Friday, August 14, 2026

 

 

Humana Agrees Not to Reference Teva's Israel Ties at US Drug Trial

(8/13, Mike Scarcella, Reuters) ...In a filing earlier this month, Tel Aviv-based Teva asked the judge overseeing the case to bar references at trial to Teva's national origin, arguing it is irrelevant to the antitrust legal proceeding in the United States and could prejudice jurors against Teva. "In the period of almost three years since the start of the Gaza War, anything connected with Israel has been subject to the highest levels of controversy, with emotions running high," Teva said... Full

 

 

PDUFA VIII Commitments: 'America First' Provisions, Faster Reviews and More

(8/13, Zachary Brennan, Endpoints News) ...The FDA's next five-year reauthorization of the prescription drug user fee program will feature new incentives for domestic pharma companies, newly sped up reviews for some applications and improved ways for industry to communicate with FDA. And while the commitment letter released Thursday doesn't include the so-called "America First" provisions that former FDA Commissioner Marty Makary had touted during the negotiations, the agency said they will be included in the final legislative package transmitted to Congress... Sub. Req'd

 

PDUFA VIII: FDA Outlines Goals, Program Enhancements in Commitment Letter

(8/13, Joanne S. Eglovitch, Regulatory Focus) ...In a Federal Register notice released alongside commitment letter announcing a meeting on September 16, to present the PDUFA VIII recommendations, FDA wrote that "the proposed enhancements for PDUFA VIII address many of the priorities identified by public stakeholders, the regulated industry, and FDA. While some of the proposed enhancements are new, many streamline or refine elements from the existing program."... Full

 

US FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?

(8/13, Derrick Gingery, Pink Sheet) ...In addition, the agency said it would reduce the target revenue total in fiscal year 2028, the first year of the program cycle if enacted by Congress and President Trump, by sunsetting "limited-time operating costs" from the current program cycle and savings from "administrative efficiencies." The FDA has reorganized and streamlined its shared services, such as human resources and information technology, in recent months and continues to experience staff departures... Global Sub. Full

 

US FDA Loses Key PFDD Figure With Theresa Mullin's Departure

(8/13, Maaisha Osman, Pink Sheet) ...Theresa Mullin played a central role in the starting the FDA's Patient Focused Drug Development initiative in 2012. Theresa Mullin, who served for nearly three decades as a senior leader at the US Food and Drug Administration's Center for Drug Evaluation and Research, retired in July, leaving a legacy that reshaped the agency's use of patient perspectives in drug development and regulatory decision-making... Global Sub. Full

 

Warren to RFK Jr: Show the Public the Negotiated Deals for TrumpRx

(8/13, Ken Alltucker, USA Today) ..."Americans deserve to know whether the deals the administration is cutting with Big Pharma will lower their prescription drug costs - or just further enrich big drug companies," Warren wrote in the letter obtained by USA TODAY. Warren's letter was sent a day after the Labor Department released a July inflation report showing prescription drug prices dropped 3.1% over the past 12 months. It was the steepest annual decline since March 1963, during the administration of President John F. Kennedy... Full

 

Major PBMs to Boost Prescription Drug Price Transparency Through TrumpRx

(8/13, Eric Revell, Fox Business) ...A group of nine pharmacy benefit managers (PBMs) announced Thursday that they will work with an industry group to boost the transparency of prescription drug pricing through the TrumpRx platform. FOX Business exclusively learned that the Pharmaceutical Care Management Association (PCMA) and nine PBMs reached an agreement to showcase the cash price of prescriptions from TrumpRx within their benefit tools. The agreement aims to give patients better visibility into the cost of the medication and how they might save money on it... Full

 

How Price Controls Could Drive Up Long-Term Drug Spending

(8/13, Thomas J. Philipson, RealClear Health) ...At the time, liberal lawmakers claimed these price negotiations would save the federal government more than $100 billion over the next 10 years, with the savings compounding in subsequent decades. Their math was -- and still is -- wildly off. As my University of Chicago colleagues and I show in a new paper, the IRA's price controls will likely increase long-term prices of medicines... Full

 

Congress Must Protect the Research Behind Tomorrow's Cures

(8/13, Mimi Walters, The Hill) ...Research shows foreign-made generic drugs are nearly twice as likely to cause severe adverse events compared with American-made drugs. With roughly 20 percent of the ingredients in our most critical medicines now sourced from abroad, more of what goes into American medicine cabinets is being made under standards we cannot fully verify or enforce... Full

 

Draft GDUFA Commitment Letter Prioritizes Production Onshoring

(8/13, Jessica Karins, Inside Health Policy) ...The draft commitment letter for the next reauthorization of FDA's Generic Drug User Fee Amendments (GDUFA) outlines new efforts to promote domestic manufacturing by increasing foreign facility fees and proposing a statutory amendment to waive applications fees waive application fees for three years for companies that establish new domestic facilities to make APIs or finished generic drugs. The agreement also would reduce authorization timelines for generics... Sub. Req'd

 

 

A Pill and a Novel Mechanism to Treat IBD-Related Inflammation

(8/13, Specialty Pharmacy Continuum) ...A meta-analysis of RELIEVE- UCCD data presented at DDW examined duvakitug's impact on both CD and UC within two subgroups: patients who had experience with and those who were naive to advanced therapies. Both subgroups showed greater TL1A inhibition compared with patients taking placebo, with a larger relative benefit seen in the experienced patients over the 14 weeks... Full

 

 

Novartis Keeps UK Entresto Generics At Bay Until 2028

(8/14, Dean Rudge, Generics Bulletin) ...Accord has failed to clear the way for its planned UK generic Entresto launch after the High Court upheld Novartis' patent and SPC, although one of the generics firm's validity attacks came close to succeeding... Global Sub. Full

 

Mabwell Secures Global Deals For Eylea Biosimilar

(8/13, Urte Fultinaviciute, Generics Bulletin) ...Mabwell has secured four new commercialization deals for its aflibercept biosimilar across the GCC and ASEAN regions, while its wholly owned subsidiary T-mab passed a second PIC/S GMP inspection for its denosumab biosimilars... Global Sub. Full

 

Sun Pharma Unit Escapes Lipitor Generic Pay-for-Delay Suit

(8/13, Katie Arcieri, Bloomberg Law) ...Judge Patty Shwartz of the US Court of Appeals for the Third Circuit wrote in a Thursday opinion that the purchaser plaintiffs failed to establish antitrust standing in a case alleging an anticompetitive settlement between Pfizer Inc. — Lipitor's maker — and the generic maker caused delays in producing the generic. The judges also affirmed a lower court's denial of the plaintiffs' class certification motion... Sub. Req'd

 

Aeon Buys Time For Botox Biosimilar As Key FDA Feedback Looms

(8/13, Dean Rudge, Generics Bulletin) ...Aeon has raised $13.6m in net proceeds through a July public offering, extending its expected cash runway into the first quarter of 2027 and strengthening its balance sheet ahead of further ABP-450 development... Global Sub. Full

 

Gilead Scores Win to Keep Pause on Cheaper, Foreign Drug Imports

(8/13, Nyah Phengsitthy, Bloomberg Law) ...The US Court of Appeals for the Fourth Circuit upheld a lower court order Thursday that enjoined the advertising and sale of imported foreign Gilead-branded medications into the US, due to the likely violation of trademark laws. The plan to sell imported Gilead products in competition with domestic Gilead drugs was initiated by a health plan, a pharmacy benefit manager, and drug savings vendors... Sub. Req'd

 

Solaris Intros Generic Clarithromycin Tablets

(8/13, Julianne Mobilian, Drug Store News) ...Solaris Pharma has launched generic clarithromycin immediate-release tablets in 250-mg and 500-mg strengths. Both strengths are available in 60-count bottles. The tablets are a generic version of AbbVie's discontinued Biaxin and are indicated for the treatment of several bacterial infections, including acute bacterial exacerbations of chronic bronchitis, acute maxillary sinusitis, community-acquired pneumonia, pharyngitis and tonsillitis, uncomplicated skin and skin structure infections and acute otitis media... Full

 

Generic Semaglutide May Make GLP-1 Therapy Cost-Effective in T2D

(8/13, Luke Halpern, Pharmacy Times) ...Modeling in Canada suggests price drops of up to 70% could make dual GLP-1 glucagon-like peptide-1 (GLP-1) RA/SGLT2 inhibitor therapy the preferred strategy for high-risk patients with type 2 diabetes (T2D). Anticipated price reductions from the arrival of generic semaglutide (generic for Ozempic, Wegovy; Eli Lilly and Company) could remove a longstanding affordability barrier to guideline-recommended cardiorenal therapy for patients with type 2 diabetes (T2D), according to a new health economic analysis published in the Canadian Journal of Cardiology... Full

 

G&W Must Face Jury Over Alleged Generics Price-Fixing Conspiracy

(8/14, Dean Rudge, Generics Bulletin) ...US district judge Michael Shea denied summary judgment to G&W on most of the claims challenged by the company, expressly finding that the record raised a genuine dispute over whether G&W participated in the alleged overarching conspiracy to fix prices, rig bids and allocate customers across dozens of generic drugs... Global Sub. Full

 

Europe May Follow France's Biosimilar Lead, Germany Reforms Cut Both Ways: Lupin CEO

(8/14, Vibha Ravi, Generics Bulletin) ...France's model of incentivizing biosimilars substitution to help drive savings, which are then plowed back into innovator drugs, might be emulated by other European nations, said Lupin's CEO, Vinita Gupta, while pointing to "very interesting dynamics in all of the European countries."... Global Sub. Full

 

 

Novo CEO Says Obesity Market Won't Be Winner-Take-All Battle With Lilly

(8/13, Michael Erman, Reuters) ...Novo Nordisk CEO Mike Doustdar said investors are underestimating the demand for differentiation among obesity drugs, and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly. Novo was first to bring a highly effective GLP-1 weight-loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly's Zepbound in a business that analysts expect will be worth more than $100 billion a year by 2030... Full

 

US FDA Approves Bristol Myers' Blood Cancer Treatment

(8/13, Sneha S K, Siddhi Mahatole, Reuters) ...The U.S. FDA on Thursday approved Bristol Myers Squibb's oral combination treatment for patients with a rare form of blood cancer whose illness had relapsed or not responded to other treatments, the health regulator said. The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J's tab Darzalex and dexamethasone, a prescription medication used to reduce inflammation... Full

 

Lawsuit Against Bristol Myers over Delayed Cancer Drug Is Revived

(8/13, Jonathan Stempel, Reuters) ...A U.S. federal appeals court said a judge erred in dismissing a $6.7 billion lawsuit accusing Bristol Myers Squibb of cheating former Celgene shareholders by delaying federal approval for three drugs, including the cancer treatment Breyanzi. In a 3-0 decision on Thursday, the 2nd U.S. Circuit Court of Appeals in Manhattan said UMB Bank was entitled to represent the Celgene shareholders as a trustee despite an error in how it was appointed... Full

 

Ovid and Takeda's Epilepsy Drug Gets New Life at Perceptive-Backed NewCo

(8/13, Kyle LaHucik, Endpoints News) ...About 26 months after failing two Phase 3 trials, an epilepsy treatment candidate is getting plucked off biopharma's shelves and will be given a new chance at life. Life sciences investment firm Perceptive Advisors is building a new company around soticlestat, an enzyme inhibitor that Ovid Therapeutics and Takeda had tried to develop for rare forms of epilepsy called Dravet syndrome and Lennox-Gastaut syndrome. Takeda ended development of the drug at the beginning of 2025 after paying almost $200 million upfront in 2021 to regain the asset from Ovid... Sub. Req'd

 

Eli Lilly Targets Booming Black Market for Retatrutide

(8/13, Meghana Keshavan, STAT+) ...Eli Lilly is escalating its war against a booming black market for retatrutide — its still-experimental obesity drug that has produced up to 29% weight loss in a Phase 3 trial. The drugmaker said yesterday that it had sued six U.S. companies — including compounding pharmacies, medical spas, and online peptide sellers — that it says are illegally selling versions of the drug, often labeled "research-use only" while being marketed for people... Sub. Req'd

 

 

Teva's Israeli Identity Becomes a Courtroom Issue in U.S. Price-Fixing Trial

(8/13, CTECH) ...The agreement underscores the increasingly contentious nature of the issue in the United States following Israel's military campaign in Gaza, which began after Hamas' October 2023 attack on Israel. Humana and Teva did not immediately respond to requests for comment... Full

 

 

Ozempic, Wegovy Get New Rivals as Kenya Approves Seven Semaglutide Drugs

(8/14, Hellen Shikanda, Daily Nation) ...Kenya's drug regulator has registered seven semaglutide products for the treatment of type 2 diabetes and weight management, as experts warn of rising obesity and diabetes cases in the country. According to the World Health Organisation (WHO), semaglutide is a prescription medicine that mimics a natural body hormone to lower blood sugar and reduce appetite. The WHO added it to its Model List of Essential Medicines in September last year... Full

 

Parliamentary Panel Recommends Integration of HTA Outputs Into NPPA's Price Fixation Guidelines

(8/14, Gireesh Babu, Pharmabiz.com) ...Observing that there are limitations of the current market-based drug pricing mechanism administered by the National Pharmaceutical pricing Authority (NPPA) in regulating prices of various drugs, the Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended integrating Health Technology Assessment (HTA) outputs into NPPA's price-fixation guidelines for certain drugs... Full

 

Stakeholders Defend German Pharma Law Amid Tariff Threat

(8/13, Brett Fortnam, Inside Health Policy) ...A key component of the German pharmaceutical pricing bill that the Office of the U.S. Trade Representative has flagged as potentially discriminatory was left out of the final legislation, several stakeholder groups have told the agency, urging that it conclude its Section 301 (Trade Act of 1974) investigation by finding that German policies are not unfair to the U.S... Sub. Req'd

 

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