Pharma & Biotech Pricing, Policy & Regulation
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Nuvation Bio’s Ibtrozi (taletrectinib), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 12 June 2025
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Generics
Medicines for Europe, a manufacturers of generic and biosimilar trade group, today presented five trade policy recommendations to strengthen global access to medicines and enhance the competitiveness of the off-patent pharmaceutical sector in a seminar with the European Commission and Member States representatives. 17 June 2025
Biotechnology
Australian biotech CSL has announced that the US Food and Drug Administration (FDA) has approved Andembry (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. 17 June 2025
Pharmaceutical
US trade association PhRMA (Pharmaceutical Research and Manufacturers of America) has cited a new IQVIA study that found that Medicare Part D plans routinely deny access to prescribed medicines for patients with newly-diagnosed chronic conditions. 17 June 2025
Pharmaceutical
French drug developer Averoa today announced that the European Commission (EC) has granted marketing authorization for Xoanacyl (ferric citrate coordination complex). 16 June 2025
Pharmaceutical
China’s National Medical Products Administration (NMPA) held a meeting last week to conduct the 2024 annual review of the quality management system (QMS) in vaccine regulation and pharmaceutical manufacturing inspection. 16 June 2025
Biotechnology
Notable research news last week included US biopharma Avidity Biosciences announcing a positive update on its muscular dystrophy candidate delpacibart braxlosiran (del-brax), and Dutch firm NewAmsterdam released new Phase III on its investigational Alzheimer’s drug obicetrapib. US Health Secretary Robert F Kennedy Jr announced he has dismissed an independent panel of vaccine experts in order to restore trust in vaccines. Also of note, Merck & Co gained US food and Drug Administration (FDA) for its Enflonsia for the prevention of respiratory syncytial virus (RSV). 15 June 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has notified KalVista Pharmaceutical that it will not meet the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for sebetralstat, the company’s investigational oral on-demand treatment for hereditary angioedema (HAE). 14 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Pharmaceutical
South Korean drugmaker JW Pharmaceutical has received regulatory approval in China for an injectable antibiotic made with its own synthesized active ingredient, marking a strategic expansion into the Asian market. 12 June 2025
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Nuvation Bio’s Ibtrozi (taletrectinib), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 12 June 2025
Pharmaceutical
US biotech Novavax has reported that its experimental combination COVID-19 and influenza vaccine generated immune responses on par with approved shots in a descriptive Phase III trial involving older adults. The company said the results would help shape a future registrational study. 12 June 2025
Pharmaceutical
The UK’s medicines regulator has released a suite of new guidelines to steer companies through its upcoming decentralized manufacturing framework, set to come into effect on July 23, 2025. 11 June 2025
Pharmaceutical
The UK government has doubled the rate that pharma companies must repay on the sales of newer products to the National Health Service (NHS) under the statutory scheme for branded medicines in the second half of 2025, to a record 31.3%. 11 June 2025
Pharmaceutical
Gilead Sciences has paused five clinical trials of its investigational HIV drugs GS-1720 and GS-4182 after the American medicines regulator raised safety concerns. The once-weekly oral regimen was being studied as an alternative to the company’s blockbuster daily pill, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). 11 June 2025
Pharmaceutical
A fresh attempt to bring more pharmaceutical manufacturing back to US soil has put the sector on alert, as a new executive order from Donald Trump seeks to overhaul how American medicines are made and regulated. But a research note from GlobalData suggests the move could raise as many questions as it tries to answer. 10 June 2025
Biotechnology
June 10, 2025
The US Food and Drug Administration (FDA) has approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season, US pharma giant Merck & Co revealed yesterday. 10 June 2025
Pharmaceutical
US Health Secretary Robert F. Kennedy Jr has removed all 17 members of a key vaccine advisory committee, a move officials say is aimed at rebuilding public trust in the country’s immunization policies. 10 June 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
Pharmaceutical
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). 17 April 2025
Pharmaceutical
Italian pharma major Recordati today announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. 16 April 2025
Biotechnology
US mRNA specialist Moderna (Nasdaq: MRNA) has announced that its manufacturing facility in the UK has been granted a manufacturer’s license by the Medicines and Healthcare products Regulatory Agency (MHRA). 16 April 2025
Pharmaceutical
UK pharm major GSK has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in the pharmaceutical industry, the trade group’s Prescription Medicines Code of Practice Authority (PMCPA) has revealed. 16 April 2025
Pharmaceutical
US President Donald Trump has passed an executive order that answers the pharmaceutical industry’s calls for the scrapping of the Inflation Reduction Act’s (IRA) ‘pill penalty’. 16 April 2025
Biotechnology
The European Commission (EC) has at last granted the amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) Marketing Authorization (MA) in the European Union (EU). 16 April 2025
Biosimilars
Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China, making it the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody cleared for TED by the National Medical Products Administration (NMPA). 16 April 2025
Pharmaceutical
New research from consultancy Vital Transformation has shown the effects of US policy the Inflation Reduction Act’s (IRA) drug pricing provisions on biopharmaceutical investment, research and development (R&D). 15 April 2025
Biosimilars
The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis. 15 April 2025
Pharmaceutical
US gastrointestinal (GI) and rare diseases specialist Ironwood Pharmaceuticals was trading 34% lower early Monday. 14 April 2025
Generics
A Texan drug compounder cannot rely on federal law to avoid a lawsuit over copycat sales of a rheumatoid arthritis treatment, clearing the way for Zyla Life Sciences to pursue claims under state competition laws. 14 April 2025
Biotechnology
US sequencing firm PacBio is cutting jobs and reducing spending across its business as it braces for the financial impact of new global tariffs and growing uncertainty around federal research funding. 14 April 2025
Pharmaceutical
The Dutch Healthcare Authority (NZa) has published a report entitled From patent to competition – Analysis of expenditure and use of seven expensive medicines in hospital treatments. 14 April 2025
Biotechnology
The European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche announced this morning. 14 April 2025
Biotechnology
Shares in US biotech Novavax fell more than 20% before the weekend, following remarks from health and human services secretary Robert F Kennedy Jr, who questioned the scientific basis of the company’s COVID-19 vaccine in a televised interview. 14 April 2025
Pharmaceutical
New regulations for running clinical trials in the UK have now been signed into law, the Medicines & Healthcare products Regulatory Agency (MHRA) announced on Friday. 14 April 2025
Pharmaceutical
According to the country’s trade group LIF, Sweden must be a driving force in the European Union (EU) to ensure that pharmaceuticals continue to be exempt from tariffs and that a negotiated solution with the US must be reached. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Biotechnology
US mRNA specialist Moderna has announced that the German Standing Committee on Vaccination (STIKO) has issued a recommendation for mRESVIA, the company’s RSV vaccine available in a pre-filled syringe (PFS). 11 April 2025
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