Monday, September 15, 2025

Alkermes Files Patent Litigation Against Teva, Apotex, MSN Pharmaceuticals

(9/12, Dean Seal, Dow Jones) ...Alkermes filed a patent infringement lawsuit against Teva Pharmaceuticals, Apotex and MSN Pharmaceuticals for trying to make generic versions of its schizophrenia and bipolar treatment Lybalvi...The company said it would vigorously defend its intellectual property and that the lawsuit should trigger stays of any FDA approval of the companies' applications... Full

Trump's Next Plan to Lower US Drug Prices: Raise Them in Other Countries

(9/12, Tami Luhby, CNN Business) ...President Donald Trump wants drugmakers to lower their prices in the US — so he'll push them to raise prices in other countries to offset the hit to their bottom line, Commerce Secretary Howard Lutnick said Friday. "The president's going to say that you drug manufacturers cannot sell here unless you sell there at a higher price. Stop being willing to sell to them at such a low price," Lutnick said Friday on "The Axios Show."... Full

Are Tariffs Actually Working for Donald Trump and the US?

(9/14, Tony Connelly, RTE) ...The European pharmaceutical lobby EFPIA says it will cost the sector €18bn, on top of the fact that there are no exemptions for innovative medicines, and no clarity on possibly higher tariffs in the future. The organisation warns that in the short term, with pharmaceutical companies tied into long-term pricing deals with national health systems, they may be forced to absorb such costs. "Adding barriers to highly functioning and complex supply chains is not a route to national resilience, increased manufacturing or better patient care," says EFPIA Director General Nathalie Moll... Full

Trump's Tariff Strategy Can Even the Playing Field on Drug Prices | Opinion

(9/10, Jeffrey Gerrish, Newsweek) ...President Trump has floated a "Most Favored Nation" pricing policy, which would tie U.S. drug prices to the lowest prices paid abroad. While well intentioned, this approach would import harmful foreign price controls into the U.S., draining the funds needed for research and development. That would slow the flow of new treatments and leave American patients worse off. A better solution would be to use America's trade leverage to dismantle the foreign policies that enable this freeloading in the first place... Full

Tariffs On Our Allies Could Trigger the Next Drug Shortage

(9/12, Patrick Kilbride, DC Journal) ...If the goal is national security, targeted measures to reduce reliance on China - a strategic rival willing to weaponize trade - may be prudent. Punishing allies is simply counterproductive. Broad tariffs on pharmaceutical imports from trusted partners will only weaken supply chains, undermine U.S. manufacturers, and force patients to pay the price through higher costs and reduced access... Full

The Wrong Tariff Could Empty America's Medicine Cabinet

(9/12, Robert Goldberg, PhD, The Well News) ...American patients could soon face shortages of lifesaving therapies because of looming new tariffs on medicines imported from our closest allies. That risk is growing each day, as the Department of Commerce investigates America's dependence on pharmaceutical imports under Section 232 of the Trade Expansion Act... Full

Cheap Pharmaceuticals from China and India Put Americans at Risk. Here's the Cure.

(9/13, Andrew Rechenberg, MarketWatch) ...America's medicine cabinet is too important to leave to the mercy of subsidized foreign suppliers and fragile supply chains. Section 232 tariffs in U.S. law exist for exactly this reason: When imports undermine national security, policymakers must act. Tariffs on generic drugs aren't a tax on patients - they're a down payment on secure medicines and resilient supply chains... Full

National Survey Finds Employers Widely Satisfied with Transparency, Flexibility, and Savings Provided by PBMs

(9/12, PCMA) ...A survey of nearly 700 employers across the country conducted by NORC at the University of Chicago found that employers are widely satisfied with the transparency, flexibility, and savings provided by pharmacy benefit managers (PBMs)... Full

Under Trump, FDA Seeks to Abandon Expert Reviews of New Drugs

(9/12, Arthur Allen, KFF Health News) ...FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public scrutiny. The agency "would like to get away" from assembling panels of experts to examine and vote on individual drugs, because "I don't think they're needed," said George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research. He relayed the message Tuesday at a meeting of health care product makers and Wednesday to an FDA advocacy group... Full

Top Drug Regulator Pushes Back On Report that FDA Wants to 'Abandon' Some Adcomms

(9/12, Zachary Brennan, Endpoints News) ...An HHS spokesperson said in a statement to Endpoints that the meetings "will continue to be a critical tool that FDA uses to obtain external expertise when needed. The decision to convene an advisory committee, including whether to convene a committee to discuss a particular application, is made on a case-by-case basis."... Sub. Req’d

I Run the F.D.A. Pharma Ads Are Hurting Americans

(9/13, Marty Makary, The New York Times) ...It's not just ads on television that are creating a misleading impression. Increasingly, social media influencers are paid to promote pharmaceutical products, often with no mention of side effects. A 2024 review in the Journal of Pharmaceutical Health Services Research found that many pharmaceutical ads on social media concealed risk information... Sub. Req’d

FDA Finalizes Guidance On Alternative Inspection Tools

(9/12, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) on Thursday finalized its guidance on the use of alternative tools for conducting preapproval inspections (PAI) or prelicense inspections (PLIs) in lieu of onsite inspections of drug manufacturing facilities that are named in pending applications... Full

AbbVie Loses Latest Bid to Block Mississippi Drug Discount Law

(9/12, Ganny Belloni, Bloomberg Law) ...The drugmaker couldn't convince the appeals panel that Mississippi's law amounted to an unconstitutional taking of its property or was preempted by the federal 340B statute. "Because AbbVie has not proffered the requisite facts as to either of its claims, the district court did not abuse its discretion in denying AbbVie preliminary injunctive relief," the appeals court panel wrote in affirming the lower court's decision... Sub. Req’d

Delaware Report Shows Growing Use of GLP-1 Meds are Driving Increased Spending, Not Drug Price Tags

(9/15, Nicole Leonard, WHYY) ...Increased spending for the medications like Wegovy and Ozempic in Delaware is not being driven by inflated drug prices, but rather an overall higher number of people using the drugs more frequently, according to a new report. In fact, the individual cost to patients and private health insurers for glucagon-like peptide-1 (GLP-1) receptor agonist prescriptions has "remained relatively flat" in the last three years while utilization has more than doubled, officials from the Delaware Office of Value-Based Health Care Delivery found... Full

Sanofi's R&D Chief 'Pretty Pragmatic' About Clinical Setbacks, Lifts Lid On Recent Asthma Fail

(9/15, James Waldron, Fierce Biotech) ...Despite these setbacks, Sanofi's head of R&D Houman Ashrafian, Ph.D., told Fierce Biotech that he takes a "pretty pragmatic" approach to the Big Pharma's portfolio. "We've had a year which has been mixed, but that reflects the risks of drug development, particularly in immunology and inflammation, and particularly in areas where … the clinical trial space has been shaped by preexisting molecules," Ashrafian said in an interview. The R&D chief spoke to Fierce ahead of the release of more detailed data from the failed phase 2 asthma trial for amlitelimab... Full

Bio-Thera Strikes Strategic Deal with Jamjoom Pharma for Securing Cosentyx® Biosimilar in MENA

(9/15, Bio-Thera Solutions Inc.) ...Under the agreement, Jamjoom Pharma will obtain the exclusive rights to commercialize BAT2306 - a proposed biosimilar to Novartis' Cosentyx® (secukinumab) - across the Middle East and North Africa (MENA) region. Jamjoom Pharma will manage regulatory submissions, market access, and commercialization in MENA, while Bio-Thera will oversee product development and global manufacturing from its state-of-the-art facilities in Guangzhou, China... Full

Kashiv Bags A LATAM Deal With Cristália For Xolair Biosimilar

(9/15, Urte Fultinaviciute, Generics Bulletin) ...Kashiv BioSciences has partnered with Cristália for its omalizumab biosimilar, referencing Genentech/Novartis' Xolair...In the US, the Xolair biosimilar race is currently led by Celltrion, whose Omlyclo (omalizumab-igec) was approved with an interchangeability designation by the FDA in March 2025. Other omalizumab biosimilar sponsors with products currently in development include Teva with its TEV-45779 candidate. However, Roche stated earlier this year that no biosimilars to Xolair are expected to launch in the US in 2025, despite key omalizumab formulation patents expiring in November... Global Sub. Full

Eli Lilly, Novo Nordisk Prepare to Face Off in the Next Obesity Drug Battleground

(9/12, Angelica Peebles, CNBC) ...Eli Lilly and Novo Nordisk are both preparing to launch obesity pills in the U.S. next year. Lilly expects results from a head-to-head trial of its pill orforglipron versus Novo's oral semaglutide in the coming months, said Lilly's Chief Scientific Officer Dan Skovronsky. Pills are expected to capture about 20% of the $80 billion obesity GLP-1 drug market by 2030, according to analyst estimates from Evaluate... Full

Lilly's UK Gateway Labs Plans Are Up in the Air in Latest Blow to Region's Biopharma Industry

(9/12, Anna Brown, Endpoints News) ...Eli Lilly said that it's "not yet in a position to finalize" plans to bring its Gateway Labs to the UK, as it is "awaiting more clarity" on the state of the country's life sciences industry...A spokesperson for the Indianapolis drugmaker told Endpoints News that it's only the Gateway Labs portion of its UK plans that is uncertain, with the rest of its multimillion-dollar pledge still underway. Lilly and the UK government said last year they were joining forces to improve obesity care as well as to potentially build new manufacturing sites in the country... Sub. Req’d

Exclusive: AstraZeneca Pauses $270 Million Investment in Britain

(9/12, Alistair Smout and Maggie Fick, Reuters) ...Britain's biggest company AstraZeneca has paused a planned 200 million pound ($271.26 million) investment in its Cambridge research site, a spokesperson said, the latest drugmaker to pull back on its business in Britain. The decision on the investment, which had been set to create 1,000 jobs, means none of AstraZeneca's planned new funding - originally announced in March 2024 - is currently proceeding... Full

Adcock Pushes On With Natco Deal As Wadeville Remains Problem Child

(9/15, Dean Rudge, Generics Bulletin) ...Adcock Ingram is progressing with a significant deal involving the sale of more than 35% of its shares to India's Natco Pharma, aiming for completion by early November. Post completion, Adcock anticipates becoming a private company. The South African firm's recent earnings report highlighted challenges, particularly with its Wadeville factory, which faced production declines and under-recovery issues... Global Sub. Full

USFDA Clears Alembic Pharma's Panelav Manufacturing Units After Inspection

(9/13, Sheersh Kapoor, CNBC TV18) ...Alembic Pharmaceuticals Limited on Saturday said it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its API–I and API–II facilities at Panelav, Gujarat. The EIR marks the closure of the inspection carried out between May 26-31, 2025, signalling regulatory compliance at the manufacturing sites... Full

Dr Reddy's Bachupally Facility Gets 5 Observations From US FDA Inspection

(9/13, Sheersh Kapoor, CNBC TV18) ...Dr Reddy's Laboratories has disclosed that the United States Food and Drug Administration (US FDA) issued it a Form 483 with five observations at its biologics manufacturing facility in Bachupally, Hyderabad. The regulator completed a pre-approval inspection at the site between September 4 and September 12, 2025... Full

Doctor Mike Calls On Healthcare, Pharma Leaders to Lean into Social Media to Rebuild Trust with Patients

(9/12, Heather Landi, Fierce Pharma) ...Social media gives qualified healthcare professionals a way to engage with patients on a broad scale and educate the public on health issues from vaccines to nutrition to misleading TikTok medical advice. But many of the most trusted and credible voices aren't there, missing out on a big opportunity to connect with the public, [Mikhail Varshavski, D.O.] told attendees at the Fierce Pharma Week 2025 conference in Philadelphia this week... Full

US Urged UK to Offer Better Drug Pricing Deal to Pharma Companies

(9/12, Anna Gross and Hannah Kuchler, Financial Times) ...The US ambassador to the UK has urged Rachel Reeves to offer a better deal on drug pricing to global pharmaceutical groups, piling pressure on the government in the same week that Merck scrapped a £1bn London development and AstraZeneca paused a Cambridge project. At a private dinner at the ambassador's residence in London on Sunday, Warren Stephens raised with the chancellor the US government's concerns about the amount the UK pays for drugs as well as the value for money formula used for drug approvals, said multiple people briefed on the meeting... Sub. Req’d

EU GMP Changes Target Supply Chain Risks And Product Shortages

(9/12, Vibha Sharma, Pink Sheet) ...The European Commission's proposed revision of Chapter 1 of the EU good manufacturing practice (GMP) guideline emphasizes the need for companies to take a proactive approach to managing supply chain vulnerabilities within their pharmaceutical quality systems. The updates aim to align the EU GMP framework with the ICH Q9(R1) guideline, fostering a more evidence-based, consistent approach to maintaining quality across the product lifecycle and supporting global harmonization of pharmaceutical standards. The proposed changes represent a "thoughtful evolution of the regulatory framework," Pete Gough, of the independent public health standards development and certification organization NSF, told the Pink Sheet... Global Sub. Full

NHS Failure to Pay More for Drugs ‘Is Killing Patients'

(9/14, Eleanor Hayward, The Times) ...Guy Oliver, the UK head of the global pharmaceutical giant Bristol Myers Squibb (BMS), said "chronic underinvestment" in medicines meant his company had no choice but to cut hundreds of UK jobs and end drug trials and partnerships with the NHS. He said: "As a company, we can't really do research, development and clinical trials in a country that doesn't value that innovation. That's why we and other companies have made big decisions to not bring medicines to the UK, not bring clinical trials to the UK and to reduce investment in the UK. It's absolutely getting worse. "There is a human cost to all of this. Patients are really suffering, and have been suffering for many, many years now. Out of all the medicines that are available in Europe, 35 per cent of those medicines are not available in the UK at all."... Full

Indian Pharma Makes a Strategic Shift to Innovate Generics via 505(b)(2) to Carve a Global Niche: Dr Hemagir Gosavi

(9/13, Nandita Vijayasimha, Pharmabiz.com) ...Indian pharma companies are moving away from merely supplying me-too versions of blockbuster drugs. Instead, these companies are increasingly leveraging the US FDA's 505(b)(2) regulatory pathway to create differentiated, value-added generics effectively carving a new global niche, said Dr Hemagir Gosavi , manager, formulation and technology centre, Application Services/R&D Division, UPM, Merck Life Sciences... Full

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