Wednesday, October 7, 2026

 

 

Millions May Face Prescription Drug Price Surge on Oct. 22

(10/7, Medora Lee, USA Today) ...Starting on Oct. 22, Customs and Border Patrol will require documentation, tariffs and FDA approval for prescription drugs imported from foreign pharmacies, ending the de-minimis, duty-free pathway and potentially cutting off cheap medicines for over 4 million Americans, especially seniors who rely on Canadian imports... Full

 

BD Commits $19B Amid US Onshoring Push, with $3b Earmarked for Manufacturing Growth

(10/6, Frasier Kansteiner, Fierce Pharma) ...Through its pledge, BD will invest $19 billion in the U.S. over the span of "several years," with the outlay taking the form of capital, operational and supply chain investments, the company said in an Oct. 6 release...With the upgrades slated to come online, BD now aims to expand its end-to-end manufacturing in the U.S. by some 5 billion essential medical consumables annually, which the company asserts could lift its share of locally supplied consumables to roughly 80%. In a further commitment, the company said that it will crank out 100% of BD needs bound for use in the U.S. through domestic production using American-made steel... Full

 

Democrats Plot a Midterms Push for MAHA Voters

(10/7, STAT) ...Left-leaning candidates are focusing on food and disregarding one of Kennedy's signature (if relatively fringe, according to pollsters) issues: vaccine injuries... Sub. Req'd

 

Doctors Run for Congress as Healthcare Costs Hit Voters

(10/6, Victoria Knight, Bloomberg) ...A crop of doctors running for Congress this election cycle hope that their healthcare experiences will connect to voters worrying about the rising cost of insurance and prescription drugs. At least six physicians from both parties, all of whom are using healthcare messaging prominently in their campaigns, are running for federal office in the 2026 midterms. Bloomberg Government talked to doctor candidates running in Arizona, California, Georgia, Kentucky, New Jersey, and South Carolina... Sub. Req'd

 

In DC, a Secretive New Thorn Has Appeared in the Pharma Industry's Side

(10/7, Max Bayer, Endpoints News) ...What do the Seattle Latino Chamber of Commerce, the Venezuelan-American Republican Club of Miami-Dade and the lower-tier professional men's soccer team Akron City Football Club have in common? They're all listed as members of the Pharmaceutical Reform Alliance (PRA), an almost two-year-old group pushing for legislation focused on lowering the price of drugs. But who the group actually represents, meaning who pays for it to exist, is unclear...A source who works with the group, granted anonymity to discuss its internal construct, told Endpoints News that it represents a diverse set of healthcare companies, and it does not accept foundation money... Sub. Req'd

 

APIIC Launches New Supply Chain Fragility Index, Finds A Fifth Of Drugs At Significant Risk

(10/6, Gabrielle Wanneh, Inside Health Policy) ...Launched Tuesday (Oct. 6), the API Innovation Center's new National Fragility Index (NFI) aims to provide a consistent framework for evaluating supply chain risks and for determining whether and what proposed domestic manufacturing investments made by federal government or private equity and private organization will work to remedy vulnerabilities that could hinder access to crucial medicines in the event of public health emergency... Sub. Req'd

 

AARP Report On Top Inhaler Fuels Calls For Immediate Patent Reforms

(10/6, Gabrielle Wanneh, Inside Health Policy) ...Groups like AARP and the Campaign for Sustainable Rx Pricing are calling on lawmakers to pass the Eliminating Thickets to Improve Competition (ETHIC) Act, a bill that would prevent brand drug companies from asserting more than a single patent from a group of related patents when litigating against potential competitors. They're also pressing for passage of the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act, which aims to curb patent evergreening practices by no longer incentivizing brand drug companies to file more patents than necessary on a single drug... Sub. Req'd

 

Bipartisan Bill Would End 340B Rebate Pilot, But Is 2027 The Year For Reform?

(10/6, Michael McCaughan, Pink Sheet) ...The bill addresses long-standing issues of controversy in the program, like the definition of a patient whose prescriptions are eligible for the discounted price and transparency about hospitals' use of the savings from the program. The bill also addresses more recent issues such as restrictions imposed by manufacturers on the use of contract pharmacies and a pilot program to test rebates in 340B... Global Sub. Full

 

Ozempic, Wegovy, Calquence Not Participating In 340B Rebate Model

(10/6, Cathy Kelly, Pink Sheet) ...The program will enable manufacturers to switch from up-front 340B discounts to back-end rebates. It will test an approach to increasing transparency and avoiding stacking 340B and Medicare-negotiated discounts on the same drug, which is prohibited by law... Global Sub. Full

 

 

Cerevance Announces Positive Phase 3 ARISE Results: Once-daily Oral Solengepras Meets Primary Endpoint and Demonstrates Motor and Non-motor Benefits in Parkinson's Disease

(10/7, Cerevance) ...Solengepras is a potential first-in-class therapy that targets the striatal indirect pathway through a novel receptor (GPR6) and has no direct impact on dopamine receptors. The ARISE results support its potential to address both motor and non-motor symptoms of Parkinson's disease... Full

 

Big Pharma-Backed Nuvig Halts Development of Lead Fusion Protein in Rare Autoimmune Disease

(10/6, Darren Incorvaia, Fierce Biotech) ...The Palo Alto biotech stopped development of the fusion protein NVG-2089 for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) earlier this year "because the cost and expected enrollment timeline in CIDP would limit our ability to move the program forward as quickly as we would like," said CEO David Woodhouse, Ph.D., in a statement to Fierce... Full

 

Nurix Therapeutics Announces First Patient Enrolled in Phase 1b/2 Combination Study of Bexobrutideg in Chronic Lymphocytic Leukemia

(10/7, Nurix Therapeutics, Inc.) ...Nurix Therapeutics, Inc. today announced that the first patient has been enrolled in the Phase 1b/2 NX-5948-203 study evaluating bexobrutideg, an investigational oral Bruton's tyrosine kinase (BTK) degrader, in combination with venetoclax, a standard-of-care therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)... Full

 

 

Alvotech and LOTTE Biologics Announce US-Based Manufacturing Agreement to Increase Global Supply

(10/7, Alvotech) ...Under the agreement, LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse facility in New York for global supply, with the potential to further expand the collaboration over time... Full

 

Kamada Launches Two Biosimilars in Israel, Eyes $25M Revenue by 2030

(10/6, StreetInsider.com) ...The two newly launched products are Ustekinumab-Kamada, a biosimilar to Stelara used to treat chronic immune-mediated inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, and Enoxaparin-Kamada, a biosimilar to Clexane used for the prevention and treatment of thromboembolic disorders such as deep vein thrombosis and pulmonary embolism... Sub. Req'd

 

Palindrome Pharma Launches in Canada to Unlock Access to High-Quality Biosimilar Medicines

(10/7, Palindrome Pharma) ..."We are launching Palindrome Pharma with a clear purpose: to help make important biologic medicines more accessible to Canadians delivering meaningful value to patients, healthcare professionals, payers and the healthcare system," said Dr. Jeremy B. Desai, Founder/Chief Executive Officer of Palindrome Pharma. "Biosimilars represent an important opportunity for Canada, and we intend to build a company that earns the trust of our partners through quality, reliability and a long-term commitment to the Canadian market."... Full

 

Two Markets After the Cliff: Rewriting the Post Exclusivity Playbook for Generics and Biosimilars

(10/6, Rahul Mittal, PharmaLive.com) ...Generics and biosimilars both reduce costs, but they are not the same business. Treating them as interchangeable strategies can turn a promising launch into a disappointing outcome. This column reframes how life sciences operators, investors, and policy leaders should evaluate and execute these programs. The discussion begins with the area where most launches achieve momentum or fail to gain traction, which is market access... Full

 

Off-Patent, On Record: Navigating The Financial Strategy Behind Litigation With Sandoz's Julia Pike

(10/6, Urte Fultinaviciute, Generics Bulletin) ...In the latest episode of Off-Patent, On Record, senior reporter Urte Fultinaviciute explores the intimidating world of intellectual property in Europe with the help of Sandoz's head of IP Julia Pike... Global Sub. Full

 

 

AstraZeneca Opens $1B-Plus R&D Hub in Massachusetts

(10/7, Anna Bratulic, FirstWord PHARMA) ...The new 18-storey hub in Kendall Square, together with AstraZeneca's existing genomic-medicine site at 100 Binney Street, will be home to nearly 2000 scientists. The facility includes 10 floors of interconnecting laboratories and incorporates technologies including robotics, continuous automation and agentic AI... Full

 

Halozyme Announces Expansion of Global Collaboration and License Agreement with argenx to Support the Development of Subcutaneous Formulations for Two Additional Exclusive Targets Using its ENHANZE® Technology

(10/6, Halozyme Therapeutics, Inc.) ..."We are pleased to expand our collaboration with argenx, a recognized leader in immunology, building on the successful development of VYVGART Hytrulo," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "The addition of two new exclusive targets further validates the value and versatility of ENHANZE as the leading platform for rapid, large-volume subcutaneous delivery. As more companies seek to focus on patient convenience, reducing treatment burden and expanding access to important therapies, ENHANZE continues to be the technology of choice..."... Full

 

Johnson & Johnson CEO Says AI Has to Be Embraced

(10/7, Bloomberg) ...Johnson & Johnson Chairman & CEO Joaquin Duato says artificial intelligence is a force multiplier and has to be embraced. He's on this week's episode of The David Rubenstein Show: Peer to Peer Conversations. This interview was recorded on June 16 in Washington... Sub. Req'd

 

AI Companies Run Virtual Drug Trials, Aim to Improve Success of Human Studies

(10/7, Deena Beasley, Reuters) ...AI firms say simulations are being used to identify which pharmaceutical programs are worth moving forward and to assess the value of acquisition targets. As AI tools get better at flagging clinical risks, they say unexpected trial failures may become less frequent... Full

 

 

EMA Seeks More Industry Data To Scale Global Reliance On Its Assessment Reports

(10/6, Vibha Sharma, Pink Sheet) ...It urged companies to be more systematic in sharing information on where and how the EMA reports are used overseas, whether to support the evaluation of a marketing authorization application or for a specific post-approval change to an existing product... Global Sub. Full

 

WHO Drafts Updated Guideline on Quality Risk Management

(10/6, Joanne S. Eglovitch, Regulatory Focus) ...The guideline defines QRM as "the overall and continuing process of appropriately managing risks to product quality throughout the product's life-cycle in order to optimize its benefit–risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the pharmaceutical product. It can be applied both proactively and retrospectively."... Full

 

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