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Pharmaceutical
The European Medicines Agency has released highlights of the March 9-12 meeting of its Pharmacovigilance Assessment Committee, which has resulted in recommendations of the use of bisphosphonates and of codeine. 13 March 2015
Biotechnology
US pharma major Bristol-Myers Squibb says that its resubmitted New Drug Application for daclatasvir (proposed trade name Daklinza), an investigational NS5A replication complex inhibitor, has been accepted for review by the US Food and Drug Administration for use in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3. 13 March 2015
Generics
Privately-held Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application with a Paragraph IV certification for dabigatran etexilate mesylate capsules, a generic of Pradaxa from Boehringer Ingelheim. 13 March 2015
Biotechnology
A drug to treat a long-term and often distressing bowel condition is being recommended for routine National Health Service funding by the medicines cost watchdog for England, the National Institute for Health and Care Excellence (NICE). 13 March 2015
Biotechnology
Shares of US biotech firm ACADIA Pharmaceuticals plunged 22% to 34.70 in after-hours trading, after it announced that it now plans to submit a New Drug application for Nuplazid (pimavanserin) for the treatment of Parkinson’s disease in the second half of 2015. 12 March 2015
Biotechnology
Medicines cost watchdog for England, the National Institute for Health and Clinical Excellence (NICE), has recommended Johnson & Johnson subsidiary Janssen’s Stelara (ustekinumab) in its Final Appraisal Determination (FAD) as a treatment option for patients with active psoriatic arthritis. 12 March 2015
Pharmaceutical
Danish diabetes care giant Novo Nordisk says that the European Commission has approved the expanded use of Tresiba (insulin degludec) for children and adolescents with diabetes aged one to 17 years. 12 March 2015
Pharmaceutical
Confirming an earlier preliminary guidance, medicines cost watchdog for England, the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UK pharma major GlaxoSmithKline’s Arzerra (ofatumumab) with chlorambucil for untreated chronic lymphocytic leukemia (CLL). 11 March 2015
Biotechnology
Shares of US biotech firm Egalet Corp rose 3.65% to $14.48 after it said it plans to file a New Drug Application by the end of 2015 for Egalet-001, an abuse-deterrent, extended-release, oral morphine product. 11 March 2015
Pharmaceutical
The European Medicines Agency has published a document accounting for its pharmacovigilance fees. 11 March 2015
Pharmaceutical
US pharma giant Merck & Co revealed yesterday that its anti-PD-1 therapy, pembrolizumab, which is marketed in the USA under the name Keytruda, is the first treatment to be accepted under the UK’s new Early Access to Medicines Scheme (EAMS). 11 March 2015
Pharmaceutical
Japanese drug major Eisai has announced that its drug Halaven (eribulin) will remain on the UK's National Cancer Drugs Fund in the UK pending reconsideration by the panel. 11 March 2015
Biotechnology
Patients in England and Wales with chronic lymphocytic leukemia (CLL) could soon benefit from Gazyvaro (obinutuzumab), after the medicines cost watchdog the National Institute for Health and Care Excellence (NICE) issued a positive Final Appraisal Determination (FAD) today recommending the drug for routine use on the National Health Service. 11 March 2015
Pharmaceutical
The medicines cost watchdog the National Institute of Health and Care Excellence (NICE) has recommended Swiss pharma giant Novartis’ Xolair (omalizumab) as an option for add-on therapy for treating severe chronic spontaneous urticaria (CSU). 11 March 2015
Biotechnology
The US Food and Drug Administration today approved US biotech firm United Therapeutics’ Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children. 10 March 2015
Pharmaceutical
The US Food and Drug Administration has updated the label on Chantix (varenicline), marketed by Pfizer, to warn that the prescription smoking cessation medication can change the way people react to alcohol. 10 March 2015
Biotechnology
US biotech firm KYTHERA Biopharmaceuticals said yesterday that the US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection. 10 March 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a new dossier assessment whether vildagliptin offers an added benefit over the appropriate comparator therapy. 9 March 2015
Pharmaceutical
The Scottish Medicines Consortium has approved Zydelig (idelalisib) from Gilead for adult chronic lymphocytic leukemia in combination with rituximab. 9 March 2015
Pharmaceutical
On March 3, the Ministry of Health of Ukraine and international research-based pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of Pharmaceutical Research and Development (APRAD) entered into a Letter of Intent. 9 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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