10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
US oncology specialist MacroGenics was trading 4% lower at lunchtime in the USA on Wednesday after presenting the final overall survival (OS) results of the SOPHIA Phase III in metastatic HER2-positive breast cancer. 8 September 2021
Indian drugmaker Hetero has announced that the Drug Controller General of India (DCGI) has issued for restricted use, Emergency Use Authorization (EUA) for the generic version of tocilizumab in India. 8 September 2021
Shares of USA-based biopharma Kadmon Holdings shot up nearly 74% to $9.21 pre-market today, after pharma major Sanofi revealed that it had reached agreement to acquire the company, which marks the fourth M&A deal for the French firm this year. 8 September 2021
Shares in Californian fibrosis specialist Pliant Therapeutics opened 14% higher on Tuesday, after the firm announced encouraging interim results from a Phase IIa trial. 8 September 2021
US drugmaker Amneal Pharmaceuticals has recently announced that its pipeline product IPX-203 (carbidopa + levodopa, (CD/LD)) achieved key primary and secondary endpoints in the pivotal Phase III RISE-PD clinical trial for patients with Parkinson’s disease (PD) who experience motor fluctuations. 8 September 2021
South Korea has recently decided to provide practical support to innovative pharmaceutical companies by revising the existing health insurance benefits system. 8 September 2021
The UK health technology assessor the National Institute of Health and Care Excellence (NICE) has reconsidered its previous decision for Erleada (apalutamide). 8 September 2021
Privately-held US early-stage gene therapy company NeuExcell Therapeutics and Spark Therapeutics, the gene therapy unit of Swiss pharma giant Roche Group, have entered a gene therapy collaboration aimed at developing a safe and effective treatment for patients suffering from Huntington's disease (HD). 8 September 2021
Netherlands-based AM-Pharma and Japan’s Kyowa Kirin have entered into an exclusive license agreement under which Kyowa Kirin gains the rights to develop and commercialize ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase. 8 September 2021
For many years, politicians, patients and drugmakers alike have warned about the risk posed by growing antimicrobial resistance, spurred on by liberal use of antibiotics in farming, and in general medical practice. 8 September 2021
British cell therapy specialist Adaptimmune Therapeutics has entered into a strategic collaboration and license agreement with Genentech, a member of the Roche group. 7 September 2021
Global Blood Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted for filing and review two submissions relating to Oxbryta (voxelotor). 7 September 2021
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today held a virtual press briefing with chief executives and top executives who are in the forefront of biopharmaceutical R&D for COVID-19. 7 September 2021
Sino-American company Brii Birosciences today announced that it is committing an additional $100 million to advance global regulatory filings and commercial efforts for its investigational SARS-CoV-2 (virus that causes COVID-19) combination therapy, BRII-196/BRII-198. 7 September 2021
US biotech BioMarin Pharmaceutical’s shares were down more than 10% at $76.25 pre-market today, after it announced on Sunday that the US Food and Drug Administration (FDA) placed a clinical hold on the BMN 307 Phearless Phase I/II study. 7 September 2021
A Scotland-based company that claims to be pioneering the future of modern medicine through microbiome-modulating therapeutics now has $21.5 million more to deliver on the promise. 7 September 2021
Medicines Australia, the leading trade group for the biotech and pharma industries in the country, has helped negotiate a five-year strategic plan with the national government. 7 September 2021
Blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by China’s National Medical Products Administration (NMPA) in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ). 7 September 2021
Lumevoq (lenadogene nolparvovec) has been granted Promising Innovative Medicine (PIM) designation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 7 September 2021
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024