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 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
US biotech Seattle Genetics closed up 2.6% at $136.87 on Friday after it revealed that the US regulator had granted approval for its new cancer drug, well ahead of the expected action date of August 20, 2020. 18 April 2020
National Health Expenditure (NHE) projections in the USA suggest growth in spending could average 5.4% for 2019 to 2028, reaching nearly 20% of gross domestic product (GDP) by the end of the period. 17 April 2020
US drug developer Lipocine today announced that the US Food and Drug Administration denied the Citizen Petition filed by Clarus Therapeutics on October 2, 2019. 17 April 2020
Antibody specialist SAB Biotherapeutics has announced it has been awarded “expanded scope” by the US authorities in its program to develop a therapeutic for COVID-19. 17 April 2020
Biocon Biologics India, a subsidiary of India’s Biocon, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. 16 April 2020
Australian drugmaker Mayne Pharma closed trading today up 11.6% at A$0.385, after saying it has submitted a New Drug Application (NDA) to the US Food and Drug Administration, seeking marketing authorization for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy. 16 April 2020
According to the latest news from Science and Technology Daily (April 14), two COVID-19 inactivated vaccines were just approved for a Phase I & II combined clinical trial by China’s National Medical Products Administration (NMPA), making them the first batch in this category. 16 April 2020
The Food and Drug Administration late yesterday granted expedited approval for Jelmyto (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). 16 April 2020
The Russian government and representatives of some of leading drugmakers operating in the local market have confirmed they will ensure uninterrupted supplies of drugs and vaccines against COVID-19 to Russia, in anticipation of a significant increase on the number of people infected with coronavirus, according to recent statements by representatives of producers, reports The Pharma Letter’s local correspondent. 15 April 2020
China recently issued the amended version of drug registration regulation, effective on July 1, reports The Pharma Letter’s local correspondent Wang Fangqing. 14 April 2020
Kolon Life Science has announced that the clinical hold issued by the US Food and Drug Administration in April 2019 has been lifted effective April 10, 2020, and that the company can continue with its knee osteoarthritis (OA) Phase III clinical trial of Invossa (TG-C). 14 April 2020
A Supplementary Protection Certificate (SPC) is an extremely valuable prize for the pharmaceutical patent owner as it extends the patent life of an authorised medicine for up to five years at a time when a successful drug is likely to be well established and at the top of its earning power. 14 April 2020
The Association of International Pharmaceutical Manufacturers (AIPM), uniting more than 60 leading world pharmaceutical companies in Russia, says it is doing everything possible to coordinate the efforts of the industry and support the state in combating the COVID-19 pandemic. 13 April 2020
The US Food and Drug Administration on Friday approved Koselugo (selumetinib) for the treatment of pediatric patients, two years of age and older, with neurofibromatosis type 1 (NF1), a genetic disorder of the nervous system causing tumors to grow on nerves. 11 April 2020
The Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Braftovi (encorafenib) from Array BioPharma, which was acquired last July by Pfizer in an $11.4 billion deal. 10 April 2020
The leading trade group representing the European pharma industry has released guidance on managing clinical trials under the changing circumstances brought about by the COVID-19 pandemic. 9 April 2020
Germany’s Merck KGaA and US pharma giant Pfizer today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). 9 April 2020
Indian generic drugs major Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for albuterol sulfate Inhalation aerosol 90mcg from the US Food and Drug Administration. 9 April 2020
"IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics."
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