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Pharmaceutical
In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether Danish diabetes care giant Novo Nordisk’s Tresiba (insulin degludec), alone or in combination with other blood-glucose lowering drugs, offers an added benefit over the appropriate comparator therapy. 2 June 2015
Pharmaceutical
Clinicians in England and Wales are now able to prescribe Gazyvaro (obinutuzumab), a breakthrough blood cancer drug from Swiss drug major Roche on the NHS. 2 June 2015
Pharmaceutical
The National Institute for Health and care Excellence (NICE) has today (June 1) opened a consultation preliminary draft guidance on the drug Anglo-Swedish pharma major AstraZeneca’s olaparib. 1 June 2015
Pharmaceutical
The European Commission has issued marketing authorization for Japanese pharma major Eisai’s Lenvima (lenvatinib) in the treatment of people with radioactive iodine refractory differentiated thyroid cancer. 1 June 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today issued a Final Appraisal Determination (FAD) recommending Cosentyx (secukinumab) from Swiss drug major Novartis for use on the National Health Service for the treatment of severe plaque psoriasis. 29 May 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today published draft guidance on TNF-alpha inhibitors for treating some types of inflammatory arthritis that affect the spine. 29 May 2015
Pharmaceutical
Merck has submitted a New Drug Application to the US Food and Drug Administration for grazoprevir/ elbasvir (100mg/50mg). 29 May 2015
Biotechnology
Gilead Sciences says its Marketing Authorization Application (MAA) for two doses of a fixed-dose investigational combination of emtricitabine and tenofovir alafenamide (200/10mg and 200/25mg) (F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). 29 May 2015
Pharmaceutical
UK-based Napp Pharmaceuticals has received approval for use in the UK of its product Targinact (oxycodone/naloxone). 29 May 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved pharma giant Pfizer’s Rapamune (sirolimus) to treat lymphangioleimyomatosis, a rare, progressive lung disease. 29 May 2015
Pharmaceutical
Boehringer Ingelheim and partner US peer Eli Lilly’s Synjardy (empagliflozin/metformin) has been granted marketing authorization by the European Commission for the treatment of adults with type 2 diabetes (T2D) in the European Union. 28 May 2015
Pharmaceutical
Retrophin has agreed to sell its Rare Pediatric Disease Priority Review Voucher to French pharma major Sanofi. 28 May 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. 28 May 2015
Pharmaceutical
The European Commission has granted marketing authorization for Japanese drugmaker Otsuka Pharmaceutical’s Jinarc (tolvaptan) for the treatment of autosomal dominant polycystic kidney disease (ADPKD). 27 May 2015
Pharmaceutical
Japanese pharma major Eisai says it has submitted a New Drug Application for mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan. 27 May 2015
Pharmaceutical
The European Commission has endorsed the Committee for Medicinal Products for Human Use’s (CHMP) Opinion recommending the approval of Aloxi (palonosetron HCl) from privately-held Swiss cancer specialist Helsinn Group. 27 May 2015
Pharmaceutical
Cancer vaccines could be divided into to two broad categories of prophylactic (preventive) and therapeutic (treatment) segments. In the USA, cancer vaccines belong to both of these groups have been marketed in past few decades. 27 May 2015
Pharmaceutical
German family-owned drug major Boehringer Ingelheim say that the US Food & Drug Administration approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray. 26 May 2015
Generics
ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative Inc (CHAI) announced today that Aurobindo Pharma has submitted an Abbreviated New Drug Application for dolutegravir 50mg to the Food and Drug Administration for the treatment of HIV. 26 May 2015
Biosimilars
The Finnish Medicines Agency, Fimea, has presented its position towards interchangeability of biosimilars licensed in the European Union. The position is a recommendation to the local health care system. 26 May 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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