Carmell Therapeutics gets IND clearance for CT-101 bone healing accelerant
January 8, 2020 No Comment
Carmell Therapeutics has secured clearance from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for CT-101, its first product, which is a bone healing accelerant (BHA). The Pennsylvania biotech company is engaged in the development and commercialization of plasma-based bioactive materials (PBMs) to speed up bone and soft tissue […]
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Biotricity said that it has wrapped up development of Biopatch, a new ECG patch platform for cardiac patients with fewer complications. The US medical technology company has developed the new ECG patch platform in a miniaturized form factor having three standard electrodes, with no lead wires. Biotricity is an extension of the company’s Bioflux device, […]
Continue reading …LIAISON QFT-Plus automated screening solution gets FDA nod for TB detection
January 1, 2020 No Comment
Qiagen and DiaSorin have secured approval from the US Food and Drug Administration (FDA) to use QuantiFERON-TB Plus (QFT-Plus automated screening solution) on the latter’s LIAISON platforms for detecting latent tuberculosis (TB). With the FDA approval, Qiagen and Diasorin can perform laboratory automation for latent TB screening, which will support the conversion from tuberculin skin […]
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Ubrelvy FDA approval : Irish pharma company Allergan has bagged approval from the US Food and Drug Administration (FDA) for Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura in adults. Aura is a sensory phenomenon or visual disturbance. Ubrelvy is now the first orally-administered calcitonin gene-related peptide (CGRP) receptor […]
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Micro Labs and Mylan Pharmaceuticals have secured approval from the US Food and Drug Administration (FDA) for two applications for the first generics of Eliquis (apixaban) tablets to cut down the risk of stroke and systemic embolism in patients having nonvalvular atrial fibrillation. Apixaban is also indicated for the preventive treatment of deep vein thrombosis […]
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Correvio Pharma said that the US Food and Drug Administration (FDA) decided not to approve its anti-arrhythmic drug Brinavess (vernakalant IV). In this connection, the Canadian specialty pharma company has been issued a complete response letter (CRL) from the FDA stating that it cannot approve the new drug application (NDA) for Brinavess in its present […]
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Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Roche’s cancer drug Rituxan (rituximab). Rituxan, which is a CD20-directed cytolytic antibody, has approval across various regions for the […]
Continue reading …Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer
December 19, 2019 No Comment
Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial cancer, the most common form of bladder cancer. Padcev, which has been co-developed by the two pharma companies, is a Nectin-4-directed antibody and microtubule […]
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Vascepa FDA approval : New Jersey-based Amarin has secured approval from the US Food and Drug Administration (FDA) for a new indication and label expansion for Vascepa (icosapent ethyl) capsules. The FDA has now approved Vascepa as an adjunctive (secondary) therapy to cut down the risk of cardiovascular events in adults having elevated triglyceride levels, […]
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Delaware-based pharma company Incyte has secured priority review for pemigatinib from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cholangiocarcinoma. The priority review for pemigatinib is for the treatment of the condition in previously treated patients having FGFR2 fusions or rearrangements. Cholangiocarcinoma is a rare cancer that occurs […]
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- ImmunoPrecise Antibodies launches vaccine development program for COVID-19
- Hunting acquires subsea production technology provider Enpro Subsea
- Whale field development : Deep Down to deliver RIV control system for FPU
