Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), an unpredictable and debilitating skin disease, also referred to as chronic hives. 23 March 2014
German family-owned drug major Boehringer Ingelheim and partner Eli Lilly of the USA have announce a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of the investigational sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin. 23 March 2014
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for US pharma giant Merck & Co and partner Endocyte’s Vynfinit (vintafolide) for the treatment of women with a subtype of platinum-resistant ovarian cancer for which there is limited approved treatment option. 21 March 2014
Takeda Pharmaceutical, Japan’s largest drugmaker, today received a positive opinion form the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP) for Entyvio (vedolizumab). 21 March 2014
The European Medicines agency’s Committee for Medicinal Products for Human Use has issued positive opinions for expanded use of Danish diabetes care giant Novo Nordisk’s Tresiba (insulin degludec) and Victoza (liraglutide) in type 2 diabetes. 21 March 2014
US biotech firm Biogen Idec has announced that Health Canada has approved Alprolix for the control and prevention of bleeding episodes and routine prophylaxis in adults with hemophilia B. 21 March 2014
The UK’s Joint Committee on Vaccination and Immunization has recommended that the meningitis B vaccine Bexsero should be given to all babies in the UK as part of the national immunization program, having last year concluded that the product was not cost-effective.
. 21 March 2014
There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially lifted the clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). 21 March 2014
In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended US health care giant Johnson & Johnson subsidiary Janssen’s Velcade (bortezomib) as a treatment for some patients with newly-diagnosed multiple myeloma. 21 March 2014
The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in people aged 10 to 25 years. 20 March 2014
The Brazilian Senate's Social Affairs Committee (CAS) held a hearing on March 18 to debate the progress and challenges of clinical research of medicines in Brazil. The event was attended by representatives of the government's regulatory agencies involved in human clinical research as well as and members of the scientific communities in the country, says Juliane Carvalho writing on Brazil Pharma News. 20 March 2014
The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Paladin was acquired by the USA’s Endo Health Solutions in a $1.6 billion deal completed last month (The Pharma Letter November 6 2013). 20 March 2014
This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in the third quarter of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. 19 March 2014
The European Union must remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules, according to a statement following the European Generic medicines Association 10th Legal Affairs Forum. 19 March 2014
The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit of ipilimumab, US pharma major Bristol-Myers Squibb’s Yervoy, this time seeing the data as uncertain. 19 March 2014
Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application with the US Food and Drug Administration seeking approval of Xtandi (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer who have not received chemotherapy. 18 March 2014
The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of US biotech firm Biogen Idec’s Biologics License Application for Plegridy (peginterferon beta-1a), a subcutaneous pegylated interferon candidate for relapsing forms of multiple sclerosis (RMS). 18 March 2014
UK specialty pharma company the Clinigen Group today announced that the European Commission has ratified the positive opinion in January 2014 from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to lift the Europe-wide suspension of Marketing Authorization for Vibativ (telavancin). 18 March 2014
Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy.” 18 March 2014
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
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