Latest Pharma and Biotech News
Pharmaceutical
30 May 2025 A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten.
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Pharmaceutical
Privately-held German drugmaker Grünenthal has acquired commercial rights to erectile dysfunction drug Cialis (tadalafil) in Mexico, Brazil and Colombia from US pharma major Eli Lilly. 2 June 2025
Pharmaceutical
Swiss biotech iOnctura has appointed Steven Sciuto as chief financial officer and Michelle Tsai as chief operating officer, marking a leadership shift as the company moves deeper into Phase II trials for its lead cancer candidate, roginolisib (IOA-244). 2 June 2025
Biotechnology
Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025
Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
Japanese drugmaker Sumitomo Pharma and Denmark’s Novo Nordisk have entered into a co-promotion agreement in Japan for Ozempic (semaglutide) Subcutaneous Injection 2mg, a once-weekly subcutaneous GLP-1 receptor agonist indicated for the treatment of type 2 diabetes. 30 May 2025
Biotechnology
Japanese drugmaker Astellas Pharma today announced an exclusive license agreement with China’s Evopoint Biosciences for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. 30 May 2025
Pharmaceutical
A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Pharmaceutical
Philadelphia-based biotech Vivodyne has raised $40 million in series A funding to advance its fully robotic, AI-powered platform that tests drug candidates on lab-grown human tissues. 30 May 2025
Pharmaceutical
Swiss pharma giant Roche today announced new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. 30 May 2025
Biotechnology
Shares in US biotech Intellia Therapeutics slid by a quarter on Thursday following a safety update from its late-stage trial of a CRISPR-based treatment for a rare heart disease. 30 May 2025
Biotechnology
US biotech Regeneron and French drugmaker Sanofi are reviewing next steps for their experimental COPD therapy itepekimab following contrasting outcomes from two Phase III studies. The companies plan to discuss the results with regulatory agencies before determining the future of the interleukin (IL)-33 inhibitor. 30 May 2025
Biotechnology
Vima Therapeutics, a Cambridge, USA-based clinical-stage biotechnology company focused on oral therapies for movement disorders, has launched with a $60 million Series A financing. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
All news
Pharmaceutical
Privately-held German drugmaker Grünenthal has acquired commercial rights to erectile dysfunction drug Cialis (tadalafil) in Mexico, Brazil and Colombia from US pharma major Eli Lilly. 2 June 2025
Pharmaceutical
Swiss biotech iOnctura has appointed Steven Sciuto as chief financial officer and Michelle Tsai as chief operating officer, marking a leadership shift as the company moves deeper into Phase II trials for its lead cancer candidate, roginolisib (IOA-244). 2 June 2025
Biotechnology
Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025
Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
Japanese drugmaker Sumitomo Pharma and Denmark’s Novo Nordisk have entered into a co-promotion agreement in Japan for Ozempic (semaglutide) Subcutaneous Injection 2mg, a once-weekly subcutaneous GLP-1 receptor agonist indicated for the treatment of type 2 diabetes. 30 May 2025
Biotechnology
Japanese drugmaker Astellas Pharma today announced an exclusive license agreement with China’s Evopoint Biosciences for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. 30 May 2025
Pharmaceutical
A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Pharmaceutical
Philadelphia-based biotech Vivodyne has raised $40 million in series A funding to advance its fully robotic, AI-powered platform that tests drug candidates on lab-grown human tissues. 30 May 2025
Pharmaceutical
Swiss pharma giant Roche today announced new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. 30 May 2025
Biotechnology
Shares in US biotech Intellia Therapeutics slid by a quarter on Thursday following a safety update from its late-stage trial of a CRISPR-based treatment for a rare heart disease. 30 May 2025
Biotechnology
US biotech Regeneron and French drugmaker Sanofi are reviewing next steps for their experimental COPD therapy itepekimab following contrasting outcomes from two Phase III studies. The companies plan to discuss the results with regulatory agencies before determining the future of the interleukin (IL)-33 inhibitor. 30 May 2025
Biotechnology
Vima Therapeutics, a Cambridge, USA-based clinical-stage biotechnology company focused on oral therapies for movement disorders, has launched with a $60 million Series A financing. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
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