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
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 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 US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy). 11 October 2022
The UK’s BioIndustry Association (BIA), the trade body for innovative life sciences, has welcomed a one-year extension to the European Commission Decision Reliance Procedure (ECDRP). 11 October 2022
German pharma major Bayer had a boost for its Kerendia (finerenone), a non-steroidal mineralocorticoid receptor antagonist, with an important endorsement for the drug’s use. 11 October 2022
In what could be a paradigm shift in the treatment of congestion due to worsening heart failure, the US Food and Drug Administration (FDA) has approved Furoscix (furosemide injection). 10 October 2022
Privately-held Covis Pharma knows what it is up against from the US Food and Drug Administration (FDA) as the regulator attempts to have the company’s preterm birth (PTB) drug Makena (hydroxyprogesterone caproate) withdrawn from the market. 10 October 2022
Commenting on a much-anticipated meeting of representatives of the Greek pharmaceutical sector with the Ministry of Health, the national trade group, the Hellenic Association of Pharmaceutical Companies (SFEE), concluded that it was fruitless. 10 October 2022
CPI, a social enterprise backed by UK government funding, has opened the doors of its new RNA Centre of Excellence and RNA Training Academy. 7 October 2022
Competition for Novo Nordisk’s recently-approved weight loss drug Wegovy (semaglutide) is coming quickly, with Eli Lilly securing Fast Track designation for its rival therapy. 7 October 2022
On Friday, the US Food and Drug Administration approved Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. 7 October 2022
Eiger BioPharmaceuticals’ hopes of grasping an emergency use authorization (EUA) for peginterferon lambda as a treatment of patients with mild-to-moderate COVID-19 have been all but ended. 6 October 2022
The Russian government plans to speed up the development and production of domestic drugs against rare diseases amid the ever tightening pressure caused by sanctions on the country due to its military conflict with Ukraine. 6 October 2022
Market authorization was granted to 92 new medicines in the European Union (EU) last year.Market authorization was granted to 92 new medicines in the European Union (EU) last year. 5 October 2022
The ability of patent holders to preserve their market exclusivity, a lack of consumer understanding and other factors have held up the widespread adoption of biosimilars in the USA compared to other markets. 5 October 2022
The US Government has expressed a vote of confidence in Vir Biotechnology, awarding the company a multi-year contract to advance the development of a full portfolio of innovative medicines. 5 October 2022
The US Department of Health and Human Services (HHS) said yesterday that it is implementing Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act to go into effect. 4 October 2022
The US Food and Drug Administration (FDA) has added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving the drug of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld, which is marketed by UK pharma major AstraZeneca. 4 October 2022
Melatonin, a natural hormone that is produced by the pineal gland and used by many long-haul airline travellers to mitigate their jet-lag symptoms, has gained its first approval in the UK, but as a treatment for sleep onset insomnia in children and adolescents aged six-17 years with attention-deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been inadequate. 4 October 2022
Indian generics major Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market mirabegron extended-release tablets USP 25mg and 50mg. 3 October 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) for Olumiant (baricitinib) for the treatment of severe alopecia areata (AA) in adult patients. 3 October 2022