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
USA and Israel-based-BrainStorm Cell Therapeutics is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). 16 August 2022
As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022
Deerfield Management is to take a stake in Swiss firm ADC Therapeutics, an antibody-drug conjugate company based in Lausanne, as the company restructures its obligations. 16 August 2022
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022
During much of the last two years, due to the COVID-19 pandemic and the movement restrictions that were imposed, US Food and Drug Administration inspections of manufacturing facilities were seriously limited and resulted in a large number of delays in new drug approvals. 16 August 2022
Japanese pharma major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor andY Welfare (MHLW) for the osteoporosis treatment Edirol (eldecalcitol) Tablet (0.5µg/0.75µg). 16 August 2022
US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022
UK pharma major AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 16 August 2022
US clinical-stage biotech CinCor Pharma, which is developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases, yesterday announced the closing of its upsized underwritten public offering consisting of an aggregate of 8,625,000 shares of common stock and pre-funded warrants. 16 August 2022
Australia's Opthea, a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, has announced a non-dilutive financing transaction for up to $170 million. 15 August 2022
US biotech major Gilead Sciences’ shares were up 4% at $65.48 in early trading today, as it announced statistically-significant and clinically-meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. 15 August 2022
Chicago-based Aptinyx, a clinical-stage biopharmaceutical company developing therapies for the treatment of brain and nervous system disorders, has announced disappointing results from a Phase IIb study evaluating the effects of NYX-2925 in patients with fibromyalgia. 15 August 2022
US mRNA biotech Moderna edged up less than 1% pre-market this morning, despite announcing the first-ever approval worldwide for its next-generation bivalent COVID-19 vaccine. 15 August 2022
Swiss pharma giant Novartis has announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab, an inhibitor of interleukin-1beta did not meet its primary endpoint of disease-free survival versus placebo. 15 August 2022
An Expert View from Emer Leahy, chief executive, and Dani Brunner, chief innovation officer, of PsychoGenics, on the challenges involved in tackling mental disorders. 15 August 2022
UK-based subsidiary of Japanese ophthalmology firm Santen Pharmaceutical has announced the launch of Ducressa in the UK and Ireland, a fixed dose combination (FDC) of levofloxacin and dexamethasone for use after cataract surgery that also offers a modern and convenient seven-day therapeutic strategy to optimize post-surgery care. 15 August 2022
Terns Pharmaceuticals saw it shares fly up more than 25% to $3.02 on Friday, after it announced a $65 million underwritten public offering, which is expected to close on August 16, 2022, subject to customary closing conditions. 15 August 2022
Switzerland-headquartered biotech Addex Therapeutics today announced that its collaboration agreement with UK-based Indivior for discovering and developing novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates has been extended until March 31, 2023. 15 August 2022
Researchers at the USA’s Johns Hopkins Medicine say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. 15 August 2022
Investments in research and development continue to pay dividends for British drugmaker AstraZeneca, with the firm’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) passing an important test in breast cancer. 15 August 2022
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"IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics."