Latest Pharma and Biotech News
Biotechnology
21 April 2025 The DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current first-line standard of care.
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Pharmaceutical
On the research front last week, China-based biotech Remegen released positive Phase III results for its telitacicept in myasthenia gravis. By contrast, US pharma giant Pfizer announced disappointing results for its obesity candidate danuglipron and its decision to discontinue development. Meantime, Eli Lilly’s shares leapt after it reported strong Phase III trial data on its diabetes and obesity candidate orforglipron. Additionally, there was welcome news last week for pharma companies operating in the USA, when US President Donald Trump issued an executive order calling for the scrapping of the Inflation Reduction ACT (IA) so-called pill penalty. 21 April 2025
Biotechnology
The US subsidiary of Chinese biotech VelaVigo Cayman Limited has announced its second out-licensing agreement of a first-in-class (FIC) asset, this time to US biotech start-up Ollin Biosciences, granting the latter an exclusive license to develop, manufacture and commercialize VBS-102, a first-in-class bispecific antibody, globally (excluding Greater China). 21 April 2025
Biotechnology
London, UK-based Alis Biosciences, an investment fund focused on returning capital to investors that is currently trapped in listed, development-stage biotech companies, has formally launched. 21 April 2025
Biotechnology
The DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current first-line standard of care. 21 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted another approval for Dupixent (dupilumab), for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. 19 April 2025
Biotechnology
Earendil Labs, a US AI-driven R&D next-generation biologics therapeutics start-up, has entered into a license agreement with French pharma major Sanofi for two potential first-in-class bispecific antibodies in the field of autoimmune and inflammatory bowel diseases. 19 April 2025
Pharmaceutical
In keeping with US Department of Health and Human Services Secretary Robert F Kennedy Jr’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and conflicts of interests, Food and Drug Administration (FDA) Commissioner Dr Martin Makary, has announced a policy directive. 19 April 2025
Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Pharmaceutical
US President Donald Trump issued an executive order on April 15 listing several potential policy changes aimed at lowering US drug prices.
Responding to the announcement, Morningstar’s healthcare equity research director Karen Andersen gave her views on why this matters. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Biotechnology
Australian clinical-stage biotech Neurizon Therapeutics, which is advancing innovative treatments for neurodegenerative diseases, has significantly strengthened its executive management team with three key appointments. 18 April 2025
Pharmaceutical
US biopharma company Galmed Pharmaceuticals has entered into a research collaboration with Virginia Commonwealth University to investigate its lead candidate Aramchol (arachidyl amido cholanoic acid) as a potential solution to drug resistance in gastrointestinal cancers. 17 April 2025
Biotechnology
BigHat Biosciences, a Californian biotech with a machine learning (ML)-guided antibody discovery and development platform, has announced a strategic collaboration with US pharma major Eli Lilly. 17 April 2025
Biotechnology
US cancer drug developer Werewolf Therapeutics today announced the appointment of Steven Bloom as chief business officer (CBOP. 17 April 2025
Pharmaceutical
Wall Street watched in awe as Eli Lilly made rampant gains in early trading Thursday. 17 April 2025
Biotechnology
Swiss pharma major Novartis has discontinued development of its experimental treatment QUC398 for knee osteoarthritis, ending hopes for a new therapy in the anti-ADAMTS-5 class. 17 April 2025
Pharmaceutical
Florida biopharma Ligand Pharmaceuticals subsidiary Pelthos Therapeutics is to merge with Channel Therapeutics, a developer of non-opioid pain treatments. 17 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
All news
Pharmaceutical
On the research front last week, China-based biotech Remegen released positive Phase III results for its telitacicept in myasthenia gravis. By contrast, US pharma giant Pfizer announced disappointing results for its obesity candidate danuglipron and its decision to discontinue development. Meantime, Eli Lilly’s shares leapt after it reported strong Phase III trial data on its diabetes and obesity candidate orforglipron. Additionally, there was welcome news last week for pharma companies operating in the USA, when US President Donald Trump issued an executive order calling for the scrapping of the Inflation Reduction ACT (IA) so-called pill penalty. 21 April 2025
Biotechnology
The US subsidiary of Chinese biotech VelaVigo Cayman Limited has announced its second out-licensing agreement of a first-in-class (FIC) asset, this time to US biotech start-up Ollin Biosciences, granting the latter an exclusive license to develop, manufacture and commercialize VBS-102, a first-in-class bispecific antibody, globally (excluding Greater China). 21 April 2025
Biotechnology
London, UK-based Alis Biosciences, an investment fund focused on returning capital to investors that is currently trapped in listed, development-stage biotech companies, has formally launched. 21 April 2025
Biotechnology
The DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current first-line standard of care. 21 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted another approval for Dupixent (dupilumab), for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. 19 April 2025
Biotechnology
Earendil Labs, a US AI-driven R&D next-generation biologics therapeutics start-up, has entered into a license agreement with French pharma major Sanofi for two potential first-in-class bispecific antibodies in the field of autoimmune and inflammatory bowel diseases. 19 April 2025
Pharmaceutical
In keeping with US Department of Health and Human Services Secretary Robert F Kennedy Jr’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and conflicts of interests, Food and Drug Administration (FDA) Commissioner Dr Martin Makary, has announced a policy directive. 19 April 2025
Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Pharmaceutical
US President Donald Trump issued an executive order on April 15 listing several potential policy changes aimed at lowering US drug prices.
Responding to the announcement, Morningstar’s healthcare equity research director Karen Andersen gave her views on why this matters. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Biotechnology
Australian clinical-stage biotech Neurizon Therapeutics, which is advancing innovative treatments for neurodegenerative diseases, has significantly strengthened its executive management team with three key appointments. 18 April 2025
Pharmaceutical
US biopharma company Galmed Pharmaceuticals has entered into a research collaboration with Virginia Commonwealth University to investigate its lead candidate Aramchol (arachidyl amido cholanoic acid) as a potential solution to drug resistance in gastrointestinal cancers. 17 April 2025
Biotechnology
BigHat Biosciences, a Californian biotech with a machine learning (ML)-guided antibody discovery and development platform, has announced a strategic collaboration with US pharma major Eli Lilly. 17 April 2025
Biotechnology
US cancer drug developer Werewolf Therapeutics today announced the appointment of Steven Bloom as chief business officer (CBOP. 17 April 2025
Pharmaceutical
Wall Street watched in awe as Eli Lilly made rampant gains in early trading Thursday. 17 April 2025
Biotechnology
Swiss pharma major Novartis has discontinued development of its experimental treatment QUC398 for knee osteoarthritis, ending hopes for a new therapy in the anti-ADAMTS-5 class. 17 April 2025
Pharmaceutical
Florida biopharma Ligand Pharmaceuticals subsidiary Pelthos Therapeutics is to merge with Channel Therapeutics, a developer of non-opioid pain treatments. 17 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
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