Friday, August 21, 2026

 

 

Aurinia Settles with Teva, Helping Stave off Potential Lupkynis Generic Until Late 2036

(8/20, Kevin Dunleavy, Fierce Pharma) ...After the agreement with Teva, Aurinia said it remains in ongoing patent infringement litigation with generics players DifGen, Dr. Reddy's, Hikma, Sandoz and Zydus. Each of the actions are being handled in U.S. District Court in New Jersey... Full

 

 

Exclusive: PhRMA Considers a Grab-Bag of Republican Policy Wonks, Former Lawmakers for CEO Post

(8/20, Max Bayer, Endpoints News) ...More than four months into PhRMA's search for a new CEO, the lobbying group has considered Republican candidates with experience spanning decades on Capitol Hill and executive know-how. According to multiple industry sources familiar with the discussions, granted anonymity to discuss private talks, candidates in the mix have included former Republican Reps. Greg Walden and Eric Cantor, former Gov. Bobby Jindal (R-LA) and former CMS Administrator Seema Verma, who served as part of the first Trump administration... Sub. Req'd

 

Families USA Urges CMS Not To Use Therapeutic Alternatives As Starting Point For MFPs

(8/20, Jessica Karins, Inside Health Policy) ..."Medicare drug negotiation is working well, and we need to extend the benefits for more discounts for more drugs for more patients. We need to double down on the progress of Medicare negotiation to expand the program, and close every loophole drug companies try to exploit," Anthony Wright, executive director at Families USA, said in a statement... Sub. Req'd

 

Four Reasons Trump's Drug Pricing Claims Are Bogus

(8/20, Public Citizen) ...This analysis will detail four reasons not to buy Trump's latest drug price boast: I. Unpublished Methods...II. Unimplemented Policies...III. Inappropriate Metric...IV. Stolen Valor... Full

 

Watch: Mark Cuban Says You Can't Fix Healthcare Until Every Price Is Known

(8/21, Julie Rovner, Hannah Norman, KFF Health News) ...Cuban said that, in thinking about the broader problems facing the U.S. healthcare system, the key is to rebuild trust. "Trust really is a formula," he said. "Trust equals transparency divided by self-interest."... Full

 

What You Need to Know About the PBM Industry's New TrumpRx Commitment on Transparency, Affordability, and Consumer Choice

(8/20, PCMA) ...PCMA and the PBMs pledged that they "commit to supporting the goals of transparency and affordability by presenting to patients the cash prices listed on TrumpRx for comparison to the prices under their benefit, through use of PBM real time benefit tools, when consistent with plan coverage and allowed by law."... Full

 

California to Provide Free Rescue Inhalers to Schools

(8/20, Anna Ashcraft, Fox5 San Diego) ...The initiative, in partnership with Amneal Pharmaceuticals, was made possible through a major expansion of CalRx. The free life-saving asthma medication will be made available to 10,000 California schools just ahead of Labor Day... Full

 

 

Xspray's Dasynoc Approval Bid Foiled Again by FDA's Manufacturer Concerns

(8/20, Fraiser Kansteiner, Fierce Biotech) ...This week, the FDA handed Xspray another Complete Response Letter on Dasynoc, an "optimized" version of Bristol Myers Squibb's cancer treatment Sprycel (dasatinib) in development to tackle chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The letter addressed "previously communicated" manufacturing observations at Xspray's third-party production partner, NerPharMa, and posed a request for additional commercial-scale batch data, which itself follows previous corrective actions, the company said in an Aug. 19 release... Full

 

Boehringer Places Phase 1 Study of Investigational Drug on Hold to Examine 'Safety Event'

(8/21, Marissa Russo, Fierce Biotech) ...The pharma didn't provide more details in response to Fierce's questions about the nature of the safety event or BI 3031185's specific mechanism of action, which remains under wraps. However, the spokesperson did point out that BI 3031185 had already completed three separate studies—including a phase 1b trial in Germany in 78 patients with borderline personality disorder or attention deficit/hyperactivity disorder (ADHD). The trial began in August 2025 and was recently marked complete on the U.S. federal trials database... Full

 

Celltrion Launches Steqeyma IV in Japan, Adds Crohn's Disease Indication

(8/21, Lee Han-soo, Korea Biomedical Review) ...The company said Friday that the intravenous (IV) formulation reached the Japanese market about four months after receiving approval from Japan's Ministry of Health, Labour and Welfare (MHLW) in April. Along with the launch, Steqeyma also added Crohn's disease as an indication in Japan, broadening its use beyond psoriasis and psoriatic arthritis... Full

 

 

The Bona Fide Marketing Standard and What That Means for Biosimilars and Generics

(8/20, Stanton Mehr, Biosimilars Review & Report) ...This week, Teva received an appellate court ruling on the IRA Medicare Fair Price (MFP) question as to whether a generic drug (or biosimilar) is to be considered a "bona fide" marketed product. This gets to the very heart of whether the reference product or originator brand is eligible for the MFP IPAY negotiations in the first place... Full

 

Celon Pharma's Generic Semaglutide Drug Matches Ozempic in Early Study, Shares Jump

(8/20, Reuters) ...Celon Pharma's experimental semaglutide product Reduzek, a generic alternative to Novo Nordisk's Wegovy and Ozempic, matched the blockbuster weight-loss drugs in an early-stage bioequivalence study, the Polish drugmaker said on Thursday... Full

 

Biosimilars Are Powering Henlius' Global Biopharma Push

(8/20, Dean Rudge, Generics Bulletin) ...Shanghai Henlius Biotech may increasingly describe its future in the language of innovation, but biosimilars remain firmly embedded in the foundations of the Chinese firm's global ambitions... Global Sub. Full

 

Outlook Bids On Lytenava's Differentiated Position As It Readies To Enter The US

(8/20, Urte Fultinaviciute, Generics Bulletin) ...Outlook Therapeutics is focusing on the long-awaited Lytenava launch in the US, after finally receiving FDA approval in July following years of complete response letters... Global Sub. Full

 

 

Bristol Myers Squibb Partners with Chai Discovery for AI Antibody Design

(8/20, Fred Pennic, HIT Consultant) ...Bristol Myers Squibb will integrate Chai's proprietary molecular folding and de novo design models across its drug discovery portfolio to power an AI-driven, continuously learning discovery system. Chai Discovery's platform acts as a computer-aided design (CAD) suite for biology, predicting and reprogramming molecular interactions to generate targeted biomolecules from scratch rather than relying on iterative experimental screening... Full

 

Eli Lilly's $3.5B Manufacturing Campus Advances in Upper Macungie, Pennsylvania

(8/20, Peter Mwaniki, Construction Review) ...A planned $3.5 billion pharmaceutical manufacturing campus in Upper Macungie Township, Pennsylvania, has moved forward through the local development process as planners recommended final subdivision and land development approval for the project... Full

 

Roche Pours $750M into Oregon Manufacturing Plant as Obesity Push Expands

(8/20, Gabrielle Masson, BioSpace) ...Roche's Genentech is pledging $750 million to double the size of its Oregon manufacturing site and create more jobs, a move designed to expand the company's capacity to make injectable medicines and delivery devices. The facility is located at a 75-acre Hillsboro campus, with the expansion expected to generate 250 manufacturing roles and 200 construction jobs in Oregon, according to a Thursday release. Commercial operation is slated to start in 2031... Full

 

Alteogen to Invest 253 Billion Won in Daejeon Bio Plant

(8/21, Park Hee-Yoon, Seoul Economic Daily) ...Daejeon City said on the 21st that it had signed a business agreement with Alteogen for the investment and the creation of 135 new jobs. Alteogen will build a facility in the Dungok district to manufacture both active pharmaceutical ingredients and finished drug products... Full

 

 

'Money Has Spoken': Why Chinese Biotech CEOs Tell Fierce They're Unfazed about Rising US Tensions

(8/20, Leslie Zhen Liang, Fierce Biotech) ...The ultimate aim is to restrict or even block the burgeoning licensing deals between the two countries in the name of protecting U.S. leadership in biotech innovation and national security. But so far, the market is telling a different story. "We see the opposite," Puru Gaur, director at market intelligence firm Evaluate, told Fierce. "For licensing, this is diligence drag, not a wall."... Full

 

Euro Roundup: EMA Seeks Feedback on Framework Designed to Drive Uptake of Data Standards

(8/20, Nick Paul Taylor, Regulatory Focus) ...If successful, the framework will lead to the implementation of more standards over "a much shorter timeframe." EMA and HMA will assess the effectiveness of the framework, providing NDSG with insights to improve the document... Full

 

Norway Raises Tariff Concerns in Talks With US Trade Official

(8/21, IANS) ...Norwegian State Secretary Andreas Motzfeldt Kravik met Deputy United States Trade Representative Jeff Goettman on Wednesday and discussed the tariffs as well as an ongoing US investigation into global industrial overcapacity, the ministry said in a statement... Full

 

Who Was Here Before? Sharing Pharmacovigilance Inspection History Could Shape Next Visit

(8/20, Vibha Sharma, The Pink Sheet) ...Drug companies facing multiple pharmacovigilance (PV) inspections could help shape how regulators plan their visits by disclosing whether they have recently been inspected by another agency, according to Claire Longman of the UK's Medicines and Healthcare products Regulatory Agency... Global Sub. Full

 

Ministry of Food and Drug Safety, WHO Host Biosimilar Regulatory Workshop

(8/21, Yeom Hyun-a, The Chosun Daily) ...The Korea National Institute of Food and Drug Safety Evaluation (NIFDS), affiliated with the Ministry of Food and Drug Safety, announced that it will jointly host a "Workshop on Implementing Biosimilar Evaluation Guidelines" with WHO from the 24th to the 26th of this month. This workshop, themed "Promoting Regulatory Harmonization of Biosimilars," will be held first in South Korea... Full

 

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