Tuesday, August 12, 2025

‘Made-In-America' Amneal Does Not Fear Trump's Proposed ‘Chaotic' Triple-Digit Tariffs On Drugs

(8/11, Urte Fultinaviciute, Generics Bulletin) ...Highlighting the firm's US manufacturing capabilities across different formulations, co-CEO Chintu Patel said that "Made in America" is a core strategic advantage for Amneal. Chief financial officer Tasos Konidaris also assured that Amneal has "multiple levels to mitigate any potential negative impact," even though there is no full clarity on tariffs yet. In addition to the large manufacturing footprint in the US, Amneal also has "extensive experience" with tech transfers, "no meaningful exposure" to countries like Mexico, Canada, China, or Europe, and will not be impacted by Trump's Most-Favored-Nation policy, said Konidaris... Global Sub. Full

Drug Price Negotiations Pose Ruinous, Unconstitutional Dangers

(8/12, Daniel Troy, Bloomberg Law) ...The Inflation Reduction Act's Medicare "negotiation" program is, at its core, a sweeping federal mandate that disregards core constitutional safeguards. These negotiations should be recognized as a sham. Pharmaceutical innovators are forced, under threat of financial penalties as high as 1,900% of daily revenue from all sources, to sell their patented medicines at government-dictated prices. This isn't bargaining—it's a coercive regime of price control masquerading as negotiation... Full

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

(8/11, Dean Rudge, Generics Bulletin) ...Amgen has expressed optimism regarding evolving regulatory guidelines for biosimilars, particularly the potential for streamlined approval processes. Nonetheless, Amgen acknowledges the scientific and technical challenges in developing these products, emphasizing the need for expertise to navigate the complexities of biosimilar design. The company remains committed to a global regulatory strategy, despite the potential for regulatory relaxation... Global Sub. Full

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

(8/11, Sarah Karlin-Smith, Pink Sheet) ...Vinay Prasad returned to the FDA as CBER director less than two weeks after President Trump's far-right allies forced him out. Whether Prasad also will continue in his other role as chief scientific and medical officer, which had also placed him in the Office of Commissioner, is unclear. Close FDA watchers believe Prasad's regulatory philosophy may need to change somewhat during his second tour of FDA and many see his reappointment as a sign of continued agency uncertainty... Global Sub. Full

FDA Pressed To Act After Report Finds Brand Cancer Drugs Smuggled Into U.S. As Antibiotics

(8/11, Maaisha Osman, Inside Health Policy) ...FDA is facing pressure to step up drug import surveillance after a nonprofit investigation found chemotherapy brand drugs are being illegally imported into the United States disguised as antibiotics to dodge federal scrutiny. The Partnership for Safe Medicines (PSM) tells Inside Health Policy the mislabeling scheme, which it dubs product code fraud, exploits gaps in border enforcement and is urging FDA to deploy better electronic screening tools and increase coordination with Customs and Border Protection (CBP)... Sub. Req’d

FDA's Drug Quality Report Notes ‘Significant' Uptick in Inspections Since Pandemic

(8/11, Joanne S. Eglovitch, Regulatory Focus) ...In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality (OPQ) reported significant increases in both foreign and domestic inspections since the COVID-19 pandemic, along with a substantial rise in warning letters following these inspections...The report highlighted that, in contrast to the overall increase in warning letters driven by inspections, the rise in warning letters issued to sites in China concerning FY2024 was mainly attributed to quality deficiencies identified in §704(a)(4) records requests... Full

A Giant Indian Drugmaker Failed to Fix Safety Breaches. The FDA Let It Off the Hook Again and Again.

(8/12, Megan Rose and Debbie Cenziper, ProPublica) ...The agency did not respond to questions about the Sun factory, the decision to wait eight years to impose the ban or the exemptions that followed, saying only it could not discuss potential or ongoing compliance matters. The FDA referred further inquiries to Sun... Full

The FDA Let Substandard Factories Ship These Medications to the U.S.

(8/12, Debbie Cenziper, Megan Rose and Katherine Dailey, ProPublica) ...The FDA said the decisions to exempt certain medications from import bans were made to fend off drug shortages and that guardrails were in place to ensure the products were safe, such as requiring the banned factories to do extra testing on the drugs before they were sent to Americans...The FDA kept the exemptions largely hidden from the public and has never released a comprehensive list of the drugs allowed into the United States from banned factories. ProPublica is publishing that list today...Teva Pharmaceuticals did not respond to requests for comment. The company said in a statement at the time that it was working to avoid drug shortages "while we focus on resolving regulatory concerns, as patients are always highest priority." The factory is still banned but no longer receiving exemptions... Full

Official OGD Statistics for June 2025 Published with Some Good and Worrisome News!

(8/11, Bob Pollock, Lachman Consultants) ...The OGD, however, issued only 85 complete response letters (CRLs), the lowest in any month so far this fiscal year. Perhaps the lower number of CRLs is indicative of the increase in first-cycle approvals as, perhaps, firms are getting it right the first time around... Full

Drug Savings Doubted for Colorado as State Nears First Pay Cap

(8/12, Celine Castronuovo, Bloomberg Law) ...The Colorado Prescription Drug Affordability Board, which is close to becoming the first panel of its kind to set a statewide cap on a high-spend drug, is facing pressure from patient and health professional coalitions who say the board has failed to adequately engage with insurance companies and their pharmacy benefit managers that will be tasked with enforcing the limit on Amgen Inc.'s autoimmune treatment... Full

Arizonans To Be Offered Up To 80% Discount On Generic Drugs

(8/12, Urte Fultinaviciute, Generics Bulletin) ...From early 2026, Arizona residents will be offered discounts of up to 80% on generic drugs through the ArrayRx discount card program. ArrayRx is a non-profit consortium that leverages collective buying power to lower prescription drug prices. Five other US states are already participating in ArrayRx's pharmacy benefit management platform and related pharmacy savings programs... Global Sub. Full

Bayer Picks Kumquat for KRAS Collaboration, With $1.3B On Offer if Pact Bears Fruit

(8/12, Nick Paul Taylor, Fierce Biotech) ...Bayer has teamed up with Kumquat Biosciences for a juicy opportunity, committing up to $1.3 billion for the global license to a KRAS G12D inhibitor that is on the cusp of the clinic. Kumquat, which also has alliances with Eli Lilly and Takeda, is advancing multiple programs targeting the KRAS pathway...Kumquat will run the phase 1a trial of its Bayer-partnered prospect. Beyond that, Bayer will handle R&D and commercialization. The deal gives Kumquat an exclusive option to negotiate for profit-loss sharing in the U.S... Full

Lupin Ties Up With Sandoz To Commercialise Biosimilar Product

(8/12, Press Trust Of India) ...Lupin has partnered with Sandoz Group AG to commercialize its biosimilar ranibizumab across multiple regions, with Sandoz handling commercialization in the EU (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia. Lupin will manufacture the product and manage regulatory submissions. Sandoz also gains exclusive rights for commercialization in Canada... Full

Celltrion Gains Ground as One of Most-Prescribed Drug Suppliers in Italy

(8/12, Dae-Kyu Ahn, The Korea Economic Daily) ...According to Celltrion on Tuesday, it recently won new orders for Steqeyma (ustekinumab), its biosimilar to the autoimmune therapy Stelara, in auctions from three state governments in Italy -- Veneto, Trentino-Alto Adige and Sardegna. That follows the contracts for the same treatment awarded by four other regional governments in the country earlier this year. Steqeyma was launched in Italy in January. Celltrion will supply Steqeyma to those regions through May 2026... Full

Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

(8/12, Dean Rudge, Generics Bulletin) ...Viatris and Amphastar have received FDA approvals for their generic versions of Venofer (iron sucrose), expanding their portfolios in the US injectable market. Sandoz also has FDA approval for a generic version but has not announced a launch timeline. Viatris has highlighted its generic entering the market with competitive generic therapy designation, which allowed for expedited review for certain strengths and a projected immediate availability in multiple doses... Global Sub. Full

Indian Drugmaker Zydus Life's First-Quarter Profit Beats Estimates On New US Drug Launches

(8/12, Kashish Tandon, Reuters) ...Most Indian generic drugmakers, including Zydus Life, which earn a large share of their revenue from the U.S., have been grappling with weak pricing due to intense competition. However, new products, particularly in the specialty portfolio, have driven Zydus Life's growth in the United States since the beginning of 2025, with three launches in the reported quarter... Full

Paracetamol Maker Granules India's Quarterly Profit Drops On Supply Backlog

(8/12, Vijay Malkar, Reuters) ...Granules holds a 30% global market share of the paracetamol drug, which is used to treat fever and moderate pain. It supplies the drug as an active pharmaceutical ingredient (API) as well as in finished dosage form. The company said manufacturing at its Gagillapur facility in Telangana was impacted following an adverse U.S. Food and Drug Administration review last year. Indian drugmakers are also grappling with pricing pressure in the key North American market due to intense competition, while also bracing for a potential hike in U.S. tariffs on pharmaceutical products from India... Full

Lupin Launches Glucagon Injection, Targets $122 Million Annual Market In US For Low Blood Sugar

(8/11, Moneycontrol) ...Lupin's 'Glucagon for Injection USP' (1mg/vial), packaged in an emergency kit, is a bioequivalent to Eli Lilly's injection...Lupin has been attempting to establish injectables and biosimilars as a growth driver, leveraging on its capabilities both in R&D and manufacturing. "...this year in particular, we're going to see a material inflection on the injectables front with products like Glucagon, Liraglutide, Risperdal Consta coming to market," Lupin said in May 2025... Full

PureTech Announces the Launch of Celea Therapeutics With a Mission to Transform the Treatment of Respiratory Diseases

(8/12, PureTech Health) ...Celea's mission is to deliver therapies that transform the lives of people with serious respiratory diseases. Its lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate that holds promise across multiple fibrotic and inflammatory lung conditions and is initially being advanced for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease. Sven Dethlefs, PhD, has been appointed to lead Celea, bringing deep expertise and a clear vision to accelerate the program's advancement. The launch of Celea reflects PureTech's commitment to advancing differentiated programs through focused, capital-efficient structures with seasoned leadership... Full

Firm Tied to Trump Jr. Debuts Direct Sales Product for Pharma

(8/11, Rachel Cohrs Zhang, Bloomberg Law) ...The company, BlinkRx, is pitching the offering as a way to set up a system for drugmakers to sell products directly to patients in "as little as 21 days."...For critics of the Trump family's business dealings, this situation could look like another example of potential conflicts of interest. The company disagrees. "Blink did not speak to anyone at any level of government about the order," a BlinkRx company spokesperson said in an email... Full

Swiss Government To Meet Pharma Firms To Discuss US Tariffs

(8/11, John Revill, Reuters) ...Economy Minister Guy Parmelin and Health Minister Elizabeth Baume-Schneider will meet with executives from Roche and Novartis, according to two people familiar with the matter, who said other companies may also take part...The talks could also be about encouraging pharmaceuticals companies to invest more in the United States, said a person familiar with the matter, to reduce Switzerland's trade surplus with the U.S. and help reduce the 39% tariff, which covers exports including Swiss watches and chocolate... Full

Novo Cuts Wegovy Prices as Mounjaro Launches, But Local Options and Adherence Will Decide the Winner

(8/12, Kim Ji-hye, Korea Biomedical Review) ...Eli Lilly's obesity drug Mounjaro (tirzepatide) will launch in Korea next week, offering a 25 percent discount compared to Novo Nordisk's Wegovy (semaglutide)...A clinic in Seoul said it plans to sell Wegovy for 280,000 won ($201) per pen, which lasts for four weeks -- a notable drop from the current price range of 420,000 to 600,000 won ($302 to $432). However, most clinics indicated they are either not planning to cut prices at all or are uncertain about price changes, with many stating that the prices have not been confirmed yet... Full

ICH Proposes Global Framework For Managing Leachables In Pharma Products

(8/11, Vibha Sharma,Pink Sheet) ...A new international guideline wants drug sponsors to adopt a tailored quality risk management process for leachables, which are chemical substances that can migrate from manufacturing equipment, packaging or delivery devices into a drug product and potentially compromise patient safety or product quality... Global Sub. Full

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