Latest Pharma and Biotech News
Biotechnology
15 September 2026 UK pharma major GSK today announced it has entered an agreement to acquire a potential best-in-class trispecific T cell-engager (TCE) from Chimagen Biosciences, a privately held biotechnology company.
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Biosimilars
India’s Shilpa Biologicals has announced an exclusive Middle East and North Africa (MENA) strategic licensing and commercialization agreement with SPIMACO Bio of Saudi Arabia for portfolio of PD-1 inhibitor biosimilars across the Middle East and North Africa (MENA). 16 September 2026
Pharmaceutical
When patients are waiting for new treatments, safety and speed both matter, according to trade group Pharmaceutical Research Manufacturers of America (PhRMA). 16 September 2026
Pharmaceutical
Medicine shortages have shifted over the past two years from a problem managed in hospital pharmacies to a matter of industrial and trade policy on both sides of the Atlantic. Active shortages in the USA peaked in early 2024 and have since fallen, while Europe has built a list of critical medicines, a reporting platform and, in May 2026, a provisional deal on its Critical Medicines Act. 16 September 2026
Biotechnology
California-based biotech company RegCell has closed $66 million in new funding, made up of a $44 million series A led by Playground Global and a further 3.4 billion yen ($22 million) in non-dilutive money from Japan's Agency for Medical Research and Development (AMED). The company said on Tuesday the cash will carry its regulatory T cell platform into clinical development across several autoimmune diseases. 16 September 2026
Pharmaceutical
Danish biopharmaceutical firm Ascendis Pharma is to regain exclusive rights to develop, manufacture and commercialize products based on its TransCon technology in metabolic and cardiovascular disease, including obesity, following termination of the collaboration agreement struck with fellow Danish company Novo Nordisk in November 2024. 16 September 2026
Pharmaceutical
An Expert View from Mike D’Ambrosio, Senior Vice President and Global Head, Real World Research, Parexel, and Tala Fakhouri, Ph.D., M.P.H., Chief AI and Regulatory Strategy Officer, Parexel. 16 September 2026
Pharmaceutical
Diasome Pharmaceuticals, a US biopharma developing liver-targeted therapies for metabolic disease, has appointed Sangeeta Sawhney as chief medical officer, as it prepares to advance its lead candidate, HDV-Insulin, into Phase III development. 15 September 2026
Generics
Swiss generics and biosimilars company Sandoz has issued a 500 million euros ($585 million) bond with a 12-year maturity and a 4.835% coupon, with proceeds earmarked for general corporate purposes including refinancing existing debt. 15 September 2026
Biotechnology
UK pharma major GSK today announced it has entered an agreement to acquire a potential best-in-class trispecific T cell-engager (TCE) from Chimagen Biosciences, a privately held biotechnology company. 15 September 2026
Biotechnology
Singapore-based biotech Hummingbird Bioscience today announced the appointment of Dr James Garner as president. Dr Garner will join Hummingbird’s leadership team and work alongside Piers Ingram, co-founder and chief executive. 15 September 2026
Pharmaceutical
Italy's Chiesi Group, a family-owned biopharma company focused on respiratory health, rare diseases and specialty care, has appointed David Khougazian as group chief executive officer (CEO). 15 September 2026
Pharmaceutical
French genetic medicines company Cyllene Therapeutics announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead candidate, EG110A, a first-in-class treatment being developed to address neurogenic detrusor overactivity (NDO) with urinary incontinence. 15 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Revolution Medicines Rasonque (daraxonrasib), the company’s RAS(ON) multi-selective inhibitor, for treatment-naïve metastatic pancreatic adenocarcinoma (PDAC) in combination with gemcitabine and nab-paclitaxel (GnP), a multiagent chemotherapy regimen widely used in treating patients with PDAC. 15 September 2026
Pharmaceutical
France-headquartered radiopharmaceutical company, Curium, has won US Food and Drug Administration (FDA) approval for Bexlutry (lutetium Lu 177 dotatate injection), its first radioligand therapy to reach the US market, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 15 September 2026
Pharmaceutical
Germany-based Biofrontera has announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, for the treatment of superficial basal cell carcinoma (sBCC) in adults. 15 September 2026
Biotechnology
Johnson & Johnson has reported final overall survival (OS) results from the Phase III PAPILLON trial of Rybrevant (amivantamab-vmjw) plus carboplatin-pemetrexed chemotherapy in previously untreated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations, a historically difficult-to-treat subgroup accounting for roughly 12% of EGFR mutations. 15 September 2026
Pharmaceutical
French biotech Axoltis Pharma today announced the top-line results of SEALS, its Phase II clinical trial evaluating the effect of NX210c in patients with amyotrophic lateral sclerosis (ALS). 15 September 2026
Pharmaceutical
Real-world data is the information generated when patients are treated in ordinary practice rather than in a clinical trial: hospital and family doctor records, insurance claims, disease registries and, increasingly, readings from wearable devices. Real-world evidence is what emerges when that information is analyzed to answer a question about how a medicine performs in use. 15 September 2026
Biotechnology
Electra Therapeutics, a South San Francisco biotech company, has set terms for its stock market debut, proposing to sell 21.7 million shares at between $14 and $16 each. At the $15 midpoint the offering would raise about $325 million and value the business at roughly $916 million. 15 September 2026
Pharmaceutical
Medicines regulators in major markets issued a run of cancer and rare-disease approvals, product recalls and safety communications over the past week, with activity concentrated in North America and Australia. 15 September 2026
All news
Biosimilars
India’s Shilpa Biologicals has announced an exclusive Middle East and North Africa (MENA) strategic licensing and commercialization agreement with SPIMACO Bio of Saudi Arabia for portfolio of PD-1 inhibitor biosimilars across the Middle East and North Africa (MENA). 16 September 2026
Pharmaceutical
When patients are waiting for new treatments, safety and speed both matter, according to trade group Pharmaceutical Research Manufacturers of America (PhRMA). 16 September 2026
Pharmaceutical
Medicine shortages have shifted over the past two years from a problem managed in hospital pharmacies to a matter of industrial and trade policy on both sides of the Atlantic. Active shortages in the USA peaked in early 2024 and have since fallen, while Europe has built a list of critical medicines, a reporting platform and, in May 2026, a provisional deal on its Critical Medicines Act. 16 September 2026
Biotechnology
California-based biotech company RegCell has closed $66 million in new funding, made up of a $44 million series A led by Playground Global and a further 3.4 billion yen ($22 million) in non-dilutive money from Japan's Agency for Medical Research and Development (AMED). The company said on Tuesday the cash will carry its regulatory T cell platform into clinical development across several autoimmune diseases. 16 September 2026
Pharmaceutical
Danish biopharmaceutical firm Ascendis Pharma is to regain exclusive rights to develop, manufacture and commercialize products based on its TransCon technology in metabolic and cardiovascular disease, including obesity, following termination of the collaboration agreement struck with fellow Danish company Novo Nordisk in November 2024. 16 September 2026
Pharmaceutical
An Expert View from Mike D’Ambrosio, Senior Vice President and Global Head, Real World Research, Parexel, and Tala Fakhouri, Ph.D., M.P.H., Chief AI and Regulatory Strategy Officer, Parexel. 16 September 2026
Pharmaceutical
Diasome Pharmaceuticals, a US biopharma developing liver-targeted therapies for metabolic disease, has appointed Sangeeta Sawhney as chief medical officer, as it prepares to advance its lead candidate, HDV-Insulin, into Phase III development. 15 September 2026
Generics
Swiss generics and biosimilars company Sandoz has issued a 500 million euros ($585 million) bond with a 12-year maturity and a 4.835% coupon, with proceeds earmarked for general corporate purposes including refinancing existing debt. 15 September 2026
Biotechnology
UK pharma major GSK today announced it has entered an agreement to acquire a potential best-in-class trispecific T cell-engager (TCE) from Chimagen Biosciences, a privately held biotechnology company. 15 September 2026
Biotechnology
Singapore-based biotech Hummingbird Bioscience today announced the appointment of Dr James Garner as president. Dr Garner will join Hummingbird’s leadership team and work alongside Piers Ingram, co-founder and chief executive. 15 September 2026
Pharmaceutical
Italy's Chiesi Group, a family-owned biopharma company focused on respiratory health, rare diseases and specialty care, has appointed David Khougazian as group chief executive officer (CEO). 15 September 2026
Pharmaceutical
French genetic medicines company Cyllene Therapeutics announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead candidate, EG110A, a first-in-class treatment being developed to address neurogenic detrusor overactivity (NDO) with urinary incontinence. 15 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Revolution Medicines Rasonque (daraxonrasib), the company’s RAS(ON) multi-selective inhibitor, for treatment-naïve metastatic pancreatic adenocarcinoma (PDAC) in combination with gemcitabine and nab-paclitaxel (GnP), a multiagent chemotherapy regimen widely used in treating patients with PDAC. 15 September 2026
Pharmaceutical
France-headquartered radiopharmaceutical company, Curium, has won US Food and Drug Administration (FDA) approval for Bexlutry (lutetium Lu 177 dotatate injection), its first radioligand therapy to reach the US market, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 15 September 2026
Pharmaceutical
Germany-based Biofrontera has announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, for the treatment of superficial basal cell carcinoma (sBCC) in adults. 15 September 2026
Biotechnology
Johnson & Johnson has reported final overall survival (OS) results from the Phase III PAPILLON trial of Rybrevant (amivantamab-vmjw) plus carboplatin-pemetrexed chemotherapy in previously untreated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations, a historically difficult-to-treat subgroup accounting for roughly 12% of EGFR mutations. 15 September 2026
Pharmaceutical
French biotech Axoltis Pharma today announced the top-line results of SEALS, its Phase II clinical trial evaluating the effect of NX210c in patients with amyotrophic lateral sclerosis (ALS). 15 September 2026
Pharmaceutical
Real-world data is the information generated when patients are treated in ordinary practice rather than in a clinical trial: hospital and family doctor records, insurance claims, disease registries and, increasingly, readings from wearable devices. Real-world evidence is what emerges when that information is analyzed to answer a question about how a medicine performs in use. 15 September 2026
Biotechnology
Electra Therapeutics, a South San Francisco biotech company, has set terms for its stock market debut, proposing to sell 21.7 million shares at between $14 and $16 each. At the $15 midpoint the offering would raise about $325 million and value the business at roughly $916 million. 15 September 2026
Pharmaceutical
Medicines regulators in major markets issued a run of cancer and rare-disease approvals, product recalls and safety communications over the past week, with activity concentrated in North America and Australia. 15 September 2026
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