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RSS FeedPosted by Michael Wonder on 17 Jan 2019
After 37 years of trying, this biotech nears a first drug approval in breast cancer
16 January 2019 - Immunomedics was founded in 1982. Thirty-seven years later, the biotech is finally on the cusp of ...
Posted by Michael Wonder on 17 Jan 2019
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...
Posted by Michael Wonder on 17 Jan 2019
Aeterna Zentaris receives European marketing clearance for macimorelin
16 January 2018 - Aeterna Zentaris announced that the EMA has granted marketing authorisation for macimorelin, an orally available ghrelin agonist, ...
Posted by Michael Wonder on 17 Jan 2019
FDA review of Aimmune drug put on hold due to government shutdown
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...
Posted by Michael Wonder on 17 Jan 2019
New drug application for insomnia disorder treatment lemborexant submitted in the United States
15 January 2019 - Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, ...
Posted by Michael Wonder on 17 Jan 2019
Acurx receives FDA fast track designation for ACX-362E for the treatment of C. difficile infection
16 January 2019 - Phase 1 clinical study underway - anticipated completion second quarter 2019. ...
Posted by Michael Wonder on 17 Jan 2019
Menlo Therapeutics’ serlopitant granted breakthrough therapy designation by FDA for the treatment of pruritus associated with prurigo nodularis
15 January 2019 - Menlo Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for serlopitant for the ...
Posted by Michael Wonder on 16 Jan 2019
The FDA has five weeks till money runs out for approving new drugs
16 January 2019 - The US FDA has roughly five weeks of funding left to review new drug applications during ...
Posted by Michael Wonder on 16 Jan 2019
FDA approves first generic version of Sabril to help treat seizures in adults and paediatric patients with epilepsy
16 January 2019 - The U.S. FDA approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex ...
Posted by Michael Wonder on 16 Jan 2019
Sweet smell of success for patients taking the sugar pill
15 January 2019 - A placebo is anything that seems to offer a real medical treatment, but doesn’t. It could ...
Posted by Michael Wonder on 16 Jan 2019
EFPIA response to the UK parliament’s decision to reject the Brexit withdrawal agreement and political declaration
15 January 2019 - EFPIA notes the UK parliament’s decision to reject the Brexit withdrawal agreement and political declaration. ...
Posted by Michael Wonder on 16 Jan 2019
Pharmaceutical industry responds to Brexit vote outcome
15 January 2019 - The Association of the British Pharmaceutical Industry has responded to the outcome of the meaningful vote on ...
Posted by Michael Wonder on 16 Jan 2019
Dublin warns medicine supply threatened by no-deal Brexit
16 January 2019 - More than half of Ireland’s medicines come from or are transited via the UK. ...
Posted by Michael Wonder on 16 Jan 2019
EMA to lose 25% of staff as hard Brexit approaches
14 January 2019 - As UK Prime Minister Theresa May’s Brexit deal is expected to be rejected Tuesday in a ...
Posted by Michael Wonder on 16 Jan 2019
European Medicines Agency validates Oasmia Pharmaceutical's application to add efficacy data to the approved Apealea product information
15 January 2019 - Oasmia Pharmaceutical today announce that the EMA has validated a type II variation application to add ...