Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 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 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
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
Earlier this month, the China Food and Drug Administration (CFDA) formally launched a new classification system for chemical drugs, with the release of the Reform Scheme of the Classification System for Registration of Chemical Drugs. 28 March 2016
In 2015, the US Food and Drug Administration set a new record for the number of drugs approved in one year, with 56 drugs getting the green light from the federal agency. 28 March 2016
The US Food and Drug Administration has approved Cinqair (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. 24 March 2016
The US Food and Drug Administration (FDA) has approved Eli Lilly’s monoclonal antibody Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis, it has been announced. 23 March 2016
Anglo-Swedish pharma firm AstraZeneca has reported disappointing top-line results from the Socrates trial testing the efficacy of Brilinta (ticagrelor) tablets to prevent strokes. 23 March 2016
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food and Drug Administration yesterday announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. 23 March 2016
US pharma firm Vertex has slammed the UK cost watchdog, the National Institute for Health and Care Excellence (NICE), for its failure to recommend the company’s treatment for cystic fibrosis. 23 March 2016
In the next five years, where is China’s pharma industry heading to? How should pharma companies allocate their resources to ensure the reward? The answers lie in the recently released guidance for the pharma industry five-year development from China’s top authority – the State Council, reports The Pharma Letter’s local correspondent Wang Fangqing. 22 March 2016
The US subsidiary of Japanese pharma major Eisai has agreed to revise the joint promotion agreement with Switzerland’s Helsinn Healthcare for their chemotherapy-induced nausea and vomiting (CINV) franchise. 22 March 2016
Australian regulator the Therapeutics Goods Administration (TGA) has been closely monitoring reports of adverse events following immunization with Bexsero meningococcal B vaccine, specifically those relating to fever in infants and children. 22 March 2016
US biopharmaceutical firm Elusys Therapeutics has received Food and Drug Administration approval for its Anthim (obiltoxaximab) injection for the treatment of inhalational anthrax. 22 March 2016
The UK cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has recommended abiraterone for some prostate cancer patients in a move described as “a big victory for men” by London-based charity The Institute of Cancer Research (ICR). 21 March 2016
German drug cost-effectiveness regulator the German Institute for Quality and Efficiency in Health Care (IQWiG) has released results of several recent reviews on cancer drugs, coming to various conclusions. 21 March 2016
Latest figures show that the Spanish pharmaceutical industry invested 382 million euros ($431 million) in contracts with the National Health system during 2014, maintaining once again its leading position in the private sector as far as public-private collaboration in Spain is concerned. 21 March 2016
Novartis says that the UK’s National Institute for Health and Care Excellence (NICE) has now recommend Entresto (sacubitril/valsartan) in its final draft guidance. 21 March 2016
In a surprise move last week, the charity Médecins Sans Frontières (MSF), for the first time ever, filed a ‘patent opposition’ in India, with the aim of preventing US pharma giant Pfizer from getting a patent on the pneumococcal conjugate vaccine (PCV13), sold under the Prevenar trade name. 20 March 2016
Shares of USA-based Eagle Pharmaceuticals slumped on Friday afternoon, after the Food and Drug Administration rejected its drug Kangio (bivalirudin injection). 19 March 2016
Following the announcement last week that it had been asked by the European Commission to start a review of the cancer medicine Zydelig (idelalisib), relating to concerns over serious adverse events in ongoing clinical trials, the European Medicines Agency’s today said its Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using to ensure that the drug continues to be used as safely as possible. 18 March 2016
The US Generic Pharmaceutical Association (GPhA) welcomed the holding of Senate Aging Committee discussions on Thursday over what it calls the ‘anti-competitive business practices’ of some brand manufacturers to stifle generics. 18 March 2016