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.
London-based cell therapy specialist Quell Therapeutics has kicked off a new collaboration with the Sheffield Institute for Translational Neuroscience (SITraN), an international center of excellence within the University of Sheffield. 26 October 2020
Moving at a slower pace than other regulators which have already approved resumption of the AZD1222 studies, the Food and Drug Administration on Friday authorized the restart in the USA, following the resumption of trials in other countries in recent weeks. 24 October 2020
US biopharma Ultragenyx Pharmaceutical and Solid Biosciences, a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, have announced a strategic collaboration and license agreement. 23 October 2020
Leverkusen-based Bayer has won a positive reimbursement decision in the UK for Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) in prostate cancer. 23 October 2020
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has reversed a draft rejection of Keytruda (pembrolizumab) and now recommends the monotherapy for the first-line treatment of adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). 23 October 2020
French biotech Nicox SA has announced a novel drug candidate, NCX 1728, which the ophthalmology specialist intends to take into the clinic. 23 October 2020
UK-based 4D pharma, which is leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome - and Longevity Acquisition Corp today announce the proposed merger of the two companies. 22 October 2020
Privately-held biotech HemoShear Therapeutics has kicked off a new research collaboration and service agreement with Japan's largest drugmaker Takeda Pharmaceutical. 22 October 2020
Danish biotech Genmab late Wednesday released positive top-line results from the second part of the Phase III CASSIOPEIA (MMY3006) study of cancer drug daratumumab monotherapy as maintenance treatment versus observation (no treatment) for patients with newly-diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT). 22 October 2020
US pharma major Bristol Myers Squibb’s blockbuster combination of Opdivo (nivolumab) and Yervoy (ipilimumab) is facing increasing scrutiny in various oncology indications as to whether the financial burden and clinical toxicity added by Yervoy is worth it. 22 October 2020
The Brazilian arm of AstraZeneca’s Phase III COVID-19 vaccine study will continue, notwithstanding the death of a participant, the country’s health authority Anvisa said on Wednesday. 22 October 2020
Ireland-based biotech Prothena saw its shares close up 6.1% at $11.95, after it announced that, based on positive signals of efficacy consistent with disease modification in the PASADENA study, Swiss pharma giant Roche and Prothena plan to advance prasinezumab into a Phase IIb study in patients with early Parkinson’s disease. 22 October 2020
Biogen saw its shares fall 2.36% to $260.82 by mid-morning after it presented financial results for the third quarter of 2020, showing that earnings missed analysts’ expectations. 21 October 2020
Antibiotics accelerator CARB-X is awarding up to $3.9 million to privately-held Cellics Therapeutics to develop a new treatment for sepsis caused by drug-resistant Gram-positive and Gram-negative bacteria. 21 October 2020
Evrysdi (risdiplam) has been approved in Brazil by the National Health Surveillance Agency (ANVISA) for the treatment of spinal muscular atrophy (SMA), the drug’s developer, PTC Therapeutics, said today. 21 October 2020
Japanese drug major Chugai Pharmaceutical has entered into a license agreement with Denmark’s Novo Nordisk, for global non-exclusive rights related to its antibody engineering technologies. 21 October 2020
As the healthcare industry continues to face financial strains brought on by the COVID-19 pandemic, the USA’s Medicaid programs need ways to reduce drug spend. 21 October 2020
US clinical-stage Aptinyx biotech said yesterday that it intends to offer and sell 12,000,000 shares of its common stock in an underwritten public offering. 21 October 2020
Australia’s CSL Limited is active in multiple therapeutic areas and across different scientific platforms, from immunology to respiratory and from plasma fractionation to egg-based vaccines. 20 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