10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
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
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
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
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
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
Japanese drug major Astellas Pharma saw its shares gain 2.44% to 1,699 yen after it revealed it had entered into an exclusive, worldwide (excluding China) option and license agreement for US biotech Juventas Therapeutics’ lead product candidate, JVS-100. 22 November 2018
British cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) that recommends inclusion of Keytruda (pembrolizumab) in the Cancer Drugs Fund (CDF) in lung cancer. 22 November 2018
With current Gilead Sciences chief executive John Milligan standing down at the end of the year, the announcement on his successor is one of the most eagerly-awaited in biopharma at present. 21 November 2018
In the latest example of biotech belying the trade tensions between political leaders, Chinese and US investors have joined in the financing of an oncology-focused biopharma based in China. 21 November 2018
Santhera Pharmaceuticals has entered into an agreement with fellow Switzerland-based Idorsia under which Santhera will acquire the option to exclusively in-license, by way of sub-license, the first-in-class dissociative steroid vamorolone in all indications and all countries worldwide except Japan and South Korea. 21 November 2018
Weeks after a US Food and Drug Administration (FDA) panel overwhelmingly voted in support of the benefit-risk profile of Sage Therapeutics’ Zulresso (brexanolone) in postpartum depression (PPD), the agency has delayed a decision on whether to approve it. 21 November 2018
The US Food and Drug Administration has granted the Biological Product Designation for Israel-based biotech BioLineRx’ novel immunotherapy compound AGI-134. 21 November 2018
The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody, in an ultra-rare syndrome of hyperinflammation with high morbidity and mortality and for which there was previously no drug on the market. 20 November 2018
Dutch biotech uniQure, the company which failed with its attempts to market Glybera (alipogene tiparvovec), the world’s first approved gene therapy, could have consigned its troubles to the past through a successful rebuilding program. 20 November 2018
There was disappointment for Germany’s Merck KGaA and pharma giant Pfizer yesterday when they announced that their late-comer checkpoint inhibitor had failed in another Phase III trial, this one in ovarian cancer. 20 November 2018
Switzerland-headquartered Roivant Sciences and South Korea’s iNtRON Biotechnology have entered into a landmark global licensing agreement for SAL200, a novel investigational biologic for the treatment of infectious diseases caused by antibiotic-resistant staphylococci. 20 November 2018
As expected, following a positive recommendation from its advisory panel in September, the European Medicines Agency has granted approval for Emgality (galcanezumab), in the treatment of migraines. 19 November 2018
UK-based Mundipharma has agreed a deal worth up to $600 million to acquire exclusive Japanese rights for Invossa (TissueGene-C) with South Korean firm Kolon Life Science. 19 November 2018
The China National Medical Products Administration (NMPA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35kg). 19 November 2018
Sitravatinib, a drug from Californian cancer specialist Mirati Therapeutics, is to be tested as part of Cancer Research UK’s Stratified Medicine Programme. 19 November 2018
Admitting that its trial results are not strong enough, Roche has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab). 19 November 2018
Immunocore, a T Cell Receptor (TCR) biotech company, today announces it has entered into a new partnership with Genentech to expand an existing discovery collaboration that was signed in 2013. 19 November 2018
Influential cost-effectiveness watchdog ICER - the Institute for Clinical and Economic Review - has found that three therapies for the ultra-rare and potentially fatal disorder hereditary angioedema (HAE) are not cost-effective. 19 November 2018