Wednesday, July 16, 2025

Trump Says Drug Tariffs Probable by Aug. 1, Downplays More Deals

(7/15, Jennifer A Dlouhy and Justin Sink, Bloomberg) ...President Donald Trump said he was likely to impose tariffs on pharmaceuticals as soon as the end of the month and that levies on semiconductors could come soon as well, suggesting that those import taxes could hit alongside broad "reciprocal" rates set for implementation on Aug. "Probably at the end of the month, and we're going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we're going to make it a very high tariff," Trump told reporters Tuesday as he returned to Washington after attending an artificial intelligence summit in Pittsburgh... Full

Trump Threatens to Impose Drug and Chip Tariffs as Soon as August 1

(7/16, Joanna Partridge, The Guardian) ...Any levies imposed on pharmaceuticals are expected to hit drugmakers including Eli Lilly, Pfizer and Merck, which have overseas production sites, while such a move risks increasing prices for US consumers. Any tariffs on semiconductors are predicted to affect chipmakers and the companies such as Apple and Samsung whose smartphones and computers require chips... Full

Swedish Drugmaker Sobi Doesn't See Pharma Tariffs as ‘Imminent'

(7/16, Maggie Shiltagh, Bloomberg) ...Drugmaker Swedish Orphan Biovitrum AB's Chief Executive Officer Guido Oelkers said he doesn't think tariff threats on the pharmaceutical industry are likely to materialize imminently. "It's hard to imagine how tariffs that are speculated about can be good for patients, can be good for players and are in the interest of government," Oelkers said in an interview. "I don't think this is imminent."..."I cannot build a strategic plan that changes by the hour," Oelkers said, noting Trump's back-and-forth. "Life-saving medicines for children isn't an area where you can win popularity contests if products are not as available or if change gets disrupted."... Sub. Req’d

Barclays: The Pharma Sector is Very Out of Favor for Tariffs

(7/14, CNBC) ...Emily Field, head of European pharma research at Barclays, discusses which drug makers would be most impacted by 30% U.S. tariffs on EU imports, and the likelihood President Trump moves ahead with up to 200% tariffs on foreign pharma products... Full

BMS Warns Against ‘Indiscriminate Use' of Renegotiations as CMS Plans Next Drug Price Talks

(7/15, Nicole DeFeudis, Endpoints News) ...Bristol Myers Squibb is calling for transparency in drug price talks if the government selects products for renegotiation under the Inflation Reduction Act, cautioning against "indiscriminate use" of the process..."CMS is committed to implementing a robust and transparent negotiation process to lower prescription drug costs for people with Medicare," HHS spokesperson Andrew Nixon told Endpoints News on Tuesday. "We remain focused on implementing the Medicare Drug Price Negotiation Program consistent with our statutory responsibilities and with meaningful engagement from stakeholders across the healthcare system."... Sub. Req’d

Bipartisan Legislators Revive PBM Reform Debate On the Hill

(7/15, Paige Minemyer, Fierce Healthcare) ...The PBM Reform Act, led by Republican Rep. Buddy Carter of Georgia, seeks to ban spread-pricing models in Medicaid and instead move to a more "transparent" system that the legislators say will more fairly reimburse pharmacies for the services they provide. In addition, the bill would delink PBM compensation from medication costs within Part D, and establish semi-annual reporting that provides further detail on spending, rebates and formulary decisions for plan sponsors and members... Full

Welch, Hawley, Klobuchar Introduce Bipartisan Legislation to Streamline Drug Patent Litigation, Lower Cost of Prescription Drugs

(7/15, U.S. Senators Peter Welch) ...Today, U.S. Senators Peter Welch (D-Vt.), Josh Hawley (R-Mo.), and Amy Klobuchar (D-Minn.) teamed up to introduce the Eliminating Thickets to Improve Competition (ETHIC) Act, bipartisan, bicameral legislation to streamline drug patent litigation, encourage fair market competition, and lower prescription drug prices by making it easier for generic and biosimilar companies to enter the market. U.S. Representative Jodey Arrington (R-TX-19) introduced companion legislation in the House... Full

About 2.5% of All Drug Patents Cite Government Funding, New Study Finds

(7/15, Zachary Brennan, Endpoints News) ...Of the nearly 10,000 patents protecting small molecule drugs and listed in the FDA's Orange Book, 2.5% cite government funding, according to a new study published in Nature Biotechnology on Tuesday. The number of patents shows the extent to which the government primarily funds early-stage research that biopharma companies harness to bring new drugs to market. A 2023 JAMA study showed how 99% of drugs approved from 2010 to 2019 had origins in NIH-funded research... Sub. Req’d

340B Pulled $6.5B in Drug Rebates from Medicaid in 2024, PhRMA-Backed Report Finds

(7/15, Dave Muoio, Fierce Healthcare) ...The pharmaceuticals lobby shored up its campaign against increasing use of the 340B Drug Discount Program with a new analysis estimating its broader use pulled $6.5 billion in rebates away from the Medicaid program in 2024. The tally comes from a Berkeley Research Group (BRG) research brief funded by the Pharmaceutical Research and Manufacturers of America (PhRMA)... Full

Amphastar to Quadruple Domestic Manufacturing

(7/15, AAM) ..."Amphastar's largest investment in company history focused exclusively on domestic manufacturing and supply chain resilience is yet another proof point that AAM member companies are focused on the U.S. health care system and patients," said John Murphy III, President and CEO of AAM...Amphastar Pharmaceuticals is a focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products. Yesterday, they announced a multi-year expansion of its U.S. manufacturing operations in California. The company plans to quadruple its production capacity over the next three to five years, reinforcing its commitment to domestic pharmaceutical manufacturing and strengthening supply chain resilience... Full

FDA Seeks More Import Enforcement Authority, Supply Chain Visibility

(7/15, Jessica Karins, Inside Health Policy) ...FDA is seeking more authority from Congress to take enforcement action against unsafe device imports and to track the supply chains of manufacturers, including the ultimate sources of active pharmaceutical ingredients. The request is part of a package of legislative changes the agency is calling for with its fiscal 2026 budget request... Sub. Req’d

Florida Rep. Byron Donalds Leads Charge Against Global Drug Price "Freeloaders"

(7/15, Danielle Shockey, Tampa Free Press) ...A group of House lawmakers, led by Congressman Byron Donalds (R-FL), is applauding the Office of the U.S. Trade Representative (USTR) for taking a firm stand on international pharmaceutical pricing, aiming to end what they term "freeloading" by foreign nations on American-funded drug innovation. The initiative aims to bring fairness to drug costs, ensuring that American patients are no longer disproportionately bearing the burden of global pharmaceutical research and development... Full

Biocon Eyes Generic Wegovy Obesity Drug Launch in India, Canada in Next 2 Years, CEO Says

(7/16, Rishika Sadam, Reuters) ...Biocon aims to launch generic copies of the blockbuster weight-loss drug Wegovy in India and Canada within the next two years, a top executive told Reuters, seeking to tap into a market that is estimated to grow to $150 billion globally by the early 2030s...Biopharmaceutical company Biocon plans to submit a request for approval to India's drug regulator by the end of 2026 and potentially launch in 2027 through a partner, CEO Siddharth Mittal said in an email interview on Tuesday... Full

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

(7/16, Dave Wallace, Generics Bulletin) ...Biocon Biologics has received US Food and Drug Administration approval for its rapid-acting insulin aspart biosimilar under the name Kirsty. The biosimilar has become the first to be formally designated as interchangeable with Novo Nordisk's Novolog reference brand by the FDA. Sanofi's Merilog version was previously approved by the FDA as the first US insulin aspart biosimilar, but launch details have not been made public... Global Sub. Full

MSN's Entresto Generic Temporarily Blocked As Key US Patent Expires

(7/16, Dean Rudge, Generics Bulletin) ...The Federal Circuit has temporarily prohibited MSN Laboratories from launching its generic version of Entresto. The appeals court has awarded Novartis temporary relief as it evaluates the company's urgent request for a longer injunction. This decision arrives after a Delaware court last week ruled in favor of MSN, finding that its generic product does not infringe Novartis' US patent 11,096,918, which is set to expire in November 2026... Global Sub. Full

J&J Beats Sales Expectations While Trump Threatens Tariffs

(7/16, Damian Garde, Bloomberg Law) ...J&J's strong second quarter comes a week after President Donald Trump told reporters in a cabinet meeting he would impose tariffs as high as 200% on drug companies if they don't shift more of their manufacturing to the US over the next year to 18 months. That was actually good news, J&J Chief Financial Officer Joe Wolk said in an interview. Trump had previously threatened to impose tariffs on the industry in a matter of weeks. The delay shows "there's an understanding you can't put up a biopharmaceutical manufacturing facility overnight," Wolk said in an interview. "As long as those conversations continue to occur, I think we're in a pretty good position."... Sub. Req’d

As GSK Eyes Blenrep's US Return, FDA Flags Eye Safety Concerns Ahead of Advisory Committee Meeting

(7/15, Eric Sagonowsky, Fierce Pharma) ...In a document posted ahead of the July 17 meeting of the Oncologic Drugs Advisory Committee, FDA reviewers flagged "high rates of ocular toxicity" and "uncertainty regarding the proposed dosages" as key issues for Thursday's discussion...In addition, treatment with GSK's Blenrep was "associated with severe ocular toxicities, including corneal ulcers and clinically significant decline in visual acuity, including severe vision loss," the document reads. In a particularly noteworthy comment from the agency, the reviewers said the corneal toxicity seen with the ADC drug is a "unique risk to this product and is not seen with currently available therapies" for multiple myeloma... Full

A Troubled Sun Pharma Plant Fails Yet Another FDA Inspection

(7/15, Ed Silverman, STAT+) ...The problems cited at the facility, which is located in Halol, involved a raft of practices that raised questions about the ability of the world's largest generic drugmaker to properly ensure sterility, environmental conditions, and cleanliness, according to a 19-page report issued by the FDA on its website. The agency inspected the Sun plant for two weeks during the first half of last month. The findings indicate ongoing difficulties at the plant, which is a key location for the company and has previously ran afoul of FDA inspectors during several inspections dating back nearly a decade... Sub. Req’d

As Weight-Loss Spending Soars, US Employers Plan to Pare Health Benefits

(7/16, Amina Niasse, Reuters) ...More than half of large U.S. employers plan to scale back healthcare benefits next year as rising costs from weight-loss and specialty drugs squeeze budgets, according to a new survey released by consulting firm Mercer on Wednesday...Prescription drug costs jumped 8% last year, according to the survey. Mercer has forecast a 5.8% rise in overall health benefit costs for 2025. Employers are also eyeing alternatives to traditional pharmacy benefit managers (PBMs), according to Mercer... Full

Gross-to-Net Bubble Hits $356B in 2024—But Growth Slows to 10-Year Low

(7/15, Adam J. Fein, Ph.D, Drug Channels) ...Drug Channels Institute (DCI) estimates that the gross-to-net reductions for all brand-name drugs reached $356 billion in 2024, a 7% increase over the previous year. Yet despite this record total, the bubble expanded at the slowest rate in at least a decade. In our analysis below, we highlight five key forces driving this shift. Among them: manufacturers' evolving market access strategies, which increasingly aim to offset—or circumvent—growing pricing pressure from both commercial and government payers... Full

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

(7/15, Urte Fultinaviciute, Generics Bulletin) ...During a conference hosted by Medicines UK on July 8, MP Karin Smyth highlighted the importance of biosimilars for the country's healthcare system. The recently announced NHS 10-Year Plan will allow NICE and MHRA to work closer with each other, but the proposal may be too ambitious and "glitzy" in reality. Meanwhile, Brexit opened the opportunity for the UK to establish its regulatory autonomy, from which biosimilars will benefit... Global Sub. Full

ABPI Says UK Life Sciences Strategy at Risk Without Medicines Investment

(7/16, The Pharma Letter) ...The UK government's new life sciences plan has been met with skepticism by the pharmaceutical industry, which says the strategy will fall flat unless there is a serious shift in the way new medicines are funded and valued...While the latest plan includes welcome commitments to support manufacturing, research and data use, the Association of the British Pharmaceutical Industry (ABPI) says it does not go far enough. The group warns that without stronger investment in innovative medicines, the UK risks further decline in global rankings for research and patient access... Sub. Req’d

How EU Price Cuts Are Fuelling a Global Drug Crisis

(7/16, Laura Clavijo Villagrasa, Medscape) ...Experts warn that uncoordinated medicine price cuts across the EU are contributing to global drug shortages. In efforts to make healthcare systems more sustainable, many EU countries have independently reduced prices, putting pressure on manufacturers and prompting them to prioritise more profitable markets. This issue is the central focus of ongoing reforms of European pharmaceutical legislation, which is currently under debate... Full

Spain's Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

(7/15, Francesca Bruce, Pink Sheet) ...The Spanish medicines regulator, AEMPS, has published a new five-year plan to improve the supply of essential medicines. Measures in the plan include streamlined administrative processes for registering essential medicines and expedited authorization of marketing applications submitted through the national procedure. The plan proposes to introduce incentives that would drive local manufacturing of essential medicines... Global Sub. Full

OBBB Act to Impact Indian Pharma Cos in Medicaid Cuts, PBM Reforms, Orphan Drug Exemptions: Experts

(7/16, Shardul Nautiyal, Pharmabiz.com) ...As the Indian pharmaceutical industry is a major supplier of generic drugs to the US market, accounting for approximately 40% of generic prescriptions, the One Big Beautiful Bill Act (OBBBA) provisions will have significant implications in the form of Medicaid cuts, Pharmacy Benefit Manager (PBM) reforms and orphan drug exemptions, according to pharma industry experts... Full

Why Indian Pharma Must Think Beyond Generics

(7/16, NK Ganguly, Hindustan Times) ...Today, India supplies 20% of global generics and meets over 60% of the world's vaccine demand, exporting to more than 200 countries. Yet, even as we celebrate these strengths, it is clear that the next phase of growth will not be driven by volume alone. To remain globally competitive and meet the complex health needs of the future, India must move up the value chain—towards biosimilars, novel biologics, precision medicine, and region-specific innovation. This evolution is not a break from our generics' legacy but a natural extension of it... Full

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