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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
Pharmaceutical
Biodel says that the US Food and Drug Administration has removed the partial clinical hold for Biodel's previously initiated Phase IIb Study 3-250, a randomized, open-label, parallel group study in patients with insulin-treated type 2 diabetes comparing the use of BIOD-531 to Humalog (insulin lispro) Mix 75/25. 13 October 2015
Biotechnology
Rebiotix Inc said its lead product to treat gastrointestinal (GI) infection has been granted Breakthrough Therapy designation by the US Food and Drug Administration. 13 October 2015
Pharmaceutical
The Scottish Medicines Consortium (SMC) has made decisions on three products. 12 October 2015
Biotechnology
Can-Fite BioPharma says that its oncology drug candidate, CF102, has been granted Orphan Drug designation by the European Medicines Agency for the indication of hepatocellular carcinoma. 12 October 2015
Pharmaceutical
Merck Millipore, the life science business of Merck KGaA, has introduced enhancements to its program of pharmaceutical raw materials. 12 October 2015
Pharmaceutical
New Phase III data has shown Halaven (eribulin) from Eisai can offer a significant overall survival benefit in rare soft tissue sarcomas compared to dacarbazine. 12 October 2015
Pharmaceutical
After tackling vaccination against seven diseases, the Indian government has set its sights on bio-medical research involving children, reports The Pharma Letter’s India correspondent. 12 October 2015
Pharmaceutical
The European Medicines Agency today launched an initiative on patient registries aimed at making better use of existing registries as a source of high-quality post-authorization data in medicines for regulatory decision-making, and to facilitate the establishment of new registries if needed. 12 October 2015
Biotechnology
The US Food and Drug Administration on Friday granted approved for pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. 10 October 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has issued final draft guidance recommending Keytruda (pembrolizumab) from Merck to treat advanced skin cancer not treated with ipilimumab. 9 October 2015
Pharmaceutical
Japanese pharma major Eisai says it has received marketing approval of its novel in-house developed anticancer agent Lenvima (lenvatinib mesylate) from the regulatory authority in South Korea (Ministry of Food and Drug Safety). 9 October 2015
Pharmaceutical
US drug major Eli Lilly on Thursday said the US Food and Drug Administration has granted Breakthrough Therapy designation to its drug candidate for metastatic breast cancer. 8 October 2015
Pharmaceutical
USA-based Sunesis Pharmaceuticals says it intends to submit a Marketing Authorization Application for vosaroxin (proposed trade name Qinprezo) as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency by the end of 2015. 8 October 2015
Pharmaceutical
Teva Pharmaceutical Industries today revealed that the Russian Ministry of Health has approved the Marketing Authorization license for three-times-a-week Copaxone (glatiramer acetate injection) 40mg/mL, a new dose of the drug for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). 8 October 2015
Pharmaceutical
Pharming Group NV and Salix Pharmaceuticals on Thursday said the US Food and Drug Administration (FDA) has granted 12 years of exclusivity to the drug for treating a rare genetic disorder. 8 October 2015
Pharmaceutical
Malaysia's policies that encourage domestic investments and local consumption are driving up its Gross Domestic Product (GDP). 8 October 2015
Pharmaceutical
Germany’s Merck KGaA and US pharma giant Pfizer said the US Food and Drug Administration has granted fast track designation to a trial stage immunotherapy for the treatment of rare skin cancer. 8 October 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has in final guidance issued today said “yes” to pembrolizumab for treating advanced skin cancer after treatment with ipilimumab. 7 October 2015
Biotechnology
Ireland-headquartered biotech firm Alkermes on Tuesday said the US Food and Drug Administration has approved its drug to treat schizophrenia and that it is looking to immediately launch for the product. 6 October 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether ceritinib offers an added benefit over the appropriate comparator therapy. 6 October 2015
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