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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
The European Commission (EC) has decided not to adopt the European Medicines Agency’ human medicines committee CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation. 21 May 2024
On Monday, the US Food and Drug Administration (FDA) approved Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy) as the first interchangeable biosimilars referencing Regeneron’s Eylea (aflibercept). 21 May 2024
The US Food and Drug Administration (FDA) announced the final withdrawal of the approval of BridgeBio Pharma Truseltiq (infigratinib) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma. 20 May 2024
As the Indian pharmaceutical industry is propelled by government initiatives to transition from its traditional focus on generic drug production to the development of high-value, innovative products, domestic pharma majors are advocating for a robust US-India trade partnership. 20 May 2024
Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to a report by the Irish Pharmaceutical Healthcare Association (IPHA), which represents the research-based biopharmaceutical industry. 20 May 2024
Shares of HLB Pharma plunged almost 30% to 67,100 won on Friday to their daily price floors, as the US Food and Drug Administration (FDA) rejected a new drug approval for rivoceranib, the Korean firm’s liver cancer treatment, according to a Korea Times report. 18 May 2024
The US Food and Drug Administration has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. 17 May 2024
Japanese drugmaker Ono Pharmaceutical has received supplemental approvals for the BRAF inhibitor Braftovi (encorafenib), and the MEK inhibitor Mektovi (binimetinib), when used in combination, in Japan for two new indications. 17 May 2024
At its meeting this week the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reviewed medicines regarding their safety. 17 May 2024
The USA’s House Committee on Oversight and Accountability held a markup meeting yesterday to consider a series of bills that address federal agency procurement of biotechnology equipment, safeguarding taxpayer dollars, improving federal cybersecurity, and more. 16 May 2024
The US Food and Drug Administration yesterday granted accelerated approval to Breyanzi (lisocabtagene maraleucel; liso-cel), from US pharma major Bristol Myers Squibb, for a new indication. 16 May 2024
A US Food and Drug Administration (FDA) panel will consider Lykos Therapeutics’ filing for midomafetamine capsules (MDMA) as a therapy-assisted treatment for post-traumatic stress disorder (PTSD) in early June. 15 May 2024
Japanese drugmaker Eisai has started the rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Leqembi (lecanemab-irmb) subcutaneous (SC) autoinjector for weekly maintenance dosing. 15 May 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for Heplisav-B vaccine, said US immunotherapy specialist Dynavax Technologies. 15 May 2024
Four-year data from the SELECT trial will significantly bolster Novo Nordisk’s bid to become the GLP-1 company of choice for payers and prescribers. 15 May 2024
A new study by diabetes awareness website Diabetes Strong reveals that “How to get Ozempic” is the most googled question about the medication. 14 May 2024
USA-based biotech Ajax Therapeutics today announced the completion of an oversubscribed $95 million Series C financing, led by Goldman Sachs with participation from new investors, including Eli Lilly. 13 May 2024