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Biotechnology
Danish biotech company Genmab has been granted accelerated assessment for daratumumab in double refractory multiple myeloma by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. 25 September 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Swiss pharma giant Novartis’ Entresto (sacubitril/valsartan). 25 September 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for UK pharma major GlaxoSmithKline's mepolizumab. 24 September 2015
Pharmaceutical
Keryx Biopharmaceuticals on Thursday said the European Commission has approved its Fexeric (ferric citrate coordination complex) for kidney disease. 24 September 2015
Biosimilars
Several British healthcare stakeholders have joined forces on biosimilars. 24 September 2015
Biotechnology
The UK medicines cost watchdog the National Institute for Health can Care Excellence (NICE) today issued final draft guidance recommending that US biotech giant Gilead Sciences’ Zydelig (idelalisib) should be made available on the National Health Service in England and Wales for some adults with chronic lymphocytic leukemia (CLL). 24 September 2015
Pharmaceutical
UK pharma major GlaxoSmithKline and Theravance are to file a supplemental Japanese New Drug Application (sJNDA) for Relvar Ellipta (fluticasone furoate/vilanterol) to treat chronic obstructive pulmonary disease (COPD) in the first quarter of 2016. 24 September 2015
Pharmaceutical
The US Food and Drug Administration on Tuesday approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies, from Japanese drugmaker Taiho Pharmaceutical. 23 September 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Lixiana (edoxaban) from Daiichi Sankyo to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation. 23 September 2015
Pharmaceutical
Grünenthal has received approval from the European Commission for Zalviso (sufentanil sublingual tablet system) for the management of acute moderate to severe post-operative pain in adult patients. 22 September 2015
Pharmaceutical
Bausch + Lomb, the ophthalmology subsidiary of Quebec-based pharma company Valeant has announced that the US Food and Drug Administration has accepted for review its New Drug Application for Vesneo (latanoprostene bunod), licensed to French pharma company NicOx. 22 September 2015
Pharmaceutical
The US Food and Drug Administration is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. 22 September 2015
Pharmaceutical
Shire says that the European Commission has granted marketing authorization for its once-daily, non-stimulant Intuniv for the treatment of attention deficit hyperactivity disorder (ADHD). 21 September 2015
Biotechnology
Merck & Co says that the two pivotal Phase III clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile infection recurrence, met their primary efficacy endpoint. 21 September 2015
Biotechnology
The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). 20 September 2015
Biotechnology
The US Food and Drug Administration has accepted for priority review the supplemental New Drug Application (sNDA) for biotech major Amgen’s Kyprolis (carfilzomib) for Injection for patients with relapsed multiple myeloma. 19 September 2015
Pharmaceutical
Novartis announced today that Swissmedic has approved Entresto (sacubitril/valsartan), previously known as LCZ696, to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HFrEF). 18 September 2015
Pharmaceutical
An Australian Senate Committee inquiry has issued its findings and has recommended the government reviews the way in which new medicines are approved and subsidized. 18 September 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved Vraylar (cariprazine) capsules, an atypical antipsychotic from Gedeon Richter and Allergan, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults. 18 September 2015
Pharmaceutical
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted to recommend the licensing of Fluad, a candidate vaccine to help protect against seasonal influenza in those aged 65 years and older via accelerated approval. 17 September 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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