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.
Japanese pharma major Shionogi today announced that ensitrelvir fumaric acid (S-217622), Shionogi’s orally administered antiviral drug for COVID-19 (caused by infection with the novel coronavirus [SARS-CoV-2]), shows high in vitro antiviral activity against the Omicron subvariant (BA.2.75), with antiviral potency in pre-clinical testing similar to its potency against other existing variants. 10 August 2022
Belgian cell therapy company Bone Therapeutics is to acquire a majority stake in Medsenic, a privately-held French biopharma specializing in the development of optimized formulations of arsenic salts and their application in inflammatory conditions and other indications. 10 August 2022
The European Commission (EC) and US biotech Moderna have reached an agreement to address the demand for COVID-19 vaccines for the late summer and winter period. 10 August 2022
US Health and Human Services (HHS) Secretary Xavier Becerra yesterday took action that will allow the US Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines, following the August 4 declaration of a public health emergency for monkeypox. 10 August 2022
US biotech Novavax, which is dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has announced its financial results for the second quarter ended June 30, 2022. 10 August 2022
California, USA-based Appia Bio, a pre-clinical-stage biotechnology company today announced that Jason Damiano has been appointed as its chief scientific officer. 10 August 2022
Catalent announced that it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in Greenville, North Carolina, USA. 10 August 2022
Miami-based Veru has presented Phase III results on sabizabulin in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) at the International Conference on Emerging Infectious Diseases. 9 August 2022
Cerevance, a British clinical-stage biotech working on new medicines for brain disorders, has inked a deal with Merck & Co, focused on Alzheimer’s disease. 9 August 2022
SIGA Technologies’ shares were up 6.8% at $23.67 mid-morning today, as it announced the exercise of procurement options under its 19C contract with the US Department of Health and Human Services for the delivery to the US government of intravenous (IV) formulation of TPOXX treatment courses valued at around $26 million. 9 August 2022
Late-breaking post-hoc exploratory results from the POSEIDON Phase III trial suggest a trend for improved overall survival (OS) with a limited course of five cycles of tremelimumab added to AstraZeneca’s Imfinzi (durvalumab) plus platinum chemotherapy, in the first-line treatment of patients with STK11, KEAP1 or KRAS-mutated Stage IV (metastatic) non-small cell lung cancer (mNSCLC). 9 August 2022
A trial testing the use of cyclosporine in the treatment of COVID-19 has been stopped after independent data monitors decided it would likely fail. 9 August 2022
UK-based Verona Pharma pleased investors today, as it announced positive results from its Phase III ENHANCE-2 trial of ensifentrine for the treatment of chronic obstructive pulmonary disease (COPD), news of which sent the firm’s shares up more than 100% to $13.93 in pre-market trading. 9 August 2022
Chinese biotech BeiGene has announced that the global Phase III RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior overall survival (OS) versus sorafenib as a first-line treatment in adults with unresectable hepatocellular carcinoma (HCC). 9 August 2022
US clinical-stage biotech Mersana Therapeutics saw its shares trading up 14.1% at $5.99 pre-market this morning, after it announced a global collaboration that provides UK pharma major GSK with an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2. 9 August 2022
French drugmaker Sanofi has paused recruitment for its global tolebrutinib Phase III trials following guidance from the independent data monitoring committee (iDMC), resulting in an almost 2% drop in its share price. 9 August 2022
Japanese drug major Chugai Pharmaceutical announced that, along with majority owner Roche and its biotech subsidiary Genentech (collectively “the companies”) have entered into a settlement agreement with Fresenius Kabi USA, on August 5, 2022 relating to the patent lawsuit filed by the companies on March 19, 2020. 9 August 2022
The outlook for a much-anticipated innovative treatment for Huntington’s disease has been muddied by a surprise serious side effect in a Phase I/II trial. 9 August 2022
German biotech company BioNTech was trading more than 10% lower on Monday afternoon in New York after announcing its latest financial results. 8 August 2022
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
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 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
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 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
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