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
US biotech bluebird bio has had a rocky ride in gaining US approval for its Skysona (elivaldogene autotemcel), but the US Food and Drug Administration (FDA), having earlier this year extended the review period for the product, on Friday granted authorization for the gene therapy. 19 September 2022
Adding to approvals of Vabysmo (faricimab) in the major markets of the USA and Japan earlier this year, Swiss pharma giant Roche has now gained marketing clearance for the drug from the European Commission (EC) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). 19 September 2022
Significant news last week included US pharma major Bristol Myers Squibb gaining Food and Drug Administration approval for its TYK2 inhibitor Sotyktu (deucravacitinib) for the treatment of plaque psoriasis. Shares of US biotech Akero skyrocketed last Tuesday when it released very positive Phase IIb results for its efruxifermin in the treatment of non-alcoholic steatohepatitis (NASH). Also, US pharma giant Pfizer released impressive new Phase III data on its pentavalent vaccine for meningococcal disease. US biotech Gilead Sciences last week entered into a settlement with several generic drugmakers relating to copy versions of its HIV drugs Descovy and Odefsey. 18 September 2022
Following approval from the US regulator in March this year, on Friday Bristol Myers Squibb revealed that the European Commission has also cleared its fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. 17 September 2022
The European Medicines Agency’s (EMA) human medicines committee (CHMP) today released its list of recommended novel medicines and one biosimilar for approval following its September 2022 meeting. 16 September 2022
The Initiative for Medicines, Access, and Knowledge (I-MAK), a campaign group seeking to drive down the cost of medicines, has taken aim at pharma firms’ protection of their patents. 16 September 2022
The World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline, which now conditionally recommends Veklury (remdesivir) for the treatment of patients with severe COVID-19, now continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization. 16 September 2022
US agencies the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND). 16 September 2022
The US Food and Drug Administration (FDA) today announced it has approved Terlivaz (terlipressin) injection to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. 15 September 2022
Positive news from the medicines regulator yesterday saw US clinical-stage biotech Larimar Therapeutics’ shares close up 15.5% at $3.64. 15 September 2022
As global pharma majors exit South America after the coronavirus pandemic, India's Pharmexcil (Pharmaceuticals Export Promotion Council of India) is looking to promote Indian pharmaceutical exports in the Latin American and Caribbean Region. 14 September 2022
India’s Bharat Biotech International, a leading in vaccine innovation and developer of vaccines for infectious diseases, revealed that iNCOVACC (BBV154) intranasal vaccine has now received approval under Restricted Use in Emergency Situation for ages 18 and above. 14 September 2022
Spanish CNS specialist Minoryx Therapeutics said today it has filed a Marketing Authorization Application (MAA) for its lead candidate leriglitazone to the European Medicines Agency (EMA) for the treatment of adult male patients with X-linked adrenoleukodystrophy (X-ALD). 14 September 2022
The USA’s medicines cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of treatment of amyotrophic lateral sclerosis (ALS). 13 September 2022
Scientists have worked to develop a vaccine for respiratory syncytial virus (RSV) for over half a century, but there is no currently approved vaccine. 13 September 2022
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. 13 September 2022
Yesterday, Nuvaxovid (NVX-CoV2373) COVID-19 vaccine was granted expanded conditional marketing authorization (CMA) in the European Union (EU) for use as a booster vaccine for adults aged 18 and older by the European Commission. 13 September 2022
Sophisticated products in the form of biologics and large molecules, produced by living materials from humans, animals, plants, or microorganisms, are increasingly prevalent in today’s market. These types of drugs may include cell and gene therapy (CGT) products typically produced in low numbers. 13 September 2022
Indian drugmaker Zydus Lifesciences has been granted approval by the US Food and Drug Administration (FDA) to market lenalidomide capsules. 13 September 2022
American president Joe Biden has announced his intent to appoint Dr Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans. 13 September 2022