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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
Pharmaceutical
Biopharmaceutical company PTC Therapeutics has received conditional marketing authorization from the European Commission for its drug Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. 4 August 2014
Biotechnology
Netherlands-based venture capital backed human gene therapy firm uniQure and privately-held Italian drugmaker Chiesi Farmaceutici have provided an update on preparations relating to the launch of Glybera (alipogene tiparvovec). 4 August 2014
Pharmaceutical
Both the European Medicines Agency and the US Food and Drug Administration have granted orphan drug designation to US drugmaker AbbVie's investigational compound ABT-414. 4 August 2014
Pharmaceutical
Fycompa (perampanel), an epilepsy drug developed by Japanese dug major Eisai, launches today in Belgium. 4 August 2014
Biotechnology
The US Food and Drug Administration on Friday approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than eight years of age. The drug is produced and marketed by Genzyme, the USA-based biotech subsidiary of French drug major Sanofi. 2 August 2014
Pharmaceutical
The US Food and Drug Administration on Friday approved Jardiance (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). 2 August 2014
Biotechnology
The European Commission has granted orphan drug designation (ODD) to US drugmaker Alexion Pharmaceuticals’ Soliris (eculizumab) for the treatment of patients with myasthenia gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation. 1 August 2014
Generics
The pharmaceutical sector is still reeling from the latest fines imposed by the European Competition Commission as part of its crackdown on so-called ‘pay-for-delay’ agreements. As a result, such practices could be used less frequently in the future but they are unlikely to disappear altogether, according to patent and trade mark attorneys Withers & Rogers. 1 August 2014
Pharmaceutical
French regulators are attempting to discourage the over-consumption and misuse of hypnotic benzodiazepines by recommending a reduction in the reimbursement rate to 15%. 1 August 2014
Biotechnology
The Blood Products Advisory Committee of the US Food and Drug Administration has voted 15-1 that HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase], Baxter International’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI), has a favorable risk/benefit profile. 1 August 2014
Biotechnology
The US Biotechnology Industry Organization’s (BIO) Laurel Todd shared concerns that the 340B program has departed significantly from its original intent, leading to evidence of abuse and potentially harmful consequences for patients. 1 August 2014
Pharmaceutical
Japanese drugmaker Kyowa Hakko Kirin has filed an application for marketing approval with the Ministry of Health, Labor and Welfare (MHLW) for its recombinant human antithrombin (AT) preparation (code name KW-3357). 1 August 2014
Biotechnology
US biotech firm Vertex Pharmaceuticals has announced that the European Commission has approved Kalydeco (ivacaftor) for people with cystic fibrosis aged six and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 1 August 2014
Pharmaceutical
The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s Striverdi Respimat (olodaterol) long-acting inhaler to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. 1 August 2014
Biosimilars
Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology services through its contract research services (CRS) business, is prepared to meet the global demand for development programs in novel biologics and biosimilars. 31 July 2014
Pharmaceutical
The European Medicines Agency (EMA) has approved a request by Japanese drug major Eisai for the accelerated assessment of the investigational oral multiple receptor typrosine kinase inhibitor lenvatinib. 31 July 2014
Pharmaceutical
French drug major Sanofi and USA-based biotech firm Regeneron Pharmaceuticals intend to use a US Food and Drug Administration rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. 31 July 2014
Pharmaceutical
The UK clinical guidance body, the National Institute for Health and Care Excellence (NICE), is again consulting on the use of lenalidomide, marketed as Revlimid by Celgene, in the treatment of blood cancer multiple myeloma after one prior treatment with bortexomib. 31 July 2014
Biotechnology
The Food and Drug Administration has approved US biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME). 30 July 2014
Pharmaceutical
The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban) for the additional indications of the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. 30 July 2014
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