Tuesday, July 7, 2026

 

 

Teva to Advance TEV-'408 into Phase 2b Study in Vitiligo in Q4

(7/7, The Fly) ...Teva announced plans to advance its TEV-'408, an investigational anti-interleukin-15 monoclonal antibody, into a Phase 2b study in vitiligo in the fourth quarter of 2026. The decision follows encouraging results from an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo... Sub. Req'd

 

 

Pharma's Data Demands Stir New Fight Over Drug Discount Program

(7/7, Nyah Phengsitthy, Bloomberg Law) ...The data requirements are not new, but rather expand policies that targeted pharmacies contracting with providers to dispense drugs. The escalation of a longstanding feud between providers and drugmakers over program transparency is raising questions over whether the data demands are legal... Full

 

Copay Assistance Is Meant To Defray Patient Drug Costs. Some Insurers Keep It Instead.

(7/7, Daniel Chang, KFF Health News) ...Drugmakers argue that insurers and pharmacy benefit managers use copay accumulators and other strategies to delay or deny care and steer patients toward medicines that insurers prefer instead. Insurers counter that coupon cards and other patient financial assistance from drug manufacturers drive up premiums and encourage patients to use higher-priced, brand-name drugs instead of less-expensive generics... Full

 

US Senator Presses Merck Over Keytruda Patents Limiting Biosimilar Competition

(7/6, Urte Fultinaviciute, Generics Bulletin) ...US senator Maggie Hassan (D-NH) has sent out a letter to Merck's CEO Robert Davis, expressing her continued "serious concerns about how Merck's anti-competitive practices have boosted profits at the expense of patients."... Global Sub. Full

 

Chairman Rick Scott Proposes Crackdown on Chinese Drugs Made With Forced Labor

(7/6, United States Senate Special Committee on Aging) ...U.S. Senate Special Committee on Aging Chairman Rick Scott sent a letter to U.S. Trade Representative (USTR) Ambassador Jamieson Greer proposing tariffs on generic pharmaceuticals and ingredients that are linked to Communist China's persecution of Uyghurs through forced labor... Full

 

Generic And Biosimilar Industry: Let Us Into US FDA National Priority Voucher Program

(7/6, Maaisha Osman, Pink Sheet) ...AAM said generics and biosimilars fit four of the FDA's five priority categories. The only one they miss is innovative breakthrough therapies...AAM also said generics and biosimilars can help fill unmet medical needs when high costs, coverage gaps and supply disruptions prevent access to brand products. In addition, NPV access could help support generic manufacturer efforts to buy and retrofit idle US manufacturing sites to increase domestic production. The classic case for generic and biosimilar use is the savings they generate for US patients, which would meet the affordability requirement... Global Sub. Full

 

New FDA Leadership Must Champion Generics & Biosimilars

(7/6, John Murphy, Pharma Boardroom) ...Following leadership changes within the FDA, actively prioritizing generic and biosimilar medicines must remain a top focus for the agency and the Trump administration. As the cost of medicine continues to place a significant burden on patients, generics are the only sector in the U.S. healthcare ecosystem that consistently results in decreased spending... Full

 

US FDA's Lisa Yanoff Takes Temple's Vacant CDER Deputy Director For Clinical Science Spot

(7/6, Sue Sutter, Pink Sheet) ...Lisa Yanoff, an 18-year US [FDA] veteran with expertise in endocrinology and obesity medicine, has been named acting deputy director of the drug center, the latest of several recent promotions to bolster the agency's senior leadership. Yanoff, deputy director of the Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) since October 2020, is now Center for Drug Evaluation and Research acting deputy director for clinical science, she announced in a LinkedIn post... Global Sub. Full

 

FDA Regulatory Agenda Includes DTC Ad, CRL Disclosure Changes

(7/6, Jessica Karins, Inside Health Policy) ...FDA will propose a rule expanding the commissioner's discretion to release complete response letters and letters stating that a product is not approvable. "This rule will eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information, thereby enabling proactive disclosure of CRLs for unapproved products while maintaining appropriate redactions for trade secrets and personal private information," the Office Management and Budget (OMB) website says... Sub. Req'd

 

Peters, Joyce Unveil Landmark Bill to Improve Discount Drug Pricing Program

(7/6, Representative Scott Peters) ...Today, Representatives Scott Peters (CA-50) and Dr. John Joyce (PA-13) introduced the bipartisan SECURE 340B Act, the first-ever comprehensive, bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992. This bill is also cosponsored by Reps. Jake Auchincloss (D-MA), Dan Crenshaw (R-TX), and Nanette Barragán (D-CA)... Full

 

Lawmakers Demand HHS Stop Lilly From Withholding 340B Discounts

(7/6, Gabrielle Wanneh, Inside Health Policy) ...A bipartisan group of 72 House members say Eli Lilly's termination of discounted 340B drug prices for disproportionate share hospitals (DSHs) that bucked the company's claims submission requirements isn't authorized by statute, and demand HHS reinstate access to 340B drug pricing. They ask the department to use all available enforcement authorities to ensure Lilly and other manufacturers comply with their obligations under 340B statute... Sub. Req'd

 

Colorado Court Decision On Enbrel Price Cap Uses 'Generous' Reading Of Precedent, Expert Says

(7/6, Cathy Kelly, Pink Sheet) ...A US District Court in Colorado's decision to grant Amgen's request for a preliminary injunction staying the state Prescription Drug Affordability Board's decision to cap the price of Enbrel may be based on an overly generous interpretation of a federal circuit court precedent, but still could help industry's campaign against pricing limits... Global Sub. Full

 

New Study: States Could Save Up to $1.8 Billion Annually by Prioritizing Lower-Cost Biosimilar Medicines

(7/7, Wayne H Winegarden, Pacific Research Institute) ...Pacific Research Institute analysis finds taxpayers and state employees could benefit from greater use of safe, effective alternatives to expensive biologic drugs... Full

 

 

AbbVie Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma

(7/6, Abbvie) ...AbbVie today announced that the European Commission (EC) granted marketing authorization for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE® FL-1 trial, which evaluated fixed-duration TEPKINLY in combination with R2 compared to standard of care R2... Full

 

Reducing Risks From Tardive Dyskinesia in Older Patients

(7/6, Martha Sajatovic, MD, Medscape) ...Tardive dyskinesia (TD) is a serious movement disorder characterized by jerky, involuntary movements that can significantly compromise functional independence in older patients. Proactive diagnosis and effective treatment options for TD in this population are reviewed by Dr Martha Sajatovic of Case Western Reserve University in Cleveland... Sub. Req'd

 

 

Cancer Drug Suppliers In Limelight As Oxaliplatin Added To US List Of Shortages

(7/7, Vibha Ravi, Generics Bulletin) ...Oncology drug suppliers like Fresenius Kabi, Sandoz, Teva, Dr. Reddy's and Aurobindo are in the spotlight as they hold keys to solving a deepening cancer drugs shortage crisis in US, EU, Australia, Canada and India, amid originator brand discontinuations and structural issues... Global Sub. Full

 

'Seeing the Evolution': As Branded Patent Cliff Looms, Biosimilar Experts Size Up US Hurdles, Opportunities Ahead

(7/6, Zoey Becker, Fraiser Kansteiner, Fierce Pharma) ..."We've been seeing the evolution, certainly since Humira went biosimilar a few years ago," Lisa Graver, the recently installed CEO of Iceland's Alvotech, said of the U.S. biosim scene in a recent interview with Fierce. "We're starting to see a different uptake pattern." But even as regulatory and physician receptivity to the category improves, issues pertaining to reimbursement and the complex intellectual property entanglements biosimilar developers must wade through continue to put up hurdles, Graver and other industry stakeholders said in series of recent conversations on the state of the field... Full

 

What European Commission Marketing Authorisation of a Teriparatide Biosimilar Means for Osteoporosis

(7/7, pharmaphorum) ...CinnaGen develops and supplies biosimilars through commercial, licensing, and distribution agreements. Following the authorisation, the company and its partners will now pursue state-level activities related to market access, product supply, pharmacovigilance, and participation in procurement and tender processes, subject to local requirements... Full

 

Towa Adds Tanabe Capacity To Stabilize Off-Patent Supply

(7/7, Dean Rudge, Generics Bulletin) ...Towa Pharmaceutical is moving to acquire the Tanabe Pharma Factory manufacturing subsidiary from Tanabe Pharma, in a deal that will give the Japanese generics manufacturer full ownership of a domestic production asset and manufacturing and marketing approvals for 17 ingredients and 35 products... Global Sub. Full

 

Keytruda Biosimilar Race Heats Up for $48 Trillion Market

(7/7, Song Hye-jin, The Chosun Daily) ...Companies are adopting diverse strategies to launch Keytruda biosimilars. Samsung Bioepis and Amgen in the U.S. are taking a "conventional approach," maintaining full-scale Phase 3 trials to ensure credibility. For high-risk oncology drugs, insufficient Phase 3 data could hinder regulatory approvals or insurance listings, making a proven path necessary despite higher costs... Full

 

Generic Mounjaro, Zepbound May Be Coming, Rivaling Current GLP-1s

(7/6, David Mills, Healthline) ...The U.S. Food and Drug Administration (FDA) has agreed to review two applications from Swiss manufacturer Sandoz to develop generic versions of those brand-name medications, both of which contain the active ingredient tirzepatide. The FDA hasn't specified how long this process will take, but on its website, the agency states that it typically completes reviews of standard drug applications within 10 months... Full

 

Lotus Pharmaceutical Announces Day 1 Launch of Generic Enzalutamide in South Korea

(7/7, Lotus Pharmaceutical) ...Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a global pharmaceutical company headquartered in Taiwan, today announced that its wholly owned subsidiary Alvogen Korea has successfully completed the Day 1 commercial launch of its generic enzalutamide in South Korea, further strengthening the Company's oncology and urology portfolio in one of Lotus' key Asian markets... Full

 

 

Novartis to Pay $1.1B Upfront for UK Biotech Myricx to Expand the Pharma's ADC Pipeline

(7/6, Nick Paul Taylor, Fierce Biotech) ...Now, Novartis has found a platform compelling enough to get more actively involved in ADCs. Myricx, a London-based biotech, is developing ADCs that deliver N-myristoyltransferase inhibitor (NMTi) payloads... Full

 

Beyond Generics: Glenmark Resets Agenda with a Bold 10-Year Pivot to Global Drug Innovation, Says Chairman Saldanha

(7/7, Jessica Jani, T. Surendar, Mint) ..."Over the next 10 years, we think we will be innovative led," Glenn Saldanha, chairman and managing director, told Mint in an interview. The company is of the view that the transition is already under way, though Saldanha cautioned that the journey to innovation is gradual and fraught with setbacks... Full

 

Alvotech Seeks Launch Momentum From Renewed FDA Push

(7/7, Dean Rudge, Generics Bulletin) ...When Generics Bulletin last spoke to Alvotech founder and chairman Róbert Wessman, the Icelandic biosimilars specialist was making the case that an early bet on streamlined development, forward-looking product design and first-wave asset selection had put it ahead of the field. Now, that theory is moving further into execution, borne out by multiple key milestones and announcements... Global Sub. Full

 

How Habil Khorakiwala's 29-Year Bet on Drug Discovery Paid Off

(7/7, Naini Thaker, Forbes India) ...Nilaya Varma, co-founder and group CEO, Primus Partners, a consulting firm, says, "Even now, most Indian pharma companies typically allocate only 5 to 10 percent of their revenues to R&D, in contrast with the 15 to 25 percent invested by global innovators… with most of this expenditure directed toward generics and biosimilars." Reverse engineering existing patented molecules has traditionally been a lower-risk, commercially attractive strategy for Indian pharma companies... Full

 

 

Trump's Drug Price Crusade Puts Europe on Guard

(7/7, Alan Beattie, Financial Times) ...Anyway, pharma's back, and Trump has a plan to push up drug prices abroad to compensate companies for driving them down in the US. This is going to be a nice little test of foreign governments' ability to resist him and particularly their ability to act collectively... Sub. Req'd

 

Some Companies Could Receive Extra Support For EU Joint Clinical Assessments

(7/6, Francesca Bruce, Pink Sheet) ...The European Commission told the Pink Sheet it was considering providing additional support to small and medium-sized enterprises (SMEs) with drugs undergoing EU-level joint clinical assessments (JCAs) under the Health Technology Assessment (HTA) Regulation, particularly companies that are "unfamiliar with the EU policy landscape."... Global Sub. Full

 

Outsourcing of New Drug Manufacturing Continues to Shift to Europe: GlobalData

(7/6, Greg Slabodkin, Pharma Manufacturing) ...Outsourced dose manufacturing for innovator drugs and biosimilars approved in the U.S. and Europe (the EU and UK) has traditionally oscillated between the two geographies, but there has been a pronounced shift toward European facilities over the last two years," the firm contends in its latest report... Full

 

UK MHRA Flags Rejection Risk For Inadequate, 'Overly Verbose' AI-Generated Inspection Responses

(7/6, Vibha Sharma, Pink Sheet) ...The Medicines and Healthcare products Regulatory Agency is encouraging companies to voluntarily disclose whether they have used AI in their responses to inspections and confirm the responses have undergone human verification, saying inspectors will view such transparency positively... Global Sub. Full

 

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