7 October 2024 India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative.
Vanflyta (quizartinib) has won US approval alongside standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for newly-diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. 21 July 2023
Privately-held Recludix Pharma has agreed a deal with French pharma major Sanofi to develop and commercialize oral small molecule STAT6 (signal transducer and activator of transcription 6) inhibitors for immunological and inflammatory (I&I) diseases. 21 July 2023
Vir Biotechnology saw its shares slump almost 45% to $12.70, a three year low, on the news that its flu prevention therapy study had failed. 21 July 2023
Polish clinical-stage biotech Molecure (WSE: MOC) revealed that it has successfully closed a secondary public offering (SPO) and entered into subscription agreements for all 2,776,000 H shares offered by way of private placement, within the authorized capital. 21 July 2023
Announcing a range of cost-cutting measures, the chief executive of Swiss biotech Idorsia has said it will take “longer than originally planned” for Quviviq (daridorexant) to become a commercial success. 21 July 2023
Following the success of the European Medicines Agency’s OPEN initiative in dealing with vaccines and treatments regulation during the height of the COVID19 pandemic, the EMA has now expanded the scope of the scheme to a wider range of medicines. 21 July 2023
The Indian government is to make 'Schedule M' compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing, to help in quality assurance and also reduce compliance burden in the pharmaceutical sector. 20 July 2023
Swiss vaccine company LimmaTech Biologics has in-licensed technology from GSK to continue development and commercialization of a quadrivalent shigellosis vaccine candidate. 20 July 2023
The US Federal Trade Commission and the Department of Justice have released a draft update of the Merger Guidelines, which describe and guide the agencies’ review of mergers and acquisitions to determine compliance with federal antitrust laws. 20 July 2023
Not surprisingly given the negative opinion from the European Medicines Agency’s (EMA) human medicines committee (CHMP), the European Commission has followed guidance and has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). 20 July 2023
US healthcare conglomerate Johnson & Johnson and Japanese drugmaker Astellas have joined a growing list of companies and groups that are suing the US government over its Medicare price-setting policies. 20 July 2023
Sandoz, the global generic and biosimilar medicines of Swiss pharma giant Novartis, today announced an investment of around $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026. 20 July 2023
New data from Merck & Co will help push its flagship immunotherapy Keytruda (pembrolizumab) into earlier lines of treatment in cervical cancer. 20 July 2023
The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of fruquintinib and sintilimab (a PD-1 antibody). 20 July 2023
Negotiations over the future of drug pricing in the UK are off to a rocky start, as the UK government seeks to sustain the high rebate rates in the current statutory regime. 20 July 2023
Boston, USA-based biotech start-up Jnana Therapeutics has appointed Dr George Vratsanos as its chief medical officer and head of research and development. 20 July 2023
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
A new analysis of clinical research into selinexor suggests it could be an effective maintenance therapy for certain people with endometrial cancer. 19 July 2023
With its recent US Food and Drug Administration (FDA) approval, Eli Lilly’s Ebglyss (lebrikizumab) adds a new competitor to the atopic dermatitis (AD) market. 8 October 2024
US antivirals specialist Gilead Sciences has released additional data from its pivotal Phase III PURPOSE 2 trial providing an overview of the efficacy and safety of twice-yearly lenacapavir. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Orchard Therapeutics has signed an exclusive distribution agreement with Turkish drugmaker Er-Kim, for the gene therapy Libmeldy (atidarsagene autotemcel). 7 October 2024
Cambridge, USA-based biotech Judo Bio has announced the company’s launch and $100 million in initial financing, including seed financing and Series A. 7 October 2024
Mosaic Therapeutics, a UK-based oncology therapeutics company dedicated to resolving cancer’s complexity to power new combination therapies for patients, has announced the appointment of Barry Davies as chief scientific officer. 7 October 2024
ABL Bio Corp on Friday revealed that it has entered into a clinical trial collaboration and supply agreement with MSD (the ex-US/Canada trading name of Merck & Co. 7 October 2024
AstraZeneca’s (Airsupra (albuterol/budesonide) has met the primary endpoint of a Phase III trial, showing a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol. 7 October 2024
AstraZeneca has entered into an exclusive license agreement with China’s CSPC Pharmaceutical to advance the development of an early stage, novel small molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia. 7 October 2024
BeiGene has launched Tevimbra (tislelizumab) in the USA for the treatment of certain adults with esophageal squamous cell carcinoma (ESCC), after chemo. 7 October 2024
Kezar Life Sciences has paused its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 7 October 2024
Johnson & Johnson revealed it is discontinuing the Phase II field study (NCT05201794) evaluating the efficacy of investigational antiviral candidate mosnodenvir. 7 October 2024
India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative. 7 October 2024
The Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry in Ireland, says it welcomes the allocation of 30 million euros ($32.9 million) for new medicines in Budget 2025. 7 October 2024