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RSS FeedPosted by Michael Wonder on 15 Nov 2018
NeuroRx receives FDA breakthrough therapy designation for NRX-101, first oral drug targeting suicidal bipolar depression
13 November 2018 - First oral rapid-acting anti-depressant to be granted breakthrough designation. ...
Posted by Michael Wonder on 15 Nov 2018
Merck begins rolling submission of licensure application for V920 (rVSV∆G-ZEBOV-GP) to U.S. FDA
13 November 2018 - V920 is the Company’s investigational vaccine for Ebola Zaire. ...
Posted by Michael Wonder on 15 Nov 2018
Stallergenes Greer announces U.S. FDA approval of paediatric indication extension for Oralair sublingual immunotherapy tablet for the treatment of grass pollen allergy
14 November 2018 - Stallergenes Greer today announced that it has received approval from the U.S. FDA for the extension of ...
Posted by Michael Wonder on 15 Nov 2018
Disclosing prescription-drug prices in advertisements — legal and public health issues
14 November 2018 - On October 15, 2018, the CMS proposed a rule requiring television advertisements for prescription drugs and ...
Posted by Michael Wonder on 14 Nov 2018
Pfizer launches epoetin alfa biosimilar, Retacrit, at 33.5% discount to reference Epogen
14 November 2018 - Pfizer announced today that it has launched its epoetin alfa biosimilar, Retacrit, at a substantial discount to ...
Posted by Michael Wonder on 14 Nov 2018
U.S. FDA accepts for filing Shire’s supplemental new drug application for Gattex (teduglutide [rDNA origin]) for children with short bowel syndrome
13 November 2018 - Seeking approval for the potential use of Gattex to paediatric patients builds on Shire’s decade-long commitment ...
Posted by Michael Wonder on 14 Nov 2018
Retrophin announces U.S. FDA acceptance of NDA filing for the new formulation of Thiola (tiopronin) in the treatment of cystinuria
12 November 2018 - PDUFA date set for 30 June 2019. ...
Posted by Michael Wonder on 14 Nov 2018
Pain Therapeutics appeals FDA decision on Remoxy
12 November 2018 - Pain Therapeutics today announced that it has petitioned the FDA regarding a complete response letter for ...
Posted by Michael Wonder on 14 Nov 2018
Palvella Therapeutics announces FDA fast track designation for PTX-022 for treatment of pachyonychia congenita
12 November 2018 - Palvella Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead product ...
Posted by Michael Wonder on 14 Nov 2018
Lilly submits new drug application to the FDA for lasmiditan for acute treatment of migraine, receives breakthrough therapy designation for Emgality (galcanezumab-gnlm) for prevention of episodic cluster headache
14 November 2018 - Lilly also plans to submit a supplemental biologics license application to the FDA for Emgality for the ...
Posted by Michael Wonder on 13 Nov 2018
FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations
13 November 2018 - Today, the U.S. FDA is proposing to amend its regulations to implement a provision of the ...
Posted by Michael Wonder on 13 Nov 2018
FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer
13 November 2018 - If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment ...
Posted by Michael Wonder on 12 Nov 2018
US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA mutated advanced ovarian cancer and grants priority review
12 November 2018 - First US regulatory submission acceptance for a PARP inhibitor as a first-line maintenance treatment for advanced ...
Posted by Michael Wonder on 12 Nov 2018
Drug prices on ads: as ‘relevant’ as percent daily value on food labels
9 November 2018 - President Trump announced late last month that his administration will push back on high drug costs ...
Posted by Michael Wonder on 10 Nov 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma
7 November 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to selinexor, the Company’s ...