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
How the issue of affordability is addressed around Europe was discussed at the Association of the British Pharmaceutical Industry’s (ABPI) annual conference in London yesterday. 24 April 2015
The US Food and Drug Administration has granted Priority Review to German family-owned drug major Boehringer Ingelheim’s Biologics License Application (BLA) for idarucizumab. 23 April 2015
Japanese drugmaker Ono Pharmaceuticals has submitted an additional indication application for the human anti-human programmed cell death-1 (PD-1) monoclonal antibody Opdivo (nivolumab). 23 April 2015
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation for Swiss pharma giant Novartis’ investigational medicine for patients with heart failure (HF) with reduced ejection fraction, LCZ696 (sacubitril/valsartan). 23 April 2015
Orexigen Therapeutics and partner, Japan’s Takeda Pharma have received notification of a Paragraph IV certification for certain patents for their weight management product Contrave (naltrexone HCl and bupropion HCl extended release). 22 April 2015
Pfizer says that its Xalkori (crizotinib) has received Breakthrough Therapy designation from the US Food and Drug Administration for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). 22 April 2015
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment whether Xtandi (enzalutamide), from Medivation and Japanese drug major Astellas Pharma, offers an added benefit over the appropriate comparator therapy for men who have metastatic prostate cancer. 21 April 2015
Ireland-headquartered Actavis, which recently completed the $66 billion acquisition of Allergan, says that the US Food and Drug Administration has approved an expansion of the Botox (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. 20 April 2015
Sweden’s Oasmia Pharmaceutical said today that its lead cancer product Paclical has received market authorization by the Russian Ministry of Health. 20 April 2015
US pharma giant Merck & Co says it has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer. 20 April 2015
In Spain last week, authorities, professionals and health care organizations, patients and the pharmaceutical industry gathered together during the Conference “Transparency as a generator of trust,” organized by Spanish pharma trade group Farmaindustria, precisely to discuss and progress in this field. 20 April 2015
The majority of clinical development plans submitted for scientific advice to the European Medicines Agency prior to a marketing authorization application were found not suitable for future benefit-risk assessment. 20 April 2015
A very small study for privately-held US firm Genervon Biopharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug GM604 has raised questions about the data that were provided by the company. 19 April 2015
Anglo-Swedish drug major AstraZeneca has been granted orphan drug designation by the US Food and Drug Administration for selumetinib, and has announced updated progression-free survival data for AZD9291. 17 April 2015
The US Food and Drug Administration yesterday approved the first generic version of Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). 17 April 2015
A committee of the US Food and Drug Administration has voted 9-2 in support of the approval of The Medicines Company’s cangrelor as an adjunct to percutaneous coronary intervention to reduce the risk of periprocedural thrombotic events 16 April 2015
Anglo-Swedish drug major AstraZeneca has been granted orphan drug designation by the US Food and Drug Administration for tremelimumab in the treatment of malignant mesothelioma. 16 April 2015
Shares of US biotech major Amgen rose 1.8% to $168.41 in after-hours trading on Wednesday, following the news that the US Food and Drug Administration has granted approval of its heart failure drug Corlanor (ivabradine). 16 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