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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 European Commission has granted marketing authorization for an additional indication for UK pharma giant GlaxoSmithKline’s pneumococcal vaccine Synflorix for the immunization against pneumonia caused by Streptococcus pneumoniae in children from six weeks up to five years of age. 5 December 2013
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations and the Global Fund to Fight AIDS, Tuberculosis and Malaria have announced a broad-based partnership to help prevent patients from being harmed by fake medicines. 5 December 2013
Pharmaceutical
Plasma-protein specialists CSL Behring, a subsidiary of Australia’s CSL Ltd (CSL: AX), announced today that the European Medicines Agency has expanded the administration options for Hizentra (human normal immunoglobulin, SCIg, 20% liquid) to include dosing once every two weeks. 5 December 2013
Pharmaceutical
Revealing an earlier agreement yesterday, Israel’s Teva Pharmaceutical Industries and Japan’s largest drugmaker Takeda Pharmaceutical says that they are now working on further deals relating to the licensing of rights to Takeda to commercialize Teva’s glatiramer acetate (the active ingredient of blockbuster multiple sclerosis drug Copaxone) in Japan. 5 December 2013
Pharmaceutical
In most African countries, pharmaceutical drugs are poorly regulated or not regulated at all, posing huge risks for those who depend on them to stay healthy, and access to safe and effective medicine can be touch and go in Africa, where the market abounds with drugs that are fake or expired. 5 December 2013
Biotechnology
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme, the biotech subsidiary of French drug major, to provide more information on its multiple sclerosis drug Lemtrada (alemtuzumab). 5 December 2013
Pharmaceutical
The chair of the UK’s regulatory body the National Institute for Health and Care Excellence shared his view of the drug approvals process at the Financial Times Global Pharmaceutical & Biotechnology Conference in London yesterday. 4 December 2013
Pharmaceutical
The US Food and Drug Administration is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. The drug was launched in the USA in late 2011 by Danish CNS drug specialist Lundbeck. 4 December 2013
Pharmaceutical
Privately-held UK drugmaker Nova Laboratories says the US Food and Drug Administration has accepted a New Drug Application for childhood acute lymphoblastic leukemia (ALL) drug that is marketed in the European Union as Xaluprine (mercaptopurine). 4 December 2013
Pharmaceutical
Three big predictions for the global health care market have been released by market research firm Frost & Sullivan, based on a 2013 Search for Growth survey which involved 1,835 executives in more than 40 countries worldwide. 4 December 2013
Pharmaceutical
USA-based Baxter International has completed submission of an amended biologics license application to the US Food and Drug Administration to re-initiate the review process for approval of HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI). 2 December 2013
Biotechnology
The US Food and Drug Administration (has extended the initial Prescription Drug User Fee Act date for the review of US biotech firm Biogen Idec’s Biologics License Application for Alprolix (recombinant factor IX Fc fusion protein). 2 December 2013
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on the following proposals on access to certain drugs, all with a proposed implementation date of February 1, 2014: 2 December 2013
Generics
Addressing the fight against counterfeiting, in connection with the Falsified Medicines Directive, the European Generic medicines Association (EGA) has asked professional services firm KPMG to conduct a study on the implementation of technical measures to ensure that this is done in the most stable, cost-effective way for the sake of patient access to medicines and the sustainability of the generic medicines industry in Europe. 29 November 2013
Pharmaceutical
US biotech company Celgene’s (Nasdaq: CELG) European subsidiary has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Abraxane (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. 29 November 2013
Pharmaceutical
German drug major Bayer (BAYN: DE) has submitted VEGF Trap-Eye, already marketed under the brand name Eylea, for the treatment of myopic choroidal neovascularization for regulatory approval in Japan. 29 November 2013
Pharmaceutical
A workshop between the European Medicines Agency (EMA) and health technology assessment bodies (HTAs) took place on Tuesday to share views on innovation. 29 November 2013
Pharmaceutical
In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker AbbVie’s arthritis product has now also been cleared for ulcerative colitis. 28 November 2013
Pharmaceutical
UK pharma giant GlaxoSmithKline says that the European Medicines Agency's Committee for Medicinal Products for Human Use is recommending marketing authorization for a two-dose schedule in nine to14 year old girls for its cervical cancer vaccine, Cervarix. 28 November 2013
Pharmaceutical
The US Food and Drug Administration has issued an import alert on medicines made by Indian drugmaker Wockhardt (BSE: WOCK). 28 November 2013
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