15 July 2025 In the high-stakes world of drug development, a pill is never just a pill. Every oral drug that reaches the market has passed through a tightly managed series of steps—none more critical, or more vulnerable, than tech transfer.
Canada and USA-based oncology biotech Repare Therapeutics has entered into an exclusive worldwide licensing agreement with privately-held Swiss firm Debiopharm International to establish tomorrow’s standards of care to cure cancer and infectious diseases, for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor. 16 July 2025
The Division of Hepatology and Nutrition of the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase IIa clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH), California, USA-based drug developer Kezar Life Sciences announced yesterday. 16 July 2025
Eli Lilly’s latest acquisition has electrified the biotech world—and sent a clear message that gene editing is no longer just for rare diseases. The US pharma major is paying $1 billion upfront, with a further $300 million in milestones, to buy Verve Therapeutics, a move that positions it squarely in the race to develop one-and-done therapies for heart disease. 16 July 2025
The number of patent disputes in the Russian pharmaceutical industry has almost doubled in the last several years, while these figures continue to grow these days, The Pharma Letter’s local correspondent reports. 16 July 2025
Alnylam has secured expanded UK regulatory approval for Amvuttra (vutrisiran), broadening its indication to include treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults. 16 July 2025
US pharma major AstraZeneca today released high-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical program showed that anselamimab, a light chain depleter antibody, did not achieve statistical significance for the primary endpoint compared to placebo in patients with Mayo stages IIIa and IIIb light chain (AL) amyloidosis. 16 July 2025
The UK government’s new life sciences plan has been met with skepticism by the pharmaceutical industry, which says the strategy will fall flat unless there is a serious shift in the way new medicines are funded and valued. 16 July 2025
The US regulator has launched a new national initiative to help Medicaid programs fund gene therapies for sickle cell disease, under an agreement aimed at broadening access while linking payments to real-world treatment results. 16 July 2025
Japanese drugmaker JCR Pharmaceuticals has entered into a joint collaboration, option and license agreement with US biotech Acumen Pharmaceuticals to develop a novel therapeutic candidate for the treatment of Alzheimer’s disease (AD), enabled by JCR’s proprietary blood-brain barrier (BBB)-penetrating technology platform, J-Brain Cargo 16 July 2025
On Tuesday, the day new global data reveal that childhood vaccine coverage has stalled and deadly disease outbreaks are accelerating, nearly 400 scientists, faith leaders, and health advocates are demanding that the US Senate take action to stop what they call Health Secretary Robert F Kennedy Jr’s “systematic assault” on global immunization. 16 July 2025
The US Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz, as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart), from Denmark’s Novo Nordisk. 16 July 2025
Sino Biopharmaceutical is acquiring the remaining stake in Chinese biotech LaNova Medicines, setting the stage for deeper expansion into the competitive cancer immunotherapy market. 16 July 2025
The USA's Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Sanofi’s tolebrutinib for the treatment of secondary progressive multiple sclerosis (SPMS). 15 July 2025
China-based Jiangsu Hengrui Pharma and US start-up Kailera Therapeutics, which is advancing a broad pipeline of next-generation therapies for the treatment of obesity, today announced positive top-line data from Hengrui’s Phase III clinical trial (HRS9531-301) of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China. 15 July 2025
Russia will begin commercial production of a new anticancer vaccine, which massive supplies for the needs of domestic patients may begin already during the period of 2025-2026, reports The Pharma Letter’s local correspondent. 15 July 2025
In the USA, the 340B hospital markup program cost state and federal taxpayers an estimated $6.5 billion per year due to lost Medicaid rebates, according to a new report from Berkeley Research Group (BRG). 15 July 2025
UK-based ViiV Healthcare, the HIV specialist company majority owned by GSK, with Pfizer and Shionogi as shareholders, has announced data from the Phase IIIb VOLITION study. 15 July 2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Ekterly (sebetralstat) 0for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. 15 July 2025
Canada and USA-based oncology biotech Repare Therapeutics has entered into an exclusive worldwide licensing agreement with privately-held Swiss firm Debiopharm International to establish tomorrow’s standards of care to cure cancer and infectious diseases, for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor. 16 July 2025
The Division of Hepatology and Nutrition of the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase IIa clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH), California, USA-based drug developer Kezar Life Sciences announced yesterday. 16 July 2025
Eli Lilly’s latest acquisition has electrified the biotech world—and sent a clear message that gene editing is no longer just for rare diseases. The US pharma major is paying $1 billion upfront, with a further $300 million in milestones, to buy Verve Therapeutics, a move that positions it squarely in the race to develop one-and-done therapies for heart disease. 16 July 2025
The number of patent disputes in the Russian pharmaceutical industry has almost doubled in the last several years, while these figures continue to grow these days, The Pharma Letter’s local correspondent reports. 16 July 2025
Alnylam has secured expanded UK regulatory approval for Amvuttra (vutrisiran), broadening its indication to include treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults. 16 July 2025
US pharma major AstraZeneca today released high-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical program showed that anselamimab, a light chain depleter antibody, did not achieve statistical significance for the primary endpoint compared to placebo in patients with Mayo stages IIIa and IIIb light chain (AL) amyloidosis. 16 July 2025
The UK government’s new life sciences plan has been met with skepticism by the pharmaceutical industry, which says the strategy will fall flat unless there is a serious shift in the way new medicines are funded and valued. 16 July 2025
The US regulator has launched a new national initiative to help Medicaid programs fund gene therapies for sickle cell disease, under an agreement aimed at broadening access while linking payments to real-world treatment results. 16 July 2025
Japanese drugmaker JCR Pharmaceuticals has entered into a joint collaboration, option and license agreement with US biotech Acumen Pharmaceuticals to develop a novel therapeutic candidate for the treatment of Alzheimer’s disease (AD), enabled by JCR’s proprietary blood-brain barrier (BBB)-penetrating technology platform, J-Brain Cargo 16 July 2025
On Tuesday, the day new global data reveal that childhood vaccine coverage has stalled and deadly disease outbreaks are accelerating, nearly 400 scientists, faith leaders, and health advocates are demanding that the US Senate take action to stop what they call Health Secretary Robert F Kennedy Jr’s “systematic assault” on global immunization. 16 July 2025
The US Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz, as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart), from Denmark’s Novo Nordisk. 16 July 2025
Sino Biopharmaceutical is acquiring the remaining stake in Chinese biotech LaNova Medicines, setting the stage for deeper expansion into the competitive cancer immunotherapy market. 16 July 2025
The USA's Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Sanofi’s tolebrutinib for the treatment of secondary progressive multiple sclerosis (SPMS). 15 July 2025
China-based Jiangsu Hengrui Pharma and US start-up Kailera Therapeutics, which is advancing a broad pipeline of next-generation therapies for the treatment of obesity, today announced positive top-line data from Hengrui’s Phase III clinical trial (HRS9531-301) of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China. 15 July 2025
Russia will begin commercial production of a new anticancer vaccine, which massive supplies for the needs of domestic patients may begin already during the period of 2025-2026, reports The Pharma Letter’s local correspondent. 15 July 2025
In the USA, the 340B hospital markup program cost state and federal taxpayers an estimated $6.5 billion per year due to lost Medicaid rebates, according to a new report from Berkeley Research Group (BRG). 15 July 2025
UK-based ViiV Healthcare, the HIV specialist company majority owned by GSK, with Pfizer and Shionogi as shareholders, has announced data from the Phase IIIb VOLITION study. 15 July 2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Ekterly (sebetralstat) 0for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. 15 July 2025
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A Swedish biotechnology company that specializes in the development of pharmaceuticals for various types of cancer and autoimmune/inflammatory diseases.