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A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.
The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
Almirall will have exclusive global rights to develop and commercialize the anti-IL-21 monoclonal antibody NN-8828 in several fields, including immune inflammatory dermatological indications.
In a Phase II study, Sanofi and Denali’s RIPK1 inhibitor SAR443820/DNL788 failed to meet the primary endpoint of improved functional performance in amyotrophic lateral sclerosis patients.
The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.
The Icelandic biotech Thursday said that it has settled its grievances with Johnson & Johnson regarding its Stelara biosimilar in markets with regulatory approval.
Pfizer plans to settle a lawsuit filed 12 years ago by distributors of Lipitor for $93 million. The pharma giant was accused of colluding with Ranbaxy Laboratories to delay generic versions of the drug.
Alnylam Pharmaceuticals is modifying the primary and secondary endpoints of the Helios-B Phase III trial investigating its next-generation RNA interference therapy in patients with ATTR amyloidosis with cardiomyopathy.
The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it.
Following a patient case of severe liver enzyme elevations, Inventiva is suspending its Phase III NATiV3 study in non-alcoholic steatohepatitis as Madrigal Pharmaceuticals awaits a March 14 PDUFA date.
The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.
PRESS RELEASES
• ASCO 2026: 2.5-Year Overall Survival Data • Jefferies Healthcare Conference: Partnering & Investor meetings • BIO International Convention: Panel Participation • MIB Agents Factor Osteosarcoma Conference: Data Presentation
The 6% naturally derived extract is set to be encapsulated for use in patients suffering from treatment-resistant depression under Australia’s Authorised Prescriber Scheme, where no serious adverse events have been reported as of December 2025
Live Presentation and Q&A: Thursday, May 28, 2026 12 PM EDT
• MustGrow has received approval from the agriculture departments of Texas, Utah, and Montana to commence sales of organic biofertility product TerraSanteTM. • Based on infield grower data, the mustard-derived TerraSanteTM biofertility product has been shown to improve crop yields, soil, and potentially the soil microbiome health for nutrient/water use efficiencies.
· Prof. Dr. med. Jürgen Braun joins the Scientific Advisory Board of MetrioPharm AG. · With more than 800 peer-reviewed publications and various prestigious awards, Prof. Braun is internationally recognized as a leading expert in the field of modern clinical and academic rheumatology.
Pharmaceutical service provider receives prestigious management award for the seventh year in a row · Family-owned company once again excels in all four key business areas · Site development and digitalization as strategic investment priorities · Focus on new sources for skilled workers and on lifelong learning
The upgraded platform offers a searchable database of over 300 risk-assessed HCPs, automated research scanning, and new flexible pricing options for mid-size drug developers.
New preprint by Jianghui Xiong, PhD, and the DeepoMe team introduces SteeraMed, a steerable biomedical world model for N-of-1 intervention reasoning across chronic diseases and aging