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The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists CellAct Pharma orphan drug designation to the company’s CAP7.1, an adapted version of the well-established anticancer agent etoposide, for the treatment of biliary tract cancers. 16 July 2014
Pharmaceutical
A coalition of major European medicines advocates has criticized the European Medicines Agency for providing confidential ‘advice’ to pharma companies in exchange for fees, to give them guidance on their development plans for new drugs. 15 July 2014
Pharmaceutical
Breakthrough therapy designation is likely to positively influence perceptions of the drug for both oncologists and payers, according to research carried out by analysis and data provider Decision Resources Group. 15 July 2014
Pharmaceutical
US specialty pharma firm Ariad Pharmaceuticals says that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has requested limited additional information regarding leukemia drug Iclusig (ponatinib) as part of its ongoing review under the Article 20 referral procedure. 15 July 2014
Pharmaceutical
German family-owned drug major Boehringer Ingelheim says that Pradaxa (dabigatran etexilate) will be commercially available in the UK from today for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). 15 July 2014
Generics
Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration has accepted for review the company’s New Drug Application for albuterol multi-dose dry-powder inhaler (MDPI). 15 July 2014
Pharmaceutical
The counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), joined by the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA), participated in oral arguments in the US Court of Appeals for the Ninth Circuit, in appeal of the district court ruling in favor of Alameda County's Safe Drug Disposal ordinance. 15 July 2014
Pharmaceutical
US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for new labeling of its Invega Sustenna (paliperidone palmitate). 15 July 2014
Pharmaceutical
USA-based Medac Pharma, a wholly-owned subsidiary of privately-held German firm medac GmbH, says that the US Food and Drug Administration has approved Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy. 14 July 2014
Pharmaceutical
Pharma companies are unsure of the extent of the commercialization of phytotherapic drugs in Brazil, according to research by Pharmaceutical Technology, reported by Brazil Pharma News. 14 July 2014
Pharmaceutical
USA-based drugmaker Sunovion Pharmaceuticals, a subsidiary of Japan’s Dainippon Sumitomo, has received approval from Health Canada for Aptiom (eslicarbazepine acetate) for use as a once-daily adjunctive drug to treat partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. 14 July 2014
Pharmaceutical
Japanese drug major Astellas Pharma has submitted a supplemental New Drug Application for the indication of the diarrhea-predominant irritable bowel syndrome in females for Irribow (ramosetron HCl) tablets 2.5mcg/5mcg and Irribow OD tablets 2.5mcg/5mcg to the Ministry of Health, Labor and Welfare in Japan. 14 July 2014
Pharmaceutical
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of a medicine at its July meeting. 14 July 2014
Pharmaceutical
Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka have submitted a New Drug Application to the US Food and Drug Administration for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD). 14 July 2014
Generics
Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical companies are fleeing for cover. Or are they? A closer look will reveal that it is not just Indian drug majors that are under the US FDA scanner, reports The Pharma Letter's India correspondent. 14 July 2014
Pharmaceutical
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative developments that have occurred in France on the use of off-label medicines. 12 July 2014
Generics
Ireland-based generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market dooxylamine succinate and pyridoxine hydrochloride delayed-release tablets, a generic version of Canadian drugmaker Duchesnay’s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. 12 July 2014
Biotechnology
UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Determination (FAD) today for US biotech firm Biogen Idec’s new oral multiple sclerosis drug Tecfidera (dimethyl fumarate). 11 July 2014
Pharmaceutical
New US research released yesterday quantifies the extent to which centralized value assessments by the UK’s health care cost watchdog National Institute for Health and Care Excellence (NICE) lead to coverage denials and patient access restrictions to new drugs and biologics. 11 July 2014
Biotechnology
US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing positive new mid-stage data on its investigational drug eteplirsen yesterday. 11 July 2014
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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