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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
Biotechnology
The US Food and Drug Administration has approved Amgen’s Kyprolis in combination with dexamethasone to treat patients with relapsed multiple myeloma, it has been announced. 22 January 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England and Wales, has issued a Final Appraisal Determination (FAD) which recommends US pharma major Bristol-Myers’ Opdivo (nivolumab), as monotherapy, for the treatment of advanced (unresectable or metastatic) melanoma in adult patients. 22 January 2016
Biotechnology
Clinical-stage gene delivery company GenVec said there is no certainty the trials for its lead product CGF166 to treat hearing loss will continue. 21 January 2016
Biotechnology
The much anticipated US Food and Drug Administration’s Peripheral and Central Nervous System Advisory Committee meeting on eteplirsen scheduled for Friday, January 22, has been postponed by the FDA due to an anticipated severe winter snowstorm forecast to hit the Washington DC area. 21 January 2016
Pharmaceutical
The US Attorney's Office in Philadelphia has charged five people including two former researchers at UK drug major GlaxoSmithKline of scheming to steal trade secrets from the company with the intention of selling them in China. 21 January 2016
Generics
India’s Glenmark Pharma on Thursday said it has received final approval from the US Food and Drug Administration to manufacture and market Potassium Chloride extended release capsules and oral contraceptive Norethindrone Acetate and Ethinyl Estradiol tablets in the US market. 21 January 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). 20 January 2016
Biosimilars
Leading Russian biotech firm Biocad has received approval for the first biosimilar trastuzumab from Russia’s Ministry of Health. 20 January 2016
Pharmaceutical
Baxalta Inc said it the European Commission has granted marketing authorization for use of Oncaspar as a combination therapy in acute lymphoblastic leukemia (ALL). 20 January 2016
Biotechnology
Biotech firm Genmab has said the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra (ofatumumab) for extended treatment of chronic lymphocytic leukemia (CLL). 20 January 2016
Pharmaceutical
US drug major Eli Lilly and Incyte Corp on Tuesday announced that Lilly has submitted a New Drug Application to the US Food and Drug Administration for the approval of baricitinib to treat rheumatoid arthritis (RA). 19 January 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined the added benefit of aclidinium bromide (trade names Eklira, Bretaris) under the Act on the Reform of the Market for Medicinal Products (AMNOG). 19 January 2016
Biotechnology
The Indian government has launched its ambitious Start-up India campaign with the aim to give a leg-up to the investment ecosystem and boost innovation. 19 January 2016
Pharmaceutical
A cumulative review of birth defects has confirmed that mycophenolate is a human teratogen, says pharmaceutical regulator Health Canada. 19 January 2016
Pharmaceutical
Japanese drugmaker Ono Pharmaceuticals has filed a manufacturing and marketing approval application in Japan for etelcalcetide hydrochloride (ONO-5163), a calcimimetic agent, to seek an indication for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. 19 January 2016
Generics
Shares in Indian drug maker Wockhardt closed down 6% Monday after the company said it expects to comply with all the US Food and Drug Administration’s observations on its Shendra unit in two months. 19 January 2016
Pharmaceutical
Kidney cancer drug lenvatinib has been accepted for Priority Review by the US Food and Drug Administration, its Japanese manufacturer Eisai has announced. 18 January 2016
Biosimilars
The European Commission has approved Benepali – a biosimilar referencing Enbrel (etanercept) – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. 18 January 2016
Pharmaceutical
The US Food and Drug Administration has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab) for the treatment of two new indications - adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). 18 January 2016
Pharmaceutical
The 21st Century Cures Act was passed by the US House of Representatives in July 2015 and is sparking debate in the medical community. The Act aims to get cures from research to medical practice faster and covers everything from discovery to research funding, drug development, Food and Drug Administration approval, and Medicare, writes Dr Nicola Davies in her regular exclusive article for The Pharma Letter. 18 January 2016
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