Blog
RSS FeedPosted by Michael Wonder on 23 Sep 2017
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent locally advanced or metastatic gastric or gastro-oesophageal junction cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
22 September 2017 - First anti-PD-1 therapy approved in the U.S. for these patients with disease progression on or after two ...
Posted by Michael Wonder on 23 Sep 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) receives FDA approval for the treatment of hepatocellular carcinoma patients previously treated with sorafenib
22 September 2017 - The CheckMate -040 pivotal study evaluated Opdivo in patients with and without active Hepatitis B or C ...
Posted by Michael Wonder on 23 Sep 2017
FDA clears biotech drug copycats, but buying them isn’t so easy
18 September 2017 - Basically, there’s a gazillion patents,’ says consultant. ...
Posted by Michael Wonder on 22 Sep 2017
Criminal and civil actions filed against Aegerion Pharmaceuticals
22 September 2017 - Today, Aegerion Pharmaceuticals agreed to plead guilty in the United States District Court for the District of ...
Posted by Michael Wonder on 19 Sep 2017
Drug development at the portfolio level is important for policy, care decisions and human protections
19 September 2017 - The development of a new drug is often portrayed as a series of increasingly demanding clinical trials, ...
Posted by Michael Wonder on 19 Sep 2017
Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US
18 September 2017 - GSK and Innoviva today announced that the FDA has approved once-daily, single inhaler triple therapy fluticasone ...
Posted by Michael Wonder on 19 Sep 2017
U.S. FDA approves new indication for Ipsen’s Somatuline Depot (lanreotide) injection for the treatment of carcinoid syndrome
18 September 2017 - Ipsen today announced that the U.S. FDA has approved a supplemental indication for Somatuline Depot (lanreotide) ...
Posted by Michael Wonder on 19 Sep 2017
FDA approves Symbiomix Therapeutics’ Solosec (secnidazole) oral granules for the treatment of bacterial vaginosis in adult women
18 September 2017 - First and only single dose oral therapy approved for most common U.S. gynecologic infection that can ...
Posted by Michael Wonder on 19 Sep 2017
FDA acceptance of NDA for CAM2038 for opioid use disorder
18 September 2017 - The FDA has assigned a Prescription Drug User Fee Act target date of 19 January 2018. ...
Posted by Michael Wonder on 19 Sep 2017
FDA grants “fast track” status to Cancer Prevention Pharmaceuticals’ lead drug CPP-1X/sul for treatment of familial adenomatous polyposis
18 September 2017 - CPP-1X/sul aims to prevent disease progression in patients with familial adenomatous polyposis. ...
Posted by Michael Wonder on 19 Sep 2017
U.S. FDA grants fast track designation to Pluristem's PLX-PAD for the treatment of critical limb ischemia
18 September 2017 - Pluristem’s on-going phase III CLI trial has been selected for accelerated approval pathways in both the U.S. ...
Posted by Michael Wonder on 18 Sep 2017
Biosimilar cancer drug threat closing in for Roche
19 September 2017 - The long-heralded threat of cut-price competition to its top-selling biological cancer medicines is finally becoming a ...
Posted by Michael Wonder on 18 Sep 2017
Strategies that delay market entry of generic drugs
18 September 2017 - Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although ...
Posted by Michael Wonder on 18 Sep 2017
Neos Therapeutics receives U.S. FDA approval of Adzenys ER (amphetamine) extended-release oral suspension for the treatment of ADHD in patients 6 years and older
15 September 2017 - Neos Therapeutics to launch third medication in ADHD franchise in January 2018. ...
Posted by Michael Wonder on 18 Sep 2017
Seqirus receives FDA approval of Afluria Quadrivalent (influenza vaccine) for people five years of age and older in the U.S.
14 September 2017 - Expanded Afluria Quadrivalent age indication offers protection against four influenza virus strains for people five years of ...