Wednesday, April 16, 2025

Wockhardt Confirms US Market Exit After Past Challenges

(4/15, Adam Zamecnik, Generics Bulletin) ...The Indian pharma player Wockhardt is seeking to leave the US market, marking a continuation of the company's longer-term withdrawal from the country...Khorakiwala discussed the potential impact of US tariffs on pharmaceutical imports in an interview with Generics Bulletin sister publication Scrip last month. Khorikwala also spoke about the company's superbug-busting novel antibiotics, having successfully completed a Phase III study of its complicated urinary tract infection treatment Zaynich (zidebactam/cefepime) in January... Global Sub. Full

Abbott to Build New US Manufacturing With Tariff Threat Looming

(4/16, Madison Muller, Bloomberg) ...Abbott Laboratories said it will build two new US manufacturing plants with the impact of tariffs on medical devices and diagnostics looming over the industry. It expects to spend $500 million on the plants, located in Illinois and Texas, and bring them online by the end of the year... Sub. Req’d

Sanofi's Kymab-Originated Inflammatory Drug Flunks Mid-Stage Asthma Trial

(4/15, Ayisha Sharma, Endpoints News) ...Sanofi's efforts to explore its OX40-ligand targeting drug for inflammatory diseases other than eczema have hit a roadblock as the drug failed a Phase 2 trial in patients with asthma...Sanofi also noted on Tuesday that it has kicked off two Phase 3 and one Phase 2 trial of its Regeneron-partnered IL-33 targeting drug, itepekimab, in chronic rhinosinusitis. Itepekimab is also in a pair of Phase 3 studies in chronic obstructive pulmonary disease, with readouts expected in the second half of this year. The company also expects to start a Phase 2/3 COPD trial of its dual IL-13/TSLP inhibitor, lunsekimig, this year... Full

Leqembi Wins EU Authorization for Some Alzheimer's Patients, Giving Biogen, Eisai a Boost Over Lilly

(4/15, Nicole DeFeudis, Endpoints News) ...The decision from the European Commission makes Leqembi the "first treatment in Europe authorized for patients in the early stages of Alzheimer's disease," Biogen's head of development Priya Singhal said in a statement to Endpoints News. It also gives the companies a head start in Europe after Eli Lilly's rival therapy Kisunla received a negative opinion from the European Medicines Agency's human medicines committee last month... Full

BMS Growth Driver Camzyos Fails in Heart Disease Trial, Denting Expansion Opportunity

(4/15, Zoey Becker, Fierce Pharma) ...Bristol Myers Squibb's examination into whether its heart med Camzyos can spark improvements in patients with non-obstructive hypertrophic cardiomyopathy (nHCM) turned out to be a conclusive failure, leaving the company with one fewer avenue to boost the drug's long-term growth trajectory... Full

Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

(4/15, Dave Wallace, Generics Bulletin) ...The Indian biosimilars giant has just announced that it has settled US patent litigation with Regeneron over the ophthalmic blockbuster, on terms that allow it to launch its US Food and Drug Administration-approved Yesafili (aflibercept-jbvf) rival in the second half of 2026. And with several other FDA-approved aflibercept biosimilars waiting for their own chance to launch – and tied up in litigation with Regeneron – Biocon's settlement could provide a sign of expectations to come for other developers who choose to settle with the originator... Global Sub. Full

An Indian Drugmaker, Investigated by ProPublica Last Year, Has Recalled Two Dozen Medications Sold to U.S. Patients

(4/16, Patricia Callahan, ProPublica) ...In February, the FDA found problems with cleaning and testing at the plant in Madhya Pradesh, India, which was the subject of a ProPublica investigation last year. The current recalls, listed in an FDA enforcement report last week, cover a wide range of commonly prescribed medicines, including ones that treat epilepsy, diabetes, multiple sclerosis, heart disease and high blood pressure, among other ailments. The agency determined that the drugs could cause temporary or reversible harm and that the chance of more serious problems was remote. However, the FDA didn't say what symptoms the flawed drugs could cause. ProPublica asked the FDA and Glenmark for more specifics, but neither responded... Full

How State Substitution Laws Shape Insulin Biosimilar Adoption

(4/15, Skylar Jeremias, The Center For Biosimilars) ...Although the FDA requires biosimilar manufacturers to submit switching study data to obtain the label, insulin biosimilars are exempt from this due to a 2020 rule based on a century's worth of data showing the safety of switching between equivalent insulin products. However, every US state has laws regulating how interchangeability works, with 4 states and Puerto Rico passing laws that restrict interchangeability entirely. Most state laws pertain to whether patients or providers need to be notified that a substitution has occurred, potentially affecting biosimilar use... Full

Trump Signs Healthcare Executive Order That Includes a Win for Pharma Companies

(4/16, Ahmed Aboulenein, Reuters) ...U.S. President Donald Trump directed his health department on Tuesday to work with Congress on revamping a law that allows Medicare to negotiate prescription drug prices, seeking to introduce a change the pharmaceutical industry has lobbied for. Drugmakers have been pushing to delay the timeline under which medications become eligible for price negotiations by four years for small molecule drugs, which are primarily pills and account for most medicines. That would align with the 13-year wait until more complex biotech drugs become eligible for Medicare price negotiations... Full

Trump Pledges His Support for a Change to the IRA Long Sought by Drugmakers

(4/15, Zachary Brennan, Endpoints News) ...A White House official said the law as written encourages an imbalance that is increasing investments in large-molecule drugs while reducing the incentive to develop small-molecule drugs, which can be less expensive and more convenient to take once they reach the market. Trump's order also calls for making the Medicare negotiation program, now entering its second round, more efficient and transparent, the White House said... Full

Donald Trump Pledges to Cut Drug Prices for Americans

(4/15, Hannah Kuchler and Steff Chávez , Financial Times) ...Trump's order will direct the US drugs regulator, the Food and Drug Administration, to allow more states to import medicines directly from countries with lower prices, after Florida was authorised in January 2024 to import from Canada...Most notably, in a win for the pharmaceutical industry, the order pushes for an end to the different price negotiation regimes for pills and injectables. Under the IRA, Medicare could negotiate the price of popular pills after nine years, but would have to wait for 13 until it could negotiate the price of injectables, which was criticised by pharma companies... Sub. Req’d

Trump Seeks to Lower Drug Prices Through Medicare and Some Imports

(4/15, Rebecca Robbins and Margot Sanger-Katz, The New York Times) ...In a statement on Tuesday, Alex Schriver, an official at the drug industry's main lobbying group, PhRMA, said that his organization would work with the Trump administration and Congress to "advance common sense solutions that lower costs and improve access for Americans." Biden officials oversaw the first round of negotiations in the program, resulting in price cuts that will go into effect in 2026. The Trump administration is overseeing negotiations this year for lower prices in 2027 for drugs including the blockbuster weight-loss medication sold as Ozempic and Wegovy... Sub. Req’d

Trump Targets IRA Drug Negotiation ‘Imbalance' In New EO, But Offers Few Details

(4/15, Maaisha Osman, Inside Health Policy) ...An alternative to extending exemption period for small molecule drugs from Medicare price negotiations would be to shorten the negotiation timeline for biologics to match that of small molecules, according to Anna Kaltenboeck, principal and head of the prescription drug reimbursement practice at Advanced Technology Institute (ATI) Advisory. "There's a very simple alternative that saves more money and protects small molecule drugs," Kaltenboeck told IHP, advocating for reducing the time before biologics face price negotiations. She noted that all drugs targeted for negotiation are high-spending drugs, with Medicare expenditures exceeding $200 million annually... Sub. Req’d

White House Pushes FDA On Drug Imports, Generic Reviews; DOL On PBMs

(4/15, Maaisha Osman, Inside Health Policy) ...The order instructs FDA to move forward on approving more state plans to import drugs from Canada, a policy first launched during Trump's first term. Seven states have enacted legislation to establish a drug importation program in accordance with a final Trump-era rule from 2020 that permits states to import more affordable drugs, but Florida is the only state so far to gain FDA approval... Sub. Req’d

Pharma Tariffs Could Leave Little Room to Hide with Sweeping Probe Underway

(4/15, Anna Brown, Endpoints News) ...The investigation, announced Monday, will cover finished drug products, medical countermeasures, active pharmaceutical ingredients, "key starting materials" and derivative products. Its scope suggests the Trump administration could be planning expansive levies on the pharma sector — potentially ensnaring companies like chemical manufacturers that previously thought they might be unaffected. "It looks like it's going to be pretty broad," but it will depend on what categories of products are ultimately covered under the potential tariffs, Adams Lee, an international lawyer at Harris Sliwoski, told Endpoints News... Full

Pharma Companies Expected to Absorb Any Tariff Hit in Short Term

(4/16, Deena Beasley, Reuters) ...Brand-name drugs unlikely to see price increases from tariffs, drugmakers expected to absorb initial costs. Tariff costs could threaten access to cheap generic drugs, which have thin profit margins. Tariffs could prompt pharmaceutical companies to cut costs, including staff and R&D activity... Full

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems'

(4/15, Dave Wallace, Generics Bulletin) ...News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe... Global Sub. Full

Biosimilars Forum Statement On Tariffs Impacting Low Cost Medicines

(4/15, Biosimilars Forum) ..."Tariffs that directly target the biosimilar supply chain—from the original ingredients to the finish products—could threaten the future viability and existence of the biosimilars industry. Already, U.S. biosimilar manufacturers spend 8 to 10 years and close to $300 million for each biosimilar they develop—which are, on average, more than 50% lower-cost than the originator biologics they reference. Worse, there is as a ‘biosimilar void' comes increasingly into view: despite 118 reference biologics expected to lose patent protection over the next decade, only 12 currently have a biosimilar in development..."... Full

Tariffs On Generic Drugs Will Cause Companies to Stop Making Them: Former FDA Commissioner Gottlieb

(4/15, CNBC) ...Dr. Scott Gottlieb, former FDA Commissioner, joins ‘Squawk Box' to discuss current pharmaceutical imports under investigation, moving production for branded and generic drugs elsewhere, and much more... Full

Pharma Tariffs Could Be a Generics Problem

(4/15, Nathan Bomey, Axios) ...The Trump administration on Monday announced an investigation into drug imports in a likely precursor to tariffs, which the president has promised as a way to boost American production. But J&J CFO Joe Wolk said the probe — which is centered on impacts to U.S. national security — would likely show that most U.S. drug imports are generics, not the type of complex brand-name treatments made by J&J...J&J management downplaying the impact of tariffs is "an important positive development for perception about the threat to JNJ and the branded biopharma industry at large," Leerink Partners analyst David Risinger writes today in a research note... Full

As Johnson & Johnson Navigates Changing Tariff Landscape, Execs Lay Out Their Expectations

(4/15, Fraiser Kansteiner, Fierce Pharma) ...Despite the company's optimistic guidance, J&J is also factoring in a potential hit from the Trump administration's sweeping tariffs on imports from other countries plus the retaliatory tariffs some of those countries have imposed on the U.S. in turn. For the coming year, J&J expects to weather a roughly $400 million hit thanks to the tariff situation in the U.S. For now, most of that squeeze will be centered on J&J's medtech division, Wolk explained on a call with analysts Tuesday... Full

J&J's Duato Says 'Not Tariffs, But Tax Policy' is Best Way to Boost US Manufacturing

(4/15, Max Gelman, Endpoints News) ...The Johnson & Johnson CEO subtly but assertively criticized the Trump administration's plans for pharmaceutical tariffs, saying they are not an effective tool to onshore drug manufacturing to the US. He said a better way is through policy, like the 2017 tax cuts passed during Trump's first term. "There's a reason why pharmaceutical tariffs are zero. It's because tariffs can create disruptions in the supply chain, leading to shortages," Duato said on a Tuesday earnings call. "If what you want is to build manufacturing capacity in the US, both in medtech and in pharmaceuticals, the most effective answer is not tariffs, but tax policy," he said... Full

Democratic Senators Call On RFK Jr. to Keep Rule Allowing Medicare Coverage of Anti-Obesity Drugs

(4/15, Joseph Choi, The Hill) ...A group of Democratic senators are calling on Health and Human Services Secretary Robert F. Kennedy Jr. to keep a proposed Biden-era rule that would have allowed Medicare and Medicaid to cover drugs used to treat obesity after the Trump administration decided not to finalize it... Full

CSRXP Statement On U.S. Senate and U.S. House Reintroduction of Q1/Q2 Reforms to Foster Greater Competition, Lower Drug Prices

(4/15, The Campaign for Sustainable Rx Pricing) ..."CSRxP applauds Senators Hassan, Hickenlooper, Lee and Paul as well as Representatives Dunn and Mullin for reintroducing these bipartisan solutions to reform the FDA's Q1/Q2 sameness requirements and help foster greater competition from more affordable generic alternatives to high-priced brand name drugs," said CSRxP executive director Lauren Aronson... Full

HHS Rejects Amgen, Lilly Fight of Clinics in Drug Discount Plan

(4/15, Nyah Phengsitthy, Bloomberg Law) ...Amgen Inc., Eli Lilly & Co., and UCB Inc., failed to exhaust regulatory administrative remedies before initiating this lawsuit, and their claims lack subject matter jurisdiction, the agency said Monday in a partial motion to dismiss filed in the US District Court for the District of Columbia. At issue before the court is whether HHS lawfully granted clinics under Sagebrush Health Services that treat STDs to obtain discounted drugs from manufacturers under the federal 340B Drug Pricing Program... Sub. Req’d

FDA Cuts Threaten New Drugs as Reviewers Saddled With Extra Jobs

(4/15, Nyah Phengsitthy, Bloomberg Law) ...Another reviewer said in an interview that it's "no longer hypothetical" that drug reviews will slow. The reviewer said they expect to miss a date required under the Prescription Drug User Fee Act because their leadership and those who sign off on approvals was pushed out. That act allows the FDA to collect sizable fees from industry so that they can complete reviews in a timely manner... Sub. Req’d

Biosimilar Adoption, Legislative Action With PBMs: JC Scott

(4/15, Pearl Steinzor and JC Scott, AJMC) ...Pharmacy benefit managers (PBMs) are working with policy makers to ensure transparency requirements and other legislative actions align with their goal of providing information to empower clients and patients, says JC Scott, CEO and president of The Pharmaceutical Care Management Association (PCMA)... Full

State AGs Demand Congress Ban PBMs From Owning Pharmacies

(4/15, Gabrielle Wanneh, Inside Health Policy) ...Members of the National Association of Attorneys General are pressing congressional leadership to pass legislation barring pharmacy benefit managers and their parent insurance companies from owning pharmacy businesses. In a letter sent Monday (April 14), they cite the increasing influence of PBMs in the drug market due to consolidation and vertical integration as a key factor of the country's issues with high, manipulated drug prices and the inaccessibility of medicines for patients... Sub. Req’d

Congress Should Bar PBMs From Owning Pharmacies, State Attorneys Urge

(4/15, Zachary Brennan, Endpoints News) ...The attorneys general lay out how PBMs "continue to devour more of the pharmaceutical industry" as Caremark and Express Scripts recently created wholly-owned subsidiary "manufacturers" that market biosimilars to AbbVie's blockbuster Humira, as they slowly chip away at Humira's dominance. The letter was signed by AGs from states including Alaska, Arizona, Arkansas, California, Massachusetts, Missouri, Hawaii and Vermont... Full

European Pharma Companies Issue Demands to Stay in EU Ahead of Expected US Tariffs

(4/15, Makini Brice, Reuters) ...In the letter sent to European Commission President Ursula von der Leyen, the companies -- including Pfizer, Eli Lilly and AstraZeneca -- said they face cost disadvantages in Europe versus the United States, where drugs are sold at prices that on average are twice that of some European countries, such as France, Les Echos reported. U.S. President Donald Trump has said he expects to impose tariffs on imported pharmaceuticals in the near future. The companies also asked the EU to simplify regulations, noting that companies currently must conduct multi-country clinical trials for drugs, the letter said... Full

Indian Drug-Makers Expect Minimal Hit To Generics, May Plan Change In Business Strategy Amid Trump Tariff Risks

(4/16, Himani Chandna, News18.com) ...News18 reached out to several pharmaceutical companies for comments, but most declined to respond, citing a ‘wait and watch' approach amid ongoing developments. However, most of these companies, speaking off the record, told News18 that they don't anticipate a major fallout for generic drugs as higher costs would primarily impact American consumers. Industry insiders believe that the brunt of the impact will likely be felt by big pharma's patented medicines... Full

Industry Experts Expect Marginal Tariffs On Pharmaceutical Sector, Unfazed by Chip Levies

(4/15, Parikshit Luthra, CNBC TV-18) ...Ashok Chandak from IESA believes that, from India's perspective, there won't be major problems in the short term even if tariffs are introduced. This is because India doesn't manufacture many semiconductors at present and imports most of them...Kewal Handa, President of Samarth Lifesciences and Former MD of Pfizer India, said, "My best case is 10% to 11% tariff, and the worst scenario would be around 25% tariffs. So in between, based on how we negotiate and what the bilateral negotiation is, that tariff would be levied." According to Handa, imposing high tariffs on the pharmaceutical industry would be difficult due to the current situation in the US, where there is a severe shortage of over 300 medical products... Full

Trump's Pharma Measures Seem More Opioid-Focused, Won't Impact Majority Generics: Pharmexcil

(4/16, Rishabh Bhatnagar, NDTV Profit) ...The US administration's latest measures against pharma imports might not impact India heavily since generics outside narcotics are likely not in focus, according to the Pharmaceuticals Export Promotion Council of India. "We're in the process of identifying companies and trying to understand the background better...the measures seem more focused on opioid based dedicates...will not impact generics outside narcotics category," Namit Joshi, Chairman of Pharmexcil told NDTV Profit, adding that these are initial views based on US' onshoring capabilities... Full

Korean Drugmakers Scramble for Clarity as US Weighs Drug Tariffs Amid Price-Cut Push

(4/16, Lee Han-soo, Korea Biomedical Review) ...Korea's pharmaceutical and biotech industry is grappling with growing uncertainty as the U.S. government shifts its trade and healthcare policy landscape—raising the specter of import tariffs on medicines just as it pushes to lower prescription drug prices...Caught between these seemingly conflicting signals, Korean pharma companies such as Celltrion, Samsung Bioepis, and SK biopharmaceuticals are closely monitoring developments but have yet to alter their core strategies. While some firms have long considered building production capacity in North America, no concrete shift has been announced in response to the latest U.S. moves... Full

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