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Pharmaceutical
UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024
Biotechnology
Germany’s Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024
Biotechnology
Colorado, USA-based OncoVerity announced the closing of a series A extension led by existing investors, argenX and RefinedScience. The value was not disclosed, but this extension follows a $30 million Series A fundraiser in March 2023. 22 November 2024
Biotechnology
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi (lecanemab) for the 2024 fiscal year (FY), which runs from April 2024 through March 2025. 11 November 2024
Biotechnology
Danish biotech Gubra announces that Germany’s Boehringer Ingelheim has decided to discontinue the development of the long-acting neuropeptide Y receptor type 2 (NPY2R) agonist BI 1820237 in obesity. 4 November 2024
Biotechnology
Japanese drugmaker Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (US brand name Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. 1 November 2024
Pharmaceutical
GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024
Pharmaceutical
Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
Pharmaceutical
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Pharmaceutical
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Pharmaceutical
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
Pharmaceutical
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
Biotechnology
Sirnaomics, a firm specializing in RNAi therapeutics, has entered into a subscription agreement with biotech specialist Poon Hung Fai. 4 October 2024
Biotechnology
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Biotechnology
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Pharmaceutical
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
article
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair. 19 September 2024
Pharmaceutical
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Biotechnology
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
Biosimilars
India’s largest biotech firm Biocon today announced that Shreehas Tambe, currently deputy chief executive of its Biocon Biologics (BBL) subsidiary, has been appointed as managing director of the company, with effect from December 5, 2022. Mr Tambe will lead BBL in realizing its goal of being a global biosimilars leader. 5 December 2022
Pharmaceutical
Additional data from the Phase III EMERALD study (NCT03778931) of elacestrant, an investigational oral selective estrogen receptor degrader (SERD), are being presented during the San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10. 5 December 2022
Biotechnology
US clinical-stage targeted oncology company Mirati Therapeutics saw its shares close up 5.2% at $96.25 on Friday, after it announced that, based on the results of an interim analysis on overall survival (OS), the registrational Phase III study evaluating sitravatinib in combination with nivolumab (Bristol Myers Squibb’s blockbuster drug Opdivo) in patients with second or third line non-squamous non-small cell lung cancer (NSQ-NSCLC) who have acquired resistance to prior therapy with chemotherapy and immune checkpoint inhibitor therapy (SAPPHIRE) will continue to the study's final analysis. 5 December 2022
Biotechnology
The Australian state of Queensland will become a global mRNA vaccine hub with French pharma major Sanofi partnering with the Palaszczuk government to establish a world-first research center in Brisbane. 5 December 2022
Biotechnology
Important regulatory news last week included US rare diseases specialist Sarepta Therapeutics last Monday revealing that the US Food and Drug Administration (FDA) has accepted for priority review its Duchenne muscular dystrophy (DMD) candidate SRP-9001. On the M&A front, UK pharma major AstraZeneca last Tuesday announced it is to acquire Dutch biotech firm Neogene Therapeutics to help accelerate its advance into oncology cell therapy. Also, Switzerland-based Roivant Sciences has established a new “Vant” company in partnership with Pfizer, to develop the US pharma giant’s ulcerative colitis and Crohn’s disease candidate RVT-3101. Clinical trial news included Eisai and Biogen last Wednesday releasing much awaited new data on their Alzheimer’s disease candidate lecanemab that attracted a lot of attention. 4 December 2022
Biotechnology
Having invented the concept, it is odd that China should have been so behind in making medicine for so long. That has changed: the Chinese pharmaceutical market is now the second biggest in the world, and for many years the Chinese state has been driving towards the enormous opportunities that a firmer grip on this drug development could bring, according to a report from McKinsey & Co. 3 December 2022
Biotechnology
US immunotherapeutic vaccines company Vaxxinity has announced positive Phase III topline data for its COVID-19 booster vaccine, UB-612. 2 December 2022
Biotechnology
Data has been cited by the US Food and Drug Administration (FDA) in support of its latest stance on bebtelovimab, Eli Lilly’s antibody treatment for COVID-19. 2 December 2022
Biotechnology
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for aumolertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). 2 December 2022
Biotechnology
Shares of UK-based biotech Immunocore Holdings edged up 2.2% to $61.29 pre-market, as the company announced a collaboration with Netherlands-based Gadeta on the first γδ ImmTAC for solid tumors, including colorectal cancer. 2 December 2022
Biotechnology
Unsurprisingly given a negative advisory committee vote a few weeks ago, the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine 131I-omburtamab in the treatment of CNS/leptomeningeal metastasis from neuroblastoma, submitted by US biotech Y-mAbs Therapeutics. 2 December 2022
Biotechnology
Franco-American pairing Valneva and Pfizer have reported new data on their Lyme disease vaccine candidate, VLA15. 2 December 2022
Biotechnology
It has been a week when Biogen and Eisai prompted fresh hope in Alzheimer’s by sharing full data on lecanemab, the successor to their failed drug Aduhelm (aducanumab). 2 December 2022
Biotechnology
A late comer to the PD-/PD-Li inhibitors sector, UK pharma major GSK has had a fair number of disappointments with its new cancer drugs. Just a few days ago, the company withdrew the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf). 2 December 2022
Pharmaceutical
Well ahead of expectations, on December 1, the US Food and Drug Administration (FDA) approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. 2 December 2022
Pharmaceutical
Today, the Pediatric Praziquantel Consortium announced that the European Medicines Agency (EMA) has validated for review the application for arpraziquantel for the treatment of schistosomiasis in preschool-aged children (three months to six years of age), submitted by its partner, German pharma and life sciences firm Merck KGaA. 2 December 2022
Biotechnology
Canada’s AbCellera and US biotech Rallybio Corporation have agreed a strategic alliance to discover, develop, and commercialize antibody-based therapeutics for rare diseases. 1 December 2022
Biotechnology
Switzerland-headquartered Roivant Sciences, a serial creator of new research-targeted start-ups, saw its share rise 7% to $5.74 by late-morning, after revealing a collaboration with US pharm giant Pfizer to establish a new “Vant” company. 1 December 2022
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of Japanese pharma major Astellas’ fezolinetant for the vasomotor symptoms (VMS) associated with menopause, finding the evidence for drug promising but inconclusive. 1 December 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved its first fecal microbiota product in the shape of Rebyota (fecal microbiota, live-jslm). 1 December 2022
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