10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Japanese drugmaker Taiho Pharmaceutical today announced it has obtained manufacturing and marketing approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for the oral heat shock protein (HSP) 90 inhibitor Jeselhy (pimitespib; development code: TAS-116), 40mg tablets for the indication of gastrointestinal stromal tumor (GIST) that has progressed after chemotherapy. 20 June 2022
A subsidiary of Japan-based Kyorin Holdings has signed a joint development and license agreement with cell-based medicine company CellGenTech over the latter firm’s genetically modified human adipocytes (GMAC) in Fabry disease. 20 June 2022
Nature Medicine has published final results from the Phase III SPR1NT trial of Zolgensma (onasemnogene abeparvovec) in spinal muscular atrophy (SMA). 20 June 2022
Swiss drugmaker Basilea Pharmaceutica has announced that the sales of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region, exceeded the threshold triggering the first sales milestone payment for this region of $1.25 million. 20 June 2022
In a filing with the US Securities and Exchange Commission, Clovis Oncology has revealed it will voluntarily withdraw part of the label for its PARP blocker Rubraca (rucaparib). 20 June 2022
UK clinical-stage Zura Bio Limited, founded in January this year, and JATT Acquisition Corp, a publicly-traded US special purpose acquisition company (SPAC) formed for the purpose of acquiring or merging with one or more businesses, have entered into a definitive business combination agreement. 20 June 2022
Over the years, cell therapy has become an essential treatment method for many incurable diseases, illnesses and injuries such as cancers, autoimmune diseases, spinal cord injuries, and neurological conditions. 20 June 2022
The continuous depreciation of the forint, the pandemic, and then the war in Ukraine has seriously endangered safe access to modern medicinal treatments, which is now exacerbated by the disproportionate and high special tax increase that may lead to unforeseen consequences, says the Hungarian pharma trade group Association of Innovative Pharmaceutical Manufacturers (AIPM). 20 June 2022
At its June 16, 2022, meeting in Amsterdam, the European Medicines Agency's (EMA) management board, among other items, heard an update about the implementation of the new EU regulation that reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. 20 June 2022
Among significant news last week, US biotech Alnylam Pharmaceutical on Monday revealed that the Food and Drug Administration has approved its rare disease drug Amvuttra (vutrisiran). Japan’s Shionogi entered into a landmark collaboration to expand global access to its antibiotic cefiderocol. Swiss pharma giant Roche last Wednesday released new data on its Alzheimer’s disease candidate crenezumab that once again proved a failure. Also, rumors surfaced on Friday that US biotech Seagen is in talks with US pharma giant Merck & Co about a possible acquisition of the company with which it already has research collaborations. 19 June 2022
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the case for approval of pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) resulted in a decisive negative vote of 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. 18 June 2022
As the COVID-19 pandemic has prompted multinational pharma corporations to adopt a ‘China Plus One’ strategy, Indian government officials are urging domestic players to take advantage of the opportunity to become a viable alternative to China. 18 June 2022
Market research firm Graphical Research has released an analysis indicating that the global biodefense market size is set to grow significantly through to 2028. 17 June 2022
Cardio-renal diseases specialist Renibus Therapeutics has announced positive interim data from its lead clinical candidate, RBT-1, from its randomized, placebo-controlled Phase II trial. 17 June 2022
US clinical-stage biotech Scholar Rock today announced new data from the Phase II TOPAZ trial extension period evaluating patient outcomes after 24-months of treatment, which support sustained and continued improvement with apitegromab (SRK-015) for non-ambulatory patients with Types 2 and 3 SMA receiving a spinal muscular atrophy (SMN) therapy. 17 June 2022
World Trade Organization (WTO) members unveiled a new package of trade accords late Thursday following a marathon negotiating session in Geneva, Switzerland, headlined by deals to create flexible intellectual property rules covering COVID-19 vaccines, as well as other trade issues such as global fishing subsidies. 17 June 2022
Switzerland-headquartered biotech Addex Therapeutics today announced that it has terminated the Phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson’s disease (PD-LID) due to the slow recruitment of patients. 17 June 2022
Shares in Akero Therapeutics ended the day up over a fifth on Thursday, after the firm announced a deal with Pfizer, including a $25 million equity investment. 17 June 2022
The US Food and Drug Administration (FDA) has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients aged six years and older with obesity due to Bardet-Biedl Syndrome (BBS). 17 June 2022
Pharma can boast a major role in improving the quality of life of patients with diseases such as breast cancer and rheumatoid arthritis in Latin America, writes The Pharma Letter’s local correspondent. 17 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