Tuesday, June 2, 2026

 

 

Teva's TAPI Sale Hits Succession Question

(6/1, Dean Rudge, Generics Bulletin) ...Teva confirmed towards the end of last year that exclusive negotiations around a sale for TAPI had been terminated after an earlier proposed deal failed to meet the firm's "terms or strategic expectations." However, chief financial officer Eli Kalif told investors that the company was "now initiating a renewed sale process to explore alternative options and maximize potential value creation," suggesting that shifting geopolitical and supply-chain dynamics - including Western reshoring pressures - had strengthened TAPI's appeal to prospective buyers... Global Sub. Full

 

 

Tariff, Cancer Drug Shortage Amendments Teed Up For FDA Spending Bill

(6/1, James Jarvis, Inside Health Policy) ...The House Rules Committee is slated to consider amendments Tuesday (June 2) to the fiscal 2027 House FDA-Department of Agriculture spending bill, including proposals that would block funding for tariffs that would raise the cost of over-the-counter drugs and bar FDA from "deprioritizing" work tied to sterile cancer drugs in shortage... Sub. Req'd

 

The Cost of a PRV Is Twice as High as it Was Three Years Ago - and It's Likely to Stay That Way

(6/1, Nicole DeFeudis, Endpoints News) ...The average going rate for a PRV between 2020 and mid-2024 was about $100 million. So far this year, at least six sales have been publicly announced, ranging in price from $180 million to $205 million... Sub. Req'd

 

The FDA Commissioner's Job Isn't Practicing Medicine, It's Building Trust.

(6/1, Tommy G. Thompson and Andrew C. Von Eschenbach, RealClear Health) ...Patients and physicians need to know FDA approval means it has been deemed "safe and effective" for its use. Sponsors need to know the rules will not change capriciously midstream. Reviewers need to know that if they follow the evidence and the proper process, their leader will stand behind them. The next Commissioner must also understand that FDA operates in a political world without becoming political itself... Full

 

FDA Should Stick to Safety

(6/1, Charles L. Hooper and David R. Henderson, The Wall Street Journal) ...Drug approvals became much slower and more expensive. Why? Roughly one-fourth of drug development costs are to demonstrate safety while three-quarters are for efficacy. The cost of the FDA's efficacy requirement is tremendous, and the value is close to zero. If the FDA went back to its pre-1962 rules, Americans would live longer and healthier lives... Sub. Req'd

 

GLP-1 Market Shows How Americans Can Get Lower Drug Prices

(6/1, Joshua Kresh, Melanie Whittington, Washington Examiner) ...In other words, market conditions, of which patents are only one part, determine drug pricing. Patent protections incentivize innovation, which in turn sparks competition. And patents expire, after which copies can enter the market and prices can fall off a cliff. But if drug companies couldn't protect their ideas and designs from being copied for a period of time, they'd have no incentive to invest in research to attempt to enter the market in the first place. And society wouldn't have the GLP-1s, direct-acting antivirals, PCSK9 inhibitors, and countless other medicines we enjoy today - many of which have already had their patents expire... Full

 

PCMA Launches New Campaign on the Value of PBMs: Lowering Drug Prices, Protecting Patients

(6/1, PCMA) ...The first ad in the campaign, titled Mom's Medicine, highlights the real-world human benefit that families see from the work PBMs do to lower drug prices. It will run in the Washington, DC area, and it represents the start of an always-on advertising effort by PCMA to make clear the value of PBMs. Additional spots will be released throughout the year... Full

 

Lilly Threatens To Cut Off 340B Providers Balking At Providing In-House Pharmacy Claims

(6/1, Cathy Kelly, Pink Sheet) ...Eli Lilly told providers who have not agreed to provide the company access to in-house pharmacy claims on drugs dispensed through the 340B program that they risk losing access to the program discounts on its drugs. The action came months after Lilly notified providers that it would begin requiring the data effective Feb. 1. Most, but not all, have complied, the company told the Health Resources and Services Administration in a June 1 letter... Global Sub. Full

 

States Form New Battleground for Pharma's Fight Against Copycats

(6/2, Nyah Phengsitthy and Ian Lopez, Bloomberg Law) ..."There's a big lobbying effort going on by the major GLP-1 manufacturers," said Jesse Dresser, head of Frier Levitt's pharmacy practice group that represents compounders. "A lot of the legislation and regulation we've seen is just more restating FDA rules around making sure that pharmacies don't make essentially copies of commercially available products," Dresser added. "Some of it seeks to go a step further."... Full

 

 

AMDAPP Series: Overviewing Austedo for Movement Disorders

(6/2, Marco Meglio, NeurologyLive) ...In this clip, Kelly Holmes, DNP, FNP-BC, a family nurse practitioner (NP) and Doctor of Nursing Practice (DNP) based in North Carolina, specializing in neurology, spoke on the clinical use of deutetrabenazine (Austedo)... Full

 

Skyhawk Reports Encouraging 12-month Results for Oral Huntington's Disease Drug SKY-0515

(6/1, Dr. Rachel Harding, HD Buzz) ...Skyhawk Therapeutics has announced by press release new 12-month data from their Phase 1/2 trial of SKY-0515, an experimental oral treatment for Huntington's disease (HD). The latest results largely extend the positive trends previously reported at earlier time points, providing additional reassurance that the drug continues to work as designed while remaining generally safe and well tolerated... Full

 

Patients With Tardive Dyskinesia Symptoms May Go Undiagnosed

(6/1, Kristen Monaco, MedPage Today) ..."Tardive dyskinesia continues to be a prevalent and clinically significant condition, particularly among older adults, women, and long-term antipsychotic users across both the United States and international settings," noted Mohsin Raza, MD, MSc, of UHS Dover Behavioral Health System in Delaware, and colleagues in StatPearls. "Geographic variations in prevalence and recognition exist within healthcare systems, with underdiagnosis persisting despite the availability of improved assessment tools," they pointed out... Sub. Req'd

 

AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults

(6/2, AbbVie) ...This approval is the second indication in the European Union for AQUIPTA, an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), which is now approved as both an acute treatment option for migraine attacks in adults and as a once-daily preventive treatment option for adults with chronic or episodic migraine who experience four or more migraine days per month... Full

 

Video: Bristol Myers Squibb CEO on Cancer Developments in the Pipeline

(6/1, CNBC) ...Bristol Myers Squibb CEO Chris Boerner sits down with CNBC's Angelica Peebles at the American Society of Clinical Oncology's annual meeting to discuss the company's latest cancer drug data, its $15 billion deal with China's Hengrui, and more... Full

 

ASCO in Brief: Lilly's Plenaries; Incyte's Frontline Data in Lymphoma

(6/1, Lei Lei Wu, Endpoints News) ...Researchers detailed findings from an investigator-sponsored trial using Lilly's CDK4/6 inhibitor Verzenio in a rare cancer called dedifferentiated liposarcoma, showing it extended progression-free survival by roughly eight months compared to placebo. "We'll work with the investigators to talk to regulators about the trial results and decide what to do next," Lilly's oncology head Jacob Van Naarden told Endpoints News... Sub. Req'd

 

'King Keytruda's Reign Continues.' Investors Aren't Wowed by Latest Data for Experimental Lung-Cancer Drug.

(6/1, Jaimy Lee, MarketWatch) ...A promising new cancer drug helped reduce the risk of death by 34% in patients with the most common form of lung cancer, but investors had a lukewarm response to the data... Full

 

J&J's Erleada Study Succeeds in Early-Stage Prostate Cancer, but Questions Remain

(6/2, Lei Lei Wu, Endpoints News) ...As part of a hormone therapy regimen for prostate cancer, J&J's Erleada cut the risk of metastasis or death by 20% when given around surgery, researchers reported Sunday... Sub. Req'd

 

 

Daewoong Partners with Chime Biologics on Dupixent Biosimilar

(6/2, Lee Han-soo, Korea Biomedical Review) ...The partnership combines a CDMO agreement covering development and production with a separate commercialization agreement, creating a framework that spans the product's full value chain from development to global market launch... Full

 

Samsung Bioepis Joins EU Eylea Rivals

(6/1, Dave Wallace, Generics Bulletin) ...The 40mg/ml vial is the fifth biosimilar to be directly commercialized by Samsung Bioepis, and joins the firm's recent launch through its own network of its Byooviz (ranibizumab) 10mg/ml vial - a rival to another major ophthalmology treatment, Lucentis - in January... Global Sub. Full

 

China Approval Seals Henlius' Global Breast Cancer Play

(6/1, Dean Rudge, Generics Bulletin) ...Henlius' Hanbeiyou has won NMPA approval in China, making it the first and only China-developed pertuzumab cleared across China, the US and the EU...The approval strengthens Henlius' breast cancer franchise by pairing Hanbeiyou with trastuzumab biosimilar Hanquyou, creating a domestic dual-target combination approved in all three major markets... Global Sub. Full

 

Sunshine Biopharma Announces Canadian Approval for Rivaroxaban, a Generic Form of Xarelto®

(6/1, Sunshine Biopharma) ...Sunshine Biopharma Inc., a leading pharmaceutical company specializing in generic and specialty prescription medications, is pleased to announce the approval of its generic Rivaroxaban tablets of 2.5mg, 10mg, 15mg and 20mg for the Canadian market. Rivaroxaban is the generic equivalent of the brand name anticoagulant, Xarelto®... Full

 

Generic and Biosimilar Economics in a Payer-Engineered Market

(6/1, Scott Biggs, Luke Greenwalt, Alexis Maharam and Anika LaFazia, IQVIA) ...The dynamics reshaping generics and biosimilars reflect a broader reconfiguration of how value is created, protected, and eroded across the pharmaceutical lifecycle. Rapid biosimilar uptake, concentrated winners, and payer-driven adoption have fundamentally altered expectations around competition and LoE, with clear consequences for both branded and biosimilar manufacturers... Full

 

Biosimilars Could Slash Specialty Drug Spend 20%

(6/2, Gina Shaw, Specialty Pharmacy Continuum) ...The launch of adalimumab biosimilars in 2023 is a case in point... Full

 

 

Servier Inks $2.6B Buyout of Edgewise's Muscular Dystrophy Unit to Beef up Neurology Pipeline

(6/1, Nick Paul Taylor, Fierce Biotech) ...The Servier deal narrows Edgewise's focus onto the cardiovascular pipeline while giving the biotech the cash to fuel development. Edgewise estimates the deal will fully fund EDG-7500 development through potential approval. In addition to the upfront fee, Servier has committed up to $1.1 billion in regulatory and commercial milestones to acquire Edgewise's muscular dystrophy business. Sevasemten is Edgewise's only molecule in clinical development as a treatment for muscular dystrophy... Full

 

Manufacturer Adding 350 Jobs in $267m Cleveland, Columbus Expansion

(6/2, Carrie Ghose; Mary Vanac, Cleveland Business Journal) ...The London, U.K.-based generic and specialty drug maker expects to invest $51 million at its Bedford plant to expand injectable pharmaceutical and IV bag production, warehousing and distribution, creating 300 jobs... Full

 

Samsung Bioepis, Samsung Medical Center Partner on AI-Driven Drug Research

(6/1, Lee Han-soo, Korea Biomedical Review) ...Under the agreement, the two organizations will establish a joint consultative body and a research advisory committee to carry out a range of collaborative research projects through the end of 2030... Full

 

Pamela Hoffman - President & CEO, Padagis

(6/1, Pharma Boardroom) ...In this interview, [Padagis president and CEO Pamela] Hoffman discusses the company's international expansion into Europe, its strategic investment in US-based naloxone manufacturing capacity, and the structural challenges facing the generics sector, from pricing pressure and patent thickets to supply chain resiliency and the need for policy reform... Full

 

Autism Therapy Is Booming -- And So Is the Billing Abuse

(6/2, Christopher Weaver and Anna Wilde Mathews, The Wall Street Journal) ...The suits alleged health-plan sponsors including Teva Pharmaceuticals, a construction workers union in Newburgh, N.Y., and the Mitchell Companies, a Meridien, Miss.-based distributor and manufacturer, failed to pay for services they had agreed to cover... Sub. Req'd

 

 

European Commission Says Biotech Act Could Save Industry Upwards Of €5Bn Per Year

(6/1, Eliza Slawther, Pink Sheet) ...In a May 27 staff report analyzing the impact of the Biotech Act, which is currently under negotiation in the EU, the commission said the act was expected to yield "direct cost savings in EU sponsor expenditure of approximately 5%."... Global Sub. Full

 

Swissmedic Secures $3.4M To Fix Financial Woes, But Must Cut Jobs And Spending

(6/1, Eliza Slawther, Pink Sheet) ...Swissmedic has announced a staff redundancy scheme that will involve a headcount reduction of 45 full-time equivalents (FTEs) over the next two years as part of a plan to resolve its ongoing financial troubles... Global Sub. Full

 

Indian Firms Beat Fourth-Quarter Estimates, but Iran War Dims Outlook

(6/2, Vivek Kumar M, Bharath Rajeswaran, Reuters) ...India's top-50 listed companies posted single-digit percent profit growth for the eighth straight quarter...The path ahead for Asia's third-largest economy could be a rough one as the energy shock starts rippling across the economy, hurting activity and raising prices... Full

 

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