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.
Shares of Japanese drugmaker Astellas Pharma rose 2.2% to 1,965 yen yesterday, after it announced a research deal with Germany’s Pantherna Therapeutics, which aims to generate mRNA-based regenerative medicine programs using direct reprogramming (transdifferentiation). 5 October 2022
Japan’s largest drugmaker Takeda says that it will discontinue manufacturing its injectable parathyroid hormone Natpar/Natpara globally at the end of 2024 due to unresolved supply issues that are specific to the product. 5 October 2022
Privately-held US biotech company ImaginAb has had what it has describes as ‘a transformational year’ in an update on its achievements over the year. 4 October 2022
French pharma major Sanofi has entered into a collaboration and licensing agreement with little known US biotech miRecule, an innovator of next-generation RNA therapeutics. 4 October 2022
The US Department of Health and Human Services (HHS) said yesterday that it is implementing Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act to go into effect. 4 October 2022
The US Food and Drug Administration (FDA) has added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving the drug of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld, which is marketed by UK pharma major AstraZeneca. 4 October 2022
Melatonin, a natural hormone that is produced by the pineal gland and used by many long-haul airline travellers to mitigate their jet-lag symptoms, has gained its first approval in the UK, but as a treatment for sleep onset insomnia in children and adolescents aged six-17 years with attention-deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been inadequate. 4 October 2022
Positive top-line data for Clovis Oncology’s PARP blocker Rubraca (rucaparib) could help the firm compete with more successful options in this class, but the benefit appears limited. 4 October 2022
Japanese pharma major Shionogi gained 1% to 7,035 yen today, after it announced a voluntary license agreement for its oral COVID-19 antiviral candidate ensitrelvir fumaric acid (S-217622) with the United Nations-backed Medicines Patent Pool (MPP), which aims to increase access to life-saving medicines for low- and middle-income countries (LMICs). 4 October 2022
Urica Therapeutics, a Fortress Biotech company focused on the development and commercialization of products for gout and chronic kidney disease, has announced the appointments of Jay Kranzler as chairman and chief executive, and Vibeke Strand to its board of directors. 3 October 2022
Apellis Pharmaceuticals has again failed to impress investors as the company keeps its fingers crossed on a potential approval for pegcetacoplan, an investigational targeted C3 therapy. 3 October 2022
Shares of USA-based LogicBio Therapeutics leapt a staggering 641% to $2.02 in early trading today, as it revealed it is being acquired by Alexion, AstraZeneca’s rare disease business. 3 October 2022
Indian generics major Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market mirabegron extended-release tablets USP 25mg and 50mg. 3 October 2022
In a blog post, the leading trade group for the US pharmaceutical industry has slammed a recent report from the Initiative for Medicines, Access & Knowledge (I-MAK). 3 October 2022
Aiming to add to its vitiligo arsenal, US biopharma firm Incyte today announced that it has entered into an agreement to acquire Villaris Therapeutics, in a deal that could cost it as much as $1.4 billion. 3 October 2022
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
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024