Wednesday, September 16, 2026

 

 

HHS Official Klomp Spars with Warren Over Drug Pricing Contracts

(9/16, Max Bayer, Endpoints News) ...Speaking to members of the Senate Finance Committee as part of his nomination to be HHS deputy secretary, Klomp defended the Trump administration's "most favored nation" pricing deals with pharmaceutical companies...Klomp argued that disclosing details could imperil ongoing pricing negotiations, presumably part of the administration's push to get other countries to pay more for drugs. The White House and CMS have also said they're negotiating more deals with other companies... Sub. Req'd

 

Elizabeth Warren Grills RFK Jr. Aide on Drug Pricing Deals: 'Show Me The Receipts!'

(9/15, Gabrielle M. Etzel, Washington Examiner) ...Sen. Ron Wyden (D-OR), ranking Democrat on the committee, also chided Klomp for the administration's secrecy over the MFN agreements during his opening statement. "Trump's plan on drug prices amounts to this: trust me and Big Pharma," Wyden said. "There's not a shred of evidence these deals have significantly lowered costs for patients. But there is ample evidence that Big Pharma got sweetheart tariff deals and boosted stock prices."... Full

 

Health Brief: Three Key Issues for The No. 2 at HHS

(9/15, Megan R. Wilson, The Washington Post) ...Klomp signaled that HHS wants to work with Congress on legislation to give the department more authority over pharmacy benefit managers, particularly on the issue of transparency...He also endorsed efforts to change incentives that can make it harder for generics and biosimilars to compete with brand-name drugs... Full

 

Price Caps Sound Great — Until You Have Cancer and a Two-Year Waitlist

(9/15, Nicole Sheahan, Washington Examiner) ...Members of both parties have recently proposed capping the U.S. price of medicines at the lower prices paid in other developed countries. They mean well - they want to make drugs more affordable. But they often don't realize that European nations pay lower prices due to rationing tactics and other artificial price controls. Importing those tactics here would deter companies from pursuing medical research, which is extraordinarily expensive and risky... Full

 

FDA to Test New Approach to Expediting Phase 1 Trials

(9/15, Joanne S. Eglovitch, Regulatory Focus) ...Under the pilot program, pharmaceutical companies will work with qualified research institutions, such as academic medical centers or contract research organizations, to develop Phase 1 Investigational New Drug (IND) submissions for first-in-human (FIH) clinical trials. This collaboration will utilize a rolling IND submission platform, designed to reduce the chances of clinical holds... Full

 

China Security Fears Could Delay PDUFA Reauthorization, US FDA Warns

(9/15, Sue Sutter, Pink Sheet) ...Lawmakers who are more focused on foreign affairs than healthcare potentially could try to leverage PDUFA's legislative renewal to temper China's role as a national security threat, including its dominance as a venue for Phase I clinical trials, Grace Graham, deputy commissioner for policy, legislation and international affairs, told the American Society of Gene and Cell Therapy Policy Summit on Sept. 14... Sub. Req'd

 

There's No Such Thing As A Free Priority Review Voucher

(9/15, Health Affairs) ...Redeeming a voucher shortens the FDA's target review timeline from ten months to six, potentially allowing for earlier market entry for the applicable product. For commercially lucrative medicines, this acceleration can be extremely valuable: Even a few months of additional time on the market may generate hundreds of millions of dollars in revenue from earlier sales, capture market share from competitors, and extend the effective period of market exclusivity before generic or biosimilar competition emerges... Full

 

Arkansas Pharmacies File Lawsuit Accusing PBM of Underpaying Them for Medications

(9/15, Tess Vrbin, Arkansas Advocate) ...Twelve Arkansas pharmacies sued a pharmacy benefit manager in federal court Tuesday, alleging the company illegally underpaid them for tens of thousands of prescription medications. The complaint accuses St. Louis-based Express Scripts of violating a 2015 law that requires pharmacy benefit managers, also known as PBMs, to pay pharmacies at least the national average of what drugstores pay wholesalers for drugs... Full

 

 

Lundbeck Receives Marketing Authorization for Vyepti® (Eptinezumab) in Japan for the Prevention of Migraine Attacks

(9/16, Lundbeck) ...Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment approved for the prevention of migraine attacks in adults and launched in over 30 countries worldwide... Full

 

Viatris Announces Approval of WAKIX® (Pitolisant) in Japan, a First-in-Class Treatment for Narcolepsy and Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Syndrome

(9/16, Viatris) ...Viatris...today announced that Japan's Ministry of Health, Labour and Welfare has granted approval for WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS) in patients receiving treatment for airway obstruction, and approval for narcolepsy (type 1 and 2 – with and without cataplexy)... Full

 

AbbVie Chips in for Neurology Advocacy Through PGA Tour Birdie Campaign

(9/16, Nick Paul Taylor, Fierce Pharma) ...The agreement makes AbbVie, which reported $3.2 billion in neuroscience sales in the second quarter, the official pharmaceutical sponsor of the PGA Tour, a professional golf organization. This month's 2026 Presidents Cup, a PGA Tour competition between U.S. and international golfers, marks the start of the alliance... Full

 

 

Shilpa Biologicals and SPIMACO Bio Sign Strategic License Agreement for PD-1 Biosimilar for MENA Market

(9/16, Express Pharma) ...Under the agreement, Shilpa Biologicals retains ownership of the intellectual property and serves as exclusive developer and manufacturer — earning upfront, development, and commercial milestone payments and product-supply revenue — while SPIMACO Bio leads commercialization, regulatory execution, and market access across the region... Full

 

Bristol-Myers Targets Amgen's Opdivo Biosimilar in Patent Suit

(9/15, Christopher Yasiejko, Bloomberg Law) ...Bristol-Myers Squibb Co. is betting that later-expiring treatment patents can preserve protection for key uses of Opdivo years after its foundational patent's expiration, with a new complaint over Amgen Inc.'s proposed biosimilar. Bristol-Myers, which initially filed the complaint Sept. 8 under seal, alleged that Amgen's biosimilar, called ABP 206, infringes seven patents related to the blockbuster cancer drug. A redacted version was filed Monday in the US District Court for the District of Delaware... Full

 

Glenmark Ahead Of Schedule With A Ryaltris Launch In Brazil

(9/15, Urte Fultinaviciute, Generics Bulletin) ...Glenmark Pharmaceuticals beat its own launch plans by entering the Brazilian market with Ryaltris (olopatadine hydrochloride/mometasone furoate) nasal spray ahead of schedule. In its financial presentation for the three months ended June 30, the Indian pharma giant disclosed it was targeting a Brazil launch in H2 FY2027, which starts in October... Sub. Req'd

 

Samsung Bioepis Escapes Pfizer Damages Threat In Australia

(9/16, Dean Rudge, Generics Bulletin) ...Samsung Bioepis and its commercial partners have defeated Pfizer's Australian patent-infringement lawsuit over the Korean firm's Brenzys (etanercept) biosimilar to Enbrel, with the Federal Court of Australia also finding all but one of the asserted claims of Pfizer's expired manufacturing patent invalid for lack of inventive step... Sub. Req'd

 

 

Sanofi Strikes Cheplapharm Deal to Divest 20 Older Medicines as CEO Pushes for Innovation

(9/15, Donavyn Coffey, Fierce Pharma) ...Per the deal, Sanofi will offload 20 older medicines and three global manufacturing sites to Cheplapharm in exchange for a 26.4% equity stake in the company...The partnership signals a transition toward in-house manufacturing for Cheplapharm as it takes over production sites for the blood thinner Lovenox in Hungary, Singapore and France. The transfer of the manufacturing sites will include a total of 565 employees... Full

 

Novo CEO Urges Staff to Embrace More Customer-Focused Culture

(9/15, Reuters) ..."We would like to become a better and a bigger company. A company that does more for many more, both patients and consumers," [CEO Mike] Doustdar said. He outlined four new principles: customer obsession, competitiveness, clarity, and care and integrity... Full

 

Novartis Veteran Ingrid Zhang Tapped to Lead Legend Biotech

(9/15, Anna Bratulic, FirstWord PHARMA) ...Legend Biotech has named former Novartis executive Ingrid Zhang as its next CEO, less than two months after Ying Huang unexpectedly stepped down from the role. Zhang, who most recently served as chief commercial officer (CCO) of Novartis' international operations, takes the helm of the CAR-T specialist effective Tuesday... Full

 

FDA Warns Bausch and Lomb, Indian API Maker for GMP Issues

(9/15, Joanne S. Eglovitch, Regulatory Focus) ...FDA issued a warning letter to API manufacturer Shoolin Pharma LLP, highlighting violations related to the poor maintenance of its facility in Gujarat, India. The company produces APIs for various medications, including erectile dysfunction drugs like sildenafil citrate and tadalafil, as well as anticonvulsant agents. FDA noted that these ingredients are produced using non-dedicated production equipment... Full

 

WSJ Tech Council Summit: CVS Uses Surveys of AI Bots for Message Testing, Market Research

(9/15, Elias Schisgall, Dow Jones Newswires) ..."We've introduced biosimilars which we think are clinically as effective and actually represent cost savings for our consumers, but we have to get those in the market and convince consumers to adopt them," Sri Narasimhan, CVS Health's vice president of enterprise customer experience & insights, said Monday at The Wall Street Journal's Technology Council Summit... Sub. Req'd

 

 

Encourage a 'Reverse Brain Drain' to Move From Generics to Innovation: Clincial Research Industry

(9/15, PT Jyothi Datta, The Hindu Businessline) ...Encourage a reverse "brain drain," say representatives of the clinical research community citing the China example as a suggestion to help the Indian biopharmaceutical industry make the research journey from generics to innovative medicines... Full

 

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