Tuesday, May 5, 2026

 

 

RFK Jr.'s Embattled FDA Chief on Thin Ice Over Chaos and Strife

(5/4, Riley Griffin, Rachel Cohrs Zhang, Jessica Nix, Gerry Smith, Bloomberg Law) ...Companies have resorted to appealing directly to HHS Secretary Robert F. Kennedy Jr., the White House and Congress to challenge processes they view as unfair, according to people familiar with the efforts. Others describe Makary as a grandstander who pushes to attend public administration events and focuses his efforts on generating attention rather than the nuts-and-bolts work of regulating... Full

 

FDA Eyes Pilot For Rx-OTC Drug Switches Where Health Benefits Big

(5/4, James Jarvis, Inside Health Policy) ...The mention of a possible pilot comes as FDA looks to accelerate prescription-to-OTC switches more broadly, including through its new Additional Conditions for Nonprescription Use pathway, which allows certain drugs to be sold over the counter with additional safeguards to support safe use... Sub. Req'd

 

US FDA's Angelo de Claro Becomes Permanent Oncology Center Director

(5/4, Derrick Gingery, Pink Sheet) ...Angelo de Claro, who has been running the US Food and Drug Administration's Oncology Center of Excellence temporarily for several months, appears to now be the permanent director. The FDA updated its leadership profiles webpage on May 4 to drop "acting" from de Claro's title. The Health and Human Services Department also confirmed the promotion later in the day... Global Sub. Full

 

US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says

(5/4, Maaisha Osman, Pink Sheet) ...Makary said the staffing expansion will support a broader reform package the FDA is expected to unveil soon, which will focus on streamlining development and review pathways and ensuring the agency is adequately resourced to handle an increased pace of innovation... Global Sub. Full

 

Get Ready for PDUFA Program Fee Invoices for 2027

(5/4, Bob Pollock, The Lachman Blog) ...Today, the FDA has sent out a PDUFA Dear Colleague letter (here) asking firms to verify program fee assessment information that the Agency has relative to applications covered under PDUFA VII. The letter states that "[U]nder PDUFA VII, a program fee is assessed annually for certain prescription drug products identified in a human drug application approved as of October 1 of such fiscal year (FY), with a maximum of five prescription drug program fees for a fiscal year for such prescription drug products identified in a single approved human drug application"... Full

 

Colorado Bill Seeks to Exempt Some Drugs From Affordability Review Over Access Concerns

(5/4, Sara Wilson, Colorado Newsline) ...Senate Bill 26-140 cleared the Senate Health and Human Services Committee on Thursday on a 5-2 vote. Senator Janice Marchman, a Loveland Democrat, said the bill came from conversations with parents of children who use the drug Trikafta to manage cystic fibrosis. The Prescription Drug Affordability Board considered whether to set an upper payment limit on the drug, which can cost upwards of $200,000 per year, in 2023... Full

 

 

Biotech Raises $42 Million to Run Huntington's Disease Trial

(5/4, STAT) ...Kiersten Stead, managing partner at Latus' investor DCVC Bio, believes targeting MSH3 will be transformative for patients. Both of Latus' treatments are designed to be injected directly into the brain during an in-hospital surgical procedure. So, too, is the Huntington's gene therapy developed by UniQure, which has stirred regulatory debate over the last few months... Sub. Req'd

 

Neurocrine Biosciences Announces New Survey Results Showing Significant Burden of Tardive Dyskinesia on Employment

(5/4, Neurocrine Biosciences) ..."These findings highlight how uncontrolled, involuntary movements associated with tardive dyskinesia can lead to reduced job responsibilities or even loss of employment," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "This reinforces the importance of routine screening for tardive dyskinesia in clinical practice, including evaluation of its impact on patients' and caregivers' lives so that appropriate treatment can be considered to help reduce this burden."... Full

 

Atogepant Shows Improvement in Migraine with No New Safety Signals over 3 Years

(5/4, Healio) ...Atogepant led to improvements and showed no new safety signals in patients with chronic and episodic migraine after 3 years of treatment, according to data presented at the American Academy of Neurology Annual Meeting... Full

 

Johnson & Johnson Advances IBD Therapy, Despite Trial Miss

(5/5, Allison DeAngelis, STAT) ...On Tuesday, trial investigators presented the results of Johnson & Johnson's DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It's a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD... Sub. Req'd

 

Takeda's Next-Gen Experimental Immune Drug Comparable to Approved Treatment in Study

(5/4, Reuters) ...Takeda Pharmaceutical said on Monday its experimental drug for primary immunodeficiency disease showed comparable immune protection to its approved therapy HyQvia in a mid-to late-stage trial, potentially offering a more convenient treatment option for patients who require lifelong therapy... Full

 

UCB Inks $2B Candid Buyout to Join Gilead in Autoimmune Field

(5/4, Nick Paul Taylor, Fierce Biotech) ...UCB has struck a deal to acquire Candid Therapeutics for $2 billion upfront, hijacking a planned reverse merger with Rallybio to challenge Gilead for an emerging opportunity for T-cell engagers (TCEs)... Full

 

Windward Bio Gets $165m to Take China-Derived Drug into Phase 3 Asthma Trial

(5/4, Kyle LaHucik, Endpoints News) ...Windward's haul will support a Phase 3 entry in the fourth quarter. Windward plans to take WIN378, a twice-yearly anti-TSLP antibody, into the final stages of clinical testing for asthma after gathering Phase 2 data in the second half of this year. The experimental medicine originated via a partnership between Kelun and Harbour BioMed... Sub. Req'd

 

As FDA Decision Nears, Celcuity Posts Win in PIK3CA-Mutant Breast Cancer

(5/4, Anna Bratulic, FirstWord PHARMA) ...With an FDA decision looming in July, Celcuity said its lead drug gedatolisib met the primary endpoint of progression-free survival (PFS) against Novartis' PI3Ka inhibitor Piqray (alpelisib) in the PIK3CA-mutant cohort of its pivotal breast cancer study. The news drove company shares up around 19% Monday in afternoon trading... Full

 

 

From Trials To Takeovers: How Global Streamlining Unleashed Billions Of Dollars In Biosimilar M&A

(5/4, Dave Wallace, Generics Bulletin) ...Speaking with Generics Bulletin for this article, Thomas Newcomer, Samsung Bioepis's senior vice-president and head of US commercial, said that "with increased regulatory predictability and improved cost efficiency in biosimilar development, manufacturers are expanding and diversifying their portfolios into a broader range of biologics - many of which were previously not considered viable for biosimilar development."... Global Sub. Full

 

The Supreme Court Case That Could Slow Generic Drugs

(5/5, KFF Health News: An Arm and a Leg) ...The Supreme Court has heard a big case about "skinny labels" on generic drugs. It could shape the future of affordable prescriptions in America...An Arm and a Leg senior producer Emily Pisacreta talks with legal experts and doctors about how this case got to the highest court in the land and what a ruling could mean for how many and how quickly new generic drugs reach the market... Full

 

Stada And Adalvo Debut Ivermectin Cream In Europe

(5/4, Dave Wallace, Generics Bulletin) ..."Working alongside Stada, one of Europe's leading generics and branded medicines companies, Adalvo has delivered on the day-one launch ambition."... Global Sub. Full

 

 

Pfizer 1Q Revenue Rises But Profit Falls Amid Boosted R&D Spending

(5/5, Nicholas G. Miller, The Wall Street Journal) ...The company said its research and development expenses rose 12% due to higher spending in certain oncology and obesity product candidates. Cost of sales also increased on the unfavorable impact of foreign exchange and the favorable revision of the company's estimate of accrued royalties in the first quarter of 2025... Sub. Req'd

 

Wockhardt Swings to Profit in FY26 Fuelled by Biotech, Emerging Markets Recovery

(5/4, Viswanath Pilla, MoneyControl.com) ...The drugmaker reported a net profit of Rs 164 crore in Q4FY26, reversing a loss of Rs 45 crore a year ago, aided by a 30 percent year-on-year (YoY) rise in revenue to Rs 965 crore, sharp improvement in margins and strong traction in its insulin-led biotech portfolio... Full

 

A $12 Billion US Deal Pushes India's Sun Pharma Into Big Leagues

(5/4, Satviki Sanjay and Baiju Kalesh, Bloomberg) ...The Organon deal renews questions over whether India Inc. can truly go global. A handful of wins including Tata Group's Jaguar Land Rover deal have been followed by costly stumbles such as Bharti Airtel Ltd.'s bet in Africa, leaving investors unsure whether Indian firms can scale like peers from Japan, China and South Korea... Full

 

Amgen Channels Another $300m into US Outlay, Bolstering Puerto Rico Biologics Expansion

(5/4, Fraiser Kansteiner, Fierce Pharma) ...Amgen is plugging an additional $300 million into the expansion at its Juncos site in Puerto Rico, which was established in 1992 and forms a critical piece of the drugmaker's global production network, serving more than 60 countries around the world... Full

 

GLP-1 Boom Pushes Oncology Off Top Spot for Late-Stage Pipeline Value: Deloitte

(5/4, Ben Adams, Fierce Pharma) ...GLP-1 drugs now account for about 38% of projected commercial inflows and roughly a quarter of forecast sales from the 2025 late-stage pipeline, driven by blockbuster products from Eli Lilly and Novo Nordisk. That, Deloitte said in its report, marks "a rapid shift from 2022," when obesity contributed just 1% of projected value. But Deloitte warns that this is masking some serious issues within pharma and leaves the industry vulnerable to area-specific shocks... Full

 

1 Big Number: Drug Development Costs

(5/5, Axios) ...The average cost of developing a drug from discovery to launch reached $2.7 billion last year - a roughly 20% increase over the average cost in 2024, Deloitte said yesterday in its annual report on pharmaceutical innovation... Full

 

Biocon's Kiran Mazumdar-Shaw Chooses Niece Claire Mazumdar as Successor: Report

(5/5, The Economic Times) ..."I am the sole owner of Biocon, and I need to make sure that I put it in good hands," Mazumdar-Shaw told Fortune India. "I have seen my niece Claire as my successor, because I think she has proved to me that she can run a company."... Full

 

 

UK Pharma Woes 'Not All About MFN,' Says ABPI Trade Body Chief

(5/4, Eliza Slawther, Pink Sheet) ...The UK has sent the "message" to global biotech and pharma investors that the country is "somewhere you go to be squeezed, rather than somewhere you go to grow," according to the Association of the British Pharmaceutical Industry's chief executive, Richard Torbett...He also warned that there has been a worrying rise in the number of pharmaceutical companies choosing to stop their health technology assessment reviews in England due to doubts about securing a viable price for their medicines... Global Sub. Full

 

UK Regulator Targets Leadership In Advanced Therapies

(5/4, Francesca Bruce, Pink Sheet) ...The MHRA, the UK healthcare products agency, aims to become a reference regulator in advanced therapies, among other product types, Lawrence Tallon, the agency's chief executive, said at the 2026 Cell & Gene Meeting on The Med, organized by the Alliance for Regenerative Medicine, on April 29... Global Sub. Full

 

US Raises Red Flags Over EU Pharmaceutical Rules

(5/4, Emma Pirnay, Euractiv) ...Stine Bosse, a Danish Renew lawmaker, told Euractiv that the EU's health industry is in a "difficult position," particularly amid national healthcare budget reforms such as those in Germany, which the industry has fiercely rejected. New patent protections are "one way" to signal better protections to European companies, Bosse added. The US said it would "continue dialogues with trading partners" to discuss innovation and pricing in the pharmaceutical and medical device sectors, including the pharma package... Full

 

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