Monday, June 22, 2026

 

 

Germany Warns US Not to Jeopardize Trade Truce With Drug Pricing Probe

(6/19, Helen Collis, Romanus Otte, Nette Nöstlinger, Politico) ..."I assume that the United States of America will honor the agreement," Chancellor Friedrich Merz told journalists Friday after meeting with EU leaders in Brussels. That includes "caps on pharmaceutical tariffs," a German government spokesperson told POLITICO earlier, warning the U.S. should not "jeopardize their proper implementation on either side."... Full

 

Trump's Plan for Medicare Drug Talks Offers Pharma Fresh Fight

(6/22, Nyah Phengsitthy, Bloomberg Law) ...The drugmakers did not respond to requests for comment, but PhRMA pushed back on the program's advancement. "As more medicines, including complex drugs administered by physicians, are pulled into government price setting, these harms will only grow, restricting patient access and weakening incentives for innovation," Chanse Jones, PhRMA spokesperson, said in an email... Full

 

The 'Most Favored Nation' Threat Is Real. Seniors Should Take Notice

(6/19, Mark Gibbons, Thair Phillips, The Washington Examiner) ...Lawmakers should reject efforts to codify MFN and instead focus on strengthening Medicare for the people it was designed to serve. It's time to protect seniors' access to care and the future of medical innovation... Full

 

CMS Seeking Input On PBM Delinking, Data Reporting For Upcoming Rules

(6/19, Cathy Kelly, Pink Sheet) ...The agency wants information on "affiliates" involved in carrying out PBM activities, which may include third-party administrators and rebate aggregators structured like group purchasing organizations that are associated with the leading PBMs: Express Scripts' Ascent, CVS Caremark's Zinc Health Services, and OptumRx's Emisar... Global Sub. Full

 

340B Rebate Model Pilot On Implementation Fast Track To Increase Accountability, Transparency

(6/19, Cathy Kelly, Pink Sheet) ...The pilot program, which pharma strongly supports, would allow manufacturers to provide 340B discounts as back-end rebates rather than up front for drugs subject to Medicare negotiated prices. The change is meant to help ensure discounts are not demanded for drugs subject to negotiated process or Medicare price inflation rebates, which is prohibited by the Inflation Reduction Act... Global Sub. Full

 

US FDA Staffing, Transparency Keys To Rebuilding Public Trust, Acting CDER Director Says

(6/19, Sue Sutter, Pink Sheet) ..."Trust is earned through the quality of our people and the rigor of our process, and we will continue to listen, engage, explain our reasoning, and improve wherever we can," said Michael Davis, acting director of the Center for Drug Evaluation and Research, said June 18 during the Drug Information Association's annual meeting in Philadelphia... Global Sub. Full

 

 

Teva Submits NDA for Ecopipam for Pediatric Tourette Syndrome

(6/20, Pharmabiz.com) ...The NDA submission is supported by positive Phase 3 data recently published in JAMA Neurology, which showed that ecopipam significantly delayed time to relapse compared with placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period... Full

 

Merck's Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

(6/22, Merck) ...[Merck] announced positive topline results from the Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score (MMS) at week 12, as well as key secondary endpoints. Consistent with previously reported Phase 2 studies, no safety concerns were identified... Full

 

Insilico, SK Biopharm Strike $2.5B AI Discovery Deal for CNS Therapies

(6/22, Pavan Kamat, FirstWord PHARMA) ...Under the deal's terms, Insilico will utilise its Pharma.AI platform, encompassing target validation, generative chemistry and molecule optimisation, to discover, design and optimise novel candidates for neuroimmune indications. SK Biopharm will then take charge of late-stage development and commercialisation activities for all resulting programmes... Full

 

Helmed by Sanofi Vet, Bionyara Emerges with $165M and Three Licensed I&I Assets

(6/22, Will Maddox, Fierce Biotech) ...For Bionyra Pharma co-founder and CEO Frédéric Marrache, M.D., Ph.D., "the planets had to align" to pull him out of his R&D VP role at Sanofi. But after weighing the opportunity to lead immunology and inflammation (I&I) biotech, he decided to take the jump and scratch the entrepreneurial itch he had been feeling for years... Full

 

 

Lupin to Sell Hypertension Drug Azilsartan Medoxomil in US

(6/20, Shajil Kumar, Pharmacy Business) ...Indian drug major Lupin Limited has announced the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States following the FDA approval for its Abbreviated New Drug Application... Full

 

Alembic Pharma Gets Tentative Approval From USFDA for Generic Cancer Drug

(6/19, PTI) ...The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing... Full

 

Samsung Bioepis, Organon Expand Stelara Biosimilar Partnership to Canada

(6/19, Lee Han-soo, Korea Biomedical Review) ...Under the agreement, Organon will obtain exclusive commercial rights to the product in Canada, while Samsung Bioepis will retain full development, manufacturing, and regulatory responsibilities... Full

 

First Xofluza Generic Approved In The US

(6/19, Anabel Costa-Ferreira, Generics Bulletin) ...On June 17, the US Food and Drug Administration announced its approval for the generic of Genentech's Xofluza (baloxavir marboxil) tablets, marking it as the country's first approved generic version. The FDA announcement also confirmed that the approved manufacturer for the tablets is a US-based generic drug maker, Norwich Pharmaceuticals Inc... Global Sub. Full

 

 

AbbVie to Acquire Apogee Therapeutics, Deepening Immunology Portfolio

(6/22, AbbVie) ...Under the terms of the transaction, AbbVie will acquire all outstanding shares of Apogee for $135.11 per share in cash. The transaction values Apogee at a total equity value of approximately $10.9 billion. The boards of directors of both companies have unanimously approved the transaction. This transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, including Apogee shareholder approval and receipt of regulatory approvals... Full

 

Sun Pharma to Acquire Innovcare Lifesciences for $28.7M

(6/22, Salong Debbarma, Pharmaceutical Technology) ...Sun Pharmaceutical Industries has agreed to purchase India-based Innovcare Lifesciences in a deal valued at approximately Rs2.71bn ($28.7m). According to a regulatory filing, Sun Pharma will buy the entire issued and outstanding share capital of Innovcare Lifesciences via a cash transaction. The company expects to close the acquisition on or before July 31, 2026... Full

 

Boltz Strikes AI Drug Discovery Pact with Takeda

(6/18, Olivia Roger, FirstWord Pharma) ...The applied AI research lab will deploy its biomolecular models and platform across the Japanese drugmaker's research organisation to help scientists predict molecular structures and design new drug candidates... Full

 

Insilico Lands Heavily Backloaded $2.5B AI Drug Discovery Deal with SK Biopharm

(6/22, Angus Liu, Fierce Biotech) ...The alliance targets conditions affecting the central nervous system, a key focus area of SK Biopharm. The two firms will develop drugs for neuroinflammatory, neurodegenerative and rare neurological disorders, although the specific diseases were not disclosed... Full

 

New Sanofi CEO Names Paulo Fontoura as Research Head

(6/22, Matthew Dennis, FirstWord PHARMA) ...Brought in to boost R&D productivity, new Sanofi CEO Belén Garijo has wasted little time in naming the company's next head of research, with the drugmaker announcing Monday that Paulo Fontoura will assume the role effective September 1... Full

 

A 5-Month Sprint: Behind Pfizer's $10B Deal and Innovent's Global Pharma Ambition

(6/21, Angus Liu, Fierce Biotech) ...Despite its massive $10.5 billion size and 12-drug scope, Pfizer's oncology deal with Innovent Biologics took less than five months to forge, but not without undergoing some stress tests. The deal talks started at the J.P. Morgan Healthcare Conference in San Francisco in January this year, Innovent CEO Michael Yu, Ph.D., told Fierce Biotech. From the start, Pfizer preferred a single multi-asset deal. Hunting for a dozen different assets from separate companies-and managing those alliances later-was simply too logistically cumbersome. To Innovent, the sentiment was the same... Full

 

Big Pharma's Big Brand: Inside Eli Lilly's Marketing Culture

(6/22, Ben Adams, Fierce Pharma) ...Pharma companies have been part of the global economy and our health systems for centuries. Novartis can trace its origins back 250 years, while Eli Lilly is celebrating its 150th year and Bayer traces its first days back to 1863. For most of that time, however, pharma companies were content to exist in the background. The products they produced, including medicines, vaccines and consumer goods, were front and center in their marketing approach... Full

 

Sandoz to Host Capital Markets Day: Maximising Sandoz Value in Its Golden Decade for Biosimilars

(6/22, Sandoz) ...Sandoz, the global leader in affordable medicines, will host its 2026 capital markets day for investors and analysts... Full

 

How Will Emerging AI Impact the Pharmacy Benefit Manager Space?

(6/19, Brian Nowosielski, Drug Topics) ..."As PBMs try to gain the respect and trust of employers, patients, physicians, and pharmacists, they will need to use AI to 'do the right thing,'" Perry Cohen, PharmD, FAMCP, CEO of The Pharmacy Group (TPG) Family of Companies, told Drug Topics®. "The newer PBMs are making this happen and the older PBMs are trying to reinvent themselves."... Full

 

Aurobindo Pharma Subsidiary Eugia Steriles Faces Five US FDA Observations

(6/19, Jomy Jos Pullokaran, CNBC TV18) ...The inspection was conducted at Eugia Steriles' manufacturing facility located in Parawada Mandal, Anakapalli District, Andhra Pradesh, from June 10, 2026, to June 19, 2026... Full

 

 

Message Received: European Parliament Backs Industry Push For UWWTD Pause

(6/19, Dave Wallace, Generics Bulletin) ...A vote held yesterday in the European Parliament - which is non-binding and therefore to some extent symbolic - saw a majority call for a pause of implementing elements of the UWWTD, which features an extended producer responsibility scheme that effectively requires companies in the pharmaceutical sector to finance European wastewater treatment, based on trace elements of medicines that become present in water after they are used... Global Sub. Full

 

Patent Expiry: A $5 Bn Opportunity for Indian Pharma Majors, Says Report

(6/19, Puneet Wadhwa, Business Standard) ..."Given India's favourable patent framework and proven cost-efficient generic manufacturing capabilities, Indian pharmaceutical companies are well-placed to capitalize on this opportunity. After accounting for significant price erosion, this is expected to create a market opportunity exceeding $30-40 billion over five years, of which, Indian companies are expected to capture nearly $3-5 billion," CareEdge Ratings said in a recent note... 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.