Ukraine’s pharmaceutical trade association APRaD, in cooperation with organizations representing international pharmaceutical manufacturers and business in general such as US-Ukraine Business Council, Association of International Pharmaceutical Manufacturers AIMP Ukraine and Indian Pharmaceutical Manufacturer’s Association (IPMA), has signed a letter concerning actions of law enforcement in the Ukraine pharmaceutical market. 17 October 2016
The pharmaceutical industry based in Spain will invest around 200 million euros ($220 million) over the next two years in order to adapt its production lines thus incorporating the technical requirements of the new system for the unitary verification of medicines. 17 October 2016
The US Food and Drug Administration and representatives from the generic drug industry have reached an agreement in principle on proposed recommendations for the first reauthorization of the generic drug user fee program. 15 October 2016
The Netherlands Medicines Evaluation Board (MEB) wants manufacturers of over-the-counter medicinal products to list the shelf life after opening on the packaging. 15 October 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new branded medicines for approval at its October 10-13 meeting. 14 October 2016
The UK’s National Institute for Health and Care Excellence (NICE) has proposed changes to the way it appraises new treatments that could see patients benefiting from the most cost effective treatments nearly three months faster than is currently the case. 14 October 2016
The US Food and Drug Administration has advised specialty drugmaker Egalet that it will not meet the previously announced October 14 prescription drug user fee act (PDUFA) date for the company’s Arymo ER (morphine sulfate). 14 October 2016
The US Food and Drug Administration has accepted for review the New Drug Application (NDA) from Sunovion Pharmaceuticals for SUN-101 (glycopyrrolate). 14 October 2016
The National Institute for Health and Care Excellence (NICE) has asked Bristol-Myers Squibb to set out a case for including its Opdivo (nivolumab) in the Cancer Drugs Fund (CDF). 14 October 2016
Allergan has received the Marketing Authorization for Belkyra (deoxycholic acid) after being granted approval by the Swedish Medical Products Agency (MPA). 13 October 2016
In draft guidance published today, the medicines cost effectiveness watchdog for England and Wales says that it does not recommend Imbruvica (ibrutinib) for treating some people with Waldenstrom’s macroglobulinemia – a rare type of slow growing non-Hodgkin’s lymphoma. 12 October 2016
The US Food and Drug Administration has approved privately-held US biotech Protein Sciences’ quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. 12 October 2016
According to a paper published in Alzheimer's Research & Therapy, prominent experts in the field of Alzheimer’s disease (AD) state that under current conditions, only a limited number of disease-modifying therapies have a chance to be approved and available to patients by 2025. 11 October 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed whether AstraZeneca’s Onglyza (saxagliptin) and the combination drug Komboglyze (saxagliptin and metformin) have advantages or javascript:void(0);disadvantages in comparison with the appropriate comparator therapies for the patients. 11 October 2016
With around 75 agency representatives from 23 countries attending, the two-day summit is being held in Switzerland for the first time and organized by Swissmedic, the Swiss Agency for Therapeutic Products. 11 October 2016
The medicines cost-effectiveness watchdog for England and Wales has today published draft updated guidance recommending National Health Service use of US biotech firm Celgene’s Otezla (apremilast) for psoriatic arthritis. 11 October 2016
NicOx has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. 10 October 2016
Sanofi and Regeneron last week reported some strong results for their atopic dermatitis drug candidate Dupixent at the European Academy of Dermatology and Venereology meeting in Vienna over the weekend. 9 October 2016
Danish diabetes care giant Novo Nordisk revealed on Friday that it has received a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Application for faster-acting insulin aspart. 8 October 2016
The US Food and Drug Administration has approved Danish CNS specialist Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. 8 October 2016
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
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024