Amicus Releases More Impressive Pompe Disease Data at WORLDSymposium
The company presented a late-breaker poster and corresponding oral presentation at the conference. Source: BioSpace
Gilead Elated as the FDA OKs New Blockbuster HIV Pill Biktarvy
The FDA approved Gilead's triple combination treatment for HIV, Biktarvy. Source: BioSpace
Interview Insider: Tips on How to Get Hired at Vertex Pharmaceuticals
Here is some insight on what Vertex may be looking for in their employees. Source: BioSpace
FDA Publishes Guidance on Microbiology Data for Antibacterial Drugs
Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly…
Macfarlan Smith Cited for GMP Deficiencies
API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements. Source: Drug…
Health Groups Say Right-to-Try Could Do ‘More Harm than Good’
A group of non-profits and activist organizations, including the American Lung Association, National Health Council and National Organization for Rare Disorders, urged lawmakers in the House of Representatives not to…
FDA Issues Considerations for Submitting Impurity Data as ANDA Approvals Drop in January
The FDA released new information for ANDA applicants on when to submit elemental impurity data, and acknowledged that new guidelines on reporting elemental impurities had slowed approvals in January. Source:…
Ousted Arcturus Founder and CEO Claims He was Improperly Pushed Out by 4 Board Members
Joseph E. Payne was shown the door as CEO of Arcturus last week - a move that Payne is not taking lightly. Source: BioSpace
2 Bay Area Biotechs That Jumped While Its Peers Cratered
Since Friday, the stock market has been volatile, to say the least. Source: BioSpace
On a Roll: FDA Calls Sage's Depression Drug a Breakthrough
This is the second Breakthrough Therapy designation granted to Sage since 2016. Source: BioSpace
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