Tuesday, May 26, 2026

 

 

Teva's Growth Story Is No Longer Just Generic, It's Getting Branded

(5/25, Willow Tree Research, Seeking Alpha) ...I believe the key message or key takeaway from this quarter is that Teva is increasingly being driven by more high-value innovative assets rather than its relatively boring legacy generic base with limited upside (with more political pressure from all nations)... Full

 

 

GOP Chairman of China Panel Seeks Biotech Clampdown, Calls out BMS Deal

(5/22, Max Bayer, Endpoints News) ...Rep. John Moolenaar (R-MI) told Treasury Secretary Scott Bessent in a letter Thursday that the department should add biotechnology to one of the sectors prohibited from receiving outbound US investment under the COINS Act. Signed in December 2025, the law restricts certain technologies in China, and other select countries, from receiving US dollars... Sub. Req'd

 

House GOP Requests CBO Explain Lacking Budget Benefits From Drug Price Controls

(5/22, Gabrielle Wanneh, Inside Health Policy) ...House Energy & Commerce Committee Chair Brett Guthrie (R-KY), Ways & Means Committee chair Jason Smith (R-MO) and Budget Committee Chair Jodey Arrington (R-TX) include a slew of questions regarding the agency's first estimates and subsequent revised determinations of the savings and costs associated with IRA price controls, like the drug price negotiation program and redesign of the Part D benefit, in a letter sent Wednesday (May 20) to CBO Director Phillip Swagel... Sub. Req'd

 

PCMA Asks DOJ and FTC to Investigate Role of Large Drug Wholesalers in Generic Drug Prices, Acquisition Costs for Pharmacies

(5/22, PCMA) ...The letter also urges DOJ and FTC to explore the role of pharmacy services administrative organizations (PSAOs), the largest of which are owned by the same "Big 3" drug wholesalers. PCMA's letter raises the question of how PSAOs may use private contract information to influence wholesale drug prices. In addition to reinstating the 2000 Collaboration Guidelines, which provided important compliance certainty, PCMA makes two additional recommendations to DOJ and FTC... Full

 

The Innovation Trap: How Pharma Weaponizes a Word to Extend Monopolies

(5/26, Tahir Amin and Rohit Malpani, STAT) ...The pharmaceutical industry's argument is that the follow-on patents are for innovations to improve an existing drug. While that may be the case, these innovations that claim to improve an existing drug do not enhance the therapeutic efficacy and are often based on commonly practiced science techniques that technically are not inventions... Sub. Req'd

 

US FDA Hiring Push Threatens Industry Efforts To Contain, Lower User Fees

(5/25, Derrick Gingery, Pink Sheet) ...Most user fee revenue supports FDA employees, including salaries and related activities. Industry had been negotiating in part believing that FDA staffing would be much lower going forward... Global Sub. Full

 

FDA Product-Specific Guidelines Guide Proper Evaluation of Generic Bioequivalence in Key Oncology Drugs

(5/25, Riley Kandel, OncLive) ...The newly published guidelines aim to properly guide clinical trials in evaluating the bioequivalence of investigational generic drugs to reference listed drugs. Product-specific guidelines for each drug seek to establish bioequivalence with the most sensitive, accurate, and reproducible processes available according to 21 CFR 320.24 regulations... Full

 

Old Drugs, New Tricks: FDA's Drug Repurposing Initiative

(5/26, Charles D. Snow & Kalie E. Richardson, FDA Law Blog) ...Let's unpack what the initiative entails, what FDA is actually asking, what regulatory tools are on the table, and what interested stakeholders should be doing right now... Full

 

How Kyle Diamantas Defied Expectations as He Rose to Lead the FDA

(5/26, Lizzy Lawrence, STAT) ..."Kyle is someone who listens to everyone," said Scott Faber, senior vice president of the Environmental Working Group. "He's earned the respect of career staff and the FDA stakeholder community. He's a natural leader, but he isn't going to rush to the cameras." STAT's sources said these qualities will serve him well as acting FDA commissioner... Sub. Req'd

 

Mehmet Oz Shuffles Leadership at Medicare and Medicaid Agency

(5/23, Rachel Cohrs Zhang, Bloomberg) ...Rebekah Armstrong, who currently leads the agency's office of legislation, will be the new chief of staff, spokesperson Christopher Krepich said...Stephanie Carlton, who had led the agency as deputy administrator and chief of staff, will now be focused on her deputy administrator role, according to Krepich... Full

 

 

Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors

(5/22, Daiichi Sankyo) ...Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca... Full

 

AstraZeneca, Daiichi Sankyo's Datroway Receives FDA Approval for TNBC

(5/25, Salong Debbarma, Pharmaceutical Technology) ...The approval allows Datroway to be used as a first-line treatment for adults with unresectable or metastatic TNBC who cannot receive programmed cell death protein 1 (PD-1) or PD-L1 inhibitor therapy... Full

 

ASCO: Merck, Kelun's Sac-TMT ADC Combo Beats Keytruda by 65% on Progression in First-Line Lung Cancer

(5/21, Angus Liu, Fierce Pharma) ...According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance... Full

 

Lundbeck Receives Marketing Authorization for Vyepti® (Eptinezumab) in South Korea for the Preventive Treatment of Migraine

(5/26, H. Lundbeck A/S) ...H. Lundbeck A/S (Lundbeck) today announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorization for eptinezumab for use in adults with migraine... Full

 

Merz Therapeutics and Kvvit Enter Exclusive Agreement for INBRIJA(R) (levodopa inhalation powder) in Mainland China, Hong Kong and Macao

(5/26, Merz Therapeutics) ...Under the agreement, Merz will supply INBRIJA® and retain responsibility for global product quality and key regulatory activities. Kvvit will lead development, regulatory activities and commercialization in the licensed territory under a jointly agreed China Development Plan... Full

 

Subcutaneous Infliximab May Improve Convenience, Adherence, and Sustained Remission in IBD Care

(5/22, BioPharm International) ...The company says the self-administered formulation may reduce infusion-related burdens while supporting long-term efficacy in IBD management... Full

 

 

Fresenius Celebrates US Federal Win On Ustekinumab

(5/25, Dave Wallace, Generics Bulletin) ..."Hot off the press," announced Fresenius group CEO Michael Sen during the firm's Q1 call earlier in May, "our US team recently secured a contractual agreement for Otulfi with a large federal buyer." While declining to confirm speculation from an analyst that the deal related to the Department of Veterans Affairs - "you said VA. I didn't say VA. I said federal" - Sen said it was "a nice contract" with a value in the "neighborhood" of $140m... Global Sub. Full

 

Aurobindo's Biologics Pipeline Includes 15 Products Across Oncology, Immunology, Respiratory Therapies

(5/22, Business Today) ...The company's biologics arm, CuraTeQ Biologics, now has a pipeline of 15 products across oncology, immunology and respiratory therapies, with filings and launches planned across Europe, the UK, Canada and other markets. Aurobindo said several global biologic drugs are expected to lose patent protection between 2028 and 2035, creating opportunities for biosimilars manufacturers... Full

 

Polpharma Biologics And Tuteur Sign Landmark LATAM Biosimilar Licensing Partnership

(5/25, BioPharma APAC) ...As part of this strategic partnership, Tuteur will obtain exclusive rights to commercialize a biosimilar for the treatment of autoimmune diseases throughout Latin America (LATAM), with the exception of Brazil. Polpharma Biologics will retain full responsibility for the development and manufacturing of the biosimilar. Tutor will be responsible for marketing, marketing and distribution in the licensed territories. This collaboration reflects a shared commitment to expanding patient access to high-quality, affordable biologic treatments across the region... Full

 

MS Pharma Boosts Biosimilar Ambitions With Minority Equity Investment

(5/25, Urte Fultinaviciute, Generics Bulletin) ...While the exact details remain confidential, MS Pharma said that the transaction involved issuing new share capital in exchange for a substantial cash investment from OFC, resulting in OFC acquiring a minority stake in the company... Global Sub. Full

 

CHMP Endorses Another Ranibizumab For Lupin

(5/22, Dave Wallace, Generics Bulletin) ...Lupin is on the verge of obtaining a second European approval for a Lucentis (ranibizumab) biosimilar, after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending granting a marketing authorization for the firm's Vislyfa version... Global Sub. Full

 

Alembic Gets USFDA Nod for Levothyroxine Generic

(5/22, PTI) ...The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of levothyroxine sodium tablets of strengths 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg, Alembic said in a regulatory filing... Full

 

Takeda Vows Appeal of $885M Jury Verdict in 'Pay-for-Delay' Antitrust Case

(5/22, Frank Vinluan, MedCity News) ...That exact sum could change with additional court proceedings, but when the court enters into final judgement in the case, Takeda will be responsible for paying much more. Under federal antitrust law, damages are automatically tripled. That would put Takeda on the hook for more than $2.6 billion... Full

 

Glenmark's US Arm Settles Generic Drug Pricing Case for $29.6 Million

(5/23, CNBC TV18) ...Glenmark Pharmaceuticals said its US subsidiary has agreed to pay $29.628 million...to settle antitrust and consumer protection litigation linked to allegations of generic drug price-fixing in the United States... Full

 

 

Lilly to Buy Three Vaccine Developers for Up to $3.8 Billion

(5/26, Madison Muller, Bloomberg) ...The agreements with Curevo, LimmaTech Biologics and Vaccine Company give Lilly access to immunizations for shingles, common bacterial pathogens and Epstein-Barr Virus, according to a statement on Tuesday... Full

 

We Are the Largest Oncology Player in India, Says Zydus MD; Eyes US Speciality Push

(5/25, Avinash Nair, The Hindu BusinessLine) ..."The growth has been there in the oncology market, with more government schemes getting implemented. We are seeing a higher incidence of cancers," Managing Director Sharvil Patel said. The company said its oncology business has scaled rapidly in recent years, supported by early entry into complex biologics and targeted therapies, along with structured patient support programmes that have improved access across treatment lines... Full

 

Astellas Says Newer Drugs Set to Drive Profit Growth by 2030

(5/26, Eru Ishikawa, Bloomberg) ...Astellas Pharma Inc. will lean on high-margin brands like cancer drug Padcev and eye treatment Izervay to reach a five-year target of at least ¥4.3 trillion ($27 billion) in cumulative core operating profit before R&D expenses. The company's strategic brands are set to double sales by fiscal 2030 from ¥480 billion in fiscal 2025, Astellas said Tuesday. It forecasts pipeline revenue of approximately ¥1 trillion in the mid-2030s... Full

 

Has Novartis' T-Charge Been Overtaken by in Vivo CAR-Ts? Execs Argue There's Room for Both

(5/22, James Waldron, Fierce Biotech) ...It's been more than four years since Novartis shook up the CAR-T space with its T-Charge platform. But that's a lifetime in the fast-moving world of cell therapies... Full

 

 

EU Agreement Ons Trade Deal With US Means More Predictable Transatlantic Relations For Pharma

(5/25, Francesca Bruce, Pink Sheet) ...An agreement between the European Parliament and Council of the EU on two regulations underpinning the Turnberry EU-US trade deal should bring more predictability for pharmaceutical companies and avoid escalating transatlantic trade tensions, according to Alexander Natz, secretary general of EUCOPE, the association that represents small and medium-sized innovative pharma firms in Europe... Global Sub. Full

 

Accord's Burden Moves Up To Chair At Medicines UK

(5/25, Dave Wallace, Generics Bulletin) ...Medicines UK has announced the appointment of a new chair, with Accord's UK country head Paul Burden moving up from vice-chair to take the position. He succeeds in the role Sandoz's head of northern cluster in Europe, Diane DiGangi Trench, who became chair a couple of years ago and who will now serve a further 12 months as vice-chair... Global Sub. Full

 

UK's Diabetes Challenge Could Be Helped by Generic GLP-1s and Biosimilars

(5/23, Shreehas Tambe, Pharmacy Business) ...More than 5.8 million people are now living with diabetes in the UK. Behind that number lies a rapidly growing challenge that threatens to overwhelm the NHS if left unchecked. The financial pressure is already significant... Full

 

Impact Of China's New Data Protection On Deals, Corporate Strategies

(5/25, Xu Hu, Pink Sheet) ...The recently finalized measures for data protection issued by China's drug regulator, the National Medical Products Administration (NMPA), send a strong signal the country is strengthening measures to support innovation and looking to provide commercial benefits for novel drugs. This may contribute to more acquisitions of, or in-licensing deals for, China-originated assets by foreign companies, including multinationals, in the view of legal experts from Han Kun, a China-headquartered multinational law firm... Global Sub. Full

 

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