Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
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
As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. 12 October 2014
At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee (PRAC) concluded three safety reviews. 10 October 2014
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with the local subsidiary of Swiss pharma giant Novartis involving the listing of nine new products and amendments to the listing of seven other products. 10 October 2014
In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Swiss pharma giant Novartis’ multiple sclerosis drug Gilenya (fingolimod) offers an added benefit over the appropriate comparator therapy in this patient group. 10 October 2014
US biotech firm Biogen Idec has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc; recombinant factor VIII Fc fusion protein) to the European Medicines Agency. 10 October 2014
US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted Orphan Drug Designation for DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. 9 October 2014
The UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance for the NHS’ management of multiple sclerosis. 9 October 2014
One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive of Drayson Technologies and previous minister for science and innovation, was that the country needs to give incentives for investors to hold their investment for more than 10 years. 8 October 2014
Australian regulator the Therapeutic Goods Administration (TGA) has completed a review of the cardiovascular risks associated with the use of the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam. 8 October 2014
Bristol-Myers Squibb has decided that it will not pursue US Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the USA. 8 October 2014
The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm Cell Therapeutics (Nasdaq: BCLI) as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). 7 October 2014
The US Food and Drug Administration has approved biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept) Injection for the treatment of macular edema following retinal vein occlusion (RVO). 7 October 2014
US drugmaker AbbVie has received approval from the US Food and Drug Administration for an extension of the approved indications for Humira. 6 October 2014
Anglo-Swedish pharma major AstraZeneca today confirmed that the American Heart Association (AHA) and American College of Cardiology (ACC) have updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes (NSTE-ACS). 6 October 2014
Transparency advice for Japanese pharma major Eisai’s Zonegran (zonisamide) monotherapy in the treatment of partial seizures, with or without secondary generalization, in adults with newly-diagnosed epilepsy, has been published by the French National Authority for Health (HAS). 6 October 2014
When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar or conventional/synthetic products and regardless of whether treatment is done in hospital or the primary sector, writes Mads Tang Dalsgaard, country director of Amgen in a blog posted on the web site of the Danish Pharmaceutical Association (LIF). 6 October 2014
The US Food and Drug Administration has granted orphan drug designation for Ireland-headquartered specialty biopharma firm Horizon Pharma’s Actimmune (interferon gamma-1b) for the treatment of Friedreich's ataxia (FA). 4 October 2014
Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan for the synthetic broad-spectrum oral antibacterial agent Cravit (levofloxacin hemihydrate) for the treatment of pulmonary and other tuberculosis disorders. 3 October 2014
US drug major Eli Lilly has received marketing authorization from the European Commission for its Humalog KwikPen 200 units/ml (insulin lispro) in the treatment of diabetes in adults. 3 October 2014
US specialty pharma firm Ariad Pharmaceuticals says that its investigational cancer drug AP26113 has received Breakthrough Therapy designation by the US Food and Drug Administration. 3 October 2014