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Pharmaceutical
The Indian government has withdrawn a Bill introduced in 2013 to amend the existing Drugs and Cosmetics Act, promising to ‘comprehensively review’ regulations to suit new science and research methods. 23 June 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for US biotech firm Incyte’s Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD). 23 June 2016
Biotechnology
US biotech giant Gilead Sciences has received European Commission marketing authorization for the once-daily single tablet regimen (STR) Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide). 23 June 2016
Pharmaceutical
Italian CNS-focused drug developer Newron Pharmaceuticals’ key value driver is safinamide (branded Xadago), a once daily oral add-on therapy for all stages of Parkinson's disease with a unique dual mechanism of action. 23 June 2016
Pharmaceutical
Updated guidance by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) states that AstraZeneca’s (LSE: AZN) FluMist Quadrivalent nasal vaccine should not be used in any setting. 23 June 2016
Pharmaceutical
The US Food and Drug Administration has announced the approval of a supplemental New Drug Application (sNDA) modifying the risk evaluation mitigation strategy (REMS) for Sabril (vigabatrin) from Danish CNS drug specialist Lundbeck. 23 June 2016
Biotechnology
England’s medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has today published final draft guidance that does not recommend US biotech firm Celgene’s Vidaza (azacitidine) to treat some people with acute myeloid leukemia (AML). 23 June 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal involving Praxbind (idarucizumab) and Pradaxa (dabigatran). 23 June 2016
Pharmaceutical
In Australia, the Annual Charge Exemption (ACE) scheme replaced the Therapeutic Goods Administration’s (TGA) low value turnover scheme on July 1, 2015, and companies wishing to claim the exemption for pre-revenue entries must do so between July 1 and 22, 2016. 23 June 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined in an early benefit assessment whether AstraZeneca’s Tagrisso (osimertinib) offers an added benefit for lung cancer patients in comparison with the appropriate comparator therapy. 22 June 2016
Biosimilars
The US trade association representing pharmacy benefit managers has said that new bipartisan legislation will bring generic drugs to market sooner. 22 June 2016
Pharmaceutical
The US Food and Drug Administration is coming under increasing pressure from other government authorities to review and provide clarity on off-label promotion regulations, as recent settlement agreements with pharmaceutical companies appear to give these companies license to extend previous working definitions of “scientific exchange” as allowed by law, notes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 22 June 2016
Pharmaceutical
US not-for-profit body the Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will inform a report on drug therapies for treatment of non-small cell lung cancer (NSCLC). 22 June 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness for England and Wales, has today published final guidance which recommends UK pharma major GlaxoSmithKline’s Benlysta (belimumab) for treating systemic lupus erythematosus. 22 June 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness for England and Wales, has today published final guidance recommending that five drugs to treat four different conditions should be routinely funded by the National Health Service. 22 June 2016
Pharmaceutical
The US Food and Drug Administration has approved OPKO Health’s Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30ng/mL. 21 June 2016
Pharmaceutical
Mundipharma International today announced that Penthrox (low dose methoxyflurane) has been granted marketing authorization in France for the emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain. 21 June 2016
Pharmaceutical
Transfers of value made by pharmaceutical companies involving the expenses incurred in relation to healthcare professionals and healthcare organizations are to be made public for the first time by the end of June as part of a European-wide initiative to enforce stricter self-regulation of the industry and boost transparency, the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA). 21 June 2016
Biosimilars
Groups representing Europe’s pharma, biotech and generics companies have welcomed the European Commission’s staging of a workshop on the uptake of biosimilars. 20 June 2016
Pharmaceutical
Mitsubishi Tanabe Pharma today revealed that a New Drug Application has been submitted to the US Food and Drug Administration for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease. 20 June 2016
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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