10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Bavarian Nordic has announced that its respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in older adults has been granted PRIME eligibility by the European Medicines Agency (EMA). 28 June 2022
Japanese pharma major Astellas Pharma today announced a worldwide, strategic collaboration and licensing agreement with USA-based drug developer Sutro Biopharma, focused on the discovery and development of novel immunostimulatory antibody-drug conjugates (iADCs). 28 June 2022
In a filing with the US Securities and Exchange Commission (SEC), central nervous system specialist Axsome Therapeutics reveals proposed labeling has been received for its depression candidate AXS-05 (bupropion/dextromethorphan). 28 June 2022
The European Commission (EC) has approved Sanofi’s Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy to treat non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. 28 June 2022
The US Food and Drug Administration (FDA) has placed a partial clinical hold on US biotech firm Nuvation Bio’s Phase I dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. 28 June 2022
The European Commission (EC) has approved its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. 28 June 2022
Japanese drugmaker Ono Pharmaceutical and US biotech Fate Therapeutics have boosted their collaboration, adding the discovery of CAR-NK cell therapies to an existing agreement. 28 June 2022
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. 28 June 2022
Russia is reducing procurements of expensive Western original drugs for the treatment of HIV, switching to cheaper medicines, due to the lack of funds and the ever-growing number of patients with HIV in the country, reports The Pharma Letter’s local correspondent. 28 June 2022
The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder, from French pharma major Sanofi. 28 June 2022
Shares of Swiss biotech Basilea Pharmaceutica gained more than 3% to 38.45 francs yesterday, after it announced an update on the progress made in the implementation of its strategic focus on anti-infectives. 28 June 2022
Russia plans to begin a second stage of clinical trials of an innovative drug for the treatment of Parkinson's disease and which was developed by scientists from Novosibirsk and Tomsk. According to scientists, this is the world’s first drug that can stop the development of the disease. 28 June 2022
National Health Service England and Improvement (NHSE/I) has announced the launch of the Innovative Medicines Fund (IMF), aimed at providing earlier access to certain promising new drugs while additional evidence is generated about their use. 27 June 2022
The US Food and Drug Administration (FDA) has placed a clinical hold on the FORTIS PhI/II trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. 27 June 2022
With strong results from its SURPASS program for gastric inhibitory peptide/glucagon-like peptide-1 receptor (GIP/GLP-1) dual agonist Mounjaro (tirzepatide) for the treatment of type 2 diabetes (T2D), US pharma major Eli Lilly’s can expect Mounjaro to gain a significant share of the GLP-1 and wider T2D and obesity markets. 27 June 2022
Family-owned Italian drugmaker Menarini Group and USA-based Radius Health have announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer. 27 June 2022
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical brought some rare good news in a challenging disease as they announced positive results from a Phase III trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's-type dementia. 27 June 2022
Novartis presented new data at the European Academy of Neurology (EAN) Congress demonstrating treatment with Kesimpta (ofatumumab) significantly increased the odds of achieving no evidence of disease activity (NEDA-3, defined as having no MS relapses, no disability worsening and no MRI activity) versus switching from teriflunomide in people living with relapsing multiple sclerosis (RMS). 27 June 2022
Leading PARP blocker Lynparza (olaparib) looks set to secure a new marketing authorization in Europe, after a positive scientific opinion. 27 June 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