Latest Pharma and Biotech News
Biotechnology
22 May 2025 US clinical-stage biotech Vigil Neuroscience saw its share price skyrocket more than 240% to $7.89 pre-market, on the news that French pharma major Sanofi had made a takeover bid for the company.
Today's issue
Refine Search
Biotechnology
Last week saw Novavax receive full approval from the US Food and Drug Administration (FDA) for its COVID-19 vaccine, but with post-market requirements. Swiss gene-editing company CRISPR Therapeutics linked up with Sirius Therapeutics to develop siRNA therapeutics, notably the latter’s SRSD107 in cardiovascular indications. The FDA last week announced a new executive order aiming to provide a pathway for prescription drugs from Canada, Also of note, Gilead Sciences released positive results for its Trodelvy ASCENT-03 study in metastatic triple negative breast cancer (mTNBC). 25 May 2025
Pharmaceutical
US antivirals major Gilead Sciences yesterday released positive top-line results from the Phase III ASCENT-03 study of Trodelvy (sacituzumab govitecan-hziy). 24 May 2025
Pharmaceutical
This week, Dr Kimberly Smith, Senior Vice President, Chief Scientific Officer, Head of Research & Development at ViiV Healthcare, provides an Expert View on how, through a deep understanding of the HIV community, the company has led the way in changing the HIV treatment and prevention paradigm. 23 May 2025
Biotechnology
US biotech Ionis Pharmaceuticals has reported positive top-line data from the Phase III ESSENCE trial of its antisense drug olezarsen in patients with moderate hypertriglyceridemia who are at risk of atherosclerotic cardiovascular disease. 23 May 2025
Pharmaceutical
Verastem Oncology has unveiled updated early-stage data from its RAMP 205 trial in metastatic pancreatic cancer, bolstering its efforts to broaden use of its dual-drug regimen, Avmapki Fakzynja Co-Pack, beyond its recently approved indication in a rare form of ovarian cancer. 23 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today revealed it has approved Akantior (polihexanide) to treat acanthamoeba keratitis (AK). 23 May 2025
Pharmaceutical
Swiss biopharma Relief Therapeutics closed Thursday’s trading 50% higher. 23 May 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari (sparsentan) can be used in the National Health Service (NHS) in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of 0.75g/g or more. 23 May 2025
Pharmaceutical
Japanese drugmaker Astellas and US pharma giant Pfizer have announced longer-term follow-up results from an open-label extension of the Phase III ARCHES study. 23 May 2025
Pharmaceutical
Privately-held French drugmaker Servier and China-based BioNova Pharmaceuticals today announce that they have entered into a definitive agreement under which Servier will acquire BN104, a potential best-in-class menin inhibitor currently in Phase I/II development for the treatment of acute leukemias. 23 May 2025
Biotechnology
Among the companies displaying the strength of Chinese research in oncology at the 2025 ASCO Annual Meeting will be Hutchmed. 23 May 2025
Biotechnology
UK pharma major GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 23 May 2025
Biotechnology
Swiss pharma major Roche has reported updated results from its Phase III STARGLO trial, showing that a fixed-duration regimen of Columvi (glofitamab) combined with gemcitabine and oxaliplatin (GemOx) continues to deliver a notable survival benefit for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 23 May 2025
Pharmaceutical
The oncology community’s biggest gathering returns to Chicago from May 30 to June 3, and all signs suggest the 2025 ASCO Annual Meeting will be a watershed moment. 23 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Roche’s(ROG: SIX) Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the USA and more than 100 million people globally. 23 May 2025
Pharmaceutical
USA-based nonprofit CureDuchenne has announced the appointment of Brenda Wong as its new chief medical advisor (CMA), effective January 5, 2026. 22 May 2025
Biotechnology
This week on The Pharma Letter Podcast, we’re joined by Quin Wills, co-founder and chief scientific officer of UK biotech Ochre Bio. 22 May 2025
Biosimilars
South Korean Samsung Group’s biopharmaceutical business is being reorganized into two separate tracks: contract development and manufacturing organization (CDMO) and biosimilars. 22 May 2025
Pharmaceutical
The US Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. 22 May 2025
All news
Biotechnology
Last week saw Novavax receive full approval from the US Food and Drug Administration (FDA) for its COVID-19 vaccine, but with post-market requirements. Swiss gene-editing company CRISPR Therapeutics linked up with Sirius Therapeutics to develop siRNA therapeutics, notably the latter’s SRSD107 in cardiovascular indications. The FDA last week announced a new executive order aiming to provide a pathway for prescription drugs from Canada, Also of note, Gilead Sciences released positive results for its Trodelvy ASCENT-03 study in metastatic triple negative breast cancer (mTNBC). 25 May 2025
Pharmaceutical
US antivirals major Gilead Sciences yesterday released positive top-line results from the Phase III ASCENT-03 study of Trodelvy (sacituzumab govitecan-hziy). 24 May 2025
Pharmaceutical
This week, Dr Kimberly Smith, Senior Vice President, Chief Scientific Officer, Head of Research & Development at ViiV Healthcare, provides an Expert View on how, through a deep understanding of the HIV community, the company has led the way in changing the HIV treatment and prevention paradigm. 23 May 2025
Biotechnology
US biotech Ionis Pharmaceuticals has reported positive top-line data from the Phase III ESSENCE trial of its antisense drug olezarsen in patients with moderate hypertriglyceridemia who are at risk of atherosclerotic cardiovascular disease. 23 May 2025
Pharmaceutical
Verastem Oncology has unveiled updated early-stage data from its RAMP 205 trial in metastatic pancreatic cancer, bolstering its efforts to broaden use of its dual-drug regimen, Avmapki Fakzynja Co-Pack, beyond its recently approved indication in a rare form of ovarian cancer. 23 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today revealed it has approved Akantior (polihexanide) to treat acanthamoeba keratitis (AK). 23 May 2025
Pharmaceutical
Swiss biopharma Relief Therapeutics closed Thursday’s trading 50% higher. 23 May 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari (sparsentan) can be used in the National Health Service (NHS) in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of 0.75g/g or more. 23 May 2025
Pharmaceutical
Japanese drugmaker Astellas and US pharma giant Pfizer have announced longer-term follow-up results from an open-label extension of the Phase III ARCHES study. 23 May 2025
Pharmaceutical
Privately-held French drugmaker Servier and China-based BioNova Pharmaceuticals today announce that they have entered into a definitive agreement under which Servier will acquire BN104, a potential best-in-class menin inhibitor currently in Phase I/II development for the treatment of acute leukemias. 23 May 2025
Biotechnology
Among the companies displaying the strength of Chinese research in oncology at the 2025 ASCO Annual Meeting will be Hutchmed. 23 May 2025
Biotechnology
UK pharma major GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 23 May 2025
Biotechnology
Swiss pharma major Roche has reported updated results from its Phase III STARGLO trial, showing that a fixed-duration regimen of Columvi (glofitamab) combined with gemcitabine and oxaliplatin (GemOx) continues to deliver a notable survival benefit for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 23 May 2025
Pharmaceutical
The oncology community’s biggest gathering returns to Chicago from May 30 to June 3, and all signs suggest the 2025 ASCO Annual Meeting will be a watershed moment. 23 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Roche’s(ROG: SIX) Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the USA and more than 100 million people globally. 23 May 2025
Pharmaceutical
USA-based nonprofit CureDuchenne has announced the appointment of Brenda Wong as its new chief medical advisor (CMA), effective January 5, 2026. 22 May 2025
Biotechnology
This week on The Pharma Letter Podcast, we’re joined by Quin Wills, co-founder and chief scientific officer of UK biotech Ochre Bio. 22 May 2025
Biosimilars
South Korean Samsung Group’s biopharmaceutical business is being reorganized into two separate tracks: contract development and manufacturing organization (CDMO) and biosimilars. 22 May 2025
Pharmaceutical
The US Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. 22 May 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze