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.
Nuvaxovid, the COVID-19 vaccine developed by US vaccines specialist Novavax (Nasdaq: NVAX), has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. This extension has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). 26 August 2022
Celsius Therapeutics, a privately-held biotech developing precision medicines for cancer and autoimmune disease through single-cell RNA sequencing, has named Sarah Grant its chief medical officer (CMO). 26 August 2022
As China seeks to increase its population size, another priority is to combat diseases prevalent in its population, such as human epidermal growth factor receptor 2-negative/hormone receptor-positive breast cancer (HER2-/HR+ BC). 26 August 2022
Moving ahead in the race to develop a jab for respiratory syncytial virus (RSV), a market that analysts estimate will generate up to $10 billion of annual sales, yesterday US pharma giant Pfizer announced positive top-line data from the Phase III clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder. 26 August 2022
The accelerated approval pathway (AAP), which was first introduced by the US Food and Drug Administration (FDA) in 1992 to tackle the HIV epidemic, enables expedited development and approval of new therapies for serious diseases that lack efficient treatment options.1,2 26 August 2022
Texas, USA-based clinical-stage biopharma Savara says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation to molgramostim for the treatment of aPAP, a rare lung disease with no approved pharmaceutical treatments. 26 August 2022
Retinal disease specialist Apellis Pharmaceuticals drew positives from 24-month Phase III data for pegcetacoplan on Wednesday, while markets appear underwhelmed. 25 August 2022
As had long been expected, Novartis has announced plans to hive off its generics business, Sandoz, creating a new publicly-traded company. 25 August 2022
STADA Arzneimittel showed persistence in a challenging operating environment marked by macroeconomic and geopolitical uncertainties to report double-digit sales and earnings growth in the first half of 2022, the German drugmaker reported today. 25 August 2022
US biotech BioMarin Pharmaceutical yesterday announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to Roctavian (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). 25 August 2022
Universal Corporation, with support from MMV and Unitaid, has become the first African manufacturer to gain World Health Organization (WHO) prequalification of sulfadoxine-pyrimethamine (SP), a medicine used to prevent malaria in pregnant women and infants. 25 August 2022
Bharat Biotech has recently completed the Phase III trials of its COVID-19 intranasal vaccine BBV154 and submitted the data to the Drug Controller General of India (DCGI) for approval both as a primary two-dose vaccine, and a heterologous booster dose. However, the company has not yet made clinical trial results publicly available. 25 August 2022
Zelluna Immunotherapy, a Norwegian company developing allogeneic T Cell Receptor Natural Killer (TCR-NK) cells for the treatment of cancer, has announced an investment from Takeda Ventures. 25 August 2022
On August 24, the US Food and Drug Administration announced it has approved Pharmacyclics application for Imbruvica (ibrutinib) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. 25 August 2022
AstriVax, a start-up working to develop novel vaccines, has raised the largest amount of seed capital in the history of Belgium-based university KU Leuven spin-offs, totalling $30 million. 25 August 2022
UK pharma major AstraZeneca this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence. 25 August 2022
Competition for AstraZeneca’s Soliris (eculizumab) is stepping closer to the market, with developer Amgen, a Californian biotech giant, announcing positive trial results. 24 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