The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 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
The European Commission (EC) on Friday approved Reblozyl (luspatercept), developed by Celgene, which is now part of US pharma major Bristol-Myers Squibb under a $74 billion buy-out that completed in November 2019, and Acceleron Pharma. 27 June 2020
At its June meeting, the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) issued positive opinions on a number of new medicines as well as biosimilars. The opinions will now be sent to the European Commission for the adoption of a decision, which normally takes two to three months 26 June 2020
The US Food and Drug Administration yesterday approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients aged two and older. 26 June 2020
The UK’s reimbursement agency has provided a positive decision on funding for Rozlytrek (entrectinib), making it the second histology-independent treatment available through the country’s National Health Service (NHS). 26 June 2020
The US regulator has rebuffed a submission for abicipar pegol, a novel, investigational therapy for neovascular (wet) age-related macular degeneration (nAMD). 26 June 2020
Unlike in Scotland, where abiraterone acetate was recommended earlier this year, men in England and Wales with newly-diagnosed high-risk, metastatic hormone-sensitive prostate cancer (mHSPC) denied access to a life-extending treatment option. 26 June 2020
The UK’s reimbursement agency has recommended against using the novel multiple sclerosis (MS) therapy Mayzent (siponimod), in draft guidance. 25 June 2020
The European Medicines Agency (EMA) Management Board has announced its nomination for the new executive director of the Agency to replace the outgoing Professor Guido Rasi, who is due to end his term in the position that he has held since 2011 (minus an off-stint due to a controversy over the selection procedure). 25 June 2020
Japanese pharma major Eisai has received marketing approval of Equfina (safinamide mesylate) for treatment of idiopathic Parkinson’s disease as adjunctive therapy with levodopa-containing products in patients with end of dose motor fluctuations from South Korea’s Ministry of Food and Drug Safety). 25 June 2020
The Institute for Clinical and Economic Review (ICER), a Boston, USA-based cost effectiveness watchdog, has updated its pricing model for remdesivir in COVID-19. 25 June 2020
American biotech firm Regeneron Pharmaceuticals is the subject of a legal action from the US government, alleging kickbacks were paid to a charity to illegally promote sales of Eylea (aflibercept). 25 June 2020
Faced with the unprecedented international urgency of the COVID-19 pandemic, global regulators have again held a meeting to discuss what they can do to ensure a quick, safe and effective vaccine. 24 June 2020
Authorities in the UK have reclassified Epidyolex (cannabidiol) as a Schedule 5 drug, the lowest level of control, making it easier for the company to distribute the therapy. 24 June 2020
There is good news for oncology specialist Innate Pharma, which has been told by the US regulator that a partial clinical hold on the Phase II TELLOMAK study has been lifted. 24 June 2020
The US Food and Drug Administration yesterday launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). 24 June 2020
The COVID-19 pandemic in Russia has resulted in an increase of drug sales in the local market and led to liberalization of the domestic legislation for pharma products, according to recent statements by some leading Russian drugmakers and local analysts, reports The Pharma Letter’s correspondent. 23 June 2020
Akili, a funded entity of London-listed biotech firm PureTech Health, today announced that it has received a Conformité Européenne (CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with attention deficit hyperactivity disorder (ADHD). 23 June 2020
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinion for idebenone for patients with Duchenne muscular dystrophy (DMD) in respiratory function decline who are not taking glucocorticoids. 23 June 2020