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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
In a recent comment letter to US President Biden’s trade ambassador, Pharmaceutical Research and Manufacturers of America (PhRMA) encourages the Office of the US Trade Representative (USTR) to strengthen medical supply chains by negotiating meaningful trade agreements. 26 April 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published its Final Draft Guidance (FDG) on a combination therapy from Swiss pharma giant Novartis. 25 April 2024
The UK’s second-largest drugmaker, GSK, expects to hear by the end of August whether the US regulator will expand the label for Jemperli (dostarlimab). 25 April 2024
Colombia’s government yesterday issued its first-ever compulsory license (CL) for use by the country’s Ministry of Health, to improve access to less-expensive generic versions of the key HIV medicine dolutegravir. 25 April 2024
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. 25 April 2024
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis company). 24 April 2024
US biopharma Abeona Therapeutics was trading nearly 50% lower in Tuesday morning’s trading after announcing a regulatory update for prademagene zamikeracel (pz-cel). 23 April 2024
Following an earlier snub, the US Food and Drug Administration has now approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG). 23 April 2024
A first-in-class treatment for paroxysmal nocturnal hemoglobinuria (PNH), Voydeya (danicopan), has been granted marketing authorization in Europe. 23 April 2024
Following a positive recommendation last month by the European Medicines Agency’s (EMA) human medicines committee (CHMP), today the European Commission (EC) granted marketing authorization for Emblaveo (aztreonam-avibactam) from Pfizer. 22 April 2024
The European Commission (EC) has granted marketing authorization for the interleukin (IL)-17A and IL-17F inhibitor Bimzelx (bimekizumab), from Belgian drugmaker UCB's, for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 22 April 2024
Menarini Stemline has welcomed the publication of final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending the use of Nexpovio (selinexor) alongside bortezomib and dexamethasone, for eligible multiple myeloma patients who have received one or two prior treatments. 22 April 2024
The European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), said Swiss generics and biosimilars company Sandoz. 22 April 2024
The European Federation of pharmaceutical Industries Associations (EFPIA) and its members support the European Union (EU) leaders call for a new European Competitiveness Deal and call for a dedicated Health and Life Sciences Strategy as part of the wider strategy. 22 April 2024