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Pharmaceutical
USA-based Amgen, the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals have submitted a supplemental New Drug Application to the US Food and Drug Administration for Kyprolis (carfilzomib). 28 January 2015
Biotechnology
England’s health costs watchdog the National Institute for Health and care Excellence has today issued final guidance recommending US drugmaker Alexion Pharmaceuticals’ Solaris (eculizumab) for funding for treating atypical hemolytic uremic syndrome (aHUS). 28 January 2015
Pharmaceutical
Ireland-headquartered drugmaker Shire has received fast-track designation from the US Food and Drug Administration for its SHP609 (idursulfase-IT). 27 January 2015
Pharmaceutical
Privately-held US drugmaker Symplmed Pharmaceuticals says that the US Food and Drug Administration has approved Prestalia (perindopril arginine and amlodipine) tablets for the treatment of hypertension. 27 January 2015
Pharmaceutical
Health care product manufacturers are now much more willing to have their products judged based on economic as well as clinical value compared to in 2010, according to a survey by global professional services firm PwC. 27 January 2015
Generics
The US Food and Drug Administration yesterday approved a generic version of Nexium (esomeprazole), Anglo-Swedish pharma major AstraZeneca’s drug to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 and older. 27 January 2015
Pharmaceutical
The US Food and Drug Administration has approved US biopharma company Rockwell Medical’s Triferic (ferric pyrophosphate solution) for commercial sale as an iron replacement product. 26 January 2015
Biotechnology
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab), which is under development by French pharma major Sanofi and US partner Regeneron Pharmaceuticals. 26 January 2015
Pharmaceutical
French ophthalmics company Nicox has held a positive pre-New Drug Application meeting with the US Food and Drug Administration for AC-170. 26 January 2015
Pharmaceutical
Denmark-based allergy specialist ALK Abello’s Japanese partner, Torii Pharmaceutical, has submitted a New Drug Application in Japan for ALK’s house dust mite sublingual allergy immunotherapy tablet for the indication of allergic rhinitis. 26 January 2015
Generics
Central European area has around 34,200 pharmacy outlets (the number includes pharmacies and pharmacy points, and does not include drugstores and hospital pharmacies), located in the six countries analysed: Poland, Romania, Bulgaria, Hungary, the Czech Republic and Slovakia. 26 January 2015
Pharmaceutical
On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’ Bexsero (Meningococcal Group B Vaccine [recombinant, adsorbed]). 24 January 2015
Biotechnology
The US Food and Drug Administration on Friday approved NPS Pharmaceuticals’ Natpara (parathyroid hormone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism. 24 January 2015
Pharmaceutical
A number of medicines for which authorization in the European Union was primarily based on clinical studies conducted at contract research organization GVK Biosciences in Hyderabad, India, should be suspended, says the European Medicines Agency. 23 January 2015
Pharmaceutical
The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has voted unanimously to recommend the approval of Cresemba (isavuconazonium) from Astellas and its partner Basilea Pharmaceutica for invasive aspergillosis. 23 January 2015
Pharmaceutical
The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese drug major Eisai’s Halaven (eribulin) for breast cancer. 23 January 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion on expanding the indication for Pfizer’s Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]). 23 January 2015
Pharmaceutical
Danish diabetes care giant Novo Nordisk revealed yesterday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Saxenda (liraglutide 3mg) for the treatment of obesity. 23 January 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England, today issued its final appraisal determination (FAD) for German pharma major Bayer’s already blockbuster oral Factor Xa inhibitor Xarelto (rivaroxaban) in a new indication. 23 January 2015
Pharmaceutical
England’s health care costs watchdog the National Institute for Health and Care Excellence (NICE) has issued further draft guidance which recommends Jardiance (empagliflozin), marketed by German family-owned pharma major Boehringer Ingelheim, for treating type 2 diabetes. 22 January 2015
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
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