9 October 2024 US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company.
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
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
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
The US Food and Drug has approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing. 27 November 2020
It has been a long and confusing week for investors and patients trying to work out what is going on with the COVID-19 vaccine being developed by the University of Oxford and Anglo-Swedish drugmaker AstraZeneca. 27 November 2020
Germany’s Merck KGaA has announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. 26 November 2020
Israel’s RedHill Biopharma yesterday announced partnerships with two leading, USA-based manufacturers for large-scale manufacturing of opaganib (trade name Yeliva). 26 November 2020
The US Food and Drug Administration has granted accelerated approval for Danyelza (naxitamab) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). 26 November 2020
The US Food and Drug Administration has completed its internal review of the Baseline-Controlled Study results of omaveloxolone for the treatment of patients with Friedreich’s ataxia (FA) and concluded that the results do not strengthen the results of Part 2 of the MOXIe study. 26 November 2020
British artificial intelligence specialist InstaDeep and German biotech firm BioNTech have deepened ties, embarking on a multi-year project to develop new technologies. 25 November 2020
Messenger RNA specialist Moderna has agreed to supply 80 million doses of its COVID-19 vaccine to the European Commission, with an option for a further 80 million. 25 November 2020
Privately-held Chinese company Gmax Biopharm has announced that the first patient has received its humanized monoclonal antibody, GMA301, as part of investigations around the drug’s efficacy for the treatment of pulmonary arterial hypertension (PAH). 24 November 2020
Danish biotech Genmab’s shares were down 2.9% to 2,210 Danish kroner by close of trading today, after it revealed that it will not advance the development of a cancer drug candidate. 24 November 2020
Roche subsidiary Genentech has successfully broadened the US label for Xofluza (baloxavir marboxil), to include treatment to prevent influenza after contact with an infected person. 24 November 2020
Swiss drug developer Idorsia has announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aneurysmal subarachnoid hemorrhage (aSAH). 24 November 2020
The US Food and Drug Administration has approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. 24 November 2020
German drugmaker Bayer has generally preferred in-licensing deals and other collaborations to multi-billion dollar acquisitions, so executives must have been highly impressed by what they saw of Asklepios BioPharmaceutical (AskBio) to spend $2 billion upfront on buying the US biotech, along with up to $2 billion more depending on certain milestones. 23 November 2020
UK-based rare diseases specialist Mereo BioPharma today announced the appointment of Dr Suba Krishnan as senior vice president of clinical development, effective December 7, 2020. 23 November 2020
Safe and effective vaccines for the novel coronavirus seem to be like buses: after a long, anxious period of waiting, finally three come along at once. 23 November 2020
Privately-held UK-based T cell receptor (TCR) specialist Immunocore has announced positive Phase III data from the IMCgp100-202 clinical trial of tebentafusp. 23 November 2020