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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
The US Food and Drug Administration has extended its priority review period by up to three months for Swiss pharma giant Novartis’ New Drug Application of LBH589 (panobinostat). 25 November 2014
Pharmaceutical
Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), met with the delegates of Canada, Brazil and the World Health Organization (WHO) who came to Beijing to attend the 9th International Summit of Heads of Medicines Regulatory Agencies. 24 November 2014
Generics
Bangladeshi drugmaker Beximco Pharma has received Good Manufacturing Practices approval from Health Canada, the Canadian regulatory body, making it the first pharma company in Bangladesh to receive such accreditation. 24 November 2014
Pharmaceutical
A total of 10 new medicines have been recommended for approval at the November 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 22 November 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a marketing authorization for US pharma company AbbVie’s Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir) for the treatment of chronic hepatitis C virus (HCV) infection in adults in combination with other medicinal products for the treatment of chronic hepatitis C 21 November 2014
Pharmaceutical
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on French drug major Sanofi and its subsidiary Genzyme’s Cerdelga (eliglustat) in adults with Gaucher disease type 1. 21 November 2014
Pharmaceutical
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Victoza (liraglutide), manufactured by Danish insulin giant Novo Nordisk, in the treatment of adult type 2 diabetes with moderate renal impairment. 21 November 2014
Pharmaceutical
The European Medicines Agency has reviewed angina medication Corlentor/Procoralan (ivibradine), manufactured by French privately-held drugmaker Servier, in a bid to reduce heart problems including heart attack and bradycardia, in patients taking the drug. 21 November 2014
Pharmaceutical
The discount negotiated by the French government on hepatitis C drug Sovaldi (sofosbuvir), produced by US biotech major Gilead Sciences, makes it the ‘lowest price in Europe,’ according to the country’s health ministry. 21 November 2014
Pharmaceutical
Japanese mid-sized drugmaker Kissei Pharmaceutical says that a new drug application for PA21 (development code) for treatment of hyperphosphatemia has been filed with the Ministry of Health, Labor and Welfare in Japan. 21 November 2014
Pharmaceutical
The vote against the recommendation that the US Food and Drug Administration approves Novartis’ panobinostat (Farydak) for use in relapsed/refractory multiple myeloma by the Oncologic Drugs Advisory Committee (ODAC) signals that a US marketing authorization is unlikely to be granted, according to an analyst. 21 November 2014
Biotechnology
Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of its Cosentyx (secukinumab). 21 November 2014
Pharmaceutical
The European Medicines Agency has today published its revised policy on handling declarations of interests for scientific-committee members and experts. 20 November 2014
Biotechnology
The UK government has announced a substantial investment package from industry, and that it is to carry out a review of the life sciences sector under the name Innovative Medicines and MedTech Review. 20 November 2014
article
The Ministers for Health from Australia and New Zealand have confirmed they are to end efforts to establish a joint regulatory body. 20 November 2014
Pharmaceutical
Denmark-based allergy specialist ALK Abello has filed a registration application for its house dust mite sublingual allergy immunotherapy tablet in Europe, which has been accepted for review. 20 November 2014
Pharmaceutical
The US Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). 20 November 2014
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major Sanofi and Regeneron’s dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. 20 November 2014
Pharmaceutical
Following an examination as to whether Jardiance (empagliflozin) offers an added benefit over appropriate comparator therapies, the German health cost advisory agency, the Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that an added benefit was not proven. 19 November 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Swiss pharma giant Novartis to provide more information on its Xolair (omalizumab), a drug to treat chronic hives. 19 November 2014
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