In Brief
Refine Search
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved garadacimab (brand name Andembry) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks. 24 January 2025
Biotechnology
New York-based biotech Tiziana Life Sciences today announces its intention not to engage in a capital raising activities for the immediate future. 23 January 2025
Pharmaceutical
Privately-held US biopharma Bluejay Therapeutics has announced that its lead product candidate brelovitug—also known as BJT-778—has received US Food and Drug Administration Breakthrough Therapy designation for the treatment of chronic hepatitis D. 22 January 2025
Biotechnology
ReciBioPharm, a division of Sweden-headquartered contract development and manufacturing organization (CDMO) Recipharm, has been awarded a three-year grant from the Bill & Melinda Gates Foundation (Gates Foundation), to enhance RNA production technologies. 20 January 2025
Biotechnology
US biotech Sage Therapeutics on Friday sued Biogen, a week after the biotech giant made an unsolicited offer to acquire the smaller neuroscience company for about $469 million, according to a Bloomberg report. 18 January 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jeraygo (aprocitentan) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension). 17 January 2025
Biotechnology
Japanese drugmaker Eisai and US partner Biogen announced today that the US Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (US brand name Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. 14 January 2025
Biotechnology
China’s National Medical Products Administration (NMPA) has approved French Pharma major Sanofi’s Sarclisa (isatuximab), an anti-CD38 medicine, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. 13 January 2025
Pharmaceutical
The US Food and Drugs Administration (FDA) has confirmed that Center for Drug Evaluation and Research (CDER) director, Patrizia Cavazzoni, has announced her resignation ahead of Donald Trump’s inauguration on January 20, according to media reports. 11 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). 10 January 2025
Biotechnology
Netherlands-based Synaffix, a Lonza company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, today announced that it has licensed its ADC technology to Japan’s Mitsubishi Tanabe Pharma (MTPC). 9 January 2025
Biotechnology
Angelini Ventures, the investment arm of Angelini Industries, has co-led a 20 million euro ($21 million) series A funding round for Neumirna Therapeutics, an RNA-focused biotech established in 2020. 8 January 2025
Pharmaceutical
UK pharma major GSK today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy. 7 January 2025
Biotechnology
TJ Bio has reportedly submitted a biologics license application (BLA) to China’s Center for Drug Evaluation for GX-H9 (eftansomatropin alfa), a second-generation therapy for pediatric growth hormone deficiency. 31 December 2024
Biotechnology
The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD). 5 December 2024
Biotechnology
Japanese drugmaker Eisai today that the humanized antisoluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) has been launched in South Korea. 28 November 2024
Pharmaceutical
UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024
Biotechnology
Germany’s Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024
Biotechnology
Colorado, USA-based OncoVerity announced the closing of a series A extension led by existing investors, argenX and RefinedScience. The value was not disclosed, but this extension follows a $30 million Series A fundraiser in March 2023. 22 November 2024
Pharmaceutical
China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), from Innovent Biologics and Aosaikang Pharmaceuticals (ASK Pharm). 17 January 2025
Pharmaceutical
The US Food and Drug Administration has granted AstraZeneca’s Calquence (acalabrutinib) full approval as part of a combination therapy for mantle cell lymphoma (MCL). 17 January 2025
Pharmaceutical
Even as the global diabetes war continues to rage, Indian pharmaceutical companies are emerging from the shadows, armed with an arsenal of innovative drugs and therapies. 17 January 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today, approved Livdelzi (seladelpar), developed by CymaBay Therapeutics, in adults for the treatment of a liver illness called primary biliary cholangitis (PBC), including pruritus. It works by controlling liver problems in the body and making the liver less inflamed 16 January 2025
Pharmaceutical
The global market for neuromuscular disease therapeutics is projected to expand by $13.7 billion from 2025 to 2029, according to a report by Technavio. 16 January 2025
Pharmaceutical
French pharmaceutical company Servier and Google Cloud have announced an expanded five-year partnership aimed at leveraging artificial intelligence (AI) and generative AI to accelerate drug research and development. 16 January 2025
Pharmaceutical
The European Medicines Agency (EMA) today revealed that, in 2024, it recommended 114 medicines for marketing authorization. Of these, 46 had a new active substance which had never been authorized in the European Union (EU) before. 16 January 2025
Biotechnology
This executive interview, sponsored by BeiGene, is with Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene. 16 January 2025
Pharmaceutical
A collection of some of the largest US health systems, in collaboration with the Regeneron Genetics Center, have announced the launch of the Truveta Genome Project. 16 January 2025
Biotechnology
French pharma major Sanofi's participation at the JP Morgan Healthcare Conference was marked by a comprehensive overview of its position in 2024 and its strategic vision for the future. 16 January 2025
Pharmaceutical
Johnson & Johnson has started the submission of an original New Drug Application with the US Food and Drug Administration (FDA) for TAR-200. 16 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz), from US pharma major Eli Lilly, for the treatment of moderately to severely active Crohn's disease in adults. 16 January 2025
Pharmaceutical
Japanese firms Veneno Technologies and ASKA Pharmaceutical have entered into a joint research agreement to conduct a drug discovery program to obtain functional disulfide-rich peptides (DRPs) for ion channels selected by the companies. 16 January 2025
Pharmaceutical
The UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE) has issued positive Final Guidance that recommends Agamree (vamorolone) for use in the National Health Service (NHS) in England, Wales and Northern Ireland for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. 16 January 2025
Biotechnology
OS Therapies has reported positive data from a Phase IIb trial evaluating OST-HER2, a HER2-targeted immunotherapy. 16 January 2025
Biotechnology
Swedish immuno-oncology firm Alligator Bioscience saw its shares jump more than 13% to 0.26 kronor this morning, as it announced the positive outcome of regulatory interactions with the Paul Ehrlich Institute (PEI) of Germany and the US Food and Drug Administration (FDA) regarding the CMC development of mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. 16 January 2025
Pharmaceutical
UK clinical-stage specialty pharma firm Actimed Therapeutics has appointed Dr Fabio Dorigotti as chief medical officer (CMO) following the retirement of previous CMO, Dr Frank Misselwitz. 16 January 2025
Biosimilars
Formycon and its commercialization partner, fellow German firm Fresenius Kabi, have received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Otulfi (ustekinumab). 15 January 2025
Pharmaceutical
Cambridge, UK-based firm Owlstone Medical has raised $27 million in a series E funding round, led by Ventura Capital and supported by Aviva, Horizons, and others including the Gates Foundation. 15 January 2025
Pharmaceutical
Two companies have joined forces to investigate the potential for palbociclib, marketed by Pfizer as Ibrance, to be used as an Alzheimer’s disease drug. 15 January 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze