Friday, July 11, 2025

Trump's 200% Tariff Threat Leaves Pharma Firms Scrambling with Scenario Planning

(7/11, Karen Gilchrist, CNBC) ...The industry is now awaiting further details at the end of this month, when the final Section 232 investigation report is due. But in the meantime, firms have little choice but to plan for various potential outcomes...A Roche spokesperson said the company was "monitoring the situation closely" and engaging with stakeholders to "advocate for policies that address barriers to patient access" and create "a more equitable and affordable healthcare ecosystem." The Swiss pharmaceutical giant had previously said that Trump's drug pricing order could jeopardize its U.S. investment. However, it noted Wednesday that its proposed funding will allow it to continue building out its manufacturing footprint in the U.S... Full

House Lawmakers Merge PBM Reforms Dropped From Reconciliation Into New Bill

(7/10, Gabrielle Wanneh, Inside Health Policy) ...House GOP and Democratic lawmakers are hopeful a new bill introduced Thursday (July 10) that revives the pharmacy benefit manger reforms kicked out of the recently enacted budget reconciliation law and a bipartisan health care deal from last year will have a decent shot at passage this Congress... Sub. Req’d

NCPA: New "PBM Reform Act" Must Pass ASAP

(7/10, NCPA) ..."As PBMs continue manipulating drug pricing, extinguishing their competition, and raking in massive profits, patients and pharmacies are suffering. We need help, and we need it quickly. Systemic changes like those in the PBM Reform Act must pass and be enacted as soon as possible. We're grateful for this bill's introduction and will do everything we can to push it across the finish line."... Full

The Culprit Impeding Drug Competition Is Not Who The Feds Expected

(7/10, Sally Pipes, Forbes) ...The title of the first session—"Anticompetitive Conduct by Pharmaceutical Companies"—made it seem that regulators would chiefly investigate biotech firms. Yet by the end, panelists had refocused the spotlight onto pharmacy benefit managers—and provided striking evidence that PBMs, not biotech companies, deserve most of the blame for the anticompetitive practices that lead to high drug prices. If the FTC and DOJ heed the panelists' warnings and crack down on this misbehavior, it could tangibly reduce drug costs for patients... Full

Fraud, Nuisance Claims Offer a Winning Strategy to Defeat PBMs

(7/11, Gregg Goldfarb, Bloomberg Law) ...While the Federal Trade Commission's lawsuit against pharmacy benefit manager giants is paused by a temporary stay, lawsuits from state attorneys general and private plaintiffs offer prime opportunities for attorneys to hold pharmacy benefit managers accountable. State lawsuits are rewriting the rules, demanding agile litigation playbooks. By wielding antitrust, fraud, and nuisance claims, you can deliver verdicts that ripple across healthcare, slashing costs, forcing accountability, and transforming healthcare's future... Full

FDA Offers to Trade Faster Drug Reviews for Lower US Prices

(7/11, Rachel Cohrs Zhang and Sam Hornblower, Bloomberg) ...Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that "equalize" the cost of their medicines between the US and other countries, an unusual proposition from the regulator that's long avoided contentious pricing debates. The comments, made in an interview on Bloomberg Television's Wall Street Week with David Westin, offer insight into an idea floated to help the administration achieve one of President Donald Trump's main health-care goals: ensuring foreign countries aren't getting a better deal on drugs... Sub. Req’d

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

(7/10, Sarah Karlin-Smith, Pink Sheet) ...The FDA would receive more non-user fee funding under a Senate Appropriations Committee FY 2026 budget bill than the House Appropriations Committee wants to provide. The Senate bill would set the FDA budget with more than half coming from taxpayers, not user fees, unlike the House. The Senate allocated $10m for unannounced foreign inspections, a priority for Commissioner Martin Makary... Global Sub. Full

F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs

(7/10, Christina Jewett and Rebecca Robbins, The New York Times) ...The documents, referred to as "complete response letters," are akin to rejection letters. Some outline problems with an experimental drug that cannot be remedied; those letters are never made public. But the letters released on Thursday described the agency's early concerns about drugs that were eventually approved...A review of the letters addressed to companies show that they often revolved around problems discovered in a manufacturing facility inspection, a routine step before a new drug is released to the public. Others outlined concerns about safety or a drug's effectiveness. Mr. Nixon, the spokesman for H.H.S., said the products in the letters were all eventually approved, "indicating that they remedied the deficiencies identified in the letter."... Full

FDA Publishing Of Over 200 CRLs is ‘False Transparency,' Expert Says

(7/10, Luke Zarzecki, Inside Health Policy) ...Former FDA associate commissioner Peter Pitts told Inside Health Policy the letters included in the announcement are all for products that have been approved. When FDA approves a product, the agency publishes the approval letter as well as any prior complete response letters...Pitts said no one outside of FDA knew of the move to publish CRLs before it was announced, and that he was disappointed Makary did not collaborate with industry, saying it creates an impression of "FDA versus industry." A source within the industry confirmed they were not involved in the decision-making process... Sub. Req’d

Ozempic and Wegovy are Expensive. Connecticut Wants to Make its Own Cheaper Version

(7/10, Dan Haar, Stamford Advocate) ...If Robert F. Kennedy Jr., the top federal health official under President Donald Trump, approves a petition that Connecticut must send by Aug. 7, and if no federal court blocks the move, Connecticut can hire a contractor to start making generic Ozempic. No other state has such a law in place for GLP-1 drugs, Lesser believes, and although states have threatened to do it for other drugs, none has actually carried out the threat, at least in recent decades... Full

Commentary: Cheap Drugs from Canada Can't Make America Healthy

(7/11, Sally C. Pipes, Orlando Sentinel) ...Importing Canadian drugs means importing price controls. And that will deprive drug makers of revenue. They'll cut their investments in research and development in response. And that means fewer new therapies for the next generation of patients. Diseases that might have been cured in the absence of widespread price controls might continue to cause undue suffering. Importation will not make drugs more affordable for Americans. It puts their safety — and future innovation — at risk... Sub. Req’d

Wockhardt Initiates Strategic Realignment of US Operations to Focus On Innovative Portfolio

(7/11, Wockhardt) ...Wockhardt is undertaking significant strategic realignment of its US business in line with its long-term vision to build a differentiated, innovation-driven pharmaceutical enterprise. As part of this transition, the Company has decided to exit the US generic pharmaceutical segment, paving the way for deeper focus and investment in its advanced product portfolio... Full

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

(7/11, Dean Rudge, Generics Bulletin) ...Shanghai Henlius Biotech has opened the door potentially for faster commercialization of a pair of key biosimilars in Europe, after receiving European Medicines Agency good manufacturing practice certification for its HLX14 denosumab and HLX11 pertuzumab biosimilar production lines. The announcement is also a boon for Organon, which in 2022 entered into a license and supply agreement with the Chinese firm granting exclusive commercialization rights to the two biosimilar candidates in markets including the US, the EU, and Canada... Global Sub. Full

Alvotech Boosts Packaging Abilities With Ivers-Lee Acquisition

(7/10, Dean Rudge, Generics Bulletin) ...Alvotech has acquired Ivers-Lee to strengthen its in-house assembly and packaging capabilities in anticipation of launching three new biosimilars in 2025. The deal enhances operational control and supports Alvotech's global growth strategy. Ivers-Lee will continue its operations as a separate entity while integrating its functions into Alvotech's Technical Operations division... Global Sub. Full

US Federal Circuit Says No To Teva And Viatris On Remanded Invega Sustenna Appeal

(7/10, Dean Rudge, Generics Bulletin) ...In the latest in a long line of legal decisions, Teva and Viatris have once again failed in their bid to knock out a key US patent shielding Janssen's Invega Sustenna (paliperidone palmitate) once-monthly injectable treatment for schizophrenia. The US Court of Appeals for the Federal Circuit has affirmed a lower court's decision that Janssen's US patent 9,439,906, which is to expire in January 2031, is not invalid due to obviousness... Global Sub. Full

Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

(7/10, Dave Wallace, Generics Bulletin) ...At Medicines for Europe's annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap... Global Sub. Full

Pricing Watchdog Will Take On the Rising Cost of Drugs at Launch

(7/10, Michael Gibney, PharmaVoice) ...Drug prices — particularly those set at launch by pharma companies — are spiraling upward, according to industry watchdog the Institute for Clinical and Economic Review. With a new report expected in October, ICER aims to explore the depth of these pricing increases, as well as how they relate to efficacy and access...The analysis is a massive undertaking. Within the scope of the report will be 160 new drug approvals over the course of three years with exclusions for products that have inapplicable pricing dynamics, like generics, biosimilars or vaccines... Full

Pfizer, Astellas Boost Case for Xtandi in Early-Stage Prostate Cancer with Combo Survival Win

(7/10, Zoey Becker, Fierce Pharma) ...The new data come from the companies' phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis. In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial's primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide... Full

Astellas Reports 22% Sales Bump for Izervay, Expects Trend to Continue this Year

(7/10, Kevin Dunleavy, Fierce Pharma) ...Astellas sees Izervay's growth continuing to track upward—in the "high 20s or above"—for the next three quarters and is reiterating its fiscal year sales guidance of 105 billion Japanese yen ($750 million). In the longer term, Astellas now is tabbing peak sales for Izervay to reach between 200 billion and 400 billion Japanese yen ($1.3 billion to $2.6 billion) in the U.S. alone. Those figures match the company's previous projection for peak global sales... Full

India's Glenmark Pharma Soars 10% to Record High On AbbVie Cancer Treatment Licensing Deal

(7/11, Kashish Tandon, Reuters) ...AbbVie will get the exclusive rights to develop and commercialise ISB 2001 in North America, Europe, Japan and Greater China, according to the deal. Ichnos Glenmark Innovation (IGI) will receive an upfront payment of $700 million and could earn up to $1.22 billion in additional milestone payments. "This is possibly the biggest deal by an Indian company in the biotechnology space," said Shrikant Akolkar, an analyst at brokerage Nuvama... Full

State AGs Unveil Opioid Settlements Totaling $720M with 8 Drugmakers

(7/10, Zoey Becker, Fierce Pharma) ...Over timeframes ranging from a single year to ten years, Viatris agreed to fork over $284 million, while Amneal committed to $71.7 million in settlement payments and Apotex is on the hook for $63.7 million, according to a release from Pennsylvania's AG. Other companies involved in the settlements are Hikma ($95.8 million), Indivior ($38 million), Sun Pharma ($30.9 million), Alvogen ($18.7 million) and Zydus ($14.8 million)... Full

Delaware Supreme Court Sides with Zantac Drugmakers Over Cancer Evidence

(7/10, Jonathan Stempel, Reuters) ...The Delaware Supreme Court unanimously sided with GSK, Pfizer, Sanofi and Boehringer Ingelheim in excluding testimony from 10 doctors and scientists, eight of whom opined that the active ingredient in Zantac causes 10 types of cancer. Justice Abigail LeGrow said the trial judge wrongly employed a lenient legal standard that presumed expert testimony was admissible, and failed to require the patients' experts to use "reliable scientific methodology" to reach their conclusions... Full

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

(7/10, Francesca Bruce, Pink Sheet) ...A new strategy from the European Commission to ensure that EU citizens can access critical medical products during times of crisis will increase the pull incentives on offer to companies developing antimicrobial drugs. This and other measures that will boost innovation in, and the production of, essential products, including a new Medical Countermeasures Accelerator, have been welcomed by Eucope, which represents small and medium sized pharmaceutical companies in Europe... Global Sub. Full

Potential U.S. Tariffs, Pricing Rules Raise Uncertainty in Drug Industry

(7/11, Chris Hannay, The Globe and Mail) ...The U.S. has the highest drug prices in the world, with the average list price more than three times higher than Canada's. The goal of the most-favoured-nation policy, the Trump administration says, is for manufacturers to lower U.S. prices to match the discounts they are giving to other countries...Innovative Medicines Canada, which represents drugmakers in this country, said the order should "invite reflection" on domestic policies. "While key details around implementation remain unclear, the United States has signalled a growing expectation that other countries contribute more meaningfully to the costs of pharmaceutical innovation," said Erin Polka, IMC's senior director of communications, in a statement... Sub. Req’d

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