Latest Pharma and Biotech News
Pharmaceutical
23 December 2024 New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review.
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Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene. 27 December 2024
Biotechnology
Privately-held immunotherapy company Inmagene Biopharmaceuticals is taking over Ikena Oncology in a reverse merger deal, forming a new company, InmageneBio. 27 December 2024
Biotechnology
California’s AusperBio Therapeutics has secured $73 million in series B financing to propel its lead candidate, AHB-137, an antisense oligonucleotide therapy. 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Biotechnology
Mumbai, India-based Mankind Pharma has entered into a partnership with China’s Innovent Biologics for exclusively licensing and commercializing of sintilimab, an immunotherapy for cancer treatment in India. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 2024
Biotechnology
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
Biotechnology
French specialty vaccine company Valneva has entered into an exclusive license agreement for its single-shot chikungunya vaccine that enables supply of the vaccine in Asia with Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses. 24 December 2024
Generics
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
Pharmaceutical
Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024
Biotechnology
US pharma major Bristol Myers Squibb has announced positive results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 24 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Biotechnology
USA-based immunology company RAPT Therapeutics has entered into an exclusive license agreement with Shanghai Jemincare Pharmaceutical for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. 24 December 2024
Pharmaceutical
USA-based clinical-stage biopharma Traws Pharma saw its shares leap more than 150% to $12.57 as it announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. 24 December 2024
Biotechnology
Japanese drugmaker Shionogi has announced that it will acquire full ownership of its joint ventures with subsidiaries of Ping An Insurance. 23 December 2024
Biotechnology
Texan biopharma firm XBiotech has announced a suspension of its clinical program in rheumatology, after its Phase II trial for rheumatoid arthritis failed to meet the primary endpoint. 23 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
All news
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene. 27 December 2024
Biotechnology
Privately-held immunotherapy company Inmagene Biopharmaceuticals is taking over Ikena Oncology in a reverse merger deal, forming a new company, InmageneBio. 27 December 2024
Biotechnology
California’s AusperBio Therapeutics has secured $73 million in series B financing to propel its lead candidate, AHB-137, an antisense oligonucleotide therapy. 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Biotechnology
Mumbai, India-based Mankind Pharma has entered into a partnership with China’s Innovent Biologics for exclusively licensing and commercializing of sintilimab, an immunotherapy for cancer treatment in India. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 2024
Biotechnology
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
Biotechnology
French specialty vaccine company Valneva has entered into an exclusive license agreement for its single-shot chikungunya vaccine that enables supply of the vaccine in Asia with Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses. 24 December 2024
Generics
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
Pharmaceutical
Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024
Biotechnology
US pharma major Bristol Myers Squibb has announced positive results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 24 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Biotechnology
USA-based immunology company RAPT Therapeutics has entered into an exclusive license agreement with Shanghai Jemincare Pharmaceutical for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. 24 December 2024
Pharmaceutical
USA-based clinical-stage biopharma Traws Pharma saw its shares leap more than 150% to $12.57 as it announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. 24 December 2024
Biotechnology
Japanese drugmaker Shionogi has announced that it will acquire full ownership of its joint ventures with subsidiaries of Ping An Insurance. 23 December 2024
Biotechnology
Texan biopharma firm XBiotech has announced a suspension of its clinical program in rheumatology, after its Phase II trial for rheumatoid arthritis failed to meet the primary endpoint. 23 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
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