Thursday, July 9, 2026

 

 

In Private Meeting, Trump Officials Push to Onshore Generic Drugmaking

(7/8, Daniel Payne, STAT) ...Though the administration's top priority is moving the supply chains back to the U.S., one official said, administration leaders and industry executives discussed the possibility of "near-shoring" some production to Mexico. That would be preferable to the current China-centric situation, while keeping costs down and avoiding more stringent environmental rules in the U.S... Sub. Req'd

 

White House Reviewing Top Contenders to Lead FDA

(7/9, Daniel Payne, STAT) ...The finalists include Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Defense Department... Sub. Req'd

 

HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers

(7/8, Kate Rawson, Pink Sheet) ...One high-level individual would be in charge of regulatory issues, which would allow the commissioner to focus on more public-facing activities. The center directors would maintain their positions, but report directly to the medical products head, according to sources familiar with the process... Global Sub. Full

 

Biosimilar Development Fees Dropped As US FDA And Industry Concluded BsUFA IV Negotiations

(7/8, Derrick Gingery, Pink Sheet) ...Beginning in fiscal year 2028, assuming Congress reauthorizes the BsUFA program, sponsors will pay one fee to file an application, regardless of whether it requires clinical data. No fee will be charged for subsequent applications for the same drug substance that are submitted on the same day. A half fee will be charged for applications involving the same drug substance not submitted on the same day... Global Sub. Full

 

FDA Halts Release of New Drug Rejection Letters While Working to Formalize Policy

(7/8, Darren Incorvaia, Fierce Pharma) ...The agency announced a plan last September to publish complete response letters (CRLs) in real-time when making decisions to approve or reject drug applications. But after a petition challenged the policy for its potential to publicize proprietary information, the FDA "temporarily paused" the effort starting in April, a Department of Health and Human Services spokesperson told Fierce. "The agency is evaluating the process and potential next steps," the spokesperson added... Full

 

Pharma at a Political Crossroads

(7/8, Kirsten Axelsen, Maggie Farley, Leslie Isenegger, Julie Tierney and Rachel Turow, PharmExec.com) ...As pharmaceutical leaders navigate IRA price negotiation, significant uncertainties remain about how policies will unfold. In this discussion, four regulatory and policy experts address the defining challenges facing pharma strategy-from CMS implementation of negotiated drug prices to how policy changes may affect physician practice economics and global launch decisions... Full

 

SCOTUS Punt On FDA Preemption Has Implications Beyond Compounding

(7/8, Jessica Karins, Inside Health Policy) ...The result creates a fragmented regulatory environment for compounding pharmacies but will also have implications beyond compounding, potentially bolstering some states' authority to go after FDA-regulated companies over issues like marketing and labeling even if FDA hasn't taken action... Sub. Req'd

 

 

Teva Submits FDA Application for Paediatric Tourette Syndrome Therapy

(7/9, PMLiVE) ...Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva, said: "The NDA submission for ecopipam is a significant milestone for a potential first-in-class treatment option in paediatric Tourette syndrome."... Full

 

Ipsen's Dysport Scores Dual Wins in Late-Stage Episodic, Chronic Migraine Trials

(7/9, Pavan Kamat, FirstWord PHARMA) ...Top-line results showed Dysport met its primary goals in both E-BEOND and C-BEOND, demonstrating statistically significant reductions in monthly migraine days versus placebo. "Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population," said Christelle Huguet, global R&D head at Ipsen... Full

 

FDA Hits Lundbeck with Untitled Letter over Efficacy Claims on Migraine Drug Vyepti

(7/8, Zoey Becker, Fierce Pharma) ...In the letter (PDF), the FDA takes issue with several of Vyepti's efficacy and two-year patient outcomes listed on its healthcare provider webpage, noting "several significant limitations" to the clinical studies referenced which ultimately "preclude the drawing of conclusory claims" regarding the drug's benefits... Full

 

AstraZeneca Pens $2.1B Sino Deal for Challenger to Merck's COPD Drug Ohtuvayre

(7/8, Nick Paul Taylor, Fierce Biotech) ...The deal, which includes (PDF) up to $1.9 billion in milestones, covers a PDE3/4 inhibitor, TQC3721. Sino, working through its Chia Tai Tianqing Pharmaceutical subsidiary, has advanced a nebulized formulation of the drug candidate into phase 3 development in China. A dry powder inhaler formulation is in phase 2 and Sino has hailed TQC3721 as a potential best-in-class asset after posting mid-stage data on the candidate... Full

 

 

Amneal and Adalvo Announce FDA Acceptance for Review of Two U.S. ANDAs for Generic Tirzepatide Autoinjector

(7/8, Amneal Pharmaceuticals) ...The two ANDAs, referencing Mounjaro® (autoinjector) and Zepbound® (autoinjector), seek approval for single-dose prefilled pen presentations of the respective reference products for all currently approved indications, including the treatment of type 2 diabetes and chronic weight management, including for adults with obesity and adults with moderate to severe obstructive sleep apnea (OSA)... Full

 

Alkermes Terminates Authorized Generic Supply Deal With Amneal

(7/8, StreetInsider.com) ...The agreement, originally entered into on September 9, 2025, had granted Amneal rights to distribute and sell a limited quantity of an authorized generic version of Vivitrol (naltrexone for extended-release injectable suspension) in the United States for a one-year term... Sub. Req'd

 

Regeneron Narrows Amgen Challenges in Case Over Eylea Biosimilar

(7/8, Christopher Yasiejko, Bloomberg Law) ...Amgen didn't plausibly allege Regeneron knowingly made false inventorship declarations or other important misstatements to the US Patent and Trademark Office while working to obtain US Patent No. 12,331,099, Judge Thomas S. Kleeh said... Full

 

Split Federal Circuit Keeps Hetero's Nuedexta Generic Sidelined

(7/8, Dean Rudge, Generics Bulletin) ...In a 2-1 precedential opinion, the Federal Circuit affirmed the injunction based on the district court's claim construction but vacated a separate order excusing Otsuka from posting a bond, sending that issue back to the lower court... Global Sub. Full

 

 

India's Dr Reddy 's on Track for Worst Day in 3 Years as Semaglutide Supplies Hit

(7/9, Reuters) ...Dr Reddy's, in a statement to exchanges, said that certain batches of semaglutide were found to be "out of specification" and that it was investigating the root cause and taking measures to ensure product quality. The drugmaker did not specify until when the supply disruption would last and did not disclose further details. "There is no impact on patient safety or on the product's existing global regulatory filings," the firm said... Full

 

GSK Walks Away from Alector Pact as Immuno-Neurology Bet Fizzles

(7/9, Ayisha Sharma, Endpoints News) ...After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK's exit effectively closes the door on the California biotech's most advanced clinical-stage approach, leaving it with a wholly owned preclinical pipeline... Sub. Req'd

 

Samsung Bioepis Partners with Proteina to Speed AI Antibody Drug Discovery in Korea

(7/9, Yeom Hyun-a, ChosunBiz) ...The two companies will collaborate to use AI to discover antibody new drug candidates by 2027. Proteina will handle AI-based candidate discovery and validation, and Samsung Bioepis will conduct preclinical studies for an investigational new drug (IND) application. If Samsung Bioepis later exercises a licensing option, it will pursue clinical development and commercialization, and Proteina will receive milestone payments based on development stages and sales royalties... Full

 

Marc Falkin - CEO, North America, Cipla

(7/8, Pharma Boardroom) ...As Cipla enters its second decade in the market, Marc Falkin discusses the company's growth strategy, its expanding presence in complex generics, specialty medicines, and biosimilars, and the role of manufacturing and innovation in supporting the next phase of expansion. He also offers a candid assessment of the opportunities and challenges shaping the future of the US pharmaceutical landscape... Full

 

 

Sanofi to Stop Disparaging Rival Flu Vaccine to Stave Off EU Antitrust Fine

(7/8, Foo Yun Chee and Inti Landauro, Reuters) ...Sanofi has offered to state publicly that a rival flu vaccine is as effective as its own, EU antitrust regulators said on Wednesday of the company, which faces a fine for allegedly disparaging its competitor... Full

 

German Rebate Hike Is A 'Missed Opportunity' To Address MFN Pressures

(7/8, Francesca Bruce, Pink Sheet) ...A German bill that aims to reduce pharmaceutical spending through bigger mandatory rebates is a "missed opportunity" to address big shifts in the pharmaceutical sector, including US Most Favored Nation (MFN) pricing policies, said Alexander Natz, secretary general of EUCOPE, which represents small and medium-sized companies in Europe... Global Sub. Full

 

Investors And Industry: EU Must Use Biotech Act To Close Gap With US And China

(7/8, Eliza Slawther, Pink Sheet) ...Addressing regulatory inefficiencies, reducing clinical trial set-up fragmentation and mobilizing investment capital are among the changes that European leaders must make to strengthen Europe's life sciences industry, according to a June 26 letter to European leaders from the European Life Sciences Coalition (ELSC)... Global Sub. Full

 

EU Biotech Act: Belgian Rapporteur Seeks Stronger Patent Incentives

(7/9, Nicole Verbeeck, Euractiv) ...Belgian MEP Wouter Beke (EPP)...proposes 24 months and more flexible criteria to keep innovation in Europe. "There are some different views on SPC; that's clear," Beke told Euractiv. "But I think there is also a big tendency to acknowledge the importance of strong intellectual property protection as one of the pieces to the puzzle." He said he wants to aim for "a very ambitious and forward-looking approach."... Full

 

Poland to Overhaul Digital Prescription Rules to Cut Drug Waste

(7/9, Paulina Mozolewska, Euractiv) ...The draft legislation would introduce changes affecting reimbursed and annual prescriptions, as well as the country's free medicines programme for older people. While some proposals have raised concerns among healthcare stakeholders about restricting patient access to medicine, health officials insist the reforms are designed to make the system more efficient rather than limit access to treatment... Full

 

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