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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
Biotechnology
In further draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence has recommended US biotech firm Gilead Sciences' Sovaldi (sofosbuvir) as a treatment option for some people with chronic hepatitis C. 15 August 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Zytiga (abiraterone) from US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen for prostate cancer in people who received hormone therapy but whose disease has spread, who have few symptoms and when chemotherapy would not yet have been given. 15 August 2014
Pharmaceutical
US drugmaker Alexza Pharmaceuticals has provided an update on its European Medicines Agency post-approval studies for its antipsychotic drug candidate Adasuve inhalation powder, pre-dispensed (Staccato loxapine). 14 August 2014
Pharmaceutical
Pharma giant Merck & Co has received US Food and Drug Administration approval for its insomnia treatment Belsomra (suvorexant) for adults. 14 August 2014
Biosimilars
South Korean biopharmaceutical firm Celltrion says it has completed the filing procedure to obtain US Food and Drug Administration approval for Remsima, its biosimilar infliximab, the active ingredient of US health care giant Johnson & Johnson’s blockbuster anti-inflammatory drug Remicade. 13 August 2014
Pharmaceutical
The inaugural Healthcare Meetings Forum Asia was over-subscribed on August 1 at Suntec Singapore, an indication of the intrigue and interest created by the Forum’s content. 13 August 2014
Pharmaceutical
“The National Institute for Health and Care Excellence’s recent rejection of Kadcyla, Roche’s latest HER2 positive cancer drug, in the UK comes as no big surprise, as it is the seventh breast cancer drug to be rejected since 2011,” says Jamie Mallinson, GlobalData’s analyst covering oncology and hematology. 13 August 2014
Biotechnology
US rare diseases focussed biotech firm Catalyst Pharmaceutical Partners provided an update on the progress of its Phase III study of Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). 13 August 2014
Pharmaceutical
Supportive care specialist Insys Therapeutics has made a New Drug Application submission to the US Food and Drug Administration for its Dronabinol Oral Solution. 13 August 2014
Pharmaceutical
New Zealand's pharmaceutical industry association, Medicines New Zealand, has updated its Code of Practice in pursuit of keeping standards high for the industry. 13 August 2014
Pharmaceutical
In reaction to West Africa is experiencing the largest, most severe and most complex outbreak of Ebola virus disease in history, on August 11 the World Health Organization convened a consultation to consider and assess the ethical implications for clinical decision-making of the potential use of unregistered interventions. 12 August 2014
Pharmaceutical
A federal program that provides billions in drug discounts to safety net hospitals and other health care providers in the USA is expanding under health care reform, but divergent views on the purpose and future scope of the program creates uncertainty for safety net providers and drug manufacturers, according to new analysis from the RAND Corporation. 12 August 2014
Biotechnology
Australian trade body AusBiotech is just one of 12 international biotech industry bodies to have joined together to express concern over the recent “judicial and administrative expansion of non-statutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States” by the US Patents and Trademarks Office. 12 August 2014
Pharmaceutical
The Scottish Medicines Consortium has approved the prescribing on the National Health Service of Roche’s subcutaneous RoActemra (tocilizumab) for use in Scotland in the treatment of rheumatoid arthritis. 11 August 2014
Pharmaceutical
Belgium’s pharmaceutical trade body, pharma.be, has issued a conclusion of its report on the shortage and unavailability of drugs in the Belgian market. 11 August 2014
Pharmaceutical
The European Commission has approved German pharma major Bayer’s Eylea (aflibercept) injection for the treatment of visual impairment due to diabetic macular edema (DME). 11 August 2014
Biosimilars
The US Food and Drug Administration has announced the availability of a draft guidance for industry titled “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.” 11 August 2014
Biotechnology
Genentech, the biotech subsidiary of Swiss pharma major Roche, has submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration for Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR). 9 August 2014
Pharmaceutical
The US Food and Drug Administration has approved US health care giant Johnson & Johnson subsidiary Janssen Pharmaceuticals’ Invokamet, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. 9 August 2014
Pharmaceutical
US biotech firm CTI BioPharma (formerly called Cell Therapeutics) says that its pacritinib has been granted Fast Track designation by the US Food and Drug Administration. 8 August 2014
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