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
Members of the Russian Parliament have not ruled out the possibility of the beginning forced transfer of licenses for the production of innovative drugs in Russia in case of exodus of their producers from the local market. 2 May 2023
As senior figures from the UK biopharma industry gathered in a gloomy London for the Annual Conference of The Association of the British Pharmaceutical Industry (ABPI), many speakers and panellists showed a stoic positivity despite the myriad of challenges engulfing the sector. 28 April 2023
Bipartisan US Senators Michael Bennet and Todd Young and Representative Scott Peters have reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, which would commit $6 billion to reinvigorate innovation in much needed R&D of new antimicrobials. 28 April 2023
Australian medicines regulator the Therapeutic Goods Administration (TGA) has approved the application from the local subsidiary of US mRNA vaccines specialist Moderna to transition its COVID-19 vaccine, Spikevax (elasomeran), from provisional to full registration. 28 April 2023
The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting. 28 April 2023
When it comes to getting a novel foreign-made treatment into China as quickly as possible, companies should also look into the local policies in some high-profile special zones. 27 April 2023
Shares of US drugmaker Vertex Pharmaceuticals closed down 2.6% at $323.30 yesterday, despite the firm announcing that the US Food and Drug Administration (FDA) has approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor). 27 April 2023
German generics drugmaker STADA Arzneimittel and Sweden’s Xbrane Biopharma are working together on a supply agreement for Ximluci (ranibizumab). 27 April 2023
In a first, more adult patients living with certain forms of blood cancer will now be able to access CAR T-cell therapy on the UK’s National Health Service (NHS). 27 April 2023
The US Food and |Drug Administration (FDA) has released briefing documents for the April 28, 2023, Advisory Committee Meeting (AdCom) discussing the supplemental new drug application (sNDA) for UK AstraZeneca’s Lynparza (olaparib) in first-line (1L) metastatic castration-resistant prostate cancer (mCRPC). 27 April 2023
The International Council for Harmonization (ICH) has initiated the process for a new guideline on bioequivalence requirements for the approval of medicines, which is an important milestone for global convergence. 26 April 2023
The US Food and Drug Administration (FDA) yesterday approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). 26 April 2023
Kidney disease specialist Akebia Therapeutics saw its shares lifted over 6% on Monday, following a European approval for Vafseo (vadadustat). 26 April 2023
Foghorn Therapeutics’ shares slid as much as 21% in pre-market activity on Monday, and closed down 7.9% at $6.19, after the US cancer-focused biotech announced a setback on the FHD-609 program in synovial sarcoma and SMARCB1-deleted tumors. 25 April 2023
When it comes to expensive treatments such as cell therapy, companies usually do not wish to cut price heavily to join China’s national drug procurement scheme (NDPS). Rather, they have been actively looking for some intriguing, alternative opportunities, said speakers at DJSeedin innovation partnering conference held on April 20 in Shanghai. 24 April 2023
The European Medicines Agency has provided Johnson & Johnson with its first regulatory approval for Akeega (niraparib/abiraterone acetate). 24 April 2023
French gene therapy company GenSight Biologics saw its shares crash 69% by close of trading on Friday, and fall a further 10.3% to 0.66 euros in early trading today, after it announced the withdrawal of its European regulatory filing for what could be the first gene therapy for Leber hereditary optic neuropathy (LHON) patients. 24 April 2023
US retinal disease specialist Apellis Pharmaceuticals has announced post hoc analyses from the 24-month, Phase III OAKS and DERBY studies evaluating Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 24 April 2023
The British Generic Manufacturers Association (BGMA) is seeking a judicial review of the decision on the part of the UK government to exclude it from negotiations over a future pricing framework. 24 April 2023