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
Following recent results on the potential of dexamethasone in COVID-19, Seattle’s AVM Biotechnology has announced plans to launch its formulation of the drug for affected people. 18 June 2020
A review of clinical trial data suggests that increasing numbers of COVID-19 hydroxychloroquine studies will be nixed in the coming months. 18 June 2020
TG Therapeutics has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration requesting accelerated approval for umbralisib as a treatment for patients with previously-treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). 18 June 2020
Even as China settles down post COVID-19, the Indian pharmaceutical industry is bracing itself for a reduction in profit margins in the short term, given the expected rise in the prices of active pharmaceutical ingredients (API) and key starting materials (KSM). Aiming to reduce import dependency and to attain self-reliance and drug security, the Indian government has decided to provide incentives to the pharmaceutical industry, reports The Pharma Letter’s India correspondent. 17 June 2020
The US Food and Drug Administration granted accelerated approval for an additional indication for Keytruda (pembrolizumab), Merck & Co’s best-selling drug with 2019 sales of $11.08 billion, and already approved for a number of cancer indications. 17 June 2020
Cosentyx (secukinumab), the only fully-human biologic directly targeting IL-17A, has picked up a new approval for a fourth indication in the USA. 17 June 2020
India is set to impose anti-dumping duty on Chinese antibacterial drug ciprofloxacin hydrochloride in order to guard its domestic industry from cheap imports from the Asian neighbor. 17 June 2020
The first ever therapy for active and adult-onset Still’s disease (AOSD) has been approved in the USA, providing hope for people with the rare autoinflammatory condition. 17 June 2020
London-listed biotech firm PureTech Health’s founded entity, Akili Interactive, has gained US Food and Drug Administration clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). 16 June 2020
Global drugmakers operating in Russia have called on the national government to lift the existing “third excess,” norm - the rule, limiting the participation of foreign drugmakers in state tenders in Russia. 16 June 2020
The International Coalition of Medicines Regulatory Authorities (ICMRA) held its regular virtual meeting of global regulators last week to discuss high-level policy issues and regulatory approaches to ensure a coordinated response to the COVID-19 pandemic. 16 June 2020
The US Food and Drug Administration has approved Lyumjev (insulin lispro-aabc) injection, 100 units/mL and 200 units/mL, a new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. 16 June 2020
The US Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 16 June 2020
On Monday, the US Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. 16 June 2020
Faced with COVID-19, Brexit and the transition to a new executive director, the European Medicines Agency (EMA) has been presented with the perfect storm of challenges that have landed on its plate thick and fast. 15 June 2020
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has granted a positive final appraisal document (FAD) for the use of Rozlytrek (entrectinib) in adults with ROS1-positive non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 15 June 2020
The US Food and Drug Administration as approved ViiV Healthcare’s Tivicay PD (dolutegravir) tablets for oral suspension for the treatment of HIV-1 infection in children as young as four weeks old and weighing at least 3kg, in combination with other antiretroviral treatments, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in pediatric HIV patients weighing 20kg and above. 13 June 2020
Under the agency’s accelerated review scheme, the US Food and Drug Administration on Friday approved an expanded indication for Gardasil 9 (human papillomavirus 9-valent vaccine) for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. 13 June 2020
The US Food and Drug Administration on Thursday approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD), also called Sjögren’s syndrome, in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). 12 June 2020
The European Medicines Agency has validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) under development by privately-held Danish dermatology specialist LEO Pharma. 12 June 2020