Blog
RSS FeedPosted by Michael Wonder on 11 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
11 February 2019 - Filing includes use of Keytruda in the first-line setting as monotherapy or in combination with chemotherapy. ...
Posted by Michael Wonder on 11 Feb 2019
Regeneron and Sanofi offer Praluent (alirocumab) at a new reduced U.S. list price
11 February 2019 - This is the latest step by the companies to help make Praluent more accessible and affordable for ...
Posted by Michael Wonder on 11 Feb 2019
RegenxBio receives rare paediatric disease designation for RGX-181 gene therapy for the treatment of CLN2 form of Batten disease
31 January 2019 - Novel, one-time investigational treatment for CLN2 disease designed to halt progression of this rare, paediatric, neurodegenerative disease. ...
Posted by Michael Wonder on 11 Feb 2019
Finch Therapeutics’ investigational drug CP101 granted breakthrough therapy designation from FDA for recurrent C. difficile infection
8 February 2019 - Designation to accelerate Finch’s efforts to provide an effective therapy for patients fighting recurrent C. difficile infection. ...
Posted by Michael Wonder on 08 Feb 2019
J&J becomes first drug maker to add prices to television ads
8 February 2019 - Johnson & Johnson said on Thursday it will start adding the price of its medicines to ...
Posted by Michael Wonder on 08 Feb 2019
Generic drug approvals surge, but hundreds still aren't for sale
7 February 2019 - The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past ...
Posted by Michael Wonder on 08 Feb 2019
Number needed to treat: conveying the likelihood of a therapeutic effect
7 February 2019 - Effectively communicating clinical trial results to patients and clinicians is a requirement for appropriate application in ...
Posted by Michael Wonder on 08 Feb 2019
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines
7 February 2019 - A key element of the U.S. FDA’s mission is focused on helping to ensure that all ...
Posted by Michael Wonder on 07 Feb 2019
Incyte announces U.S. FDA has extended the review period for ruxolitinib (Jakafi) in acute graft-versus-host disease
7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 07 Feb 2019
What is a biosimilar, exactly?
5 February 2019 - They’re meant to save money for the health care system, carve into pharma’s profits, and finally ...
Posted by Michael Wonder on 07 Feb 2019
Zogenix submits new drug application to U.S. FDA and marketing authorisation application to EMA for Fintepla for the treatment of Dravet syndrome
6 February 2019 - Zogenix today announced it has completed its rolling submission of a new drug application to the ...
Posted by Michael Wonder on 06 Feb 2019
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder
6 February 2019 - The U.S. FDA today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma ...
Posted by Michael Wonder on 06 Feb 2019
FDA finalises new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder
6 February 2019 - Today, the U.S. FDA issued a final guidance, “Opioid Use Disorder: Developing Buprenorphine Depot Products for Treatment,” ...
Posted by Michael Wonder on 06 Feb 2019
FDA grants priority review for Daiichi Sankyo’s new drug application for CSF1R inhibitor pexidartinib for treatment of patients with TGCT, a rare, debilitating tumour
6 February 2019 - If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant ...
Posted by Michael Wonder on 05 Feb 2019
FDA accepts for review new drug application for Merck’s investigational combination of imipenem/cilastatin and relebactam, and supplemental NDA for Zerbaxa (ceftolozane and tazobactam)
5 February 2019 - Merck today announced that the U.S. FDA has accepted for review regulatory filings for two antibacterial ...