Regulatory Affairs
Following Takeda Pharmaceuticals’ recall of its hypoparathyroidism drug Natpara (parathyroid hormone) early last month, people who need the drug to stay alive are struggling to find it and ending up in the hospital.
Posted: October 18, 2019, 6:58 pm
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus.
Posted: October 18, 2019, 6:39 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: October 18, 2019, 6:32 pm
The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, packaging and storing drugs.
Posted: October 18, 2019, 5:28 pm
Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US.
Posted: October 18, 2019, 2:33 pm
Biotechnology
Isofol Medical AB, announced the successful completion of Japan's Pharmaceutical and Medical Devices Agency review of the Clinical Trial Notification, allowing the start of the pivotal Phase 3 AGENT clinical study in metastatic colorectal cancer at Japanese sites.
Posted: October 18, 2019, 12:00 am
Cyclo Therapeutics, Inc. (OTCQB:CTDH), formerly CTD Holdings, Inc., a biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced that the company has provided a grant to The Firefly Fund in support of its newborn screening program for Niemann-Pick Disease Type C.
Posted: October 18, 2019, 12:00 am
Reference is made to the announcement by Nordic Nanovector ASA on 18 October 2019 concerning a private placement with gross proceeds in the amount of NOK 242 525 624 and that the Company is considering to conduct a repair offering of up to 2,204,778 new shares with non-tradeable subscription rights to eligible shareholders.
Posted: October 18, 2019, 12:00 am
Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, today announced that Dr. Torsten Madsen, acting Chief Medical Officer will be presenting preclinical data highlighting the strong association between bacteria-derived metabolites and autism spectrum disorder (ASD) at the Society for Neuroscience 2019 Annual Meeting on Saturday, October 19, 2019 in Chicago, IL.
Posted: October 18, 2019, 12:00 am
As the first part of a six-part series describing the hottest careers in the biopharma industry, we discussed the rewarding career of genetic counselor. Now, let’s take a look at the high in demand biopharma careers of biostatistician and biometrician.
Posted: October 18, 2019, 12:00 am
Pharmaceuticals
Under a proposed federal rule, scores of biotech startups would have to go through federal review before accepting overseas dollars.
Posted: October 18, 2019, 7:11 pm
Sanofi is recalling Zantac from the U.S. and Canada, joining numerous companies that began extensive recalls of their heartburn drugs because traces of a possible carcinogen were found in certain…
Posted: October 18, 2019, 6:16 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: October 18, 2019, 2:06 pm
Sen. Bernie Sanders, other lawmakers say the FDA is not being transparent about Takeda's recall of lifesaving drug.
Posted: October 18, 2019, 1:29 pm
The top executives of several drug companies will meet with a judge to review a proposal to resolve lawsuits alleging they fueled the opioid crisis.
Posted: October 18, 2019, 1:08 pm
Human Resources
Employees aren't alone in worrying about health benefit cost. The problem vexes employers, many of whom are rushing to find solutions.
Posted: October 18, 2019, 4:49 pm
The changes were made after a survey revealed that 1 in 6 students experienced sexual harassment.
Posted: October 18, 2019, 3:39 pm
In general, employers have a lot of leeway over workplace policies, but they should be careful with phrasing, attorneys told HR Dive.
Posted: October 18, 2019, 3:33 pm
Employers may reap long-term advantages by engaging short-term workers through customizable schedules and other benefits.
Posted: October 18, 2019, 2:30 pm
Companies on "best place to work" lists often are noted for treating employees with the same attention usually reserved for customers.
Posted: October 18, 2019, 2:10 pm