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.
PsiOxus, a clinical-stage biotechnology company developing a novel platform technology for the targeted delivery of therapeutic transgenes to solid tumors, has announced the appointment of its new chief executive, Howard Davis. 12 August 2022
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche's Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. 12 August 2022
USA-based Amneal Pharmaceuticals has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for four generics products. 12 August 2022
The US Food and Drug Administration (FDA) has granted regular approval to Swiss pharma giant Novartis’ Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. 12 August 2022
Amid the ongoing military conflict between Ukraine and Russia and the ever-tightening sanctions pressure on Russia, the Kremlin is considering investing about 200 billion roubles ($12.1 billion) in the achievement of so-called medicine and pharmaceutical sovereignty. 12 August 2022
French specialty vaccine company Valneva, a late-comer in the race to develop coronavirus vaccines, announced it has suspended manufacturing of VLA2001 and is exploring strategic options. 12 August 2022
Russian drugmaker Biocad is eyeing becoming the largest supplier of oncology drugs for state needs, achieving this by producing analogues of some popular drugs for the treatment of cancer. 11 August 2022
The US Food and Drug Administration is not ready to let French microbiome specialist MaaT Pharma continue work on its acute graft-versus-host disease (aGvHD) candidate. 11 August 2022
Florida, USA-based firm Fortress Biotech has been awarded a $20 million grant to help develop its cytomegalovirus (CMV) vaccine Triplex. 11 August 2022
Belgo-Dutch autoimmune diseases specialist argenx has announced that the European Commission (EC) has approved Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 11 August 2022
Dutch rare diseases biotech firm ProQR Therapeutics today provided an update on its ophthalmology programs following feedback from the European Medicines Agency (EMA) related to sepofarsen and will now focus exclusively on its Axiomer RNA-editing technology platform. 11 August 2022
Shares of US biopharma company VYNE Therapeutics closed down 22.9% at $0.31 yesterday, having plunged as much as 35%, after it revealed results from the Phase IIa segment of a Phase Ib/IIa clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) that failed to hit its goal. 11 August 2022
Danish allergy immunotherapy specialist ALK Abello saw its shares rise 8.7% to 153.80 kroner by mid-morning today, as it reported strong financial results for the second quarter of 2022. 11 August 2022
Indian drugmaker Strides Pharma Science today announced that its formulation facility at Singapore underwent a US Food and Drug Administration (FDA) inspection that ended on August 8, 2022. 11 August 2022
Positive top-line results from a Phase III trial of the first CAR T-cell therapy in multiple myeloma have been presented by developers Bristol Myers Squibb and 2seventy bio. 10 August 2022
Gemini Therapeutics and privately-held clinical-stage Disc Medicine today announced a merger agreement to create a NASDAQ-listed, clinical stage biopharma focused on advancing Disc’s pipeline of hematology programs. 10 August 2022
Boston, USA-based engineered regulatory T cells (Tregs) company GentiBio has entered into a collaboration with US pharma major Bristol Myers Squibb to develop new engineered Treg therapies to re-establish immune tolerance and repair tissue in patients living with inflammatory bowel diseases (IBD). 10 August 2022
Efforts on the part of Swiss pharma giant Roche to take on AstraZeneca in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) advanced a step this week. 10 August 2022
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
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 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
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 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
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