Latest Pharma and Biotech News
Biotechnology
6 March 2025 German biotech major BioNTech has suffered a blow as it seeks to add new revenue streams beyond its COVID-19 vaccine, Comirnaty.
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Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Pharmaceutical
Following swiftly after US regulatory clearance for the same indication for Odactra tablet brand, Danish allergy expert ALK Abello its Acarizax announced that Health Canada has approved tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. 8 March 2025
Biotechnology
Nona Biosciences has introduced Hu-mAtrIx, an AI-assisted drug discovery platform designed to accelerate the identification and development of antibody-based therapies. 7 March 2025
Pharmaceutical
Marty Makary, nominated by Donald Trump to lead the Food and Drug Administration (FDA), has faced rigorous Senate scrutiny over recent agency job cuts and the abrupt cancellation of a flu vaccine advisory meeting. 7 March 2025
Generics
German generics and consumer healthcare major STADA Arzneimittel today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. 7 March 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). 7 March 2025
Pharmaceutical
French ophthalmic drug specialist Nicox has provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc Phase III clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting. 7 March 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Alyftrek (triple combination medicine deutivacaftor/tezacaftor/vanzacaftor. 7 March 2025
Pharmaceutical
Cardiorenal specialist scPharmaceuticals has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). 7 March 2025
Biotechnology
US clinical stage biotech Rapport Therapeutics has announced the appointment of Dr Jeffrey Sevigny as chief medical officer (CMO), effective immediately. 7 March 2025
Biotechnology
A recent study by TEConomy Partners, commissioned by industry group PhRMA, has revealed that biopharmaceutical company-sponsored trials generated over $62 billion in economic activity in the USA in 2023. 7 March 2025
Pharmaceutical
US healthcare giant Johnson & Johnson yesterday revealed that it has made the decision to discontinue the Phase III VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder (aMDD) due to insufficient efficacy in the target patient population. 7 March 2025
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lazcluze (lazertinib) for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). 7 March 2025
Biotechnology
A treatment combining AstraZeneca’s immunotherapy Imfinzi (durvalumab) with chemotherapy has significantly reduced the risk of cancer recurrence in patients with early-stage stomach and gastroesophageal junction cancers, according to results from the MATTERHORN Phase III trial. 7 March 2025
Biotechnology
Tenaya Therapeutics, a clinical-stage biotechnology company based in South San Francisco, has announced plans to raise approximately $52.5 million through a public offering. 6 March 2025
Pharmaceutical
Private equity firms acquiring assets were among the most eye-catching deals in pharma M&A during February. 6 March 2025
Pharmaceutical
China’s Enhua Pharma has announced a $3.5 million investment in NeuroThree Therapeutics, a biotech firm specializing in treatments for central nervous system disorders. The investment secures a 10.4% stake in the company as part of its Pre-A funding round. 6 March 2025
Pharmaceutical
Privately-held US drugmaker Tris Pharma today announced positive top-line results from its ALLEVIATE-2 Phase III pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. 6 March 2025
Pharmaceutical
USA-based Medicus Pharma has announced a positive-trending interim analysis for the SKNJCT-003 Phase II study, which aims to treat non-invasively basal cell carcinoma of the skin (BCC). 6 March 2025
Generics
Indian drugmaker Biocon’s Biocon Biologics unit and USA-based Civica Rx, a not-for-profit generic drug and pharmaceutical company, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the USA, with the news sending Biocon’s shares up nearly 4% to 333 rupees. 6 March 2025
All news
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Pharmaceutical
Following swiftly after US regulatory clearance for the same indication for Odactra tablet brand, Danish allergy expert ALK Abello its Acarizax announced that Health Canada has approved tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. 8 March 2025
Biotechnology
Nona Biosciences has introduced Hu-mAtrIx, an AI-assisted drug discovery platform designed to accelerate the identification and development of antibody-based therapies. 7 March 2025
Pharmaceutical
Marty Makary, nominated by Donald Trump to lead the Food and Drug Administration (FDA), has faced rigorous Senate scrutiny over recent agency job cuts and the abrupt cancellation of a flu vaccine advisory meeting. 7 March 2025
Generics
German generics and consumer healthcare major STADA Arzneimittel today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. 7 March 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). 7 March 2025
Pharmaceutical
French ophthalmic drug specialist Nicox has provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc Phase III clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting. 7 March 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Alyftrek (triple combination medicine deutivacaftor/tezacaftor/vanzacaftor. 7 March 2025
Pharmaceutical
Cardiorenal specialist scPharmaceuticals has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). 7 March 2025
Biotechnology
US clinical stage biotech Rapport Therapeutics has announced the appointment of Dr Jeffrey Sevigny as chief medical officer (CMO), effective immediately. 7 March 2025
Biotechnology
A recent study by TEConomy Partners, commissioned by industry group PhRMA, has revealed that biopharmaceutical company-sponsored trials generated over $62 billion in economic activity in the USA in 2023. 7 March 2025
Pharmaceutical
US healthcare giant Johnson & Johnson yesterday revealed that it has made the decision to discontinue the Phase III VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder (aMDD) due to insufficient efficacy in the target patient population. 7 March 2025
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lazcluze (lazertinib) for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). 7 March 2025
Biotechnology
A treatment combining AstraZeneca’s immunotherapy Imfinzi (durvalumab) with chemotherapy has significantly reduced the risk of cancer recurrence in patients with early-stage stomach and gastroesophageal junction cancers, according to results from the MATTERHORN Phase III trial. 7 March 2025
Biotechnology
Tenaya Therapeutics, a clinical-stage biotechnology company based in South San Francisco, has announced plans to raise approximately $52.5 million through a public offering. 6 March 2025
Pharmaceutical
Private equity firms acquiring assets were among the most eye-catching deals in pharma M&A during February. 6 March 2025
Pharmaceutical
China’s Enhua Pharma has announced a $3.5 million investment in NeuroThree Therapeutics, a biotech firm specializing in treatments for central nervous system disorders. The investment secures a 10.4% stake in the company as part of its Pre-A funding round. 6 March 2025
Pharmaceutical
Privately-held US drugmaker Tris Pharma today announced positive top-line results from its ALLEVIATE-2 Phase III pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. 6 March 2025
Pharmaceutical
USA-based Medicus Pharma has announced a positive-trending interim analysis for the SKNJCT-003 Phase II study, which aims to treat non-invasively basal cell carcinoma of the skin (BCC). 6 March 2025
Generics
Indian drugmaker Biocon’s Biocon Biologics unit and USA-based Civica Rx, a not-for-profit generic drug and pharmaceutical company, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the USA, with the news sending Biocon’s shares up nearly 4% to 333 rupees. 6 March 2025
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