Regulation
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Pharmaceutical
The US Food and Drug Administration has granted Breakthorugh Therapy designation to Actemra/RoActemra (tocilizumab) from Swiss pharma major Roche for systemic sclerosis (SSc). 10 June 2015
Biotechnology
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration yesterday voted to recommend the approval of the investigational therapy Praluent (alirocumab) Injection. 10 June 2015
Pharmaceutical
USA-based InSite Vision says it has entered into a definitive agreement to be acquired by Canadian firm QLT in an all-stock transaction for $0.178 per share, 9 June 2015
Pharmaceutical
BioMarin Pharmaceutical has submitted a Marketing Authorization Application to the European Medicines Agency for drisapersen, an investigational antisense oligonucleotide drug candidate for the treatment of the largest subset of Duchenne muscular dystrophy. 8 June 2015
Pharmaceutical
The Scottish Medicines Consortium has issued positive advice for Cosentyx (secukinumab) from Novartis for the treatment of moderate to severe plaque psoriasis. 8 June 2015
Pharmaceutical
The National Institute for Health and care Excellence (NICE) today issued guidance recommending Xolair (omalizumab) as an option for treating severe chronic spontaneous urticaria (also known as hives) in some adults and young people aged 12 years and over. 8 June 2015
Pharmaceutical
The US National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. 5 June 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has launched public consultations on draft recommendations for two separate prostate cancer drugs. 5 June 2015
Pharmaceutical
The UK drug watchdog the National Institute for Health and Care Excellence (NICE) has today published final Technology Appraisal Guidance (TAG) for Entyvio (vedolizumab) from Japan’s largest drugmaker Takeda for ulcerative colitis (UC). 5 June 2015
Pharmaceutical
A US Food and Drug Administration advisory panel yesterday voted in favor of approving Sprout Pharmaceutical’s flibanserin, dubbed a “female Viagra,” but expressed some safety concerns. 5 June 2015
Pharmaceutical
French pharma major Sanofi’s subsidiary Genzyme has been granted Breakthrough Therapy designation for its investigational drug olipudase alfa by the US Food and Drug Administration. 4 June 2015
Biotechnology
The National Institute for Health and Clinical Excellence (NICE), the medicines watchdog for England and Wales, has recommended Stelara (ustekinumab) in its definitive Technology Appraisal Guidance (TAG). 4 June 2015
Pharmaceutical
Consumers and health professionals are advised that a recently completed review by Australia’s Therapeutic Goods Administration (TGA) has found that, based on the current information, there is no evidence to support a recommendation for routine blood monitoring to improve the safety of the new oral anticoagulants (NOACs). 4 June 2015
Pharmaceutical
The decision of the UK’s National Institute for Health and Care Excellence (NICE) to not initially recommend Anglo-Swedish pharma major AstraZeneca’s Lynparza (olaparib) has sparked a backlash from the company’s chief executive Pascal Soriot. 4 June 2015
Biosimilars
Hospira says its partner, South Korea’s Celltrion, has received approval from ANVISA, the National Health Surveillance Agency in Brazil, for Remsima (infliximab). 3 June 2015
Pharmaceutical
The National Institute for Health and care Excellence (NICE) the watchdog of medicines in England, has recommended the National Health Service (NHS) use of two products for ophthalmic use, in two separate final draft guidances published today. 2 June 2015
Pharmaceutical
The Australian Health Minister Sussan Ley has announced that crizotinib, marketed as Xalkori by Pfizer, is now listed on the Pharmaceutical Benefit Scheme. 2 June 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending German family-owned pharma major Boehringer Ingelheim’s Vargatef (nintedanib). 2 June 2015
Pharmaceutical
The European Commission has approved Helsinn's Akynzeo (netuputant-palonosetron) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy, and moderately emetogenic cancer chemotherapy. 2 June 2015
Pharmaceutical
The US Food and Drug Administration has accepted a filing from Bristol-Myers Squibb seeking approval of the PD-1 inhibitor Opdivo (nivolumab) in combination with CTLA-4 inhibitor Yervoy (ipilimumab) for previously-untreated advanced melanoma. 2 June 2015
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
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
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