Regulation
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Pharmaceutical
The US Food and Drug Administration yesterday approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure, from Novartis. 8 July 2015
Pharmaceutical
Swiss drug major Novartis has submitted a variation to the Marketing Authorization with the European Medicines Agency for the use of Arzerra (ofatumumab) as a maintenance therapy for patients with relapsed chronic lymphocytic leukemia. 7 July 2015
Biotechnology
Innate Pharma says that the co-development and commercialization agreement with AstraZeneca on Innate’s proprietary anti-NKG2A antibody, IPH2201, has received Hart-Scott-Rodino (HSR) antitrust clearance in the USA. 7 July 2015
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare has approved the New Drug Application from US pharma company Alexion for Strensiq (asfotase alfa) as a treatment for hypophosphatasia (HPP). 7 July 2015
Pharmaceutical
US drugmaker Retrophin says it has closed the agreement to sell its Rare Pediatric Disease Priority Review Voucher to French pharma major Sanofi. 7 July 2015
Generics
The Pharmaceutical Manufacturers Association of Nigeria (PMGMAN) has raised concerns over the New Drug Distribution Guideline, NDDG, and Common External Tariff (CET), saying that they are threats to the survival of the local pharmaceutical industry, reports the local Vanguard newspaper. 7 July 2015
Pharmaceutical
Akcea Therapeutics says that the US Food and Drug Administration has granted Orphan Drug designation to volanesorsen (ISIS-APOCIIIRx) for the treatment of patients with familial chylomicronemia syndrome (FCS). 6 July 2015
Pharmaceutical
New Zealand's Pharmaceutical Management Agency PHARMAC will have a preferred brand of recombinant Factor VIII, while also maintaining full funding for the other three currently-funded haemophilia products. 6 July 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed Swiss drug major Novartis’ Gilenya (fingolimod). 6 July 2015
Pharmaceutical
The Japanese subsidiary of US pharma major Eli Lilly has received manufacturing and marketing approval in Japan for Torurishiti subcutaneous injection. 6 July 2015
Pharmaceutical
Japanese drugmaker Kyowa Hakko Kirin has received approval for thrombophilia due to congenital antithrombin (AT) deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT of recombinant human AT preparation Acoalan injection in Japan. 6 July 2015
Pharmaceutical
Medicines Australia, the representative body for the Australian pharma industry, has launched an awareness campaign to ensure that health care professionals understand the new transparency enhancements contained in its updated code of conduct. 6 July 2015
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has has approved Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for chronic hepatitis C genotype 1 infection in adults from USA-based Gilead Sciences. 3 July 2015
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for insulin glargine [rDNA origin] injection from French drug major Sanofi. 3 July 2015
Biotechnology
The US Food and Drug Administration yesterday approved the first drug for cystic fibrosis (CF) directed at treating the underlying cause of the disease in people who have two copies of a specific mutation. 3 July 2015
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim has now received regulatory authority approvals for Spiolto Respimat (tiotropium/olodaterol) in the first European countries. 2 July 2015
Pharmaceutical
The US Food and Drug Administration (FDA) has postponed the action date for the regulatory filing of cobimetinib from Roche and Exelixis by three months. 2 July 2015
Biosimilars
The Biosimilars Council, a division of the USA's Generic Pharmaceutical Association has joined the call to maintain the currently accepted international nonproprietary naming system. 2 July 2015
Pharmaceutical
Germany’s Bayer has submitted an application for marketing authorization for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, as a treatment of hemophilia A. 1 July 2015
Biosimilars
The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with growth primarily driven by a promising pipeline in active development and government efforts to reduce health care spending, new research indicates. 1 July 2015
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
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