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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
UK pharma major GlaxoSmithKline has reportedly sacked more than 100 employees in China due to misconduct over 18 months ago, according to Bloomberg. 9 March 2015
Generics
US Federal Trade Commission imposes divestiture conditions on proposed acquisition by generic drugmaker Impax Laboratories of CorePharma. 9 March 2015
Biosimilars
Prime Therapeutics, a non-profit US pharmacy benefit manager serving more than 26 million members, has responded to the US Food and Drug Administration's approval of the first biosimilar to enter the US market. 9 March 2015
Pharmaceutical
The US Food and Drug Administration on Friday approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections, from Japan's Astellas Pharma. 7 March 2015
Biosimilars
Sandoz, the generics unit of Swiss pharma giant Novartis, today received approval from the US Food and Drug Administration for its biosimilar drug Zarxio (filgrastim-sndz) for all indications included in the label of the reference product. 6 March 2015
Pharmaceutical
In draft guidance published today, the National Institute for Health and care Excellence (NICE), the medical costs watchdog for England, has recommended the anti-blood clotting drug Eliquis (apixaban), from US pharma majors Bristol-Myers Squibb and Pfizer as a National Health Service option for treating and preventing venous thromboembolism (VTE) in adults. 6 March 2015
Biosimilars
Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a study recently completed by the Tufts Center for the Study of Drug Development. 5 March 2015
Biosimilars
Following the adoption of the European Commission Guiding Principles Promoting Good Governance in the Pharmaceutical Sector initiated by the former Vice-President of the Commission, Antonio Tajani, the European Generic and Biosimilar medicines Association (EGA) is strengthening its commitment on ethics and transparency by introducing its Code of Conduct today. 5 March 2015
Biotechnology
The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC). 5 March 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a Type-II Variation related to the update of the European summary of the product characteristics (SmPC) for Brintellix (vortioxetine), from Danish CNS drug specialist Lundbeck. 5 March 2015
Biotechnology
The US Food and Drug Administration has accepted German pharma major Bayer’s Biologics License Application for Kovaltry (BAY 81-8973), its investigational treatment in hemophilia A. 4 March 2015
Pharmaceutical
The US Food and Drug Administration is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. 4 March 2015
Pharmaceutical
The US Food and Drug Administration has said it is “disappointed” by Orexigen Therapeutics’ decision to disclose interim data showing its obesity treatment Contrave (bupropion/naltrexone) reduces the risk of cardiovascular events. 4 March 2015
Biotechnology
Switzerland-based Actelion, Europe’s largest biotech company, says that the US Food and Drug Administration has formally accepted, with a standard review time, its New Drug Application for Uptravi (selexipag). 4 March 2015
Pharmaceutical
The European Commission has approved an expanded indication for the world’s most most widely used pneumococcal conjugate vaccine (PCV) Prevenar 13 (13-valent, adsorbed) from US pharma giant Pfizer. 4 March 2015
Biotechnology
Canada’s Oncolytics Biotech revealed today that the US Food and Drug Administration has granted Orphan Drug designation for its lead product candidate, Reolysin (pelareorep), a proprietary formulation of human reovirus, for the treatment of primary peritoneal cancers. 3 March 2015
Pharmaceutical
The US Food and Drug Administration has declined to expand the approval of Exparel (bupivacaine), manufactured by Pacira Pharmaceuticals, to include sue in nerve block to provide postsurgical analgesia. 3 March 2015
Biotechnology
Belgian cell therapy specialist Cardio3 BioSciences has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency for C-Cure, the Company’s lead product-candidate currently in Phase III clinical development for the treatment of ischemic heart failure. 3 March 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England, in draft guidance released today, has recommended US biotech major Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir) as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C. 3 March 2015
Biotechnology
USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results from a Phase III study of andexanet alfa, which is being developed as a anticoagulant antidote to German pharma major Bayer’s Xarelto (rivaroxaban). 2 March 2015
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