Monday, July 13, 2026

 

 

The Israel Innovation Authority is Spearheading a $23.3M Investment to Establish an AI Consortium for Personalized Medicine

(7/12, Meir Orbach, CTech) ...The Israel Innovation Authority and a group of companies including NVIDIA, Teva, Sheba, CytoReason, TerraCyte, and MeMed, alongside leading researchers from the Weizmann Institute, the Technion, and Ben-Gurion University, will invest approximately NIS 70 million (approx. $23.3M) to establish a consortium dedicated to developing the next generation of AI applications in biology, drug discovery, and personalized medicine... Full

 

Israel Launches National AI R&D Consortium to Advance Drug Discovery

(7/12, Xinhua) ...The consortium will develop a shared technological infrastructure for companies, researchers and healthcare organizations to build advanced AI models based on complex biological data... Full

 

Teva Takes On Global Rights To Polpharma Biologics' Ocrevus Biosimilar

(7/10, Urte Fultinaviciute, Generics Bulletin) ...Under the agreement, Polpharma Biologics retains full responsibility for the development and manufacturing of the products. Meanwhile, Teva will be responsible for regulatory submissions and commercialization in the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey... Global Sub. Full

 

Teva and Polpharma Biologics Sign Global Deal for Ocrelizumab Biosimilar

(7/10, Salong Debbarma, Pharmaceutical Technology) ...The arrangement covers markets, including Australia, Canada, Brazil, Europe, Israel, New Zealand, Turkey, and the US... Full

 

Teva and Polpharma Biologics Sign Global Licensing Deal for Ocrevus Biosimilar Candidate

(7/10, Manufacturing Chemist) ..."This agreement is aligned with Teva's Pivot to Growth strategy and our focus on expanding our biosimilars pipeline," said Yolanda Tibbe, Vice President and Global Head of Biosimilars at Teva... Full

 

Teva Secures Global Rights to Polpharma's Ocrevus Biosimilar Candidate for Multiple Sclerosis

(7/10, Emily Schoenthaler, BioPharmInternational.com) ...In addition, an Iranian company, CinnaGen, has reported phase 3 results for its own ocrelizumab biosimilar candidate, though its plans for the US market remain unclear...That makes the Teva-Polpharma agreement one entry in what is shaping up to be a multi-company race toward the first approved ocrelizumab biosimilar... Full

 

 

Why Patients Need Trump's Great Healthcare Plan | Opinion

(7/13, Bobby Jindal, Hannah Anderson, Newsweek) ...The Great Healthcare Plan restores the simple principle that the patient, not the middleman, the bureaucrat or the broker, is the customer. Every part of the president's plan flows from the belief that patients are best equipped to make health care decisions... Full

 

'How Did They Get There First?' Biotechs Forced to Learn New Patent Tricks to Protect Pipelines

(7/12, Will Maddox, Fierce Biotech) ...Omar Khalil, managing partner at early-stage life sciences VC firm Santé Ventures, also voiced the anxiety that being too open about your research can increase the risk of someone beating you to market. "The concern is that things take longer here in the U.S., and if you publicize what you're doing, it may lay the path for somebody to follow you or do something similar," Khalil said. "If they can do it faster and cheaper, you're creating competition for yourself," he added... Full

 

Sorry, We Just Can't Cover Those Effective Drugs

(7/13, Carey Goldberg, The Boston Globe) ...Though GLP-1's are not for everyone, some analysts estimate that they hold the potential to help at least half of all Americans. "The magnitude of the potential benefit for public health, and for individual health, is unmatched," says ICER's president, Sarah Emond. "And the potential for significant and harmful budget impact is also unmatched." In other words: These drugs work. We just can't afford them... Full

 

The FDA Moves to Modernize Drug Manufacturing Registration

(7/10, Susan Haigney, PharmTech) ...On July 10, 2026, the FDA announced a proposed rule to streamline registration for single distributed manufacturing establishments that operate using a "hub-and-spoke" model...The proposed rule would create a streamlined pathway and clarify registration requirements for certain foreign companies that manufacture APIs and drug products that indirectly enter the US drug supply. In addition, it would help reduce registration costs and generate efficiencies, according to the agency... Full

 

FDA Resumes Complete Response Letter Publication After Pause

(7/10, Jessica Karins, Inside Health Policy) ...According to FDA's regulatory agenda released this week, the agency plans to propose a rule expanding the commissioner's discretion to release complete response letters and letters stating that a product is not approvable... Sub. Req'd

 

U.S. Supreme Court Weighs Inducement Liability Beyond FDA Carve-Out Labels

(7/10, Jeremy Lowe, PharmExec.com) ...The issue is not whether a generic may use a section viii carve-out. It may. The harder question is whether FDA-compliant carve-out labeling can still support inducement when paired with public statements, sales materials, website language, or investor communications that allegedly steer physicians back to the patented use... Full

 

US FDA Hiring Binge: CDER, CBER Report Q3 Bump, First Since Trump Administration Cuts

(7/10, Derrick Gingery, Pink Sheet) ...CDER added 101 new employees and lost 75 during the third quarter, which ended June 30. The net gain of 26 was the largest in a quarter since the first quarter of FY 2025, which also was the last time CDER posted a net increase in employees... Global Sub. Full

 

ADHD Patients in N.J. Can Now Refill Their Medications from Home

(7/10, Jackie Roman, NJ.com) ...A bill signed into law by Gov. Mikie Sherrill on Thursday allows Schedule II drugs such as Adderall, Ritalin and Vyvanse to be refilled via telehealth. The change will make it easier for patients to access the drug, supporters say... Full

 

 

Sanofi Snags FDA Thumbs Up for Sarclisa as 1st Cancer Drug Delivered by On-Body Injector

(7/10, Kevin Dunleavy, Fierce Pharma) ...Sanofi's new formulation, which is dubbed Sarclisa Escena, now becomes the first subcutaneous anticancer drug that can be administered manually or by an on-body injector (OBI). The endorsement for Sarclisa Escena applies to each of the indications for which its intravenous (IV) formulation is approved... Full

 

GSK's Hansoh-Partnered B7-H3 ADC Shows Survival Benefit in Lung Cancer Study

(7/10, Anna Bratulic, FirstWord PHARMA) ...The Chinese Phase III ARTEMIS-008 trial, testing the B7-H3-targeting asset risvutatug rezetecan (ris-rez), has succeeded on its primary endpoint of overall survival (OS) in patients with advanced or relapsed small-cell lung cancer (SCLC), the UK drugmaker said. Hansoh will use the results to back its request for regulatory approval in China... Full

 

Insilico, China Medical System Deepen Partnership with New $177M CNS Deal

(7/13, Pavan Kamat, FirstWord PHARMA) ...The programme will leverage a novel mechanism of action identified by Insilico's PandaOmics platform, which the AI biotech's Chief Scientific Officer Feng Ren said "streamlines the development of high-potential drugs, enhancing translational efficiency, and accelerating the transition of molecules from 'proof of concept' to…patient therapies."... Full

 

Large Registry Study Questions Utility of Plasma CGRP as Diagnostic Biomarker for Migraine

(7/12, Louie Pasculli, Neurology Live) ...A large cross-sectional registry study revealed that patients with migraine did not have higher plasma concentrations of calcitonin gene-related peptide (CGRP) compared to healthy individuals, adding to growing evidence that circulating CGRP may have limited value as a diagnostic biomarker for migraine despite its established role in migraine pathophysiology.¹... Full

 

 

Intas Pharma's US Specialty Division, Accord BioPharma Receives US FDA Approval for Ennumo, a Biosimilar to Neulasta

(7/11, Pharmabiz.com) ...With this approval, Accord BioPharma is now the only company in the US offering two distinct pegfilgrastim biosimilars - Ennumo and Udenyca (pegfilgrastim-cbqv) - alongside Filkri (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026. Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve... Full

 

Tom Shea - CEO, Meitheal Pharmaceuticals

(7/10, Pharma Boardroom) ...Tom Shea, Founder and CEO of Meitheal Pharmaceuticals, discusses his career across commercial and operational roles in generic injectables and the creation of Meitheal in 2017. He highlights the company's growth into a top-five US injectable generic player, its expansion into biosimilars, and its commitment to manufacturing investment, supply reliability, and long-term partnerships. Shea also addresses tariffs, market competition, affordability, and Meitheal's ambition to become a leader in both generics and biosimilars... Full

 

 

AstraZeneca CEO: 'Biology Will Catch Up With Me at Some Point'

(7/12, Aanu Adeoye, Financial Times) ...Pfizer's final offer in 2014 was £55 a share. AstraZeneca now trades at about £128 a share and its £207bn market cap makes it more valuable than its would-be buyer. "We thought we had what it took to create more value on our own," [Sir Pascal] Soriot tells the FT. Such calculated risk-taking has characterised the 67-year-old's time at the company he joined in October 2012. To meet ambitious growth targets, he has focused on in-house drug development, US expansion and investing in emerging markets before it became fashionable in the sector, making AstraZeneca the largest western pharma company in China... Sub. Req'd

 

Can AI Make Better Drugs? Not on Wall Street's Timeline

(7/12, David Wainer, The Wall Street Journal) ...At Roche's Genentech, computational biologist Aviv Regev has built what she calls a "lab in the loop." AI models predict promising targets and molecules, researchers test those predictions experimentally, and the resulting data are fed back into the models to improve their next round of predictions... Sub. Req'd

 

Celltrion Scales Biosimilars and Advances New Drugs to Power Growth

(7/13, Heo Ju-yoon, Chosun Biz) ...Based on the profitability secured in its existing biosimilar (biosimilar) business, the company plans to expand its next-generation product portfolio while investing in new-drug development, including antibody-drug conjugates (ADCs), multispecific antibodies and obesity treatments, to diversify its growth pillars... Full

 

Insurance Denials for Brand-Name Drugs Surge Over Past Six Years

(7/11, News Medical) ...A new study led by researchers at the Johns Hopkins Bloomberg School of Public Health and the American Enterprise Institute found that insurance denials of first attempts to fill prescriptions for brand-name prescription drugs with no generic competitors increased more than two-thirds between 2018 and 2024... Full

 

 

German Lawmakers Pass Healthcare Cost-Saving Measures

(7/10, Elizabeth S. Eaton, FirstWord PHARMA) ...Despite opposition from the pharmaceutical industry, Germany's federal and state governments approved a law on Friday that will reduce federal funding for the country's statutory health insurance system. The system rework, which comes as Germany faces a steep budget shortfall of more than €40 billion ($45.8 billion) by 2030, is designed to cut costs by €16.3 billion ($18.6 billion)... Full

 

Is There 'Leeway' For EU Countries To Extend Wastewater Directive Costs Beyond Pharma And Cosmetics?

(7/10, Francesca Bruce, Pink Sheet) ...The revised UWWTD is very unpopular with the pharmaceutical and cosmetics industries as its extended producer responsibility (EPR) provisions makes these sectors responsible for paying at least 80% of the costs of setting up and operating a fourth stage of wastewater treatment at all major EU treatment plants... Global Sub. Full

 

Drug Pricing Authority Caps Cost of 39 Medicines; Includes Meds Treating BP, Diabetes and Heart Disease

(7/11, Deccan Herald) ...To restore some equality, the National Pharmaceutical Pricing Authority (NPPA) has capped the retail price of around 39 medicines, including drugs that treat blood pressure, diabetes and heart disease. The price fixing of these essential medicines happened under the provision of Drugs (Price Control) Order (DPCO), 2013, read a notice issued by the Ministry of Chemicals and Fertilizers, on July 8... Full

 

How Stronger Data Protection Reshaping India's Generic Drug Industry

(7/13, Ayoshi Mondal, Businessworld) ...India is considering stronger regulatory data protection for new medicines. The country's generic pharmaceutical industry has warned that the move could delay affordable treatments, disrupt business models and alter the delicate balance between encouraging innovation and ensuring access to low-cost healthcare... Full

 

India's Trade Curbs and PLI Push to Boost Domestic Pharma Against China: Arun Patel

(7/13, Nandita Vijayasimha, Pharmabiz.com) ...The Indian pharmaceutical companies are profiting from the Union government's minimum import-price measures, anti-dumping action and PLI-led (production linked incentive) capacity creation which are gradually reducing the asymmetric advantage that China has enjoyed. This does not remove China dependence overnight, but it does make the earnings outlook less vulnerable to uncontrolled Chinese undercutting than it was in the recent past, said Arun Patel, founder & partner, Arunasset Investment Services... Full

 

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