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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 Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback to clinical trials for new pharmaceutical drugs in the country and has called for several changes in the Drugs and Cosmetics Amendment Rules to meet industry concerns about these trials. 10 September 2014
Biosimilars
The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned German pharma company Boehringer Ingelheim’s insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged two years and above. 10 September 2014
Pharmaceutical
An expert panel as part of the US National Institutes of Health has recommended expanding the adoption of the drug hydroxyurea in the treatment of sickle cell disease. 10 September 2014
Pharmaceutical
Ireland-based generic drug major Actavis yesterday confirmed that the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted by six to four to not recommend approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. 10 September 2014
Pharmaceutical
The US Food and Drug Administration has published briefing documents on Danish insulin giant Novo Nordisk’s Saxenda for the treatment of obesity ahead of its Advisory Committee Meeting on September 11. 9 September 2014
Biotechnology
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft guidance which recommends that US biotech major Celgene’s Abraxane (nab-paclitaxel) taken with gemcitabine should not be funded by the National Health Service. 9 September 2014
Pharmaceutical
On Friday, after two days of discussion on potential Ebola therapies and vaccines, more than 150 participants attending a World Health Organization forum in Geneva, Switzerland, representing the fields of research and clinical investigation, ethics, legal, regulatory, financing, and data collection, identified several therapeutic and vaccine interventions that should be the focus of priority clinical evaluation at this time. 8 September 2014
Pharmaceutical
The European Commission has approved Swiss pharma major Roche’s RoActemra (tocilizumab) for use in patients with severe, active and progressive RA who previously have not been treated with methotrexate (MTX). 8 September 2014
Pharmaceutical
The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major Astellas Pharma for its fungal infection therapy isavuconazole. 8 September 2014
Pharmaceutical
The 2014 edition of the Thomson Reuters CMR Pharmaceutical R&D Factbook, published today, contains some surprising findings that debunk the commonly-held perception that R&D productivity is in decline. 8 September 2014
Pharmaceutical
US drugmaker Keryx Biopharmaceuticals has received approval from the US Food and Drug Administration for ferric citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. 7 September 2014
Pharmaceutical
Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration has accepted for filing Actavis' New Drug Application for ceftazidime-avibactam. 5 September 2014
Biotechnology
Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and Drug Administration removed the partial clinical hold on the company's ipafricept (FZD8-Fc, OMP-54F28) Phase I clinical trials. 5 September 2014
Biotechnology
The Full Bench of the Federal Court of Australia has decided a private company may hold a patent on a mutation in a breast cancer gene. 5 September 2014
Pharmaceutical
The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs, the agency announced late yesterday. 5 September 2014
Pharmaceutical
Swiss independent pharma company Debiopharm has received Qualified Infectious Disease Product designation for its Debio 1450 from the US Food and Drug Administration. 4 September 2014
Biotechnology
American biotech company Regeneron's global development partner for Eylea (aflibercept), Germany's Bayer (BAYN: DE), has submitted a marketing authorization application for the drug to treat macular edema following branch retinal vein occlusion to the Japanese Ministry of Health, Labour and Welfare. 4 September 2014
Biotechnology
A drug to treat a very rare blood disorder affecting around 200 people in England has been recommended by the UK drugs watch dog the National Institute for Health and Care Excellence (NICE) in further draft guidance. 4 September 2014
Pharmaceutical
The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir 50mg/abacavir 600mg/lamivudine 300mg) tablets for the treatment of HIV in adults and adolescents aged 12 years and older. 3 September 2014
Pharmaceutical
Ireland-headquartered generic drug major Actavis says that the US Food and Drug Administration has accepted for filing Actavis' New Drug Application for eluxadoline. 3 September 2014
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