Latest Pharma and Biotech News
Biotechnology
22 August 2024 Stockholm-based biotechnology firm Oblique Therapeutics has announced an expanded research collaboration with US pharma giant Eli Lilly (NYSE: LLY).
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Pharmaceutical
The European Commission (EC) has approved Balversa (erdafitinib) from US healthcare giant Johnson & Johnson in bladder cancer. 23 August 2024
Biotechnology
Moderna today received approval from the European Commission (EC) for its mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 23 August 2024
Pharmaceutical
Rafael Holdings (NYSE: RFL) and Cyclo Therapeutics (Nasdaq: CYTH) have agreed to merge, with the goal of focusing on the development of Trappsol Cyclo (hydroxypropyl beta cyclodextrin). 23 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has scheduled a public meeting of key scientific advisors to discuss the use of predictive biomarkers for immune checkpoint inhibitors. 23 August 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical effectiveness and value of Rytelo (imetelstat), raising concerns about the drug's net health benefits and its high cost. 23 August 2024
Biotechnology
Updated versions of the leading vaccines for coronavirus have been approved by the US Food and Drug Administration. 23 August 2024
Biotechnology
Next-gen RNA-focused biotech Borealis Biosciences has emerged from stealth with $150 million in combined Series A financing from founding investor Versant Ventures and Swiss pharma giant Novartis. 23 August 2024
Pharmaceutical
Danish dermatology specialist LEO Pharma’s Timber Pharmaceuticals subsidiary has announced disappointing results for the randomized, double-blind 12-week period of the ASCEND trial. 23 August 2024
Biosimilars
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
Biotechnology
US pharma major AbbVie today revealed that the UK’s National Institute for Health and Care Excellence (NICE) had accepted the firms Skyrizi (risankizumab) for adults with modera 22 August 2024
Biotechnology
China's National Medical Products Administration (NMPA) has approved domestic biopharma firm Innovent Biologics’ Dupert (fulzerasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. 22 August 2024
Biotechnology
Stockholm-based biotechnology firm Oblique Therapeutics has announced an expanded research collaboration with US pharma giant Eli Lilly (NYSE: LLY). 22 August 2024
Pharmaceutical
Russia plans to create conditions for a significant increase of domestic production of anti-Rhesus immunoglobulin drugs after a sharp decrease of their imports to the local market this year, reports The Pharma Letter’s local correspondent. 22 August 2024
Biotechnology
BridgeBio Pharma (Nasdaq: BBIO) has announced the formation of a new joint venture, GondolaBio, in collaboration with a syndicate of prominent investors. 22 August 2024
Biotechnology
Ambrosia Biosciences has announced the successful first closing of its Series A financing. 22 August 2024
Biotechnology
Leqembi (lecanemab) has been granted a marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 22 August 2024
Pharmaceutical
The Russian pharmaceutical company Binnopharm Group is aiming to become one of the leading players in the domestic market in years to come and to begin exports of its drugs to foreign markets. 22 August 2024
All news
Pharmaceutical
The European Commission (EC) has approved Balversa (erdafitinib) from US healthcare giant Johnson & Johnson in bladder cancer. 23 August 2024
Biotechnology
Moderna today received approval from the European Commission (EC) for its mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 23 August 2024
Pharmaceutical
Rafael Holdings (NYSE: RFL) and Cyclo Therapeutics (Nasdaq: CYTH) have agreed to merge, with the goal of focusing on the development of Trappsol Cyclo (hydroxypropyl beta cyclodextrin). 23 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has scheduled a public meeting of key scientific advisors to discuss the use of predictive biomarkers for immune checkpoint inhibitors. 23 August 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical effectiveness and value of Rytelo (imetelstat), raising concerns about the drug's net health benefits and its high cost. 23 August 2024
Biotechnology
Updated versions of the leading vaccines for coronavirus have been approved by the US Food and Drug Administration. 23 August 2024
Biotechnology
Next-gen RNA-focused biotech Borealis Biosciences has emerged from stealth with $150 million in combined Series A financing from founding investor Versant Ventures and Swiss pharma giant Novartis. 23 August 2024
Pharmaceutical
Danish dermatology specialist LEO Pharma’s Timber Pharmaceuticals subsidiary has announced disappointing results for the randomized, double-blind 12-week period of the ASCEND trial. 23 August 2024
Biosimilars
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
Biotechnology
US pharma major AbbVie today revealed that the UK’s National Institute for Health and Care Excellence (NICE) had accepted the firms Skyrizi (risankizumab) for adults with modera 22 August 2024
Biotechnology
China's National Medical Products Administration (NMPA) has approved domestic biopharma firm Innovent Biologics’ Dupert (fulzerasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. 22 August 2024
Biotechnology
Stockholm-based biotechnology firm Oblique Therapeutics has announced an expanded research collaboration with US pharma giant Eli Lilly (NYSE: LLY). 22 August 2024
Pharmaceutical
Russia plans to create conditions for a significant increase of domestic production of anti-Rhesus immunoglobulin drugs after a sharp decrease of their imports to the local market this year, reports The Pharma Letter’s local correspondent. 22 August 2024
Biotechnology
BridgeBio Pharma (Nasdaq: BBIO) has announced the formation of a new joint venture, GondolaBio, in collaboration with a syndicate of prominent investors. 22 August 2024
Biotechnology
Ambrosia Biosciences has announced the successful first closing of its Series A financing. 22 August 2024
Biotechnology
Leqembi (lecanemab) has been granted a marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 22 August 2024
Pharmaceutical
The Russian pharmaceutical company Binnopharm Group is aiming to become one of the leading players in the domestic market in years to come and to begin exports of its drugs to foreign markets. 22 August 2024
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