Friday, June 12, 2026

 

 

Teva Pharmaceutical Closes Acquisition of Emalex Biosciences

(6/12, Pharmabiz.com) ...The acquisition expands Teva's innovative pipeline in a specialized area of neuroscience with significant unmet need and is expected to support near- and long-term growth... Full

 

Paragon Advances Registration-Ready CNS Asset Addressing Important Unmet Need and Closes Sale to Teva Pharmaceutical

(6/11, Paragon Biosciences) ...Paragon, supporting Emalex, advanced the drug through clinical development and the compilation of the NDA that will be submitted in the second half of 2026. The acquisition by Teva comprises $700 million in cash and up to $200 million in commercial milestone payments as well as net-sales-based royalties, subject to regulatory approval... Full

 

Urgent Warning Issued for Popular Medicine over Label Issue

(6/12, Tannur Anders, Express) ...The Medicines and Healthcare products Regulatory Agency (MHRA) issued a class 4 defect notification for the osteoporosis medicine Ponlimsi (denosumab) 60mg solution for injection in a pre-filled syringe. The defect was issued due to a labelling error on the packaging...The warning was issued after Teva UK Limited reported that the cartons of three batches state "For application to the skin"... Full

 

 

'Significant Number of Applications' For GENEROUS MFN Model Arrive Despite Questions

(6/11, Maaisha Osman, Cathy Kelly, Pink Sheet) ...Sources also told the Pink Sheet that drug manufacturers beyond the initial 17 companies that joined the Trump Administration's MFN pricing initiative were negotiating agreements with states to participate in GENEROUS (Generating Cost Reductions For US Medicaid). The comments suggest the administration's pricing initiative may be gaining traction among some manufacturers despite skepticism within the biotechnology industry...But a mid-sized industry source told the Pink Sheet they are not aware of significant interest among mid-sized companies in pursuing agreements under the framework. Many are taking a wait-and-see approach... Global Sub. Full

 

INSULIN Act Secures All Votes Needed To Pass Senate

(6/11, Gabrielle Wanneh, Inside Health Policy) ...A source connected to the involved lawmakers says the hope of the co-sponsors now is that the committee of jurisdiction will recognize the bill's mass bipartisan support, mark it up and send it to the floor for full Senate consideration... Sub. Req'd

 

Rep. Kennedy Signs Letter Urging Investigation into Foreign Drug Pricing Practices Shifting Costs to Americans

(6/11, U.S. Congressman Mike Kennedy) ...In a letter to U.S. Trade Representative Jamieson Greer and Secretary of Commerce Howard Lutnick, the lawmakers expressed support for President Trump's efforts to ensure that foreign nations pay their fair share for American pharmaceutical innovation. Many countries benefit from the U.S.-developed medicines while implementing policies that allow them to avoid contributing equitably to the costs of research and development... Full

 

Trump Wants You to Know This RFK Jr. Aide's Name

(6/12, Carmen Paun, Politico) ...President Donald Trump calls Chris Klomp "a real star." Democrats say he's Robert F. Kennedy Jr.'s babysitter... Full

 

AI Use Is Surging Across HHS, Jumping 148% at the FDA in 2025, Bipartisan Policy Center Data Finds

(6/11, Cailey Gleeson, Fierce Pharma) ...Researchers included the development stages of AI use cases across the NIH, CDC, CMS and FDA, noting most are in still in pre-deployment-"signaling more growth ahead."... Full

 

Quality Culture Comes from the Top, Say Experts

(6/11, Ferdous Al-Faruque, Regulatory Focus) ...Steven Niedelman, lead quality systems and compliance consultant to the FDA and Life Sciences practice at King & Spalding, said that to establish organizational expectations for developing a strong quality culture, there must be buy-in from the very top of the company...Kristen Hastings, senior director of quality at Haemonetics, said it's important to get company leaders on the same page about quality culture and to standardize the language the company uses in its operations... Full

 

Tiered, Risk-Based Approach Could Increase US FDA Biomarker Qualification Utility

(6/11, Sue Sutter, Pink Sheet) ...A Friends of Cancer Research working group wants an overhaul of the US Food and Drug Administration's biomarker qualification program to better reflect evidence development over time, including statutory changes to establish a tiered, risk-based approach to validation... Global Sub. Full

 

Louisiana Lawmakers Passed Bills to Try to Keep Prescription Drug Costs Down. Will it Work?

(6/11, Alyse Pfeil, Nola.com) ...While legislators say the new state-level regulations are aimed at tamping down drug costs for patients, some people involved in the complex system of pharmacies, drugmakers and insurance companies say it's unclear whether consumers will see a difference... Full

 

 

Enliven's Phase III-Bound CML Hopeful Shows Steady Efficacy in Latest Update

(6/11, Anna Bratulic, FirstWord PHARMA) ...Enliven Therapeutics is getting ready to advance its experimental chronic myeloid leukaemia (CML) drug ELVN-001 after aligning with the FDA on Phase III testing, as a new update on an ongoing early-stage trial showed continued response activity in heavily pretreated patients... Full

 

AbbVie Presents New Data at EHA 2026 Congress for VENCLEXTA®/VENCLYXTO® (venetoclax) in First-Line Chronic Lymphocytic Leukemia Highlighting Long-Term Treatment Outcomes for Patients: Nine-Year Results

(6/12, AbbVie) ..."The nine-year results from the landmark Phase 3 CLL14 trial affirm venetoclax's enduring safety and efficacy," said Daejin Abidoye, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These data continue to add to the impressive body of evidence supporting the first-line use of venetoclax-based combination regimens in broader CLL patient populations, offering patients unprecedented time to next treatment - and therefore time off treatment - after one year of fixed-duration therapy. This research advances our mission to transform care and deliver better outcomes for patients living with difficult-to-cure blood cancers."... Full

 

Amneal Announces Full Study Population Interim Phase 4 ELEVATE-PD Results, Reinforcing Previously Reported Benefits of CREXONT in Parkinson's Disease

(6/11, Chain Drug Review) ...After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in "Good On" time, reductions in "Off" time, and improved motor symptom control. Patients switching from RYTARY achieved consistent gains in continuous "Good On" intervals, the length of uninterrupted time patients experience "Good On."... Full

 

 

Xbrane Bets On Partners To Unlock Darzalex Biosimilar

(6/12, Dean Rudge, Generics Bulletin) ...Under the agreement, JOINN will carry out further chemistry, manufacturing and controls work, as well as pilot-scale process development, for the multiple myeloma biologic, using Xbrane's existing development work as the starting point... Global Sub. Full

 

Sanofi And Regeneron Signal 'Vigorous' Patent Defense Plans For Dupixent

(6/12, Urte Fultinaviciute, Generics Bulletin) ...Most recently, Regeneron's chief financial officer Christopher Fenimore highlighted Dupixent's "very broad and layered intellectual property estate that has expiries beginning in the early 2030s, including its composition of matter patent in March of 2031." Additional patents, covering manufacturing, formulation, as well as methods of treatment for various diseases, are valid until the mid-2040s... Global Sub. Full

 

Generic Semaglutide Market Shows Signs of Excess Inventory Bulge

(6/12, Anjali Singh, Business Standard) ...Distributors could begin returning stocks if liquidation does not improve over the next one to two months, particularly because semaglutide products require cold-chain storage and are occupying refrigerator space typically used for vaccines and insulin... Full

 

 

Accelerating Speed to Patient: A Conversation With Eli Lilly's Sarah O'Keeffe

(6/11, Michael Christel, PharmExec.com) ...In the following exclusive Q&A, [Sarah] O'Keeffe goes inside the conception of the Foundry and its fundamental mission; what she believes are the evolving bottlenecks in modern drug development; and why "speed to patient" has become Lilly's guiding principle. She also discusses the company's strategy around manufacturing innovation and shares the leadership philosophy of a chemist who never stopped being curious, directing efforts today at the convergence of science and operations... Full

 

'Not Simply Saving Cost': Inside Astellas CEO's 5-Year Strategy to Counter Xtandi's Patent Cliff

(6/11, Angus Liu, Fierce Pharma) ...The new blueprint relies heavily on internalizing core R&D capabilities, adopting new technologies and centralizing scattered functions to turn Astellas into a more flattened organization... Full

 

UK Health Regulator Approves Novo Nordisk's Weight-Loss Pill

(6/11, Bhanvi Satija, Christy Santhosh, Reuters) ...UK's Medicines and Healthcare products Regulatory Agency approved the pill for adults with obesity who have a body mass index of 30 or above, or those with a BMI between 27 and 30 and at least one related condition... Full

 

Healthcare Costs Poised to Jump 9% in 2027 as Health Plans Blame AI Adoption, Drug Prices

(6/11, Heather Landi, Fierce Healthcare) ...Payers are pointing the finger at several inflationary factors, including the increasing use of artificial intelligence tools by health systems, hospitals and medical practices. AI-enabled documentation and coding tools allow providers to capture greater specificity and reimbursable severity without proportionate increases in care intensity, according to PwC's report. As a result, payers see higher paid amounts per claim... Full

 

Drugmakers Are Turning to Logistics Providers as Trade Disruptions Linger, DHL Exec Says

(6/12, Anna Brown, Endpoints News) ...Pharma companies are increasingly seeking for ways to reduce their exposure to trade bottlenecks caused by geopolitics, [CEO Hendrik] Venter told Endpoints News in an interview. "We will be buying those warehouses from them, taking over [their staff] visas, taking the assets - and then we operate that for them," he said... Sub. Req'd

 

 

Biosimilars Reshape Immunology Care Across EU A Decade After Market Entry

(6/12, Nicole Verbeeck, Euractiv) ...The introduction of copycat versions of expensive biologic medicines has transformed treatment access for millions of Europeans living with immune-mediated inflammatory diseases, as cost savings from biosimilar competition are increasingly being reinvested into broader patient care... Full

 

Streamlining Alone Will Not Fill Europe's Biosimilar Void

(6/12, Dean Rudge, Generics Bulletin) ...In an exclusive interview on the sidelines of the recent Biosimilar Medicines Conference in Amsterdam, [Christine Berndt, chair of Medicines for Europe's Biosimilar Medicines Group, vice chair Eugenio Rossi and Medicines for Europe's director general Adrian van den Hoven,] spoke to Generics Bulletin after sessions that put regulatory streamlining, the EU Biotech Act, procurement reform, intellectual property and the biosimilar void at the center of the sector's agenda... Global Sub. Full

 

UK's HRA Maps Path To Regulatory Clarity For AI-Enabled Trials

(6/11, Eliza Slawther, Pink Sheet) ...The UK is looking to increase support for clinical trial sponsors that are using artificial intelligence (AI) tools in research through a new two-year workplan set out by the Health Research Authority, the organization that oversees research ethics committees in the country... Global Sub. Full

 

India Allows Regulator to Raise Cancer Drug Prices to Tackle Shortage

(6/11, Reuters) ..."The government has approved a price increase. The final decision will be taken by NPPA as it is an independent regulatory body which works under the government," a government source told Reuters on the condition of anonymity... Full

 

India's Trade Agreements to Open New Opportunities for Pharma Sector: Mohit Yadav

(6/12, Shardul Nautiyal, Pharmabiz.com) ...Agreements and ongoing engagements with partners such as the United Arab Emirates (UAE), Australia, the United Kingdom (UK), the European Union (EU), EFTA, the Sultanate of Oman and New Zealand are expected to support market access, regulatory cooperation, investment partnerships and technology collaboration... Full

 

India Ready to Lead Next Wave of Biopharma Innovation: Anupriya Patel

(6/12, Pharmabiz.com) ...India is rapidly strengthening its position as a global pharmaceutical powerhouse while preparing to lead the next wave of biopharmaceutical innovation, Union minister of state for health & family welfare and chemicals & fertilizers, Anupriya Patel, said while addressing Assocham's Pharma Summit & Awards 2026...Anupriya Patel highlighted the success of the production linked incentive (PLI) schemes in strengthening domestic manufacturing of APIs and critical drugs, noting that India has significantly enhanced its production capabilities and reduced import dependence across key pharmaceutical inputs... Full

 

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