Wednesday, September 3, 2025

Americans to Gain New Access to Real-Time Prescription Drug Price Information

(9/2, U.S. Department of Health and Human Services) ...The reform will help them identify the most appropriate, cost-effective treatments while preventing health insurers from blocking physician-approved care. Thanks to this rule change taking effect October 1, millions of Americans for the first time will be able to compare drug prices, view out-of-pocket costs, and access prior authorization requirements. HHS' final rule ensures that health care providers using certified health IT systems are able to submit prior authorizations electronically, select drugs consistent with a patient's insurance coverage, and exchange electronic prescription information with pharmacies and insurance plans... Full

Price Controls Won't Help Americans Access Affordable Drugs

(9/2, Satya Marar, RealClearHealth) ...MFN aside, US drug prices can be lowered without unduly compromising innovation by reforming and streamlining the regulatory approvals process for new drugs. This would reduce costs and lower the risk of R&D investment. The Medicare 340B program should also be reformed or replaced. It lets tax-exempt hospitals purchase drugs for rock-bottom prices while marking up prices faced by patients and their insurers without passing on savings... Full

Pharmacy Benefit Managers Aren't the High-Priced Drug Problem

(9/3, Agustin Forzani, RealClearMarkets) ...The FTC and the state legislatures seeking to restrict PBMs are misdiagnosing the problem. PBMs not only help reduce prices but also perform services that are highly valued by consumers. To lower drug prices for everyday Americans, lawmakers should instead address the real drivers of high prices — regulatory delays, trade barriers, patent abuses, and restrictions on competition — and allow Pharmacy Benefit Managers continue doing their essential work... Full

Alex Keeton Named Head of the Biosimilars Council, SVP of Policy

(9/2, AAM) ...Alex Keeton will serve as Executive Director of the Biosimilars Council and Senior Vice President of Policy at the Association for Accessible Medicines where he will lead all aspects of biosimilars advocacy, policy, and outreach as well as AAM's policy development and issues management to improve overall market sustainability and increase access to affordable generic and biosimilar medicines... Full

FDA to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars

(9/2, Gillian McGovern, Pharmacy Times) ...The FDA's waiver of clinical efficacy studies for monoclonal antibody biosimilars will significantly reduce development costs and accelerate approval timelines. This regulatory change aligns the FDA with European and UK agencies, promoting global harmonization in biosimilar approvals. Smaller companies are expected to enter the biosimilar market, increasing competition and potentially lowering drug prices... Full

Drugmakers, Louisiana Spar in Court Over Contract Pharmacy Law

(9/2, Ganny Belloni, Bloomberg Law) ...A federal appeals court panel lobbed pointed questions Tuesday at lawyers for drugmakers and the state of Louisiana in an effort to determine whether the state's contract pharmacy law is preempted by federal law. The over one-hour discussion at the US Court of Appeals for the Fifth Circuit heard arguments from lawyers representing the Louisiana Department of Justice and attorneys from pharmaceutical giants AbbVie, AstraZeneca, and the Pharmaceutical Research and Manufacturers of America... Sub. Req’d

Arrowhead, Novartis in Up to $2 Billion Deal for Neuromuscular Therapy License

(9/2, Padmanabhan Ananthan and Christy Santhosh, Reuters) ...Arrowhead Pharmaceuticals will get up to $2 billion from Swiss pharma major Novartis for an exclusive worldwide license to the U.S. drugmaker's experimental therapy that targets neuromuscular conditions such as Parkinson's...H.C. Wainwright analysts said the collaboration was a "strategically clean deal" that would extend Arrowhead's cash runway without diluting its ownership... Full

Lupin Receives USFDA Nod for Injectable Used to Treat Schizophrenia and Bipolar Disorder

(9/3, Shloka Badkar, CNBC TV-18) ...It said it has received USFDA's approval for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials...Lupin said this is its first product using proprietary Nanomi B.V.'s (Nanomi) technology and has a 180-day CGT exclusivity. The drugmaker said its subsidiary Nanomi is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients... Full

Celltrion Demonstrates Long-Term Efficacy of EYDENZELT in 52-Week Clinical Trial

(9/3, Heo Ji-yoon, ChosunBiz) ...According to the study results, both administration groups showed a gradual improvement in maximum corrected visual acuity (BCVA), which was maintained steadily until the 52nd week after improvement compared to the baseline value up to the 16th week, confirming the long-term therapeutic effect of EYDENZELT...The company noted that, as the efficacy and safety data of EYDENZELT have been continuously adopted and made public, the preference and trust of healthcare providers in prescribing it are expected to increase significantly... Full

Polpharma And MS Pharma Sign Triple Biosimilar Deal In MENA

(9/2, Urte Fultinaviciute, Generics Bulletin) ...Polpharma and MS Pharma have signed a licensing deal covering vedolizumab, ocrelizumab, and guselkumab biosimilars in the MENA region...In a recent exclusive interview with Generics Bulletin, MS Pharma's CEO explained that the firm is transitioning from a generics to a biosimilar business, already having the largest pipeline so far compared to other local companies in the region. "These three products will significantly strengthen our offering and reinforce our leadership in the MENA region," said Känd in the agreement announcement... Global Sub. Full

Amgen to Invest $600 Million in New Research and Development Facility in California

(9/2, Annika Kim Constantino, CNBC) ...Amgen said it will spend more than $600 million to build a new research and development facility at its headquarters in Thousand Oaks, California. It is the latest in a string of new U.S. investments by the pharmaceutical industry as President Donald Trump threatens to clamp down on the industry with tariffs on pharmaceuticals imported into the country. Amgen said construction of the facility will begin in the third quarter of this year and will create hundreds of U.S. jobs... Full

Roche Makes Preclinical IBD Play in $420M+ OMass Pact

(9/2, Tristan Manalac, BioSpace) ...The OMass partnership will boost Roche's strategy in inflammatory bowel diseases, currently led by afimkibart, an anti-TL1A therapy the pharma obtained from its $7.1 billion acquisition of Telavant in 2023...Other industry heavy-hitters are also working on IBD, including Merck, which in April 2023 dropped $10.8 billion to buy Prometheus Biosciences,gaining ownership of PRA023, an anti-TL1A monoclonal antibody. The molecule is now called tulisokibart and is in late-stage development for Crohn's disease and ulcerative colitis. Joining Roche and Merck is Sanofi, which in October 2023 bet $1.5 billion to partner with Teva and advance their own TL1A program for IBD... Full

AstraZeneca Surrenders its Manufacturing Licence in India

(9/2, The Hindu BusinessLine) ...Multinational drugmaker AstraZeneca said it was surrendering its manufacturing licence, two years ahead of the expiry date...A company insider told businessline the company looks to import its products from the 20-odd facilities it has across the world as part of a global review. The plan was to sell the manufacturing unit, though that is yet to take place... Full

FDA Cites Drugmakers and Testing Lab for CGMP Violations

(9/2, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration (FDA) recently warned two drug makers and a drug testing lab for current good manufacturing practices (CGMP) violations, such as marketing products after detecting microbes and particles. It has also cited half a dozen online retailers for selling unapproved eye drops... Full

‘Antibiotics Cannot Be Taken For Granted' – Centrient's CEO On Ensuring A Sustainable Industry

(9/3, Dave Wallace, Generics Bulletin) ...Centrient CEO Rex Clements talks to Generics Bulletin about how the antibiotics specialist has seen the industry landscape evolve in recent years. Clements touches on aspects including supply-chain security, US tariffs, localized manufacturing and AMR, as well as how the firm is incorporating AI into its plans. In particular, the chief executive questions whether major state investments in manufacturing should favor larger generics players such as Sandoz in Austria over smaller pure-play antibiotics operators such as Centrient. The CEO also reveals plans for Centrient to begin launching a pipeline of new products from next year... Global Sub. Full

Swissmedic Slashes Months Off Review Time For Certain Drug Filings

(9/2, Anabel Costa-Ferreira, Pink Sheet) ...Swissmedic, Switzerland's health care products agency, has cut by 195 days the time it will take to review applications for drugs with "known active substances without innovation" that are submitted via its regulatory reliance pathway. The move applies mainly to generic drugs... Global Sub. Full

China Readies Affordable "Best in Class' Therapies for the World

(9/2, Wang Fangqing, The Pharma Letter) ...The pivot toward innovation is attracting significant attention. In the first half of 2025, China secured more than $60 billion in out-licensing deals, surpassing the $51.9 billion from all of 2024, according to China Post Securities. The most significant deal to date was Pfizer's agreement to pay up to $6 billion for a PD-1/VEGF bispecific antibody from 3SBIO. Frost Sullivan predicted that China's innovative, high quality, cost effective BsMabs and ADCs will continue to attract foreign buyers in the near term... Sub. Req’d

Exclusive: China's Innovative Drug Market to Become World's Third-Largest by 2028

(9/3, Song Hye-jin, The Chosun Daily) ...A survey result has emerged indicating that China, which is rapidly growing in the bio field including the discovery of new drug candidate substances, is set to rise to become one of the world's top three innovative drug markets. According to McKinsey & Company's *Asia Biopharma Report*, to be released in late September, it was analyzed that China will soon overtake Germany, currently ranked third in the world in terms of innovative market size... Full

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