texans with asthma may soon lose coverage for their in-clinic treatments and be forced to do them at home. This medical policy change is from the parent company, Health Care Service Corporation, of Blue Cross Blue Shield Texas, but those against this move say it puts patients more at risk... Full

‘Hope And Scientific Spillover' – Cross-Atlantic HTA Alliance To Focus On Novel Benefits

(3/21, Fracnesca Bruce, Pink Sheet) ...HEMA, the collaborative initiative on health technology appraisals (HTAs) involving the US, Canada and England, has announced the first topic it will explore with the aim of delivering guidance. The initiative will produce guidance on how non-traditional treatment benefits can be used in economic evaluations to inform HTA decisions and the understanding of value. The guidance could lead HTA bodies across the world to make changes to their appraisal processes... Global Sub. Full

DIA Europe: EU Regulators Report Steady Progress in RWD Acceptance

(3/21, Joanne S. Eglovitch, Regulatory Focus) ...Regulators and a representative from the pharmaceutical industry discussed the increasing acceptance of real-world data (RWD) in regulatory procedures in the EU during a panel discussion at DIA Europe 2025 on Wednesday. They emphasized the importance of RWD in informing decision making for new drug approvals and improving drug safety data collection... Full

Pharma Industry Wants Streamlined EU Medical Device Rules

(3/21, Emma Pirnay and Thomas Mangin, Euractiv) ...Health Commissioner Oliver Varhelyi confirmed yesterday that the regulations on medical devices (MDR) and in vitro diagnostics (IVDR) will be revised by the end of the year. The consultation drew nearly 500 contributions from industry players, along with patient associations and federations. Among them, pharmaceutical giant Takeda emphasised the need to align MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations, and clinical trial regulations...Similarly, the Swiss pharmaceutical company Roche called for an impact assessment to evaluate the MDR/IVDR's coherence with other EU legislation... Full

Reliance On Pharma a 'Significant Risk' for Ireland Amid Tariff Dispute

(3/24, Ronan Smyth, Irish Examiner) ...Protectionist economic measures coming out of the US could have significant impact on the pharmaceutical sector in Ireland potentially leading to job losses and reduced investment, a new study by a global consultancy group Sia has warned...US president Donald Trump is expected to unveil a raft of new tariffs against the EU on April 2. Protectionist measures that impact the biopharma sector, the study said, could lead to Irish job losses, reduced investment, and a potential reduction in intellectual property registered here resulting in a decrease in corporate tax receipts... Full

Donald Trump May Find Himself in a Bind On Tariffs On Generic Drugs

(3/24, Viswanath Pilla, Money Control) ...India's pharma industry, too, is closely watching President Donald Trump's tit-for-tat tariffs, which are expected to come into effect on April 2, as the US is the biggest market for Indian generics. The administration thinks that tariffs will encourage pharmaceutical companies to shift manufacturing to the United States and balance the trade with countries that impose "higher" tariffs on American goods. "We are concerned that distributors and generic manufacturers cannot absorb the rising costs of broad tariffs," the Healthcare Distribution Alliance (HDA) has said in a statement... Full

Make Meds Affordable

(3/23, Yogendra K Gupta, Deccan Herald) ...Access to affordable healthcare has long been a challenge in India. The government is making efforts to address this through innovative strategies, technology integration, and increased budgetary allocations. One such initiative is the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), launched to provide quality generic medicines at significantly lower prices. This initiative has emerged as a game-changer in India's healthcare system... Full

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