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.
North Carolina, USA-based 9 Meters Biopharma saw its shares rise nearly 22% to $0.25, after it announced positive final results from the Phase II study of vurolenatide and the outcome from its End-of-Phase II meeting with the US Food and Drug Administration (FDA). 27 September 2022
Merck & Co has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW). 27 September 2022
Cambridge, USA-base immuno-oncology company DEM BioPharma has appointment of Nenad Grmusa as chief executive and Christophe Quéva, as chief scientific officer. 27 September 2022
KiOmed Pharma, a Belgian biotech developing medical devices based on a highly pure natural chitosan-derivative, has announced a deal with China’s Hansoh Pharmaceutical Group. 27 September 2022
In a busy day for the Japanese regulator, the Japanese Ministry of Health, Labor and Welfare (MHLW) has cleared three new medicines from European drugmakers for marketing in the country. 27 September 2022
China-based Contract Research Development and Manufacturing Organization (CRDMO) WuXi STA has opened its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. 27 September 2022
In what is the biggest ‘whistleblower’ settlement, US major Biogen has agreed to pay $900 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe its multiple sclerosis drugs. 27 September 2022
Hot on the heels of approval in Europe, the biologic Tezspire (tezepelumab) has won a regulatory nod from the British Medicines and Healthcare products Regulatory Agency (MHRA). 26 September 2022
US biotech Seagen has entered into exclusive license agreement with Dutch and US firm LAVA Therapeutics to develop and commercialize the latter’s LAVA-1223. 26 September 2022
There was a tepid market reaction to news that Japan’s Daiichi Sankyo had secured its first regulatory approval for Ezharmia (valemetostat tosilate), in a disease area where there is a severe lack of effective treatments. 26 September 2022
German companies Navigo Proteins and Mannin will work together on the development of a “Precision X” affinity ligand, using Navigo’s proprietary technology. 26 September 2022
Astellas Pharma saw its share gain 1.6% in early trading, though it later drifted back, as it revealed it has won a reprieve in its patent dispute with generics and biosimilar injectables specialist Hospira, albeit just short term. 26 September 2022
According to the trade association pharma.be, new latest figures demonstrate the important role that Belgium’s biopharmaceutical sector plays in the European Union. 26 September 2022
Australia’s National Medicines Policy (NMP) Review started in August 2021 but was paused until after the Federal Election to allow stakeholders more time to provide feedback. 26 September 2022
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
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 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
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 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
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 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
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 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
Some two-and-a-half years after buying the Novo Holdings portfolio company ReViral and its respiratory syncytial virus (RSV) candidate sisunatovir in a deal worth up to $525 million, US pharma giant Pfizer may have signalled an early end to the pricey project. 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. 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