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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
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Pharmaceutical
Pfizer says that its Xalkori (crizotinib) has received Breakthrough Therapy designation from the US Food and Drug Administration for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). 22 April 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment whether Xtandi (enzalutamide), from Medivation and Japanese drug major Astellas Pharma, offers an added benefit over the appropriate comparator therapy for men who have metastatic prostate cancer. 21 April 2015
Pharmaceutical
Ireland-headquartered Actavis, which recently completed the $66 billion acquisition of Allergan, says that the US Food and Drug Administration has approved an expansion of the Botox (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. 20 April 2015
Pharmaceutical
Sweden’s Oasmia Pharmaceutical said today that its lead cancer product Paclical has received market authorization by the Russian Ministry of Health. 20 April 2015
Biotechnology
US pharma giant Merck & Co says it has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer. 20 April 2015
Pharmaceutical
In Spain last week, authorities, professionals and health care organizations, patients and the pharmaceutical industry gathered together during the Conference “Transparency as a generator of trust,” organized by Spanish pharma trade group Farmaindustria, precisely to discuss and progress in this field. 20 April 2015
Pharmaceutical
The majority of clinical development plans submitted for scientific advice to the European Medicines Agency prior to a marketing authorization application were found not suitable for future benefit-risk assessment. 20 April 2015
Biotechnology
A very small study for privately-held US firm Genervon Biopharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug GM604 has raised questions about the data that were provided by the company. 19 April 2015
Pharmaceutical
Anglo-Swedish drug major AstraZeneca has been granted orphan drug designation by the US Food and Drug Administration for selumetinib, and has announced updated progression-free survival data for AZD9291. 17 April 2015
Generics
The US Food and Drug Administration yesterday approved the first generic version of Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). 17 April 2015
Pharmaceutical
A committee of the US Food and Drug Administration has voted 9-2 in support of the approval of The Medicines Company’s cangrelor as an adjunct to percutaneous coronary intervention to reduce the risk of periprocedural thrombotic events 16 April 2015
Pharmaceutical
Anglo-Swedish drug major AstraZeneca has been granted orphan drug designation by the US Food and Drug Administration for tremelimumab in the treatment of malignant mesothelioma. 16 April 2015
Biotechnology
Shares of US biotech major Amgen rose 1.8% to $168.41 in after-hours trading on Wednesday, following the news that the US Food and Drug Administration has granted approval of its heart failure drug Corlanor (ivabradine). 16 April 2015
Pharmaceutical
A US Food and Drug Administrationadvisory panel has voted to recommend that labels for UK pharma major AstraZeneca’sdiabetes drug Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin) include a warning regarding a potential risk of heart failure and death. 15 April 2015
Pharmaceutical
Japanese drug major Daiichi Sankyo has received approval in Switzerland for Lixiana (edoxaban) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 15 April 2015
Pharmaceutical
Canada’s Health Minister Rona Ambrose this week launched the Drug Health and Health Product Inspections database, a new online resource designed to provide ready access to information on inspections of companies that manufacture and sell drug products for the Canadian market. 15 April 2015
Pharmaceutical
Flexibility and a willingness to learn from each other are key factors that enable drug companies and regulators to engage successfully in development projects that have been accorded Breakthrough Therapy designation, or BTD, according to R&D executives participating in a roundtable recently hosted by the USA’s Tufts Center for the Study of Drug Development. 15 April 2015
Pharmaceutical
Staff of the US Food and Drug Administration have backed the approval of The Medicines Company’s cangrelor to prevent blood clots during angioplasty. 14 April 2015
Biotechnology
Biotech firm Swedish Orphan Biovitrum has received orphan drug designation in Switzerland for its long-acting hemophilia drug candidate Elocta for the treatment of hemophilia A. 14 April 2015
Pharmaceutical
The Scottish Medicines Consortium (SMC) today announced that German pharma major Bayer’s Stivarga (regorafenib) has been accepted for use within NHS Scotland. 13 April 2015
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