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.
Top-line results from the Phase IIIb PONENTE study show that 62% of people with severe asthma were able to stop using oral corticosteroids (OCS) when treated with Fasenra (benralizumab). 29 October 2020
Japan’s largest drugmaker Takeda Pharmaceutical said today that it will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. 29 October 2020
Flagship Pioneering has announced the unveiling of Senda Biosciences, a therapeutics platform company leveraging insights into the molecular connections between humans and co-evolved non-human species. 29 October 2020
US clinical-stage biotech Scholar Rock skyrocketed 119% by close of trading Tuesday and was up a further 13.9% to $34.16 this morning, after it released stunning trial results on its lead investigational drug SRK-015 and announced a public offering of shares. 28 October 2020
Swiss firm Molecular Partners’ shares were up almost 30% at 19.92 Swiss francs by early afternoon, after it a collaboration with pharma giant Novartis in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin program, consisting of two therapeutic candidates, MP0420 and MP0423. 28 October 2020
COVID-19 vaccine developer Novavax has provided an update on the Phase III program for NVX-CoV2373, a stable, prefusion protein made using the firm’s nanoparticle technology. 28 October 2020
US biopharma firm Apellis Pharmaceuticals and Swedish Orphan Biovitrum (also known as Sobi) have announced a strategic collaboration to accelerate the advancement of systemic pegcetacoplan, a targeted C3 therapy, for the treatment of multiple rare diseases with high unmet need, impacting more than 275,000 patients globally. 28 October 2020
A further boost for antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has come in the form of Priority Review designation from the US regulator. 28 October 2020
US biotech Moderna today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started the rolling review process of mRNA-1273, the company’s vaccine candidate against COVID-19. 27 October 2020
Sweden-based biotech firm BioInvent International and USA-based CASI Pharmaceuticals today announced an exclusive licensing agreement for the development and commercialization of novel anti-FcγRIIB antibody, BI-1206, in mainland China, Taiwan, Hong Kong and Macau. 27 October 2020
Chinese biotech firm CStone Pharmaceuticals (HKEX: 2616) has signed an agreement to out-license ex-Greater China rights for two key late-stage immuno-oncology assets, sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1), to EQRx. 27 October 2020
Boston-based Catabasis Pharmaceuticals has announced that the Phase III PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet its primary endpoint. 27 October 2020
People involved in the ongoing Phase III program for AstraZeneca’s COVID-19 vaccine candidate say it produces a robust immune response in the elderly. 27 October 2020
Oncology specialist Spectrum Pharmaceuticals has announced that the US Food and Drug Administration (FDA) is deferring its action on the company’s Biologics License Application (BLA) for Rolontis (eflapegrastim). 26 October 2020
Israel’s BiondVax Pharmaceuticals has announced top-line data from the company’s pivotal, Phase III trial of M-001 as a standalone universal flu vaccine candidate. 26 October 2020
Canada-based biotech firm Medicago, a subsidiary of Mitsubishi Tanabe Pharma, has reached an agreement with the Canadian government to develop its COVID-19 candidate. 26 October 2020
Privately-held UK regenerative medicine company Rexgenero today announced that the Independent Data Monitoring Committee (IDMC) for its REX-001 Phase III clinical trial recently met to review patient safety and tolerability data from the initial 22 subjects. 26 October 2020
Germany’s largest drugmaker Bayer today revealed it is taking a hefty punt on expanding its cell and gene therapy portfolio, with the acquisition of privately-held US biotech Asklepios BioPharmaceutical (also known as AskBio). 26 October 2020
London-based cell therapy specialist Quell Therapeutics has kicked off a new collaboration with the Sheffield Institute for Translational Neuroscience (SITraN), an international center of excellence within the University of Sheffield. 26 October 2020
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
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024