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Pharmaceutical
The China Food and Drug Administration (CFDA) on January 14 approved the production of the first inactivated poliomyelitis vaccine made from Sabin strains (Sabin IPV) (single component) in the country. 19 January 2015
Biotechnology
US biotech firm Celgene’s European subsidiary has received marketing authorization from the European Commission (EC) for Otezla (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications. 18 January 2015
Generics
US generic drugmaker Akorn has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market difluprednate ophthalmic emulsion 0.05%. 16 January 2015
Pharmaceutical
The European Commission has granted marketing authorizations for US drugmaker AbbVie’s all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets). 16 January 2015
Biotechnology
In final draft guidance issued today, England health costs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of two new drugs for National Health Service treatment of hepatitis C. 16 January 2015
Pharmaceutical
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted not to recommend for approval the orally disintegrating tablet formulation of desmopressin from privately-held Switzerland-headquartered Ferring Pharmaceuticals. 15 January 2015
Pharmaceutical
The US Food and Drug Administration has launched an Office of Pharmaceutical Quality in a bid to clamp down on manufacturing problems experienced by some generic drug producers. 14 January 2015
Pharmaceutical
The US Food and Drug Administration has approved US drugmaker AbbVie’s Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson’s disease. 13 January 2015
Pharmaceutical
US pharma giant Merck & Co has reported on the ongoing execution of its multi-year, strategic initiative to sharpen its commercial and research and development focus, redesign its operating model and reduce its cost base at the 33rd Annual JP Morgan Healthcare Conference. 13 January 2015
Biotechnology
England’s health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance not recommending US biotech firm Dendreon’s Provenge (sipuleucel-T) for prostate cancer in people whose disease has spread, who have few symptoms and whose disease is not yet suitable for treatment with chemotherapy. 13 January 2015
Biosimilars
US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for Retacrit (epoetin zeta). 12 January 2015
Biotechnology
French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines Agency has accepted their Marketing Authorization Application for Praluent (alirocumab) for review. 12 January 2015
Pharmaceutical
Australian pharma representative body Medicines Australia has put forward its recommendations for consideration in its submission to the Therapeutic Goods Administration’s Expert Review of Medicines and Medical Devices Regulation. 12 January 2015
Biotechnology
Chinese biotech firm Chipscreen Biosciences has received regulatory approval of Epidaza (chidamide), the world first orally-administrated and subtype-selective histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL) patients, from the Chinese Food and Drug Administration (CFDA). 12 January 2015
Pharmaceutical
The European Medicines Agency recommended the highest number of orphan designated medicines for marketing authorization in 2014. 11 January 2015
Pharmaceutical
The director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA) has argued in favor of homogenizing European health technology assessment HTA bodies and regulation. 9 January 2015
article
This week the Acting Director of US Food and Drug Administration’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Science Lawrence Yu discussed the important roles of FDA and drug companies in ensuring quality drug products. 9 January 2015
Pharmaceutical
US pharma giant Pfizer says it has been advised by the Food and Drug Administration that at this time there is no plan for an Oncologic Drugs Advisory Committee meeting for Ibrance (palbociclib). 9 January 2015
Pharmaceutical
Big pharmaceutical companies and foreign investors are flocking to Turkey to capitalize on its encouraging economic policies. 9 January 2015
Pharmaceutical
The US Food and Drug Administration late yesterday approved Japanese drug major Daiichi Sankyo’s anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. 9 January 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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