Regulation
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Pharmaceutical
The US Food and Drug Administration has granted priority review for Kyprolis (carfilzomib) from Amgen and has approved a label update for Zytiga (abiraterone acetate) from Janssen. 30 March 2015
Pharmaceutical
The Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek (trelagliptin succinate), a drug for treating type 2 diabetes from Takeda Pharmaceutical. 30 March 2015
Pharmaceutical
French allergy immunotherapy company Stallergenes says that its partner Shionogi has received approval from Japanese health authorities for STG320. 30 March 2015
Pharmaceutical
Swiss drugmaker Galderma has received a positive outcome of the European Decentralized Procedure (DCP) for Soolantra (ivermectin) Cream 10mg/g for the once-daily topical treatment of inflammatory lesions of papulopustular rosacea in adult patients. 29 March 2015
Biotechnology
The European Medicines Agency has validated the Marketing Authorization Application for US biotech firms Biogen and AbbVie for Zinbryta (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS). 27 March 2015
Pharmaceutical
Obesity speciality Orexigen has been granted marketing authorization by the European Commission for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in obese and overweight patients. 27 March 2015
Pharmaceutical
Leading global pharmaceutical manufacturers operating in the Russian market have expressed their concerns regarding current Russian legislation in the field of pharmaceuticals, which prevents their further investments in the local market. 27 March 2015
Pharmaceutical
While Germany is the leading pharmaceutical market in Europe, valued at $58.6 billion in 2014, the sector will expand at a modest compound annual growth rate (CAGR) of 1.7% to reach an estimated $65 billion by 2020, a new study finds. 27 March 2015
Pharmaceutical
Danish diabetes care giant Novo Nordisk has decided to submit the pre-specified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications of Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) to the US Food and Drug Administration. 27 March 2015
Pharmaceutical
GlaxoSmithKline, Actelion and Gilead have all obtained new product approvals in Japan. 26 March 2015
Pharmaceutical
French pharma major Sanofi’s (Euronext: SAN) Sanofi Pasteur has received approval from the US Food and Drug Administration for its Quadracel vaccine for children. 26 March 2015
Biotechnology
The US Food and Drug Administration today expanded the approved use for US biotech firm Regeneron’s Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema (DME). 25 March 2015
Pharmaceutical
US biopharma company Emergent BioSolutions has received approval from the US Food and Drug Administration for its Anthrasil (anthrax immune globulin intravenous [human]) for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs. 25 March 2015
Pharmaceutical
The US Food and Drug Administration is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. 25 March 2015
Pharmaceutical
Japanese drugmaker Santen Pharmaceutical has received approval of the Marketing Authorization Application for Ikervis (ciclosporin) from the European Commission. 25 March 2015
Biotechnology
Japanese drugmaker Ono Pharmaceutical has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its New Drug Application for the human anti-human PD-1 monoclonal antibody Opdivo (nivolumab). 24 March 2015
Pharmaceutical
The US Food and Drug Administration has concluded a review of a study undertaken to determine the cause of elevated levels of US pharma major Eli Lilly’s injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. 24 March 2015
Biotechnology
The Regenerative Medicine Expert Group has published its report ‘Building on our own potential: a UK pathway for regenerative medicine’ as the culmination of work with other stakeholders to develop a strategy for regenerative medicines in the UK. 24 March 2015
Pharmaceutical
There was good news for Danish diabetes care giant Novo Nordisk yesterday, when, late in the day, the company announced that it had received European marketing authorization for Saxenda (liraglutide 3mg) for the treatment of obesity. 24 March 2015
Pharmaceutical
US pharma majors Pfizer and Eli Lilly both saw their shares rise in pre-market trading today, as they revealed that they are preparing to resume the Phase III clinical program for tanezumab. 23 March 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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