Thursday, April 2, 2026

 

 

Teva Clarifies Operations Stable After Neot Hovav Strike

(4/2, Dean Rudge, Generics Bulletin) ...In a statement provided to Generics Bulletin, the company said: "No missiles have hit or impacted a Teva facility, all our colleagues are safe, and all operations are running as usual."... Global Sub. Full

 

Iran War and Drug Supplies: Don't Panic, But Pay Attention

(4/2, Ron Southwick, Chief Healthcare Executive) ...Teva Pharmaceuticals is based in Israel, but the company also has manufacturing plants across the United States. There's also some production in Jordan, which so far hasn't been affected, [Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health-System Pharmacist,] says. And he says most products from the region can be sourced elsewhere. Still, Ganio says there could be some impacts on pricing. With Iran effectively closing off the Strait of Hormuz, some goods are being transported by planes, which is more costly, he says... Full

 

 

Trump Administration Readies New Tariffs on Select Drugmakers

(4/1, Madison Muller, Jennifer A. Dlouhy, Hadriana Lowenkron, Bloomberg) ...The Trump administration is set to announce tariffs as soon as Thursday on drugmakers that haven't struck deals guaranteeing low prices in the US, according to people familiar with the plan, the latest move to tax imported goods on national security grounds... Sub. Req’d

 

Trump Administration Readies New Tariffs on Select Drugmakers, Bloomberg News Reports

(4/1, Fabiola Arámburo, Reuters) ...Companies that do not have agreements and are not in negotiations with the administration will be subject to 100% tariffs, the report said... Full

 

Threat of Trump's Pharma Tariffs Looms Again

(4/2, Phil Taylor, PharmaPhorum) ...It is understood that the new tariffs would apply to patented medicines, so would exclude low-cost generic drugs and active pharmaceutical ingredients on which US health systems are still heavily reliant. Further complicating the picture are the myriad trade agreements between the US and other countries – including the UK and EU– which have set separate rates for pharma imports into the US... Full

 

Eli Lilly Opposes Push to Pass Trump's Drug Pricing Deals into Law, CEO Says

(4/1, Angelica Peebles, CNBC) ..."When you throw it into the congressional process, what goes in is not what's going to come out," [Lilly CEO Dave] Ricks said...Ricks said he thinks the Trump administration and leadership on the Hill are listening to the company's concerns, but he said Lilly will use "all the tools we have to combat bad policy, and we think it would be bad policy."... Full

 

Bayer in Talks With European Governments on Higher Drug Prices

(4/1, Sonja Wind, Bloomberg) ..."In Europe, we need to raise the price level for new product launches," said Stefan Oelrich, the head of Bayer's pharmaceuticals division, in an interview. "Otherwise, as an industry — and this naturally applies to us as well — we'll be faced with additional discounts in the US that wouldn't allow us to recoup our total expenses."..."US prices will be linked to prices in countries like Germany and others," Oelrich said. "That's at least our current understanding, and we are preparing for that."... Sub. Req’d

 

More Than Just Pricing: MFN's Impact on Pharma: Q&A With Lindsay Bealor Greenleaf

(4/2, Mike Hollan, PharmExec.com) ...With the launch of TrumpRx earlier this year, Americans got their first taste of how the administration is attempting to implement its most favored nation (MFN) pricing policies. Lindsay Bealor Greenleaf, head of market access policy strategy at ADVI, spoke with Pharmaceutical Executive about the current state of MFN and how the industry expects it to impact operations as more of the policies come online... Full

 

The Real Profiteers in Healthcare Aren't Drugmakers

(4/1, Sally Pipes, DC Journal) ...The real profits in healthcare aren't flowing to the laboratories that discover new medicines. They're being captured by middlemen who control how those medicines reach patients... Full

 

Congress Takes Fresh Look at GLP-1 Legislation on Cost, Safety

(4/2, Victoria Knight, Bloomberg) ...Senate Health, Education, Labor and Pensions Chair Bill Cassidy (R-La.), one of the bill's cosponsors, told Bloomberg Government that he would like to take action on GLP-1s but was noncommittal about when, saying his committee had other priorities at the moment... Full

 

To Counter China, FDA Chief Wants to Speed Process for Approving New Drug Trials

(4/2, Max Bayer, Endpoints News) ...The FDA plans to reduce the amount of data required to start a new drug trial in the US, cutting out most parts that aren't safety-related, FDA Commissioner Marty Makary told reporters on Wednesday. The goal is to simplify and expedite the process of applying for an investigational new drug (IND) application, said Makary, who is entering his second year leading the FDA under the Trump administration. It's a goal supported by drug developers, who have framed these reforms as essential to competing against China's speedy clinical trial process... Sub. Req’d

 

FDA Commissioner Credits Himself with ‘Healing' Agency After DOGE Cuts

(4/1, The Hill) ...Scientific reviewers are being given AI tools to evaluate medications, but that doesn't mean that reviewers will be replaced by the technology, he said... Full

 

The One-Day FDA: US Commissioner Sees Drastic Time Savings In Filing, Inspections

(4/1, Bridget Silverman, Pink Sheet) ...Filing review took 60 days "for many years at the agency," Makary noted. The FDA's "extremely successful" pilot program will bring the review period to "a matter of minutes." The time savings "will enable every approval at the FDA to happen two months sooner."...Makary has similar ambitions to reduce the amount of time spent on facility inspections. "I'd like to see one day inspections," he stated. "Right now, inspections can be two weeks on site."... Global Sub. Full

 

Makary Promises OTC Revamp With Clearer Guidance, Faster Pathways

(4/1, Maaisha Osman, Inside Health Policy) ..."Every single over-the-counter pill needs to have that study repeated. It's just not common sense," he told Inside Health Policy in the press call, adding that the agency wants to focus more directly on safety and labeling rather than duplicative requirements... Sub. Req’d

 

One Year After HHS Layoffs, a Department in Disarray

(4/1, Rebecca Pifer Parduhn, BioPharma DIVE) ...Healthcare Dive staff interviewed almost 25 current and former HHS employees for this project, most of whom requested to remain unnamed for fear of retribution from the Trump administration. Staffers expressed horror at what they described as damage being done to career civil servants and to the integrity of the HHS, including the callousness of the mass firings, the diminished state of HHS agencies and the controversial priorities of Secretary Robert F. Kennedy Jr. that — to them — don't reflect the HHS' mission to enhance the health and well-being of all Americans... Full

 

Judge Voids HHS Policy Limiting Hospital Discount Drug Purchases

(4/1, Nyah Phengsitthy, Bloomberg Law) ..."HRSA offers almost no reasoning in the 2013 Policy-and the little it does provide fails to explain why the agency reached the conclusion it did," Judge Loren L. Alikhan for the US District Court for the District of Columbia said in an order filed Tuesday. The policy is arbitrary and capricious and must be vacated, Alikhan concluded... Sub. Req’d

 

EPIC Act Would Be A Multi-Billion Dollar Pharma Windfall At The Expense of Seniors

(4/1, Sarah Karlin-Smith, Public Citizen) ...Six out of the eight (75%) small molecule drugs selected for Medicare drug price negotiations this year, representing more than $11 billion in annual Medicare spending, would have been excluded had the EPIC Act been in place... Full

 

Virginia Should Be Cautious About Importing Federal Price-Setting Mechanisms

(4/1, Will May, PhRMA Blog) ...[R]ecent price-setting legislation in Virginia could limit prescription options by failing to recognize the complexity of a pharmaceutical supply chain that functions nationally, not state by state, and by targeting only manufacturers... Full

 

 

FDA Extends Review of Orca Bio's Novel Cell Therapy for Blood Cancers

(4/1, Angus Liu, Fierce Pharma) ...The review extension comes after the company submitted additional data related to chemistry, manufacturing and controls (CMC) a couple of weeks ago upon request by the agency, Orca Bio's CEO Nate Fernhoff, Ph.D., told Fierce. Fernhoff wouldn't specify the exact nature of the FDA's questions but said the company doesn't believe "any of these to be fundamental or unaddressable."... Full

 

Oric to Advance Prostate Cancer Drug to Phase 3, but Combo Choice Raises Doubts

(4/1, Ayisha Sharma, Endpoints News) ...Oric said it plans to advance its candidate, known as rinzimetostat, and Bayer's Nubeqa into a Phase 3 study. The trial will enroll 600 patients with metastatic castration-resistant prostate cancer (mCRPC) across more than 20 countries. It is set to start in the first half of this year... Sub. Req’d

 

Drug Combo Treats Multiple Cancers with ‘Paradox' Mutation in Mice

(4/1, Darren Incorvaia, Fierce Biotech) ...A detailed look at a mysterious mutation present in many different cancer types has revealed new drug targets that, when hit with a combo of well-known compounds, led to tumor cell death and prolonged survival in mice. The results may eventually lead to new therapeutics that are effective across a broad swath of cancers... Full

 

Alto Suffers Mid-Stage Blow for Schizophrenia Drug, Ramps up Lead Depression Programme

(4/2, Pavan Kamat, FirstWord PHARMA) ...ALTO-207 — a fixed-dose combination of pramipexole and ondansetron gained from Chase Therapeutics last year — is slated to begin a Phase IIb trial in the first half of this year, which will enrol adults with TRD who have had two to five prior treatment failures. Moreover, a Phase III study is set to commence next year... Full

 

Glenmark Pharmaceuticals Announces Strategic Shift to Direct Commercialization and Distribution of RYALTRIS® in the U.S., Significantly Expanding Its Innovative Portfolio

(4/1, Glenmark Pharmaceuticals Inc.) ...Glenmark Pharmaceuticals Inc., USA (Glenmark) today announced that it will manage end-to-end commercialization and distribution for RYALTRIS® (Olopatadine Hydrochloride and Mometasone Furoate) Nasal Spray, 665 mcg/25 mcg* per spray in the United States, effective April 1, 2026... Full

 

 

Teva Intensifies Biosimilar Competition with FDA Approval and Dual Filing Acceptance in US and Europe

(4/1, Feliza Mirasol, BioPharmInternational.com) ...With biosimilar competition now targeting high-value immunology biologics, Teva Pharmaceutical Industries has achieved several milestones with the FDA approval of denosumab-adet (brand name Ponlimsi), its biosimilar product referencing denosumab (brand name Prolia from Amgen), and the dual acceptances by FDA and the European Medicines Agency of regulatory filings for a biosimilar candidate referencing omalizumab (brand name Xolair from Novartis and Genentech)... Full

 

FDA, EMA Accept Filings for Teva Xolair Biosimilar

(4/1, Respiratory Therapy) ..."Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we're building a highly competitive portfolio," said Steffen Nock, PhD, head of biosimilars R&D and chief science officer at Teva, in a news release... Full

 

Generic Drugmakers Redefine Value

(4/1, Julie Gallagher, Drug Store News ) ...DSN asked several pharmaceutical company executives about the greatest areas of opportunity, how their organizations are positioning to capitalize on them and what changes they believe are necessary to build a more resilient, patient-focused generics ecosystem... Full

 

Amarin Insists Skinny Labels Are Not A Safe Harbor

(4/2, Dean Rudge, Generics Bulletin) ...Amarin has urged the US Supreme Court to affirm the US Court of Appeals for the Federal Circuit's decision in its long-running dispute with Hikma over skinny-label generics, arguing that "this case at bottom does not call for interpreting any statute or regulation governing the pharmaceutical industry," but instead turns on what generic companies do beyond the label...According to Amarin, the ways in which Hikma launched and marketed its generic Vascepa product "broke that bargain."... Global Sub. Full

 

 

Eli Lilly Bets $7.8 Billion That Sleep Will Be the Next Obesity

(4/1, Robert Langreth, Ashleigh Furlong, Madison Muller, Bloomberg) ...As with obesity drugs, Lilly might not be first to gain approval, but the American drugmaker is willing to bet almost $8 billion for a chance to tap into what's been pegged as a multi-billion-dollar market for narcolepsy and idiopathic hypersomnia, another sleep disorder for which Centessa's drug is being tested. The medicines might even someday help with sleep apnea, a much more common disorder that affects millions of people, researchers said... Sub Req’d

 

Bayer Eyes Expansion In U.S. to Aid Revival

(4/2, Adria Calatayud, The Wall Street Journal) ...Stefan Oelrich, the president of Bayer's pharma division, said the business is leaving the patent cliff behind and poised to grow again..."We built a commercial footprint that we didn't have in cardiovascular, we already were present to some degree in oncology, which we've broadened significantly since, and the success proves that this is the right strategy," Oelrich said. "Today our growth comes predominantly from the U.S."... Sub. Req’d

 

How Pharma Is Capitalizing on the Sudden Revival and Success of an Old Asthma Drug

(4/2, Max Gelman, Endpoints News) ...Already this year, GSK acquired RAPT Therapeutics for $1.9 billion upfront to get its allergy drug ozureprubart; Novartis, seeking to bridge the incoming Xolair cliff, bought out six-month-old Excellergy last week for up to $2 billion; and Regeneron has added allergic programs for food, cats and birch tree pollen as well. The resurgence suggests a clear and eager demand among patients and families for new treatments. If other companies can develop better and longer-lasting allergy drugs, profits should follow and patients should benefit... Sub. Req’d

 

With an FDA Nod, Lilly's Oral GLP-1 Enters the Obesity Ring as Foundayo

(4/1, Elizabeth S. Eaton, FirstWord PHARMA) ...According to the US agency, Foundayo is the first new molecular entity to win approval under the Commissioner's National Priority Voucher programme, and the fifth drug overall. Lilly had initially been expecting a regulatory decision in the first quarter, but a delay at the FDA had pushed it back to April, according to a report from Reuters. Lilly's direct-to-consumer site LillyDirect is already accepting prescriptions, and shipping will begin on April 6. Availability via telehealth providers and retail pharmacies is coming "shortly," the pharma said... Full

 

Alzheimer's-Focused Korsana to Use Cyclerion Reverse Merger to Go Public

(4/1, Will Maddox, Fierce Biotech) ...The Waltham, Massachusetts-based company has entered into a reverse merger with the neuro-focused public company Cyclerion Therapeutics. Following the all-stock transaction—which is expected to complete in the third quarter—the merged company will operate under the Korsana brand, with a focus on Korsana's lead Alzheimer's asset and its Nasdaq ticker will be changed to "KRSA."... Full

 

Exclusive-Pfizer, BioNTech Halt US COVID Vaccine Study After Recruitment Struggles

(4/1, Reuters ) ...In a letter to trial investigators dated March 30, seen by Reuters and previously unreported, Pfizer said it would stop surveillance for signs of COVID illness for all participants in the study after April 3...The move comes as COVID vaccine makers grapple with pushback from the U.S. administration and weak U.S. demand for the shots... Full

 

Stryker Says Operations Fully Restored After March Cyberattack

(4/2, Zac Harmon, FOX 17) ...Stryker announced on Wednesday it has fully restored operations exactly three weeks after a cyberattack disrupted the company's network. The Portage-based business said production facilities are returning to peak capacity, thanks to the disciplined work of employees. Most of the company's product lines have healthy amounts of available stock to fulfill customers' orders, said Stryker in a blog post... Full

 

Insight Gaps Leave Biopharma Vulnerable to Patent Cliff Crisis, Warns Expert

(4/1, PMLiVE) ...With unprecedented patent cliffs looming, putting an estimated $200 to $400 billion in annual global sales at risk , senior strategy consultant and Nmblr founder, Janice MacLennan, is issuing a stark warning to biopharma organisations tasked with delivering innovative new therapies to market... Full

 

 

Europe Must Pay More for Medicines, Says Bayer

(4/1, Florian Muller and Aanu Adeoye, Financial Times) ..."The American government has made it clear it does not see why the US should finance global R&D alone," [Stefan Oelrich, head of Bayer's pharmaceuticals division,] said, adding that Europe would "have to reorient" towards higher price levels over time. The comments come as the industrial conglomerate pushes a turnaround of its pharma business following a wave of patent expiries and pivots towards the US as its main source of growth. The company expects the US to become its largest market, having increased the size of its sales and marketing operations in the country... Sub. Req’d

 

MFN: England's HTA Appraisals ‘Hold Steady' For Now

(4/1, Francesca Bruce, Pink Sheet) ...Despite uncertainty about how US most favored nations (MFN) drug pricing policies will impact global launch strategies, health technology appraisals conducted by NICE, the HTA institute for England and Wales, remain steady, according to Helen Knight, the body's director of medicines evaluations... Global Sub. Full

 

Thousands of Clinical Trial Sites Impacted by Middle East Conflict: Report

(4/1, Will Maddox, Fierce Biotech) ...The firm analyzed more than 65,000 global trials conducted across over 350,000 sites in 186 countries. It found that 6.7% of active studies (4,361 trials) have been disrupted by the conflict in the affected region, impacting a total of 7,958 trial sites... Full

 

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