Regulation
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Pharmaceutical
The European Medicines Agency has published its guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union. 22 January 2015
Biotechnology
French drug major Sanofi and its subsidiary Genzyme have been granted marketing authorization by the European Commission for Cerdelga (eliglustat) capsules in Gaucher disease type 1. 22 January 2015
Pharmaceutical
The European Medicines Agency has accepted the marketing authorization application by AstraZeneca for lesinuirad. 22 January 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers to assess whether the drugs offer patients an added benefit over one of the appropriate comparator therapies. 22 January 2015
Biotechnology
Adding to recent marketing clearances in Japan and the European Union, the US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis. 22 January 2015
Pharmaceutical
Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European Union for its investigational antiepileptic drug brivaracetam. 21 January 2015
Biosimilars
South Korea’s Samsung Bioepis says that the Marketing Authorization Application for its Enbrel (etanercept) biosimilar candidate, SB4, has been validated and accepted for review by European Medicines Agency. 21 January 2015
Pharmaceutical
The European Medicines Agency has launched a public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database. 21 January 2015
Biosimilars
Following recent international developments in the area of biosimilar naming, Australian regulator the Therapeutic Goods Administration (TGA) said today that it will not be continuing with the previously proposed naming convention for biosimilars while a review of the policy is undertaken. 21 January 2015
Pharmaceutical
Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling charges that Swiss pharma major Novartis’ consumer health care products joint venture with UK peer GlaxoSmithKline would likely be anticompetitive. 21 January 2015
Biosimilars
The launch of Remicade (infliximab, from Johnson & Johnson) biosimilar in December 2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than the USA in adapting to biosimilar use, according to a new report from marketresearchreports. 21 January 2015
Pharmaceutical
European pharma bodies including the European Federation of Pharmaceutical Industries and Associations (EFPIA), European Generic medicines Association (EGA) and Plasma Protein Therapeutics Association (PPTA) have announced joint principles that aim to limit supply chain disruption. 21 January 2015
Pharmaceutical
A license extension has been granted in the UK for Victoza (liraglutide) from Danish insulin giant Novo Nordisk. 20 January 2015
Pharmaceutical
USA-based Ariad Pharmaceuticals today revealed that the European Commission has endorsed the final opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on Iclusig (ponatinib) following recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC). 20 January 2015
Biotechnology
The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company CytRx’s aldoxorubicin trials. 20 January 2015
Pharmaceutical
Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group, has received approval from the US Food and Drug Administration to market neostigmine methylsulfate injection. 20 January 2015
Pharmaceutical
German drug major Bayer has updated the label for its Xarelto (rivaroxaban) in Europe. 20 January 2015
Generics
The European Medicines Agency is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union. 19 January 2015
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim revealed today that the European Commission has approved its Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). 19 January 2015
Biotechnology
The European Commission (EC) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. 19 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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