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.
A drug candidate that Japan’s largest drugmaker Takeda Pharmaceutical pretty much decided to discontinue back in 2015, has now been out-licensed in a deal that could earn the firm nearly $300 million should it prove successful, albeit with a modest upfront payment. 21 September 2022
Drug pricing policy changes in the USA were signed into law as part of the Inflation Reduction Act last month in one of the most impactful acts of the Biden administration so far. 21 September 2022
Aiming to delve further into the use of poly ADP-ribose polymerase inhibitor, German life sciences major Merck KGaA has linked up with a leading Italian oncology discovery organization. 21 September 2022
Shares in US biopharma Spectrum Pharmaceuticals dropped by a massive 37% on Tuesday while those in Swedish biotech Oncopeptides closed 25% lower. 21 September 2022
Nine months after gaining its first approval in the USA, AstraZeneca’s Tezspire (tezepelumab) has now been approved in the European Union (EU). 21 September 2022
More clinical setbacks for the systemic vasodilator treprostinil have forced United Therapeutics to stop a late-stage trial, sending shares down 5% on Tuesday. 21 September 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final appraisal document (FAD) recommending Brukinsa (zanubrutinib). 21 September 2022
Driven by the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies among other pioneering pipeline therapies, the diabetic macular edema market is expected to more than double over the next decade. 21 September 2022
The US Court of Appeals for the Federal Circuit (CAFC) has denied its petition to rehear the negative decision regarding the validity of US Patent No 9,187,405, covering a dosing regimen for 0.5mg of its blockbuster multiple sclerosis drug Gilenya (fingolimod), Swiss pharma giant Novartis announced this morning. 21 September 2022
Extending a previous accord with the US pharma giant, Israel-based CytoReason has now signed a new partnership with Pfizer to use CytoReason’s artificial intelligence technology for Pfizer’s drug development programs for a further five years. 20 September 2022
Belgium’s NeuVasQ Biotechnologies, a Université Libre de Bruxelles (ULB) spin-off developing pharmaceuticals to restore blood-brain barrier function, has named Emmanuel Lacroix chief executive and company director. 20 September 2022
The European Commission (EC) has granted marketing authorization for Nulibry (fosdenopterin) for Injection as the first therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. 20 September 2022
Sage Therapeutics closed up 3.8% at $42.14 on Tuesday after, along with partner Biogen, it announced new analyses from across the development program for zuranolone. 20 September 2022
German biotech Evotec has been awarded a contract valued at up to $49.9 million by the US Department of Defense (DOD) for the rapid development of monoclonal antibody (MAb)-based drug product prototypes targeting plague. 20 September 2022
ViroCell Biologics, a UK contract development and manufacturing organization (CDMO), has announced the appointment of Susan Nichols to its senior management team as chief business officer (CBO). 20 September 2022
Less than two months after Theravance Biopharma sold off rights to its share of royalties from parts of GSK’s respiratory franchise, the company announced an agreement to buy back equity from the British drugmaker. 20 September 2022
In an effort to bring clarity to the use of biosimilars in Europe, health authorities have issued a statement confirming their interchangeability with reference medicines. 20 September 2022
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
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
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 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
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 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
Some two-and-a-half years after buying the Novo Holdings portfolio company ReViral and its respiratory syncytial virus (RSV) candidate sisunatovir in a deal worth up to $525 million, US pharma giant Pfizer may have signalled an early end to the pricey project. 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. 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