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
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
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