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The US Food and Drug Administration has approved biotech giant Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. 13 November 2015
Biotechnology
The German regulator has granted marketing approval for Rizaport (RHB-103) from Israeli pharma company RedHill Biopharma to treat acute migraines. 13 November 2015
Pharmaceutical
Helsinn Group and partner Japan’s Eisai announced today that the American Society of Clinical Oncology (ASCO) has published a focused update to its clinical practice guidelines for antiemetics in oncology recognizing their drug Akynzeo (netupitant/palonosetron) as an additional option for the prevention of acute and delayed nausea and vomiting in patients receiving highly-emetogenic chemotherapy regimens. 13 November 2015
Biotechnology
Belgian pharma company Bone Therapeutics has been granted orphan drug designation by the European Medicines Agency and the US Food and Drug Administration for Allob, its allogenic bone cell therapy product. 13 November 2015
Pharmaceutical
US drug developer Portola Pharmaceuticals has updated on its development of its investigational antidote to the anticoagulant effects of FXa inhibitors, noting results of the Phase III ANNEXA study have been published online in the New England Journal of Medicine. 12 November 2015
Pharmaceutical
Only two thirds of clinical trials per drug were disclosed in supporting new drug approvals in 2012, according to a new report from non-profit Bioethics International. 12 November 2015
Pharmaceutical
Medicines regulator Health Canada has issued a safety warning on two news hepatitis treatments from US drugmaker AbbVie. 12 November 2015
Pharmaceutical
Swiss drugmaker Santhera Pharmaceuticals has reported new data and updates on regulatory filings for Raxone (idebenone) in Duchenne muscular dystrophy (DMD. 11 November 2015
Biotechnology
The US Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib (trade name Zelboraf) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation). 10 November 2015
Pharmaceutical
Teva Pharmaceutical Industries has received US Food and Drug Administration Breakthrough Therapy designation status for SD-809 (deutetrabenazine) for the treatment of patients with moderate to severe tardive dyskinesia. 9 November 2015
Pharmaceutical
The Anesthetic and Analgesic Drug Products Advisory Committee of the US Food and Drug Administration on Friday discussed pharma giant Merck & Co’s Bridion (sugammadex). 7 November 2015
Biotechnology
The US Food and Drug Administration has accepted for review biotech major Amgen's New Drug Application for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. 7 November 2015
Pharmaceutical
A US Food and Drug Administration review released on Friday has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. 7 November 2015
Generics
Indian drugmaker Dr Reddy’s Laboratories saw its shares plummet 16.65% to 3,629.55 rupees today, after confirming it has received a warning letter issued by the US Food and Drug Administration. 6 November 2015
Pharmaceutical
Since relatively few people suffer from rare diseases – fewer than 200,000 in the US - the development of new drugs for these diseases can be difficult to gain approval for. Dr Nicola Davies examines US Food and Drug Administration guidance to aid drug developers working in the area of rare diseases. 6 November 2015
Biotechnology
The US Food and Drug Administration yesterday approved US biotech giant Gilead Sciences’ Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. 6 November 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Lixiana (edoxaban) from Japanese drug major Daiichi Sankyo offers an added benefit over the appropriate comparator therapy. 6 November 2015
Pharmaceutical
The European Medicines Agency said that there is no proof to support a causal link between human papillomavirus (HPV) vaccines, such as GlaxoSmithKline's Cervarix and Merck & Co's Gardasil, and the development of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women. 6 November 2015
Pharmaceutical
Swiss pharma giant Roche has provided an update on its late-stage pipeline at an investor event in London, including promising investigational medicines for multiple sclerosis, asthma, hemophilia, eye disease and cancer. 6 November 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE) has begun a consultation on draft guidance this morning about a treatment for neuroblastoma. We will not be issuing a formal press release, but I wanted to let you know in case it is of interest. 5 November 2015
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 BeOne Medicines, formerly 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 US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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