UK pharma major GlaxoSmithKline, Fondazione Telethon and Ospedale San Raffaele have submitted a marketing application to the European Medicines Agency for a gene therapy to treat patients with a rare disease. 5 May 2015
Isis Pharmaceuticals has entered into an exclusive license agreement with German pharma major Bayer to develop and commercialize ISIS-FXIRx for the prevention of thrombosis. 4 May 2015
Vernalis revealed that the US Food and Drug Administration has approved the New Drug Application for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension. 1 May 2015
The US Food and Drug Administration has approved asthma medication Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) from UK pharma major GlaxoSmithKline and US partner Theravance. 1 May 2015
The US Food and Drug Administration has approved KYTHERA Biopharmaceuticals’ Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. 30 April 2015
The USA’s Generic Pharmaceutical Association (GPhA) has submitted new comments on the Food and Drug Administration’s Proposed Rule to update generic drug labeling requirements, urging the agency to adopt the joint alternative proposal known as the Expedited Agency Review (EAR), that it has put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA). 29 April 2015
French drug major Sanofi has been granted marketing authorization in Europe for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) by the European Commission. 29 April 2015
The US Food and Drug Administration yesterday approved the first generic versions of Bristol-Myers Squibb and Japanese drugmaker Otsuka Pharmaceutical’s Abilify (aripiprazole). 29 April 2015
The US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Anglo-Swedish pharma major AstraZeneca’s Brilinta (ticagrelor) tablets for patients with a history of heart attack. 29 April 2015
Government policies that support UK pharmaceutical science and enhance export income are costing the country’s National Health Service (NHS) millions and undermine the National Institute for Health and Care Excellence. 29 April 2015
Substandard medicines from India continue to be a major problem, with the number of recalls and alerts for defective prescription drugs reaching a new crescendo, reports The Pharma Letter’s India correspondent. 28 April 2015
USA-based Amgen’s marketing application for talimogene laherparepvec (T-Vec) currently does not support it being reviewed under an accelerated approval pathway, according to briefing documents prepared by agency staff released ahead of the US Food and Drug Administration’s advisory committee meeting tomorrow. 28 April 2015
US-based BioMarin Pharmaceutical has completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for drisapersen to treat Duchenne muscular dystrophy (DMD). 28 April 2015
Swiss drug major Roche’s Avastin (bevacizumab) has been authorized in the UK in combination with standard chemotherapy for the treatment of women with advanced cervical cancer. 28 April 2015
A review of Australia’s Pharmaceutical Benefits Advisory Committee’s (PBAC) submission guidelines has been announced by the country’s Minister for Health Sussan Ley. 27 April 2015
The UK BioIndustry Association (BIA) has called for a separate framework to evaluate and commission medicines and treatments for rare and very rare diseases in response to NHS England (NHSE)’s consultation on investing in specialized services. The consultation opened in January and closes today. 27 April 2015
Privately held French biotechnology firm MedDay has announced positive results from the pivotal Phase III clinical trial, MS-SPI, with its multiple sclerosis drug candidate MD1003, at the annual meeting of the American Academy of Neurology. 27 April 2015
The European Medicines Agency has confirmed a risk of severe bradycardia or heart block when certain hepatitis C medicines are used in patients who are also taking amiodarone. 27 April 2015
A total of seven generic drugs were recommended for approval at the April 2015 meeting of the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP). 25 April 2015
The Food and Drug Administration has accepted US drugmaker AbbVie’s New Drug Application and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV). 24 April 2015
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
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