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.
Biosimilars are compounds that have demonstrated no clinically meaningful differences in safety, purity and potency from a reference biologic drug. As of September 2022, 38 biosimilars have been approved for use within the USA. 29 September 2022
Adding to recent market authorizations in the European Union, Japan and the UK, South Korea-based Celltrion Healthcare says its biosimilar of a Roche (ROG: SIX) cancer drug has now gained approval in the USA, sending the firm’s share up 2.7% to 171,100 won. 29 September 2022
Spanish dermatology specialist Almirall and Simcere Pharmaceutical Group have signed an exclusive licensing agreement for the Chinese firm’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. 29 September 2022
Japanese drug major Sumitomo Pharma has filed an appeal with the US Court of Appeals for the Federal Circuit (CAFC) seeking revocation of the decision of the US Patent and Trademark Office (USPTO) relating to the proprietary atypical antipsychotic agent Latuda (lurasidone HCl tablets). 29 September 2022
Continuing its impressive rise, Dupixent (dupilumab) has secured US Food and Drug Administration approval for prurigo nodularis, a debilitating skin condition. 29 September 2022
Private equity firm SK Capital Partners has entered into a deal to acquire Apotex Pharmaceutical Holdings, a Canada-based generic drugmaker with products across all major therapeutic areas for patients around the world. 29 September 2022
Russia plans to accelerate the production of active pharmaceutical ingredients (APIs) for antibiotics, as well as to pay more attention to the development of drugs against chronic infections, as part of a new State Concept for the Development of Pharmaceutical industry in Russia that is designed until 2030, reports The Pharma Letter’s local correspondent. 29 September 2022
Increasing access to capital has resulted in a surge of Indian biopharmaceutical companies focusing on research and development. A think-tank has advised the government that it is imperative to streamline regulatory approval procedures for the biotechnology industry and eliminate redundant steps so as to expedite the approval process, reports The Pharma Letter’s India correspondent. 28 September 2022
Elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM) by US pharma giant Pfizer, has been granted an ‘Innovation Passport’ from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 28 September 2022
AstraZeneca has written to US healthcare professionals to notify them of the company’s volunatary withdrawal of an indication for Lynparza (olaparib). 28 September 2022
Drugmakers in Europe are arguing for a new economic model for reimbursement of antibiotics, paving the way for a breakthrough in the fight against antimicrobial resistance. 28 September 2022
Shares in Avidity Biosciences were down as much as 26% on the news that the US Food and Drug Administration (FDA) has placed a partial clinical hold on new participant enrollment in the Phase I/II MARINA clinical trial of AOC 1001 - an antibody-oligonucleotide conjugate (AOC) - in adults with myotonic dystrophy type 1 (DM1). 28 September 2022
The Russian Parliament (State Duma) has said it will consider establishing the priority of using domestic reference materials in the pharmaceutical industry. 28 September 2022
Japanese drugmaker Eisai’s shares gained more than 17% to 6,784 yen today, after it released top-line results from the Clarity AD Phase III clinical trial for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential treatment of early Alzheimer’s disease. 28 September 2022
Japan’s Ministry of Health, Labor and Welfare (MHLW )has granted approval of the manufacturing and marketing application for Berinert SC Injection 2000 submitted by CSL Behring KK, a subsidiary of Australia’s CSL Limited. 28 September 2022
Privately-held Arsenal Biosciences, a programmable cell therapy company engineering advanced CAR T therapies for solid tumors, has announced a multi-year collaboration with the Roche subsidiary Genentech. 27 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