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Pharmaceutical
The US Food and Drug Administration (FDA) is set to sharply restrict vaccine availability to millions of Americans without a persuasive justification based in science. 22 May 2025
Biotechnology
US biotech Moderna today announced that in consultation with the US Food and Drug Administration (FDA), the company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. 21 May 2025
Pharmaceutical
Earlier this month, the US Department of Health and Human Services (HHS) said it would require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 21 May 2025
Pharmaceutical
North Carolina, USA-based vTv Therapeutics has announced that screening has been reinitiated in the company’s CATT1 Phase III trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes (T1D). 21 May 2025
Biotechnology
A panel of experts convened by the US regulator has given a cautious nod to Johnson & Johnson’s Darzalex Faspro (daratumumab/hyaluronidase-fihj) for some multiple myeloma patients. 21 May 2025
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved UK pharma major GSK’s Blenrep (belantamab mafodotin) combination for the treatment of adults with relapsed or refractory multiple myeloma. 20 May 2025
Pharmaceutical
Major progress has been made in delivering a more efficient and adaptable regulatory framework for clinical trials, and Lawrence Tallon, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reflected on International Clinical Trials Day. 20 May 2025
Pharmaceutical
Marking International Clinical Trials Day, we bring you a special Q&A with Andrea Manfrin, Deputy Director of Clinical Trials from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). 20 May 2025
Biosimilars
Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab). 19 May 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced that it obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo intravitreal injection 120mg/mL (aricimab genetical recombination), for an additional indication of the treatment of choroidal neovascularization associated with angioid streaks. Vabysmo is the first approved drug in Japan for the treatment of this disease. 19 May 2025
Biotechnology
After a prolonged wait, American company Novavax has received full approval from the US regulator for its protein-based COVID-19 vaccine, Nuvaxovid (COVID-19 vaccine, adjuvanted). 19 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign. 19 May 2025
Pharmaceutical
Vaccines Europe’s response to the Call for Evidence on the European Centre for Disease Prevention and Control evaluation Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). 19 May 2025
Pharmaceutical
Trade group Medicines Australia congratulates Mark Butler on his reappointment as the Minister for Health and Aging and for adding the portfolios of Disability and the National Disability Insurance Scheme to his remit. 19 May 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Tremfya (guselkumab) (Tremfya) to treat Crohn’s disease and ulcerative colitis (UC). 17 May 2025
Pharmaceutical
US biopharma Biohaven has been told by the US Food and Drug Administration (FDA) that the agency is extending the PDUFA date for the company’s troriluzole new drug application (NDA) for the treatment of spinocerebellar ataxia (SCA) by three months. 16 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Incyte’s Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). 16 May 2025
Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Pharmaceutical
Shares of Travere Therapeutics fell 15.8% to $21.15 in after-hours trading, as the company revealed that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for traditional approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS), but with an unexpected glitch. 16 May 2025
Biotechnology
Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the US Food and Drug Administration (FDA), said the drug’s developer, AbbVie. 15 May 2025
Biotechnology
Swiss pharma giant Roche has won approval from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for its combination treatment of Columvi (glofitamab) alongside gemcitabine and oxaliplatin (GemOx) for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant. 17 July 2025
Pharmaceutical
Artificial intelligence has edged past the pilot phase in clinical development. Once a niche add-on, AI is now helping biopharma companies design, recruit, and run trials faster, cheaper, and—crucially—more inclusively. And regulators are starting to pay serious attention. 17 July 2025
Biotechnology
UK pharma major GSK has gained US regulatory approval for a new prefilled syringe presentation of its shingles vaccine, Shingrix (zoster vaccine), a move aimed at streamlining administration and boosting immunization coverage. 17 July 2025
Biotechnology
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biosimilars
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
A quiet shift with potentially big implications for cancer drug access is underway in the UK. In June, the country’s health technology assessor, NICE, recommended GSK’s Blenrep (belantamab mafodotin) in multiple myeloma. 14 July 2025
Pharmaceutical
Germany’s Bayer has announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). 14 July 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of Bayer's Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 14 July 2025
Generics
Even as the US Food and Drug Administration (FDA) has unveiled a strategic expansion of its oversight mechanisms for foreign manufacturing facilities supplying the American market, aiming to bolster product safety and ensure consistent quality for US consumers, the intensified oversight presents significant long-term benefits for the Indian pharmaceutical sector as a whole, reports The Pharma Letter’s India correspondent. 14 July 2025
Biosimilars
South Korea’s Samsung Bioepis today published a whitepaper titled ‘Solving the Biosimilar Void in Europe’ that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. 14 July 2025
Pharmaceutical
US biotech Crinetics Pharmaceuticals has released new data on its investigational oral therapy Palsonify (paltusotine), supporting its potential as a convenient alternative to monthly injections for patients with acromegaly. 14 July 2025
Biotechnology
Ultragenyx Pharmaceutical has been dealt a regulatory setback, as the American medicines regulator has declined to approve its gene therapy UX111 (formerly ABO-102) for Sanfilippo syndrome type A. The decision, delivered in a complete response letter, will delay any potential approval until at least 2026. 14 July 2025
Biotechnology
US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for deramiocel, the company’s lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). 11 July 2025
Pharmaceutical
At its July meeting, the European Medicines Agency’s pharmacovigilance committee (PRAC) completed its review of French specialty vaccine maker Valneva Ixchiq (chikungunya virus vaccine, a live attenuated chikungunya vaccine, following reports of serious side effects. 11 July 2025
Biotechnology
Sino-American biopharma Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China’s National Medical Products Administration (NMPA). 11 July 2025
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