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
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
US biotech major Gilead Sciences’ Japanese subsidiary and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). 24 December 2019
Sarepta has signed a licensing agreement providing Swiss pharma giant Roche with exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the USA. 23 December 2019
With yet another earlier-than-expected US regulatory approval, on Friday, the US Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 23 December 2019
Danish dermatology specialist LEO Pharma recently announced that its anti-interleukin-13 (IL-13) biologic therapy tralokinumab, which is in development for the treatment of moderate-to-severe atopic dermatitis, met all its primary and secondary endpoints across three pivotal Phase III studies as part of the company’s ECZTRA trial series. 23 December 2019
The Chinese National Medical Products Administration (NMPA) has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. 21 December 2019
In a second licensing deal signed by the Japanese pharma major this week, Takeda Pharmaceuticals has entered into a billion-dollar deal with privately-held Canadian biotech Turnstone Biologics to develop multiple products from its proprietary vaccinia virus platform targeting a broad range of cancer indications. 20 December 2019
Announcing its first commercial deal, US biotech start-up Rheos Medicines yesterday said that it has entered into a worldwide exclusive collaboration, option and license agreement with Swiss pharma giant Roche to discover, develop and commercialize novel therapeutics in the field of immunometabolism. 20 December 2019
US RNA-targeted drug developer Ionis Pharmaceuticals yesterday revealed that Biogen, a collaboration partner for neurological diseases, has licensed IONIS-MAPTRx, an antisense therapy designed to selectively reduce production of microtubule-associated protein tau (MAPT), or tau, in the central nervous system. 20 December 2019
A more personalized series of options are emerging to treat human epidermal growth factor receptor 2 negative (HER2) hormone receptor positive (HR+) breast cancer, according to GlobalData. 19 December 2019
Oxford Biomedica today announced an extension to its commercial supply agreement with Novartis for the manufacture of lentiviral vectors for the Swiss pharma giant’s CAR-T portfolio including five lentiviral vectors for CAR-T products 19 December 2019
East Coast, USA-based cancer specialist Epizyme has scored a unanimous vote in favor of its candidate tazemetostat, from the US regulator's cancer advisory panel. 19 December 2019
Minerva Neurosciences yesterday announced disappointing Phase IIb trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder (MDD) and presenting with symptoms of anxious distress failed to meet its primary and key secondary endpoints. 19 December 2019
The US Food and Drug Administration has accepted US pharm giant Pfizer’s supplemental New Drug Application (sNDA) for Braftovi (encorafenib), in combination with Erbitux (cetuximab; Braftovi Doublet) based on the results from the Phase III BEACON CRC trial. 19 December 2019
European Commission has granted approval for Rinvoq (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). 19 December 2019
The US Food and Drug Administration’s (FDA) Janet Woodcock has delivered a statement on the impact of the agency’s proposals on bringing low-cost biosimilar and interchangeable protein products to market. 18 December 2019
Keytruda (pembrolizumab) looks set to become the first in its class to win approval for a hard-to-treat kind of bladder cancer, following a positive vote from the US regulator’s cancer advisory panel. 18 December 2019
Californian company Adamas Pharmaceuticals closed 43% down after Tuesday’s trading, despite the firm announcing that a Phase III trial had met its primary endpoint. 18 December 2019