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While development of personalized medicines has grown since the human genome was first sequenced in 2001, biopharmaceutical sponsors face a number of hurdles that are impeding more rapid market uptake, according to a recently completed study by the USA-based Tufts Center for the Study of Drug Development. 14 May 2015
Pharmaceutical
Since the US Food and Drug Administration was created in 1938 by then President Franklin D Roosevelt, its primary task has been to test drugs and approve them for sale, if they are found to be safe and effective, for the treatment of diseases and conditions they were meant to treat. Thus, “FDA approved” is a mark of safety and quality that patients and consumers can trust. Since the 1980s, the FDA’s task has evolved to also include the investigation and prosecution of counterfeit drugs. 14 May 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined the dossier for Anglo-Swedish pharma major AstraZeneca’s Duaklir Genuair (aclidinium bromide/formoterol fixed dose combination). 13 May 2015
Pharmaceutical
Amsterdam, Netherlands-based biopharma company Kiadis has received an Advanced Therapy Medicinal Product certificate from the European Medicines Agency for its lead product ATIR. 13 May 2015
Pharmaceutical
The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee voted 12 to 1 to recommend Orkambi (lumacaftor/ivacaftor) from Vertex Pharmaceuticals. 13 May 2015
Pharmaceutical
German life sciences firm Merck KGaA says that the US Food and Drug Administration has granted Fast Track designation for the development of evofosfamide in pancreatic cancer. 12 May 2015
Pharmaceutical
Ahead of the International Day of Clinical Trials on May 20, the Belgian General Association of Pharmaceutical Manufacturers (pharma.be) has called on all partners to preserve and strengthen Belgium’s place as a world-leader in clinical studies. 12 May 2015
Pharmaceutical
The US Food and Drug Administration issued a Complete Response letter regarding the supplemental New Drug Application for once-monthly long-acting antipsychotic Invega Sustenna (paliperidone palmitate) filed by Janssen Pharmaceuticals. 12 May 2015
Pharmaceutical
The US Food and Drug Administration on Friday approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. 11 May 2015
Biotechnology
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started two new safety reviews at its May 2015 meeting. 11 May 2015
Pharmaceutical
Swiss pharma major Roche and US drugmaker AbbVie have been granted Breakthrough Therapy designation by the US Food and Drug Administration for their investigational medicine venetoclax. 8 May 2015
Pharmaceutical
Cardiovascular biopharma specialist Amarin and four independent physicians have filed a law suit to permit off-label promotion. 8 May 2015
Pharmaceutical
Swiss pharma giant Novartis has received European Commission approval for Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. 8 May 2015
Pharmaceutical
Nearly 40% of approved products in Europe and the USA in 2014 came from non top pharma companies, according to new research for the NDA Group. 7 May 2015
Pharmaceutical
The European Medicines Agency has updated its rules on declarations of interests for scientific committee members and experts, meaning that anyone taking up job in pharma industry will trigger immediate halt of involvement in medicines evaluation. 6 May 2015
Biotechnology
US biopharma company Emergent BioSolutions has received US Food and Drug Administration approval for Ixinity (coagulation Factor IX [recombinant]). 5 May 2015
Pharmaceutical
UK pharma major GlaxoSmithKline, Fondazione Telethon and Ospedale San Raffaele have submitted a marketing application to the European Medicines Agency for a gene therapy to treat patients with a rare disease. 5 May 2015
Pharmaceutical
Isis Pharmaceuticals has entered into an exclusive license agreement with German pharma major Bayer to develop and commercialize ISIS-FXIRx for the prevention of thrombosis. 4 May 2015
Pharmaceutical
Vernalis revealed that the US Food and Drug Administration has approved the New Drug Application for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension. 1 May 2015
Pharmaceutical
The US Food and Drug Administration has approved asthma medication Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) from UK pharma major GlaxoSmithKline and US partner Theravance. 1 May 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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