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.
US biotech Moderna says that medicines regulator Health Canada has authorized its vaccine against COVID-19, mRNA-1273, for the immunization of people 18 years of age and older under an Interim Order. 24 December 2020
US pharma giant Merck & Co has entered into an agreement with the US Department of the Health and Human Services (HHS) and the Department of Defense (DoD) to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) on approval or Emergency Use Authorization (EUA) from the US Food and Drug Administration. 23 December 2020
US pharma giant Pfizer and German partner BioNTech have signed a second deal with the US government to supply an additional 100 million doses of BNT162b2, their COVID-19 vaccine, from production facilities in the USA. 23 December 2020
Privately-held US biotech Skyhawk Therapeutics and Vertex Pharmaceuticals have signed a strategic research collaboration and licensing agreement aimed at the discovery and development of novel small molecules that modulate RNA splicing for the treatment of serious diseases. 23 December 2020
The European Commission has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection for the treatment of early and metastatic HER2-positive breast cancer. 23 December 2020
company Regenxbio has entered into an agreement to sell a portion of the royalty rights due to the company from Novartis Gene Therapies (formerly AveXis) from the net sales of Zolgensma (onasemnogene abeparvovec-xioi) to entities managed by Healthcare Royalty Management (HCR) for a gross purchase price of $200 million. 23 December 2020
US biotech Rhythm Pharmaceuticals today reported top-line results from its pivotal Phase III clinical trial evaluating setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of insatiable hunger and severe obesity in individuals with Bardet-Biedl syndrome (BBS) or Alström syndrome, two ultra-rare genetic diseases that often manifest with these symptoms. 22 December 2020
Sosei Group and Captor Therapeutics are kicking off a collaboration to discover and develop drugs focused on G protein-coupled receptors (GPCRs). 22 December 2020
Shares of the Cambridge, Mass, U SA-based Agios Pharmaceuticals closed up more than 28% at $42.62 yesterday, in reaction to the news that it is selling its oncology business, aiming to focus on genetically-defined diseases. 22 December 2020
Netherlands-based gene therapy company uniQure saw its shares down 15.7% at $38.75 around midday in New York trading today, after it announced that its hemophilia B gene therapy program, including the pivotal, Phase III HOPE-B study, has been placed on clinical hold by the US Food and Drug Administration. 21 December 2020
UK drugmaker GlaxoSmithKline has inked two early pipeline deals in neurology and immunology, boosting its investment in genetically validated treatments. 21 December 2020
A Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial. 21 December 2020
The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer and BioNTech’s vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age. 21 December 2020
Swiss pharma giant Roche has announced positive top-line results from two identically designed global Phase III studies, testing the novel biologic faricimab. 21 December 2020
The US Food and Drug Administration on Friday issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. 21 December 2020
US biotech major Biogen has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using charitable foundations as a conduit to pay the co-pays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex (interferon beta 1a) and Tysabri (natalizumab), according to the US Justice Department. 19 December 2020
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
UK-based Mestag Therapeutics has entered into a license and collaboration agreement with Merck & Co to explore new therapeutic options for inflammatory diseases. 8 October 2024
With its recent US Food and Drug Administration (FDA) approval, Eli Lilly’s Ebglyss (lebrikizumab) adds a new competitor to the atopic dermatitis (AD) market. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Orchard Therapeutics has signed an exclusive distribution agreement with Turkish drugmaker Er-Kim, for the gene therapy Libmeldy (atidarsagene autotemcel). 7 October 2024
Cambridge, USA-based biotech Judo Bio has announced the company’s launch and $100 million in initial financing, including seed financing and Series A. 7 October 2024