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
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
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
The US Food and Drug Administration has granted Breakthrough Therapy designation to Swiss biotech firm Novimmune’s NI-0501 for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory disease, or with recurrent or progressive disease during conventional therapy. 18 March 2016
Allergan today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market paclitaxel protein-bound particles for injectable suspension. 17 March 2016
The US Federal Trade Commission (FTC) has urged the Court of Appeals to correct four errors in a district court’s analysis of an alleged reverse-payment agreement involving UK pharma giant GlaxoSmithKline and generics firms Teva Pharmaceuticals and Anchen Pharmaceuticals. 17 March 2016
The UK government has committed to renegotiate its membership of the European Union and to giving the UK electorate the chance, in a referendum, to choose between the revised membership terms or “Brexit.” 17 March 2016
Alleged failures to follow regulations by US pharma company Orexigen Therapeutics in its trial of obesity drug Contrave must not “become a trend,” former US Food and Drug Administration (FDA) deputy commissioner Joshua Sharfstein told The Pharma Letter. 17 March 2016
The US Food and Drug Administration has approved Bayer's Kovaltry (octocog alfa; antihemophilic Factor [recombinant]), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. 17 March 2016
Drugs cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending talimogene laherparepvec as an option for people with melanoma that has spread and can’t be surgically removed. 16 March 2016
Stephen Ubl, president and chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA), is optimistic that the association’s series of policy proposals can help to prompt a bright new period in drug discovery. 15 March 2016
Allergan has received a Complete Response Letter from the US Food and Drug Administration for its Prior Approval Supplement for its Restasis (cyclosporine ophthalmic emulsion) container. 15 March 2016
A small notification by Indian drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has ensured that drug formulations under price control have risen to over 800, reports The Pharma Letter’s India correspondent. 15 March 2016
The US Food and Drink Administration has granted Roche’s cancer immunotherapy atezolizumab (anti-PDL1; MPDL3280A) priority review for advanced bladder cancer. 15 March 2016
Increases in anti-depressant usage by children have come about because of the decisions of the general practitioners (GPs) and other health professionals prescribing them, pharma companies have said. 15 March 2016
KemPharm says that a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has been scheduled for May 5, to review its New Drug Application for KP201/APAP. 14 March 2016
PTC Therapeutics says it intends to submit the results of the recently completed Phase III ACT DMD study for review by drugs regulatory Health Canada as part of the New Drug Submission (NDS) for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD). 14 March 2016
Following the AIDS crisis in the 1980s, the US FDA, in response to criticism of slow drug approvals, introduced the first of its expedited approval processes – Accelerated Approval, writes Dr Nicola Davies in her monthly exclusive article for The Pharma Letter. 14 March 2016
The European Medicines Agency has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), following concerns over serious adverse events in ongoing clinical trials. 12 March 2016
The US Food and Drug Administration on Friday approved pharma giant Pfizer’s Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. 12 March 2016