Friday, May 15, 2026

 

 

Teva Stock Is at Its Highest Level in Nearly a Decade. Here's Why It Could Soar Even More.

(5/15, Thomas Niel, The Motley Fool) ...Teva still has plenty of room to run and appears poised to take off in a big way over the next few years, as this turnaround company has the potential to become a promising growth stock... Full

 

 

Top U.S. Officials Pressured Germany to Pay More for Prescription Drugs

(5/15, Daniel Payne, STAT+) ...The U.S. officials discussed the possible use of tariffs under Section 301 - which grants the government authority to combat trade practices considered "unfair." The move would be similar to the tactic of threatening new tariffs to get other countries to pay more for drugs. The ambassador agreed to review the matter with officials in Germany, but no deal was made, the person said... Sub. Req'd

 

Drugmakers Have to Go Through Rigorous Tests to Get a Lower Tariff Rate

(5/14, Anna Brown, Endpoints News) ...A document released Wednesday outlines a detailed application process drugmakers must complete - and the initial step must be done before June 12. The 11-page document shows companies must detail what products they manufacture, where they are currently made, and if they are made internally or with the help of a third-party service provider... Sub. Req'd

 

Pharma Onshoring Agreements Would Include Stiff Tariff Penalties, Import Scrutiny

(5/14, Cathy Kelly, Pink Sheet) ...Companies must submit onshoring agreement applications by June 12. Manufacturers entering into the agreements would be subject to a reduced 20% tariff through April 2, 2030, under the administration's plan. Companies striking onshoring agreements and Most Favored Nation pricing agreements would not be subject to tariffs through the end of President Trump's term in January 2029... Global Sub. Full

 

Bipartisan Lawmakers Reintroduce Bill Barring PBMs from Owning Pharmacies

(5/14, Paige Minemyer, Fierce Healthcare) ...The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level... Full

 

Trump Admin Pushes EHRs To Show Doctors Rx Cash-Pay Prices

(5/14, Christian Robles, Inside Health Policy) ...Thomas Keane, the National Coordinator for Health Information Technology, wants electronic health records (EHR) to show doctors cash-pay drug prices from data sources, such as TrumpRx, GoodRx and Cost Plus Drugs, when they write a prescription, but one expert told Inside Health Policy that implementing the feature in the real world could be challenging... Sub. Req'd

 

Biopharma Leaders Rally Behind Pazdur for FDA Commissioner Pick. But Does He Want the Role?

(5/14, Fraiser Kansteiner, Fierce Pharma) ...But despite the vote of confidence in a letter to Trump signed by more than 100 industry leaders-including pharma and biotech CEOs, VC firm partners and patient advocacy group directors-it remains unclear whether Pazdur would want the job. Last month, he told Fierce that another administration would need to occupy the White House before he might consider returning to the FDA... Full

 

What the FDA Won't Tell You About Your Medications

(5/14, Jessica Lussenhop, Debbie Cenziper, Megan Rose, ProPublica) ...For years, the Food and Drug Administration told the public that generic medications are just as safe and effective as the brand-name versions. But ProPublica reporters uncovered information that proves this isn't always true...This episode details why and how a secretive group inside the FDA made the decision to keep this information from the public and how you can find out where your own medications are made... Full

 

One Day at a Time: FDA's New AI-Informed Inspection Pilot and What It Means for Industry

(5/15, Kalie E. Richardson, Charles D. Snow, FDA Law Blog) ...Nothing in this pilot changes the evidentiary standards FDA applies to compliance determinations. But it does change the odds that any given facility will receive an inspection visit-and it raises the operational stakes for facilities that might have been lulled into comfort by long gaps between inspections... Full

 

Farxiga Patent Expiry Fuels US FDA ANDA Approval Spike

(5/14, Derrick Gingery, Pink Sheet) ...The US Food and Drug Administration reported 85 full ANDA approvals during April, the highest total in a single month since August 2023. Included were 41 first-time generic approvals, which smashed the previous single-month record of 30, set in May 2022. The agency approved five more first generics in April than during the previous six months combined... Global Sub. Full

 

 

FDA Approval Gives BeOne Medicines a New Challenger to AbbVie, Roche Cancer Drug

(5/14, Frank Vinluan, Med City News) ...The regulatory decision for the drug, sonrotoclax, covers the treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two prior lines of systemic therapy. Basel, Swizerland-based BeOne will market this new daily pill under the brand name Beqalzi... Full

 

New AML Regimen for Unfit Patients Gets FDA's Blessing

(5/14, Ian Ingram, MedPage Today) ...The FDA on Wednesday approved a new all-oral regimen for newly diagnosed acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy. The combination of decitabine-cedazuridine (Inqovi) plus venetoclax (Venclexta) is specifically indicated for either adults 75 and older or those whose comorbidities would preclude an intensive induction regimen... Sub. Req'd

 

Aptose, Facing Cash Crunch, Exits Blood Cancer Pact after Hanmi Buyout Blocks Development

(5/14, Nick Paul Taylor, Fierce Biotech) ...Aptose expects the deal to close, albeit later than anticipated, and has returned rights, materials and data associated with CG-806 to CrystalGenomics. The transaction frees CrystalGenomics to "pursue business development opportunities with other identified parties," Aptose said... Full

 

 

Alteogen Secures South Korea Approval for Eylea Biosimilar Izenpiju

(5/15, Park Su-Hyeon, Chosun Biz) ...Alteogen said on the 15th it won domestic approval for the macular degeneration treatment "Izenpiju (ingredient Aflibercept)" from the Ministery of Food and Drug Safety... Full

 

US Jury to Decide If Takeda Delayed Generic Constipation Drug

(5/14, Nate Raymond, Reuters) ...After five weeks of trial, jurors are set to begin deliberations on Friday after hearing closing arguments in lawsuits by pharmacies, insurers, health funds and retailers including CVS and Walgreens who allege they were overcharged for the drug due to an antitrust conspiracy Takeda joined... Full

 

Mylan Epoprostenol Win Clarifies US Measurement Rules And Equivalents Limits

(5/14, Dean Rudge, Generics Bulletin) ...In a precedential opinion, the Federal Circuit held that Mylan did not literally infringe US patents 8,318,802 and 8,598,227 because the relevant patent claim required a bulk solution pH of 13 or higher as measured at the pharmaceutical field's standard temperature, not at the lower refrigerated temperature used during manufacture. The court also agreed that Johnson & Johnson's Actelion subsidiary could not rely on the doctrine of equivalents to capture Mylan's generic referencing Actelion's pulmonary arterial hypertension therapy... Global Sub. Full

 

Apotex Leapfrogs Dr Reddy's With First Canadian Semaglutide Launch

(5/15, Dave Wallace, Generics Bulletin) ..."With initial inventory now available and shipping to wholesalers, Apo-Semaglutide Injection will be on pharmacy shelves across Canada within the coming weeks," Apotex announced, "giving patients and their healthcare providers access to high-quality, affordable alternatives aligned to all available brand-equivalent formats."... Global Sub. Full

 

Alembic Pharmaceuticals Secures USFDA Nod for Prostate Cancer Drug

(5/14, Devdiscourse) ...The tentative approval covers Alembic's Abbreviated New Drug Application for the tablets, each at a strength of 300 mg, making them therapeutically equivalent to Bayer HealthCare Pharmaceuticals' Nubeqa tablets... Full

 

Sun Recalls US Chemotherapy Batch, Citing Glass Particle Contamination Concerns

(5/14, Fraiser Kansteiner, Fierce Pharma) ...Sun's voluntary recall concerns a single batch containing 675 vials of the chemotherapy doxorubicin hydrochloride liposome injection, which is used to treat ovarian cancer, Kaposi sarcoma and multiple myeloma, according to a notice posted on the FDA's website... Full

 

The Generics Bulletin Podcast: Biosimilars Conference Report And Big M&A Deals

(5/14, Urte Fultinaviciute, Dean Rudge, Anabel Costa-Ferreira, Dave Wallace, Generics Bulletin) ...Following last week's Medicines for Europe biosimilars conference in Amsterdam, Generics Bulletin's deputy editor Dean Rudge reports on all the hot topics from the event, following earlier articles direct from the conference itself. Also in this episode, Generics Bulletin editor Dave Wallace talks about recent big biosimilars deals involving Amneal and Kashiv as well as Sun and Organon, discussing how regulatory streamlining for biosimilars has given investors the confidence to pull the trigger on major transactions... Global Sub. Full

 

Heart Transplant Survivor Says Problems With Generic Drugs Nearly Cost Her Life

(5/14, Lisa Fletcher, Andrea Nejman, Nathan Aaron, Spotlight on America) ...Now, a sweeping drug-testing effort by an independent laboratory is raising new concerns about the quality of some generic medications used by millions of patients, including life-sustaining drugs for transplant recipients... Full

 

 

Big Pharma Emerges from Q1 Intact but Keeps Eyes on IRA, Iran War Impact

(5/14, Gordon Faylor, MM+M) ...Eli Lilly and Novo Nordisk, the primary GLP-1 manufacturers, continue to dominate the headlines thanks to the sustained success of their respective medications and the expansion into oral offerings. Meanwhile, AstraZeneca and Roche both expressed optimism about hitting ambitious revenue targets by the end of the decade... Full

 

Gilead Raises $3 Billion to Help Fund Acquisition Spree

(5/14, Michael Gambale, Kevin Kingsbury, Bloomberg Law) ...Gilead Sciences Inc. sold $3 billion of bonds on Thursday, marking the company's first investment-grade bond deal in 18 months, following a string of multi billion-dollar acquisitions... Full

 

Alembic Pharma Gains after Q4 PAT Climbs 29% YoY to Rs 203 cr

(5/15, Business Standard) ...Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026... Full

 

Zydus to Acquire Assertio in $166m Deal

(5/14, Pharmaceutical Business Review) ...The offer was approved by Assertio's Board of Directors, following a revised merger agreement process and is considered a "superior proposal" compared to the previous agreement with Garda Therapeutics. It represents a 30.6% premium over Garda's earlier $18.00 per share all-cash offer on 8 April 2026 and a 7.8% premium to its revised $21.80 per share offer on 4 May 2026... Full

 

BioAge CEO Has Big Plans for 'Multi-Disease Impact' of NLRP3 Drug Across Cardio, Ocular and CNS

(5/14, Will Maddox, Fierce Biotech) ..."These drugs might be used initially to treat patients who are already quite sick, but the potential is to go earlier in the course of disease, when they don't have the disease yet, but their biomarkers are off," [CEO Kristen] Fortney told Fierce on the sidelines of the Fierce Biotech Week in Boston Wednesday. "If you could intervene at that point and delay disease, there's a lot of potential."... Full

 

Biogen Pushing Tau Drug Forward Despite Alzheimer's Study Failure

(5/14, Kristin Jensen, BioPharma DIVE) ...Biogen said the experimental medicine also successfully reduced levels of tau, a protein that builds up into destructive tangles in the brains of Alzheimer's patients. The company didn't release any detailed results, but noted that full findings would be presented at the upcoming Alzheimer's Association International Conference in July... Full

 

 

Why UK and EU Drug Regulators Are Calling For Enhanced Collaboration With China

(5/14, Francesca Bruce, Pink Sheet) ...Increasing clinical research and product development taking place in China mean that European regulators need to develop good relationships with authorities in China, according to the European Medicines Agency's chief scientific officer, Steffen Thirstrup, and Laurence Tallon, chief executive of the UK's Medicines and Healthcare products Regulatory Agency's (MHRA)... Global Sub. Full

 

China Introduces Protection Periods for Clinical Trial Data

(5/15, Zou Shuo, China Daily) ...The six-year protection applies to innovative drugs and originator drugs, calculated from the date of drug registration. Improved new drugs receive four years of data protection, and first generic drugs receive three years, according to a guideline issued by the administration. Ordinary generic drugs and biosimilars are not granted data protection... Sub. Req'd

 

Complex Generics Are Driving Indian Pharma's High-Margin Future in 2026: Experts

(5/15, Shardul Nautiyal, Pharmabiz.com) ...Pharma industry expert Vikas Nim explains that unlike simple generics, which rely primarily on bioequivalence studies, complex generics demand advanced analytical characterization, comparative clinical studies, and often product-specific guidance from regulators like the US FDA. This raises the technical and financial bar, resulting in fewer competitors and better pricing power... Full

 

Indian Regulators Tighten Drug Quality Oversight as Substandard and Spurious Medicine Cases Rise in Five Years

(5/14, Shardul Nautiyal, PharmaBiz) ...Amid increasing concerns over medicine quality and patient safety in India, there has been a significant increase in enforcement actions against manufacturers and distributors involved in the sale of substandard, spurious, and adulterated medicines... Full

 

Japan Slashes Mounjaro Price 25%, Readies Revised Price Cut System

(5/15, Lisa Takagi, Pink Sheet) ...Japanese regulatory authorities have finalized the latest batch of quarterly reimbursement pricing cuts, which will include a major 25% reduction for Eli Lilly's GIP/GLP-1 receptor agonist Mounjaro (tirzepatide) under the Special Price Adjustment for Sustainable Health System and Sales Scale (SPA-SSS) program, an expansion of the country's existing Market Expansion Repricing (MER) scheme... Global Sub. Full

 

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