The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
The National Institute for Health and Care Excellence (NICE) has recommended access Vabysmo (faricimab) for the treatment of adults with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
Following an inspection from the US medicines regulator, a manufacturing site run by Indian active pharmaceutical ingredient (API) specialist Aparna Pharmaceuticals has received a VAI classification. 12 February 2024
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Japan’s Chugai Pharmaceutical (TYO: 4519), has been approved by China’s National Medical Products Administration (NMPA) for treatment of PNH. 8 February 2024
Hong Kong-listed biotech BeiGene has received Health Canada authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL). 8 February 2024
The USA’s Federal Trade Commission yesterday issued a comment in response to the National Institute of Standards and Technology’s (NIST) request for information on its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights under the Bayh-Dole Act. 7 February 2024
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has licensed subcutaneous (SC) injectable Vyvgart (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. 7 February 2024
The share of cheap drugs in the Russian pharmaceutical market is steadily declining, while in the last three years their overall range in the market has declined two-fold, reports The Pharma Letter’s local correspondent. 7 February 2024
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics’ made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease with vaso-occlusive crisis. 6 February 2024
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
In the USA, the House of Representatives have voted overwhelmingly in favor of legislation which would restore the ability of drugmakers to fully expense R&D costs incurred within the same tax year. 5 February 2024
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan, from Novartis and danicopan from AstraZeneca’s rare diseases unit Alexion, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 2 February 2024
Yesterday, the US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), said it is sending initial offers to the participating drug companies of the first 10 prescription drugs selected for negotiation in the first cycle of the Medicare Drug Price Negotiation Program. 2 February 2024
A new cell and gene therapy initiative from the USA's White House will launch with an initial focus on treatments for sickle cell disease (SCD). 1 February 2024
Adaptimmune Therapeutics saw its shares leap almost 10% by close of trading Wednesday and a further 5.2% to $1.01 in after-hours trading as it announced a regulator development for its cell therapy. 1 February 2024
The UK’s health technology assessor the National Instituted for Health and Care excellence (NICE) has recommended Tepkinly (epcoritamab), from US pharma major AbbVie, as a treatment option for eligible adults with an aggressive and fast-growing blood cancer. 1 February 2024