Monday, August 17, 2026

 

 

Teva Canada Recalls Some Pregabalin Capsules over Sertraline Contamination Concerns

(8/16, CBC) ...Teva Canada is recalling some of its Teva-Pregabalin 150 mg capsules after it said routine testing identified possible contamination with the drug sertraline. Toronto-based Teva Canada said in its recall notice on Friday that the move is a "precautionary measure."... Full

 

 

Warren Doubts TrumpRx Savings, Pushes for Details on Drug Deals

(8/14, Erin Durkin, Bloomberg Government) ...She wrote in a letter to Kennedy Thursday that consumers still risk overpaying for drugs that do not have generics readily available on the site and continued to question the stated savings. "The American public deserves to know if — in exchange for the Trump administration's valuable giveaways to drug manufacturers — they are saving anything more than pennies on the dollar," she wrote... Sub. Req'd

 

Trump Shows Off Article on Lower Drug Prices That Says Biden Deserves Credit, Not Him

(8/15, Robert Mackey, The Guardian) ..."The Inflation Reduction Act was a signature accomplishment of former president Joe Biden, a sprawling measure enacted in 2022 that aimed to lower prescription drug prices by requiring Medicare, the federal health program for the elderly, to begin negotiating the prices it pays drugmakers for an array of popular and costly prescription drugs," the Post's report noted. "The first price reductions took effect at the beginning of this year."... Full

 

Why Prescription Drug Prices Are Plunging

(8/17, Courtenay Brown, Axios) ...Why it matters: By one important measure, there is a striking reversal underway for one of health care's most stubbornly expensive necessities amid a major Washington push to lower drug costs. By the numbers: Prescription drug prices fell 0.8% in July and are down 3.1% from a year ago — the steepest annual decline in more than six decades, according to the recent Consumer Price Index... Full

 

US Offers Funding to Make Medicines on Shore

(8/14, Aayushi Pratap, C&EN) ...Democratic and Republican administrations alike have acknowledged the need for the US to build a self-reliant supply chain for active pharmaceutical ingredients (APIs). They have made efforts to attract domestic production, but major changes have been hard to come by. Now more federal dollars are making their way to projects to boost domestic API production. Experts call it a step in the right direction but say more government support is needed to bring lasting change... Full

 

Was PDUFA VIII A Better 'America First' Vehicle Than GDUFA IV?

(8/14, Derrick Gingery, Pink Sheet) ...America First incentives planned for the brand prescription drug user fee reauthorization appear more lucrative than the carrots intended to help the domestic generic drug industry as a part of its new user fee package. New drug sponsors could receive a 50% application fee reduction if the submission includes clinical data from "at least one Phase I trial anchored in the US after Oct. 1, 2027," according to the Federal Register notice announcing the completed PDUFA VIII agreement. The waiver eligibility requirements were not clear during negotiations and not included in the notice... Global Sub. Full

 

Pink Sheet Podcast: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change

(8/14, Derrick Gignery, Nielsen Hobbs and Sue Sutter, Pink Sheet) ...Aside from setting the usual fees for applications, the agreement also will expand some formal meeting programs, including the model-informed drug development and rare disease endpoint advancement programs. Those programs eventually will transition to ongoing availability rather than a limited number of participants. The FDA also is going to direct fees to push forward the next upgrade of the Sentinel program, which monitors drug adverse events, and it will allow additional meetings between FDA and sponsors about CMC issues, in part to avoid application and inspection issues that can delay approval... Global Sub. Full

 

FDA Finalizes Guidance on Formal Meetings With Drug and Biologics Sponsors

(8/14, Joanne S. Eglovitch, Regulatory Focus) ...Changes made from the draft guidance include additional examples of Type D meetings, clarification on Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings, and the addition of information on meeting formats that FDA may grant, according to FDA. In addition, editorial changes were made to improve clarity. Meetings are classified into five categories: Type A, Type B, Type C, Type D, and INTERACT meetings... Full

 

US FDA Modernizes Drug Product Packaging Assessments With Risk-Based Framework

(8/14, Sue Sutter, Pink Sheet) ...The draft guidance, "Container Closure Systems for Human Drugs and Biological Products," provides guiding principles and specific considerations for the development and assessment of container closure systems (CCSs) for drug products and drug substances. The document also applies to CCSs that are device constituent parts of combination products or that are used to hold the drug or biological part of the product. While the scope of the guidance excludes standalone devices, some recommendations may apply to standalone devices intended to deliver drugs... Global Sub. Full

 

Industry Groups Seek Clarity, Flexibility in Manufacturer-Payor Communications Guidance

(8/14, Ferdus Al-Faruque, Regulatory Focus) ..."In practice, FDA could strengthen the Draft Guidance's statements regarding unapproved products and uses, for example to state that the Agency 'will not object' to communications related to unapproved products or uses that satisfy the requirements of section 502(gg)," said PhRMA. "Such clarification would more clearly reflect the legal effect of the statute and further Congress's objective of facilitating appropriate information exchange with payors and similar entities... Full

 

 

Glenmark USA Agrees to USD 15.28 Mn Settlement With Humana Over Generic Drug Antitrust Claims

(8/16, Parthika Patel, Medical Dialogues) ...Three complaints filed by Humana Inc. were also included in the consolidated litigation. The plaintiffs, including Humana, alleged both individual drug-specific conspiracies and an "overarching" conspiracy involving numerous generic drug manufacturers in the United States. Glenmark USA and the other defendants have denied the allegations and have vigorously defended the litigation. The company has maintained that the allegations against its U.S. subsidiary were disputed... Full

 

Shilpa Medicare Recalls Over 27K Vials of Chemotherapy Drug in US

(8/17, ETPharma.com) ...Shilpa Medicare is undertaking a voluntary recall of over 27,000 vials of 10 mg and 50 mg strength of chemotherapy drug "Pemetri RTU " in the US. According to the US FDA's latest enforcement report, the recall was initiated following market complaints reporting "green to dark-green discoloration in certain vials." In two separate voluntary actions, the company is recalling 9,489 50 mL vials and 18,434 10 mL vials... Full

 

Respiratory Feats Put Glenmark's US Recovery On Firmer Footing

(8/14, Dean Rudge, Generics Bulletin) ...Glenmark's US business accelerated sharply in the first quarter of its 2027 financial year, with underlying North American growth reaching almost 20% as the firm's widening respiratory generics portfolio and renewed launch pace began to deliver the recovery management had promised. North America revenues rose by 41.1% to INR10.97bn ($115m) for the three months ended June 30, although that figure included deferred out-licensing income recognition related to its IGI subsidiary's novel trispecific antibody ISB 2001... Global Sub. Full

 

Sandoz to License Three Biosimilar Drugs From Shanghai Henlius Biotech

(8/17, Reuters) ...Swiss generic drugmaker Sandoz will pay up to $77 million upfront to Shanghai Henlius Biotech for rights to three biosimilar drugs to treat cholesterol, lupus and colorectal cancer, the Chinese drugmaker said on Monday. The three treatments are in clinical or pre-clinical development. Biosimilars are similar versions of biologic drugs and are comparable to generic versions of traditional pharmaceuticals. Sandoz said in a separate statement that it will gain global commercialisation rights to the drugs outside China... Full

 

New Hypertension Drugs Show No Advantage Over Older Generics

(8/14, Briana Contreras, Managed Healthcare Executive) ...A draft ICER report found that baxdrostat and lorundrostat don't lower blood pressure more than older generics but do cost much more. Two new drugs for treatment-resistant hypertension, Baxfendy (baxdrostat) and lorundrostat, did not lower blood pressure much more than decades-old generic drugs and are even more expensive than what is considered a standard value in the healthcare market, according to a draft evidence report from the Institute for Clinical and Economic Review (ICER)... Full

 

Rituximab Biosimilars Show Comparable 6-Month Outcomes in AAV

(8/14, Brooke McCormick, The Center for Biosimilars) ...A 6-month, real-world comparison of rituximab biosimilars vs the originator biologic in antineutrophil cytoplasmic antibody–associated vasculitis (AAV) found no significant differences in remission rates, relapse rates, or serious adverse events, supporting continued use of biosimilars as mandates expand across this rare disease space... Full

 

 

Cytokinetics Brings Patent Suit Against Bristol Myers, Escalating Rivalry

(8/14, Nicole DeFeudis, Endpoints News) ...Cytokinetics and Bristol Myers Squibb are fierce market rivals. Now they're rivals in court. Cytokinetics filed a lawsuit against Bristol Myers on Wednesday, seeking to invalidate a recently granted patent protecting BMS' heart drug Camzyos. Cytokinetics launched its heart drug Myqorzo in January, and has accused Bristol Myers of "wielding the patent system as a weapon" to unfairly compete with Myqorzo... Sub. Req'd

 

Bristol Myers Squibb Protein Degrader Wins First-in-Class FDA Nod in Multiple Myeloma

(8/14, Frank Vinluan, MedCity News) ...The Thursday approval of the drug, iberdomide, covers the treatment of adults who have received at least one prior line of therapy for multiple myeloma. BMS's once-daily capsule is indicated for use alongside Johnson & Johnson's Darzalex Faspro and dexamethasone, a standard multiple myeloma drug combination. BMS will commercialize its new multiple myeloma therapy under the brand name Zenbexus... Full

 

Novo Nordisk, AWS Partner on AI Drug Discovery

(8/14, Kimberly Redmond, NJBIZ) ...Novo Nordisk is deepening its push into artificial intelligence through a new strategic partnership with Amazon Web Services. The collaboration aims to accelerate drug discovery and expand the use of AI across the pharmaceutical company. Under the agreement announced Aug. 10, AWS will become Novo Nordisk's preferred cloud partner and strategic AI partner. Financial terms were not disclosed... Full

 

 

Drugmakers Shifting to Non-US, Non-Generic Markets to Ward Off Margin Squeeze

(8/17, Manu Kaushik, Financial Express) ...India's leading pharmaceutical companies including Sun Pharma, Lupin and Dr Reddy's are looking beyond the United States, their conventional growth market, and shifting focus away from commoditised generics to premium specialty and complex drugs. The shift began even before Washington's tariff assault on imported drugs under the guise of an aggressive indigenisation policy, but it has indeed gained pace after it, an analysis of these companies' results over recent quarters shows... Full

 

Call for an Ecosystem to Boost Biosimilar and Vaccine Production Capacity

(8/16, The Business Standard) ...Bangladesh must move beyond its generic drug industry and develop capabilities in biologics, biosimilars, vaccines and other high-value medicines by building a comprehensive biopharmaceutical ecosystem, industry stakeholders said today (August 16). They called for an integrated Life Science and Biopharmaceutical Strategy by 2035, focusing on technology transfer, clinical research, regulatory accreditation, shared infrastructure, and skilled workforce development... Full

 

Indian Pharma Firms Should Aim to Be Among World's Top Five: PM Modi

(8/15, IANS) ...The Prime Minister highlighted the transformation of India's pharmaceutical sector from a major supplier of affordable medicines to an emerging hub of innovation. "From the pharmacy of the world to a hub of innovation, India's pharma sector is moving up the value chain," PM Modi said in a post on X. He said the focus was increasingly shifting towards research and development, biologics, biosimilars and next-generation therapies... Full

 

Swiss Drug Launches Sacrificed Due To US MFN, Industry Group Warns

(8/14, Eliza Slawther, Pink Sheet) ...Switzerland, like many other less populous nations, is feeling the impact of US pricing policies on access to innovative new drugs, according to Interpharma, the country's association of research-based pharmaceutical companies. Almost a third of innovative new drugs (seven out of 22) were not submitted for reimbursement in Switzerland specifically due to US' Most Favored Nation (MFN) policies between January 2025 and June 2026, according to a survey of Interpharma members... Global Sub. Full

 

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