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.
Sacubitril-valsartan (trade name Entresto) has been proven to decrease hospitalization and reduce death due to heart failure with reduced ejection fraction (HFrEF) also known as systolic heart failure, according to a new study. 20 October 2020
Privately-held US biopharma company Synspira Therapeutics today announced that the Cystic Fibrosis Foundation has made equity and structured investments in the company of up to $14 million in additional funding. 20 October 2020
Aptinyx has announced positive results from the first Phase II study of its novel NMDA receptor modulator, NYX-783, in 153 patients with post-traumatic stress disorder (PTSD). 20 October 2020
The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of BioMarin Pharmaceutical’s Roctavian (valoctocogene roxaparvovec) and Roche’s Hemlibra (emicizumab) for the treatment of hemophilia A. 20 October 2020
ImmunoGen has announced an exclusive collaboration with Hangzhou Zhongmei Huadong Pharmaceutical to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan (Greater China). 20 October 2020
Contract development and manufacturing organization (CDMO) Akron Biotechnology has inked a deal with London-listed firm Synairgen, for the provision of SNG001. 19 October 2020
US cancer metabolism specialist Agios Pharmaceuticals late Friday announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. 19 October 2020
On Friday, Pfizer chairman and chief executive Albert Bourla issued an ‘open letter’ aiming to provide greater clarity around the development timelines for Pfizer and partner Germany’s BioNTech’s COVID-19 vaccine, known as BNT162b2, and when it might be submitted for review by the US Food and Drug Administration. 17 October 2020
US biotech major Gilead Sciences has announced findings from multiple studies in Asian population that evaluated the safety and efficacy of switching to once-daily, single tablet regimen, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) from baseline regimens. 16 October 2020
Chugai Pharmaceutical says it has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for risdiplam, an oral survival motor neuron-2 (SMN2) splicing modifier, for the treatment of spinal muscular atrophy (SMA). 16 October 2020
Belgium-based biotech Galapagos, along with partner French independent drugmaker Servier, reported that no signal of activity was observed in the top-line results in their ROCCELLA Phase II trial of GLPG1972/S20186. 16 October 2020
The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma (cHL). 15 October 2020
Health Canada has approved Luxturna (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. 15 October 2020
With the objective of expanding its R&D efforts in pain and neurodegeneration, US pharma major Eli Lilly today announced that it acquiring privately-held US biotech Disarm Therapeutics, which is creating a new class of disease-modifying therapeutics for patients with axonal degeneration. 15 October 2020
Japanese drugmaker Otsuka and its member company Astex Pharmaceuticals have announced top-line results of the ASTRAL-2 and ASTRAL-3 clinical studies. 15 October 2020
US biopharma Vertex Pharmaceuticals has announced that the Phase II study of VX-814 in alpha-1 antitrypsin deficiency has been discontinued based upon safety and pharmacokinetic data. 15 October 2020
On Wednesday, the US Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn; REGN-EB3), a mixture of three monoclonal antibodies, as the first FDA-cleared treatment for Zaire ebolavirus (Ebola virus) infection. 15 October 2020
The European Medicines Agency has confirmed that mRNA-1273, a vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure, said the vaccine’s developer. 14 October 2020
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
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 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
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024