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Pharmaceutical
US drugmaker Durect Corporation says that it has received meeting minutes from its face-to-face meeting with the US Food and Drug Administration on September 23 regarding the Posidur program. 12 November 2014
Pharmaceutical
New legislation known as Vanessa’s Law (Bill C 17; the Protecting Canadians from Unsafe Drugs Act) has received Royal Assent and is now law, Canadian Minister of Health Rona Ambrose has announced. 11 November 2014
Generics
An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals into the country earlier this month may have been the last straw for the Indian government battling counterfeit drugs. 10 November 2014
Pharmaceutical
The Scottish Medicines Consortium has approved two new treatments today, one for skin cancer and one for hepatitis C. 10 November 2014
Pharmaceutical
The Scottish Medicines Consortium has issued a positive recommendation for Swiss pharma major Novartis’ Afinitor (everolimus) which has been accepted for use in NHS Scotland, as a treatment option for advanced kidney cancer patients who have failed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. 10 November 2014
Pharmaceutical
In the fourth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at the history of the FDA in the historic Shirley Amendment. 10 November 2014
Pharmaceutical
Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have said the FDA’s recently finalized guidance on neoadjuvant treatments will speed drug approval for high-risk patients. 10 November 2014
Pharmaceutical
At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on products that contain Factor VIII and discussed a fatality in a patient treated with Tecfidera. 9 November 2014
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems. 9 November 2014
Pharmaceutical
The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé (ANSM), has contacted Swiss drug major Roche to request information on off-label use of its cancer drug Avastin (bevacizumab) to treat wet age-related macular degeneration. 7 November 2014
Generics
Indian generics drugmaker Ranbaxy Laboratories revealed in a Bombay Stock Exchange filing that it has received communication from the US Food and Drug Administration, in which the agency said it has determined that Ranbaxy’s Abbreviated New Drug Applications of concern did not have any data integrity issues. 7 November 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence is consulting on provisional recommendations on a treatment for Dupuytren’s contracture, a condition where fingers gradually bend in towards the palm of the hand and cannot be straightened. 7 November 2014
Pharmaceutical
At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) did not recommend Swiss pharma major Novartis’ investigational compound LBH589 (panobinostat). 7 November 2014
Biotechnology
The Food and Drug Administration has approved US health care giant Johnson & Johnson's Olysio (simeprevir) in combination with sofosbuvir. 6 November 2014
Pharmaceutical
Canadian biopharma firm AEterna Zentaris has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). 6 November 2014
Pharmaceutical
Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee (G-BA) has decided that the additional benefit for its new generation anti-epileptic drug (AED) Fycompa (perampanel) has not been proven. 6 November 2014
Pharmaceutical
US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne muscular dystrophy (DMD) treatment market, despite a delay in the development of its novel, exon-skipping drug eteplirsen from the end of this year, says an analyst. 6 November 2014
Biotechnology
UK pharma major GlaxoSmithKline says it has filed regulatory submissions in the USA and Europe for mepolizumab (proposed trade name Bosatria) for approval as a maintenance treatment for patients with severe eosinophilic asthma. 5 November 2014
Biotechnology
US biotech firm Vertex Pharmaceuticals has filed for marketing approval for a fully co-formulated combination of lumacaftor and ivacaftor with the US Food and Drug Administration and the European Medicines Agency 5 November 2014
Pharmaceutical
The US Food and Drug Administration has responded to a 2011 petition from consumer rights advocacy group Public Citizen regarding certain common antacid medications. 5 November 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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