23 September 2024 The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance.
USA-based Generate:Biomedicines (Generate) today announced a multi-target collaboration with Swiss pharm giant Novartis to discover and develop protein therapeutics across multiple disease areas. 24 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
BioAtla has granted an exclusive global license to Context Therapeutics for BA3362, a T cell-engaging antibody targeting solid tumors. 24 September 2024
Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study. 24 September 2024
Belgian drugmaker UCB and US biotech Biogen have announced positive top-line results from the Phase III PHOENYCS GO study evaluating dapirolizumab pegol, 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
Aptadir Therapeutics, a biotech company focused on RNA inhibitor-based therapies for cancer and genetic conditions, has launched with $1.6 million in pre-seed funding. 24 September 2024
Australian biotech company Telix Pharmaceuticals is to acquire USA-based RLS Radiopharmacies, expanding its manufacturing and distribution footprint in North America. 24 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
German privately-held biotech ARTCLINE Bio-Therapies today announced the appointment of Dirk Hessel as additional managing director of the company. 23 September 2024
Israeli drugmaker Teva Pharmaceuticals has announced new findings from research that could shape treatment strategies in schizophrenia and tardive dyskinesia (TD). 23 September 2024
The H5N1 virus, known for its 50% human case fatality rate, has persisted globally for over two decades, causing thousands of infections. 23 September 2024
With the US Generic Drug User Fee Amendments (GDUFA) reauthorized by Congress on September 30, 2022, known as GDUFA III, these provisions are in effect October 1, 2022, through September 30, 2027. 17 October 2022
Confirming that there are still plenty of investors ready to wager on attractive biotechnology prospects, France’s Mablink Biosciences today announced it has raised a 31 million-euro ($30 million) Series A funding round to advance its lead candidate to the clinic and to build a pipeline of antibody-drug conjugates (ADCs) using its proprietary platform technology. 14 October 2022
The European Medicines Agency (EMA) today announced recommendations made by its human medicines committee (CHMP) following its October 2022 meeting. 14 October 2022
US clinical-stage firm Reata Pharmaceuticals edged up 2.6% to $25.05 yesterday, when it puzzled investors with the news that the US Food and Drug Administration (FDA) has decided not to hold an advisory committee (AdCom) meeting in connection with its review of the company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. 14 October 2022
After just a year in the role of chief medical officer and head of global clinical development at Californian biotech BioMarin, Harold Bernstein has taken a new job elsewhere. 14 October 2022
US neurology company Otonomy saw its shares plunge nearly 54% to $0.12, a far cry from its height of more than $39 in mid-2015, after releasing disappointing data for its hearing loss candidate OTO-413. 14 October 2022
Troubled Boston, USA-based rare disease specialist Imara saw its shares rise 4.4% yesterday and a further 17% to $3.01 pre-market today, after a planned merger with fellow USA-based Enliven Therapeutics was revealed. 14 October 2022
New data from Pfizer and BioNTech’s Comirnaty program show the firms’ updated jab produces antibodies against the latest variants of the coronavirus. 14 October 2022
The Russian pharmaceutical sector is steadily developing despite the ongoing military conflict in Ukraine and the ever-tightening sanctions pressure against the country, according to recent statements by some leading local pharma analysts and Russian media, reports The Pharma Letter’s local correspondent. 14 October 2022
Russia has been faced with a shortage of Oncaspar (pegaspargase), a drug from French independent pharma major Servier, which is designed for the treatment of leukemia in children. 14 October 2022
A significant late stage trial win lifted GSK stock by around 1.5% in early morning trading on Friday, with the company hailing the result as “truly exceptional.” 14 October 2022
Late-stage US biotech Relmada Therapeutics’ shares sank 78% to $7.00 by mid-morning, after it revealed that its RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for major depressive disorder (MDD), did not achieve its primary endpoint. 13 October 2022
The migraine market has seen the introduction of a large number of highly effective monoclonal antibody (Mab) drugs for the prevention of the condition, leading to expectations for the overall therapy sector to grow from $4.7 billion in 2020 to $12 billion in 2030 across the seven major markets. 13 October 2022
Sino-American biotech BeiGene shot up on Wednesday, after the company's chronic lymphocytic leukemia (CLL) treatment was shown to beat out a blockbuster drug from Johnson & Johnson. 13 October 2022
Shares of US biotech Moderna leapt almost 12% to $134.96 yesterday, after it announced that pharma giant Merck & Co has opted to develop a personalized cancer vaccine based on messenger RNA technology. 13 October 2022
The US Food and Drug Administration yesterday said it has amended the emergency use authorizations (EUAs) for two COVID-19 vaccine, bivalent to authorize their use as a single booster dose in younger age groups. 13 October 2022
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Company Spotlight
"IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics."