Latest Pharma and Biotech News
Pharmaceutical
12 November 2024 While not everything appears rosy in one of AstraZeneca’s major markets, the company has announced a huge investment in another.
Today's issue
Refine Search
Pharmaceutical
Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. 12 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, US vaccines developer Novavax revealed yesterday. 12 November 2024
Biotechnology
Danish life sciences investor Novo Holdings is continuing the spread of its cash pile, this time as co-leader of a $181.4 million Series D financing in Alentis Therapeutics. 12 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Biotechnology
Norwegian clinical-stage biotech Nykode Therapeutics revealed that it has received notification from Genentech, a US subsidiary of Roche, of its decision to terminate the collaboration and licensing agreement for Nykode’s VB10.NEO cancer vaccine program. 12 November 2024
Pharmaceutical
While not everything appears rosy in one of AstraZeneca’s major markets, the company has announced a huge investment in another. 12 November 2024
Pharmaceutical
Merck KGaA today announced that the Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate (ORR) in patients with tenosynovial giant cell tumor (TGCT). The ORR for pimicotinib at week 25 was 54.0% compared with 3.2% for placebo (p<0.0001). 12 November 2024
Pharmaceutical
AstraZeneca and Merck & Co announced that their jointly developed drug Koselugo (selumetinib) has shown positive outcomes in the KOMET Phase III trial. 12 November 2024
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca beat analyst expectations with its third-quarter 2024 revenue and earnings figures. 12 November 2024
Pharmaceutical
Germany’s Bayer saw its shares tumble almost 11% to 21.76 euros this morning, as it reported level third-quarter 2024 sales while earnings declined. 12 November 2024
Pharmaceutical
Twelve leading health economists have published a paper in the Forum for Health Economics and Policy that challenges the drug pricing math used by groups like the Institute for Clinical and Economic Review (ICER). 12 November 2024
Biotechnology
French biotech DiogenX, which is focused on regenerating insulin-producing beta cells for the treatment of diabetes, today announces the appointment of Dr Klara Owen as chief medical officer. 12 November 2024
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
23andMe, a human genetics firm and consumer health innovator, has announced a major restructuring, cutting approximately 40% of its workforce. 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Biotechnology
Rubedo Life Sciences, a US biopharma developing first-in-class therapies targeting senescent cells which drive age-related diseases, has announced the appointment of Frederick C Beddingfield III, as chief executive officer and board director. 11 November 2024
Biotechnology
The combination of Merck & Co’s Keytruda (pembrolizumab) and Citius Pharmaceuticals’ Lymphir (denileukin diftitox-cxdl) showed promising preliminary results in an investigator-initiated Phase I clinical trial for cancer patients with recurrent solid tumors. 11 November 2024
article
US company IDEAYA Biosciences has exercised the option for an exclusive worldwide license for Biocytogen Pharmaceuticals’ B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate. 11 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
All news
Pharmaceutical
Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. 12 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, US vaccines developer Novavax revealed yesterday. 12 November 2024
Biotechnology
Danish life sciences investor Novo Holdings is continuing the spread of its cash pile, this time as co-leader of a $181.4 million Series D financing in Alentis Therapeutics. 12 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Biotechnology
Norwegian clinical-stage biotech Nykode Therapeutics revealed that it has received notification from Genentech, a US subsidiary of Roche, of its decision to terminate the collaboration and licensing agreement for Nykode’s VB10.NEO cancer vaccine program. 12 November 2024
Pharmaceutical
While not everything appears rosy in one of AstraZeneca’s major markets, the company has announced a huge investment in another. 12 November 2024
Pharmaceutical
Merck KGaA today announced that the Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate (ORR) in patients with tenosynovial giant cell tumor (TGCT). The ORR for pimicotinib at week 25 was 54.0% compared with 3.2% for placebo (p<0.0001). 12 November 2024
Pharmaceutical
AstraZeneca and Merck & Co announced that their jointly developed drug Koselugo (selumetinib) has shown positive outcomes in the KOMET Phase III trial. 12 November 2024
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca beat analyst expectations with its third-quarter 2024 revenue and earnings figures. 12 November 2024
Pharmaceutical
Germany’s Bayer saw its shares tumble almost 11% to 21.76 euros this morning, as it reported level third-quarter 2024 sales while earnings declined. 12 November 2024
Pharmaceutical
Twelve leading health economists have published a paper in the Forum for Health Economics and Policy that challenges the drug pricing math used by groups like the Institute for Clinical and Economic Review (ICER). 12 November 2024
Biotechnology
French biotech DiogenX, which is focused on regenerating insulin-producing beta cells for the treatment of diabetes, today announces the appointment of Dr Klara Owen as chief medical officer. 12 November 2024
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
23andMe, a human genetics firm and consumer health innovator, has announced a major restructuring, cutting approximately 40% of its workforce. 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Biotechnology
Rubedo Life Sciences, a US biopharma developing first-in-class therapies targeting senescent cells which drive age-related diseases, has announced the appointment of Frederick C Beddingfield III, as chief executive officer and board director. 11 November 2024
Biotechnology
The combination of Merck & Co’s Keytruda (pembrolizumab) and Citius Pharmaceuticals’ Lymphir (denileukin diftitox-cxdl) showed promising preliminary results in an investigator-initiated Phase I clinical trial for cancer patients with recurrent solid tumors. 11 November 2024
article
US company IDEAYA Biosciences has exercised the option for an exclusive worldwide license for Biocytogen Pharmaceuticals’ B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate. 11 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze