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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
Generics
Yesterday, the US Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate) for the treatment of erectile dysfunction. 10 March 2016
Biotechnology
Danish biotech company Genmab has reached a new milestone in its daratumumab collaboration with Janssen, the Europe-based subsidiary of US health care giant Johnson & Johnson. 10 March 2016
Pharmaceutical
Taiwanese biopharma company PharmaEngine says that the Taiwan Food and Drug Administration (TFDA) has approved the product license of Onivyde (irinotecan liposome injection, nal-IRI). 8 March 2016
Pharmaceutical
Patients are promised earlier access to new drugs which are showing potential, following the launch of a new scheme on Monday by the European Medicines Agency (EMA). 7 March 2016
Pharmaceutical
Drug cost-effectiveness regulator the Scottish Medicines Consortium (CSM) issued a bunch of recommendations today, two of which were negative for important new cancer treatments. 7 March 2016
Pharmaceutical
The US Food and Drug Administration has given fast-track status to MedImmune’s investigational human monoclonal antibody (MAb), MEDI8852, for the treatment of patients hospitalized with Type A strain influenza. 7 March 2016
Pharmaceutical
The Ministry of Health of Ukraine has signed a Memorandum of Understanding (MoU) with a number of manufacturers of insulin aimed for successful implementation of a pilot project to introduce state regulation of prices for insulin and proper provision of medicines to the population of Ukraine. 7 March 2016
Generics
Pharmaceutical companies in China have been ordered to make sure the quality and efficacy of their generics are on par with brand-name drugs, a move that aims to improve the nation's pharma industry, reports the state news agency Xinhua. 7 March 2016
Biotechnology
The US Food and Drug Administration on Friday approved Idelvion (coagulation Factor IX [recombinant], albumin fusion protein; albutrepenonacog alfa), for use in children and adults with hemophilia B. 5 March 2016
Biotechnology
The US Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for an additional indication, in the treatment-naïve patients with chronic lymphocytic leukemia (CLL). 5 March 2016
Pharmaceutical
The Russian government, together with the Federal Anti-Monopoly Service (FAS), may provide a right to domestic companies to produce foreign drugs without the permission of a patent holder. 4 March 2016
Pharmaceutical
It is too early to gauge whether the US Food and Drug Administration's pediatric voucher program has stimulated the development of drugs to treat or prevent rare pediatric diseases, according to a Government Accountability Office (GAO) report released this week. 3 March 2016
Biotechnology
BioMarin Pharmaceutical late yesterday announced positive 48-week results from its Phase I/II pivotal study for cerliponase alfa, a recombinant human tripeptidyl peptidase 1 (rhTPP1) to treat children with CLN2 disease, a form of Batten disease. 3 March 2016
Pharmaceutical
Belgian biopharmaceutical company TiGenix has submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product Cx601, it has been announced. 3 March 2016
Biotechnology
Baxalta has submitted a Marketing Authorization Application to the European Medicines Agency for approval of Adynovi, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment. 3 March 2016
Biotechnology
The US Food and Drug Administration has approved Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. 2 March 2016
Pharmaceutical
“We are outraged that the Minister of Health has today confirmed NZ$30 million [~$20 million] of PHARMAC’s budget was not reinvested in medicines in 2015. PHARMAC’s gross underfunding has left New Zealanders missing out on innovative medicines,” said Graeme Jarvis, general manager of Medicines New Zealand. 2 March 2016
Pharmaceutical
Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new indication for Merck & Co’s heart drug Ezetrol (ezetimibe). 2 March 2016
Biotechnology
Janssen says it is extremely disappointed with the UK’s drugs cost watchdog the National Institute for Health and Care Excellence’s (NICE) initial response regarding its Imbruvica (ibrutinib) which was released this morning. 2 March 2016
Pharmaceutical
Bayer’s blockbuster ophthalmic drug Eylea (aflibercept) has already undergone several early benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG) for other therapeutic indications. 1 March 2016
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