Wednesday, June 3, 2026

 

 

Teva Deal Preserves Most Of Jelmyto Patent Protection Period

(6/3, Dean Rudge, Generics Bulletin) ...Under the deal, UroGen will grant Teva a non-exclusive license to sell its generic Jelmyto beginning Sept. 15, 2030, if the product is approved by the FDA... Global Sub. Full

 

 

Oz: All MFN Deals To End When Admin Ends, Trump Rx To Host 160 More Drugs

(6/2, Gabrielle Wanneh, Inside Health Policy) ...Oz also announced an additional 160 drugs have been added to the TrumpRx.gov website..."These contracts expire after this administration is done," Oz told reporters at Tuesday's White House press briefing. "Now, it is going to be difficult for pharmaceutical companies to pull back, but we still believe it makes sense for Congress to codify what we've been able to achieve because it's been so helpful." Merck and Sanofi, previously disclosed in SEC filings that their most favored nation agreements will last only three years... Sub. Req'd

 

CMS Administrator Dr Oz Says Pharma Investment Shifting to US

(6/3, Indo-Asian News Service) ...Oz said pharmaceutical executives view the United States as an increasingly attractive destination for research, development and manufacturing. "If you're a pharma executive, and America is open for business, and we're trying to support innovation, you know, saving people from cancer, autoimmune problems, dementia, all these different - you want to be where the action is," he said... Full

 

Patient Subgroups, Private Insurance, Pay For Performance: Negotiating MFN Pricing In Europe

(6/2, Francesca Bruce, Pink Sheet) ...While innovative pricing agreements or contracts for targeted patient populations may be avenues to achieve reimbursement in some markets, private insurance might be the answer in others, said [Jesper] Zacho, CEO of Zealth, a market access consultancy headquartered in Copenhagen, Denmark... Global Sub. Full

 

Trump's Most Favored Nation Drug Pricing Has Bold Aims, But Limited Impact

(6/2, Joshua P. Cohen, Forbes) ...Overall, the administration's two-pronged approach to reducing prescription drug costs for Americans by pegging U.S. prices to ones offered in comparably wealthy nations is limited in impact or, in some instances, lacks clarity... Full

 

Medicines and IP: Balancing Innovation and Access

(6/2, House Judiciary Committee) ...The House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet will hold a hearing on Thursday, June 4, 2026, at 10:00 a.m. ET. The hearing, "Medicines and IP: Balancing Innovation and Access," will examine how to balance robust patent rights with greater access to affordable medicines, like generics and biosimilars, to sustain the United States' innovative edge in today's environment... Full

 

Exclusive: Bipartisan Group of Lawmakers Unveil New Bill to Restrict China Biotech

(6/2, Max Bayer, Endpoints News) ...Rep. John Moolenaar (R-MI) and Rep. Debbie Dingell (D-MI) on Tuesday unveiled a bill that would require the Treasury secretary to consider significantly more restrictions on outbound US investments in the China biotech industry. If ultimately passed, it would be one of the most protectionist measures taken by the US government to stop the swell of deals between US and Chinese companies, and would be a significant advance from the Biosecure Act that was passed last December... Sub. Req'd

 

They Said It! Broad Based Support for Bipartisan Ethic Act and Skinny Labels, Big Savings Act

(6/2, CSRxP) ...Congress can act immediately to hold Big Pharma accountable by advancing two bipartisan, market-based solutions: The Eliminating Thickets to Improve Competition (ETHIC) Act and Skinny Labels, Big Savings Act... Full

 

Evidence on Drug Patents, Not Metaphors

(6/2, RealClear Health) ...If lawmakers are going to consider rewriting patent rules for medicines, they must do so based on evidence, not metaphors... Full

 

USP Publishes Biologics Standards for Public Comment

(6/2, Susan Haigney, Pharm Tech) ...Wider USP modernization efforts target greener, more sustainable standards, including reduced animal testing and toxic chemical use, with global impact across approximately 22,000 manufacturing facilities... Full

 

CNPV Program Facing Legal Durability Questions As Public Meeting Impacting Its Future Approaches

(6/2, Maaisha Osman, Pink Sheet) ...Stakeholders continue to question the NPV program as the FDA prepares to solicit stakeholder comments on it, one of the most controversial launched under former FDA Commissioner Martin Makary, at a June 4 public meeting. The program's future is unclear. The FDA plans to use the feedback to help determine modifications or potential formalization... Global Sub. Full

 

Grading US FDA's National Priority Voucher Program After One Year

(6/2, Sue Sutter, Bridget Silverman, Pink Sheet) ...Entry into the voucher program is no guarantee of approval, as Disc Medicine discovered with a complete response letter for the porphyria treatment bitopertin. Reports of internal disputes over pending applications also have surfaced. At least one product, Sanofi's teplizumab, is well past the target one- to two-month review timeline... Global Sub. Full

 

Unapproved Uses Safe Harbor Codified In Revised US FDA Payor Communications Guidance

(6/2, Sue Sutter, Pink Sheet) ...The guidance, "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers," incorporates updates to the Food, Drug and Cosmetic Act included in the 2023 Consolidated Appropriations Act, such as the ability of drug and device manufacturers to provide payors with truthful and nonmisleading communications about unapproved medical products or unapproved uses of approved or cleared medical products... Global Sub. Full

 

 

AbbVie Receives EC Approval for Aquipta to Treat Migraine

(6/3, Salong Debbarma, Pharmaceutical Technology) ...This marks the second indication for Aquipta in the EU, where it is now approved both for acute attacks and as a once-daily preventive treatment for adults experiencing four or more migraine days each month... Full

 

SKY-0515 Data Suggest Slower Progression in Huntington's Disease

(6/2, Marisa Wexler, MS, Huntington's Disease News) ...Interim clinical trial data suggest people with early-stage Huntington's disease who were treated with the investigational oral therapy SKY-0515 for up to one year had slower disease progression than would be expected based on natural history data... Full

 

ASCO26: Blood Cancer Readouts Take Centre Stage

(6/2, Annabel Kartal Allen, Clinical Trials Arena) ...According to BeOne's haematology CMO, Amit Agarwal, these findings are significant, as the best measure of a therapy's benefit is "how it performs over the long arc of treatment," due to CLL's often chronic nature. "Our data at ASCO show that Brukinsa continues to deliver sustained disease control, which can give physicians and patients confidence to stay the course," Agarwal said. "Robust, real-world analyses reinforce its role as a best-in-class BTK inhibitor, with data favouring Brukinsa over other BTK inhibitors across several efficacy and safety endpoints," he added... Full

 

ASCO 2026: Kelonia Presents Positive in Vivo CAR-T Data in Multiple Myeloma

(6/2, Pharmaceutical Technology) ...As with all published in vivo CAR-T data to date, this data is immature and requires more patients monitored for longer to determine safety and efficacy. Despite this modality being early in development, it is possible to draw comparisons to AstraZeneca's ESOT-01, another BCMA-targeting lentiviral in vivo CAR-T, which had data published in the r/r MM setting in the Lancet in March 2026... Full

 

Celcuity Breast Cancer Drug Misses 'Lofty' Expectations in ASCO-Spotlighted Trial

(6/2, Delilah Alvarado, BioPharma DIVE) ...Data presented Tuesday show both the "triplet" and "doublet" regimens halved the risk of disease progression or death. Those combinations held patients' disease in check for a median of 11.1 months and 11.3 months, respectively, versus 5.6 months for patients treated with Piqray and hormone therapy... Full

 

ASCO: Roche, Head Held High, Details Oral SERD's First-Line Flop in Breast Cancer

(6/2, Angus Liu, Fierce Biotech) ...In fact, results from the failed persevERA trial in first-line HR-positive, HER2-negative metastatic breast cancer have given Roche confidence in a new study that will test the combination of giredestrant with a CDK4/6 inhibitor for the adjuvant treatment of early-stage breast cancer, Roche's deputy chief medical officer, Stefan Frings, M.D., Ph.D., told Fierce in an interview... Full

 

ASCO: Pfizer Scores in Lung, Colorectal and Prostate Cancer but Key Readouts Still to Come

(6/2, Brianna Abbott, BioSpace) ...The New York pharma giant showcased data across more than 40 abstracts at ASCO 2026, plus three late-breakers and several oral presentations. All told, the data ranged from striking, long-term results for approved drugs to previews of what's coming, including some assets out of China. "We want to go big and make impact," Johanna Bendell, Pfizer's chief development officer of oncology, told BioSpace prior to the conference... Full

 

 

Lupin and Natco Receive Approval From U.S. FDA for Eribulin Mesylate Injection

(6/3, Lupin) ...Lupin Limited and its alliance partner Natco Pharma Limited today announced the approval from the United States [FDA] for Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials... Full

 

Torrent On Rezdiffra Generic, Brazil Market Shift To Wegovy

(6/3, Vibha Ravi, Generics Bulletin) ..."We are currently conducting a Phase III clinical trial for resmetirom. There is currently no innovative presence in India. Assuming the trial completes successfully and within our projected timelines, we may be the first to launch this in the India market after the patent expires," managing director Aman Mehta said recently... Global Sub. Full

 

Heron Loses Bids to Block Azurity Copy of Cinvanti Nausea Drug

(6/2, Christopher Yasiejko, Bloomberg Law) ...Heron Therapeutics Inc. lost two lawsuits over Azurity Pharmaceuticals Inc.'s proposed copy of nausea-prevention drug Cinvanti, as a federal judge's invalidation of two patents in one case triggered a prior agreement that 10 other patents aren't infringed... Full

 

Treatment for Millions of Americans at Stake in 'Skinny Label' Supreme Court Case

(6/2, Kristina Acri, Washington Examiner) ...If the Court rules that Amarin cannot make a plausible claim that Hikma's marketing tactics induced infringement of the patented use, it could destroy the delicate balance embedded in the Hatch-Waxman framework... Full

 

 

Exclusive: Cigna Drops Coverage of GLP-1 Obesity Drugs for Its Own Employees

(6/2, Amina Niasse, Reuters) ...Details of the change in the Cigna Group Medical Plan were announced in an email to employees on June 1..."As availability has increased and new options have emerged, we've made the decision to end our plan's coverage for GLP-1s for weight loss," the spokesperson said. "We remain committed to supporting our employees' health through a range of weight management programs and resources."... Full

 

Surge in M&As Driven by Patent Expirations

(6/3, Roohi Mariam Peter, Labiotech) ...Yale Jen, healthcare equity Analyst and Managing Director at Laidlaw & Company, attributes this surge in buyouts to two factors. "One is that biotech valuation is still in a reasonable if not at an overvalued stage. This makes the M&A more affordable," said Jen, who added that many companies have a "very healthy balance sheet", which makes M&A much more manageable... Full

 

$300B Patent Cliff Could Reshape Hospital Drug Spending: Moody's

(6/2, Ella Jeffries, Becker's Hospital Review) ...Moody's estimates the revenue at risk represents roughly 40% of rated pharmaceutical companies' 2025 revenue. For health systems, that figure signals a window: As blockbuster drugs lose exclusivity, lower-cost generics and biosimilars typically enter the market, giving hospital pharmacy teams more leverage on acquisition costs for some of their most expensive product lines... Full

 

 

Biosimilars: Canada Drops Need For Comparative Clinical Efficacy Studies

(6/2, Neena Brizmohun, Pink Sheet) ...Comparative clinical efficacy studies are no longer "typically required" in Canada for the approval of biosimilar drugs, according to final revised guidance that contains changes that lawyers believe may make it faster and cheaper to bring such drugs to market in the country... Global Sub. Full

 

US-India Partnership Most Consequential Relationship of Our Time: Sergio Gor

(6/3, Archana Solanki, CNBC TV18) ...Highlighting the growing economic engagement between the two countries, [Sergio Gor, Ambassador of the United States of America to the India,] said that 99% of India-US trade deal is in place and last 1% is being finalised...Gor also highlighted the importance of India to the US healthcare system, noting that more than 40% of generic drugs used in the United States are sourced from India. He said the achievements of the two countries together would have a significant impact on the future global order... Full

 

South Korea's Pharma-Bio: Asia's Second Innovation Engine

(6/3, Yeom Hyun-a, The Chosun Daily) ...According to the report, South Korea's pharmaceutical industry is rapidly transitioning from a structure centered on generic drugs and biosimilars to a nation of biopharmaceutical innovation. This shift has been driven by government-led bio cluster development, expanded public and private R&D investments, and the growth of global companies such as Celltrion, Samsung Epis Holdings subsidiary Samsung Bioepis, and Samsung Biologics... Full

 

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

 

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.