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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 Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition of Novartis’ vaccines business (excluding influenza vaccines) and the proposed creation of a consumer health care joint venture between GSK and Swiss peer Novartis announced earlier this year. 27 November 2014
Pharmaceutical
The World Health Organization (WHO) has made an official statement on the disclosure of clinical trial results by pharma companies, urging them to release this information to the public domain following concerns that negative results are kept private. 27 November 2014
Pharmaceutical
US pharma major Bristol-Myers Squibb has received a Complete Response Letter from the US Food and Drug Administration regarding its New Drug Application for hepatitis C drug daclatasvir. 27 November 2014
Generics
Only the first three generics, along with generics intended for minors, as well as orphan drugs, will become subject of accelerated procedures for state registration in Russia, according to new amendments to the law "On the circulation of drugs," which were recently approved by the Russian State Duma (Parliament). 27 November 2014
Pharmaceutical
Last week, US Representatives Gus Bilirakis (Republican, Florida) and G K Butterfield (Democrat, North Carolina) took a bipartisan step on behalf of patients with rare diseases by introducing the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 (OPEN ACT). 26 November 2014
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has given a provisional approval to Entyvio (vedolizumab), produced by Japan’s largest drugmaker Takeda Pharmaceutical. 26 November 2014
Pharmaceutical
Representatives from 16 Latin American and Caribbean countries laid the foundation for a regional mechanism for South-South collaboration for quality assurance of medicines during a workshop held in Lima, Peru on November 11-13. 26 November 2014
Pharmaceutical
US drug major Eli Lilly has received approval from the European Commission for its GLP-1 receptor agonist Trulicity (dulaglutide) for the improvement of glycemic control in adult type 2 diabetes. 26 November 2014
Pharmaceutical
The US Food and Drug Administration has issued a warning that a patient with multiple sclerosis who was being treated with Tecfidera (dimethyl fumarate), from US biotech major Biogen Idec, developed a serious brain infection called PML and later died. 26 November 2014
Biotechnology
The chief executive of Medicines Australia has called for a strengthening of Australia’s intellectual property system in order to restore the country’s place as a global biotech and pharma leader. 26 November 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance to the National Health Service NHS) recommending Swiss pharma giant Novartis’ Glivec (imatinib). 26 November 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Selincro (nalmefene) from Danish CNS specialist Lundbeck for alcohol dependence. 26 November 2014
Pharmaceutical
US pharma giant Merck & Co has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, in Japan. 25 November 2014
Pharmaceutical
US health care giant Johnson & Johnson’s subsidiary Janssen Research & Development has submitted a New Drug Application for Yondelis (trabectedin) to the US Food and Drug Administration. 25 November 2014
Generics
US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker Baxter International and two of its affiliates in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for esmolol HCl in sodium chloride injection. 25 November 2014
Biotechnology
US biotech Regeneron Pharmaceuticals and French pharma major Sanofi have said that the US Food and Drug Administration has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD). 25 November 2014
Pharmaceutical
The Russian pharmaceutical industry is booming, despite the economic recession in the country and devaluation of national currency, caused by sanctions, according to Sergey Tsyb, Russia’s Deputy Minister of Industry and Trade. 25 November 2014
Pharmaceutical
Belgium-based Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johnson, has announced that the European Commission has approved the use of Rezolsta (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection. 25 November 2014
Pharmaceutical
The European Commission has approved Swiss drug major Novartis’ Signifor (pasireotide) for patients with acromegaly for whom surgery is not an option or has not been curative, and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA). 25 November 2014
Pharmaceutical
The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12mcg) as maintenance bronchodilator treatment in chronic obstructive pulmonary disease (COPD). 25 November 2014
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