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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
China’s State Council has formally authorized a pilot for a new drug marketing authorization holder (MAH) system for 10 of its 23 provinces. 20 June 2016
Pharmaceutical
The Ukraine Association of Pharmaceutical Research and Development (APRaD) has called its disclosure of information on transfers of value to health care professionals and organizations made in the country’s pharma industry in 2015 a step forward for transparency. 20 June 2016
Biosimilars
Access to affordable biosimilars is around the corner in India, with the government looking to release guidelines after nearly two years of consultations with the pharma industry and the Central Drugs Standard Control Organization (CDSCO), reports The Pharma Letter’s India correspondent. 20 June 2016
Pharmaceutical
Leading global drugmakers operating in the Russian market have called on the country’s government to ease the current conditions for conducting clinical trials of their drugs in Russia, according to recent statements from the press-service of the Russian Ministry of Health. 20 June 2016
Biosimilars
Medicines for Europe, the trade group representing the continent’s generics and biosimilars industry, has said it will work with health ministers to ensure swift implementation of calls for greater pharma competition which were made in the council of the European Union this week. 17 June 2016
Pharmaceutical
At its June meeting, the European Medicine Agency’s Management Board adopted the EMA’s multiannual work program to 2020. 17 June 2016
Pharmaceutical
USA-base Ariad Pharmaceuticals today announced the initiation of a New Drug Application submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the US Food and Drug Administration. 17 June 2016
Biotechnology
Roche has received approval from the European Commission for Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma. 17 June 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended the combination therapy of Opdivo (nivolumab) + Yervoy (ipilimumab), both drugs from US pharma major Bristol-Myers Squibb, to treat National Health Service patients with advanced skin cancer. 17 June 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has said it will not be able to recommend Orkambi (lumacaftor-ivacaftor) from US drugmaker Vertex Pharmaceuticals for treating cystic fibrosis. 17 June 2016
Pharmaceutical
Netherlands-headquartered independent drugmaker Norgine has received approval from the Dutch Ministry of Health for the reimbursement of Xifaxan 550 (rifaximin-α 550mg) in hepatic encephalopathy (HE). 16 June 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has today published draft guidance on Cotellic (cobimetinib) with Zelboraf (vemurafenib) for a type of advanced skin cancer. 16 June 2016
Pharmaceutical
The National Pharmaceutical Pricing Authority (NPPA) in India has taken action against major drug firms for not registering their products on the online database Integrated Pharmaceutical Database Management System. 16 June 2016
Pharmaceutical
French pharma major Sanofi has announced that two late-stage Phase III trials of its LixiLan diabetes drugs have met their primary endpoints. 14 June 2016
Pharmaceutical
Immediate contingency plans should be put in place to safeguard the UK’s science and innovation sector in case Britain votes to leave the EU, a government report has said. 14 June 2016
Biotechnology
USA-based Eleven Biotherapeutics, specialized in protein therapeutics to treat diseases of the eye, yesterday entered into an exclusive license agreement with Swiss pharma giant Roche 14 June 2016
Biotechnology
Taiwanese drug developer TaiGen Biotechnology has received approval from the China Food and Drug Administration (CFDA) to market the oral formulation of its novel antibiotic, Taigexyn (nemonoxacin), in mainland China. 14 June 2016
Pharmaceutical
Research findings from specialists treating advanced lung cancer have today highlighted worrying concerns that UK patients are being denied the best possible chance of survival. 14 June 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for two investigational products for rare diseases from Shire. 13 June 2016
Pharmaceutical
The US Food and Drug Administration has granted approval for privately-held PaxVax’ Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. 13 June 2016
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