Tuesday, July 22, 2025

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models'

(7/21, Anju Ghangurde, Generics Bulletin) ...Responding to tariff-related questions at the AGM, Cipla's global CEO and managing director Umang Vohra stated that the environment right now is "highly unpredictable," but assured shareholders that the company has one of the "most well diversified models", specifically with respect to the US. "About one third of our US products is made in the US and that ratio is likely to increase as we launch our inhaler products and for the rest, the supply chain is fairly diversified, out of products, not just from India but from across the world," Vohra stated at the company's 89th AGM... Global Sub. Full

AstraZeneca Unveils $50 Billion US Investment as Pharma Tariff Threat Looms

(7/22, Ahmed Aboulenein and Maggie Fick, Reuters) ...Trump has called on pharma companies to make more of the medicines they sell in the U.S. within the country, rather than importing active ingredients or finished medicines. He is also pushing for prices in the U.S. to fall to what other countries pay. CEO Pascal Soriot announced the plans in Washington, saying he believes that drug prices need to rise elsewhere and "equalize" with other countries effectively contributing more to research and development costs. "The United States cannot build or carry the cost of R&D for the entire world," he said... Full

Biogen Beefs Up North Carolina Manufacturing Ahead of Potential Drug Tariff Storm

(7/21, Christy Santhosh, Reuters) ...Biogen will invest $2 billion more in its existing manufacturing plants in North Carolina, the drugmaker said on Monday, as it seeks to expand in the U.S. amid President Donald Trump's tariff threats...The investments will expand Biogen's ability to develop and produce certain gene-targeting therapies, and add fill-finish facilities, automation and artificial intelligence, the company said... Full

As Trump Threatens Drug Tariffs, Could Drug Manufacturing Be Reshored?

(7/21, Savannah Peters, Marketplace) ...Where your prescription medications are made depends mostly on whether they're patent protected, according to health care economist Marta Wosinska, a senior fellow at the Center on Health Policy at the Brookings Institution. "When it comes to branded drugs, it really is either the U.S. or Europe," she said. But pricey name-brand medications comprise only about 10% of those dispensed to Americans. The remaining 90%, Wosinska said, are low-cost generics... Full

FTC's Latest Effort To Dispute Improper Patent Listings Barely Made A Dent

(7/21, Urte Fultinaviciute, Generics Bulletin) ...The FTC's recent initiative aimed at delisting improper patents in the FDA's Orange Book has seen little success. Out of five companies targeted, only one updated its patent listing following warning letters. Previous campaigns had a similar effect, putting the effectiveness of the FTC's tactics into question... Global Sub. Full

‘Prescription Drugs Are Not Golf Balls': FTC/DoJ Solicit Clashing Opinions On Patents

(7/21, Urte Fultinaviciute, Pink Sheet) ...Event moderators asked the Biotechnology Innovation Organization about the intellectual property related strategies used by drug manufacturers that could impact generic and biosimilar entry. Hans Sauer, BIO deputy general counsel and VP for intellectual property, said the answer is "clouded by the very large amounts of information out there in the public sphere that have been published … sometimes in peer-reviewed journals, other times in white papers." Sauer said that while patents filed for small-molecule drugs have doubled since the early 1990s, the typical number now is about four to six that have been found in the US Food and Drug Administration's Orange Book. For biosimilars, about 10 to 15 are litigated... Global Sub. Full

Expert: Direct Drug Sales Model Suited For Generics, Not Brand Drugs

(7/21, Maaisha Osman, Inside Health Policy) ...Two top brand drug companies Bristol Myers Squibb and Pfizer announced on July 17 they will begin selling their blockbuster blood thinner Eliquis directly to consumer at a more than 40% discount off the current list price. But the direct-to-patient discounted price still surpasses what Medicare and many peer countries will pay, said Juliette Cubanski, deputy director of the Medicare policy program at the Kaiser Family Foundation (KFF), who questioned the program's overall impact on drug affordability... Sub. Req’d

Interchangeable Medicine, or Inaccessible Medicine?

(7/21, Justin Leventhal, Inside Sources) ...The solution is simple: let biosimilars compete and give patients effective, low-cost treatments. The Senate bill offers a straightforward fix to align pharmaceutical policy with science and patients' needs. Giving patients access to affordable biosimilars would mean access to affordable medicine, lower costs across the board, and a healthcare system that actually works for the people it is intended to serve. It's time to cut the red tape and give biosimilars the competitive footing they — and patients — deserve... Full

Will Tidmarsh's Industry Experience Translate As US FDA's Chief Drug Regulator?

(7/21, Sarah Karlin-Smith and Derrick Gingery, Pink Sheet) ...Tidmarsh's industry history, which includes seven drug approvals, is also colored by some more infamous, rather than famous, examples of drug development. But he appears to have been picked at least in part for his close ties to other HHS leaders and their ideologies...Some close FDA watchers are concerned about the appointment and his association with industry. Reshma Ramachandran, co-director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, said she "was struck by how FDA framed him in his press release as a Stanford faculty doctor, where in reality he's an adjunct professor and primarily, a biotech executive,' she told the Pink Sheet... Global Sub. Full

AAM Congratulates Dr. Tidmarsh On Appointment as Director of CDER

(7/21, AAM) ..."Improving the health of patients through more timely access to lower-cost generic and biosimilar medicines is essential to the livelihood of America. We look forward to a collaborative partnership with Dr. Tidmarsh and the larger team at CDER to prioritize regulatory efficiency and help ensure the medicines that cost less and make up 90 percent of all prescriptions filled in the U.S. are always available for patients." AAM and the Biosimilars Council congratulate Dr. Tidmarsh and stand ready to support CDER's continued success in advancing public health... Full

Amgen Quiet On Future Of Copay Assistance If CO Approves UPL

(7/21, Luke Zarzecki, Inside Health Policy) ...As the Colorado Prescription Drug Affordability Board (PDAB) is set to decide whether to place an upper payment limit on Amgen's medication for autoimmune conditions Enbrel, the company is staying quiet on whether it plans to keep or nix patient copay assistance programs based on the decision... Sub. Req’d

Iowa's New Prescription Drug Law Partially Halted by Federal Judge

(7/21, Erin Murphy, The Dispatch Argus) ...The law, which was set to go into effect this week, sought to bar pharmaceutical companies and pharmacy benefit managers from adjusting prescription drug prices based on location or other market factors. It also included language on rebates and discounts... Full

Teva Introduces Generic Dificid

(7/21, Sandra Levy, Drug Store News) ...Teva is rolling out fidaxomicin tablets. The medication is the generic of Dificid. Fidaxomicin tablets are an antibiotic medicine used to treat an infection called Clostridioides difficile-associated diarrhea in adults... Full

More Than 57K Bottles of This Medication Have Been Recalled

(7/21, Shaina McLawrence, Silive.com) ...More than 57,000 bottles of prescription cholesterol medication Pitavastatin are being recalled due to quality concerns, according to a report from the U.S. Food and Drug Administration. The FDA issued an enforcement report for bottles of 90-count prescription tablets...The 2 mg Pitavastatin tablets were manufactured in Taiwan and distributed by Teva Pharmaceuticals in Parsippany, New Jersey. The recall remains ongoing, and no public press release has been issued at this time... Full

Cipla Buys 20% Stake in iCaltech to Broaden Respiratory Device Portfolio

(7/21, Anjali Singh, Business Standard) ...Cipla has acquired a 20% stake in iCaltech Innovations for Rs 5 crore, expanding its presence in the respiratory diagnostics segment with a strategic investment in medical device development...The transaction is expected to be completed within a month, subject to customary closing conditions. The investment aligns with Cipla's strategy to strengthen its presence in the respiratory care space, particularly in the diagnostics segment. iCaltech, an ISO 13485 certified medical device company, is engaged in the design, development, manufacturing, and commercialisation of diagnostic products, with a core focus on respiratory applications... Full

Neuraxpharm Continues International Expansion with Launch of Neuraxpharm Australia

(7/21, Neuraxpharm) ...Neuraxpharm Australia will commercialise the prescription brands Nuvigil® (armodafinil) and Modavigil® (modafinil), both indicated for the treatment of Excessive Daytime Sleepiness (EDS) in adults with narcolepsy, which were acquired by Neuraxpharm in December 2024. The Australian affiliate will also bring to market BRIUMVI® (ublituximab) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) after receiving approval from Australia's Therapeutic Goods Administration (TGA) in June 2025... Full

France's Sanofi to Acquire Biotech Firm Vicebio for $1.15 Billion

(7/22, Mateusz Rabiega, Reuters) ...Following the acquisition, Vicebio's non-mRNA candidate vaccine for treating respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) will be added to Sanofi's range...Sanofi will also obtain "Molecular Clamp" technology aimed at enabling quicker development of fully liquid combination vaccines that can be stored at standard refrigeration temperatures, eliminating the need for freezing or freeze-drying... Full

Drugmakers Are Racing to Help Patients Stay Awake — and Could Also Make Billions

(7/22, Elaine Chen, STAT+) ...But the companies have ambitions to go much broader and study the drugs in a host of conditions that lead patients to feel sleepy and fatigued during the day, like Alzheimer's disease and depression. The medications work by mimicking the effects of orexin and activating the peptide's receptors; emerging research suggests that the orexin system not only regulates the cycle of sleeping and waking, but may also boost attentiveness, cognition, and mood... Sub. Req’d

Industry Welcomes Support From UK Life Sciences Plan

(7/22, Dave Wallace, Generics Bulletin) ...Kim Innes – general manager of Teva UK – also welcomed the plan in a LinkedIn post. "I warmly welcome the plan's bold focus on biosimilars and generic medicines – the first time they have been written into a life sciences sector plan – which signals a forward-thinking approach to transforming patient care and strengthening the NHS," Innes said. In particular, "the emphasis on biosimilars has the potential to be a game-changer in saving the NHS millions over the course of the next few years," she highlighted. And "equally significant is the inclusion of generic medicines in the plan – a historic first for sector plans such as these in the UK."... Global Sub. Full

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

(7/21, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has launched a revised sponsor handbook for the Clinical Trials Information System (CTIS), consolidating a raft of fragmented resources into a single, user-friendly reference tool designed to support both new and experienced users. The updated handbook includes a clickable table of contents, step-by-step guides, embedded instructional videos, and links to key regulatory resources, making it easier for sponsors to navigate the entire clinical trial lifecycle within the CTIS... Global Sub. Full

Slow Biosimilar Uptake in Latin America Signals Missed Opportunities for Patient Access, Cost Savings

(7/21, Skylar Jeremias, Center for Biosimilars) ...Despite the recognized potential of biosimilars to expand patient access to critical biologic medicines and significantly reduce health care costs, their uptake in Latin American (LatAm) countries has remained notably slow. A recent manuscript, drawing on a comprehensive analysis involving key opinion leaders and industry representatives across Latin America and Europe, shed light on the multifaceted barriers hindering biosimilar adoption and proposed strategic initiatives to accelerate their use... Full

Irish Ruling Gives Go-Ahead For Endo-Mallinckrodt Merger

(7/22, Dave Wallace, Generics Bulletin) ...Mallinckrodt and Endo are now set to complete their merger by early August. A recent ruling from the Irish High Court to confirm the scheme of arrangement was one of the last hurdles for the deal to overcome. Once the merger is complete, Mallinckrodt and Endo plan to combine their generics and sterile injectables businesses and spin them off from the combined company... Global Sub. Full

Global Pharma Companies Do Record Deals With Chinese Biotechs

(7/22, Patrick Temple-West, Financial Times) ...The Trump administration is finalising unprecedented US tariffs for the global pharmaceutical sector. President Donald Trump said last week that these tariffs, which were proposed in April, could be unveiled by the end of July. In regulatory filings since April, pharmaceutical companies have warned shareholders that these "Section 232" tariffs pose a threat to profits. While pharmaceutical companies are moving more manufacturing into the US, "from the tariffs standpoint, reshoring more of the [pharmaceutical] manufacturing won't happen overnight", said Mark McClellan, a former Food and Drug Administration commissioner who is now at Duke University. "China is running ahead of the US" in biotechnology innovation, and that poses national security concerns for the US, he said... Sub. Req’d

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