Regulatory Affairs
The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.
Posted: April 16, 2021, 9:01 pm
As part of an ongoing focus on rare diseases, FDA and industry discussed a proposed pilot program to identify novel endpoints for rare diseases, envisioning “potentially a limited number of common disease programs with innovative endpoints that have applicability to rare diseases."
Posted: April 16, 2021, 8:49 pm
Making a transition from a life and health science research scientist to regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.
Posted: April 16, 2021, 6:51 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: April 16, 2021, 6:06 pm
Updated 16 April to include new information on baricitinib, dexamethasone, Veklury, MK-7110, Farxiga, casirivimab/imdevimab, bamlanivimab, bamlanivimab/etesevimab and mavrilimumab.
Posted: April 16, 2021, 1:21 pm
Biotechnology
Synlogic a clinical stage company bringing the transformative potential of synthetic biology to medicine, announced the pricing of its underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $3.00 per share.
Posted: April 16, 2021, 12:00 am
Akoya Biosciences, Inc., The Spatial Biology Company®, announced the pricing of its initial public offering of 6,580,000 shares of its common stock at a price of $20.00 per share, for gross proceeds of $131.6 million, before underwriting discounts and commissions and offering expenses payable by Akoya.
Posted: April 16, 2021, 12:00 am
Keith Lenden and Dr. Honggang Bi has been appointed as new members of the Advisory Board at GT Apeiron Therapeutics, an AI empowered drug discovery start-up developing oncology therapeutics.
Posted: April 16, 2021, 12:00 am
Medivir AB announced that its Board of Directors appoints Magnus Christensen, the company's CFO, as interim CEO of Medivir.
Posted: April 16, 2021, 12:00 am
Shenzhen Chipscreen Biosciences announces that it has received Investigational New Drug clearance from the US Food and Drug Administration to proceed with a Phase 1b/2 clinical trial of Chiauranib/CS2164, a potential treatment for multiple oncological indications including Small Cell Lung Cancer, Ovarian Cancer, Liver Cancer, and Breast Cancer, etc.
Posted: April 16, 2021, 12:00 am
Pharmaceuticals
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: April 16, 2021, 3:00 pm
Some scientists are increasingly concerned that, because of a quirk of our own biology, future iterations of Covid-19 vaccines might not always be quite as effective as they are today
Posted: April 16, 2021, 1:20 pm
Josh Schimmer, who has been analyzing the pharmaceutical industry for decades, weighs in on drug development during the pandemic.
Posted: April 16, 2021, 8:50 am
The promise of microbiome-based therapies has been hindered by significant barriers in drug development, which manufacturers must strategically address to successfully drive adoption.
Posted: April 16, 2021, 8:45 am
A ketogenic diet, maligned by the medical establishment, has made a huge difference in my fight against ulcerative colitis. Am I being fooled by this, or is conventional medicine turning…
Posted: April 16, 2021, 8:40 am
Human Resources
Employers' concerns coming out of the pandemic appear to align with the worries they experienced throughout.
Posted: April 16, 2021, 2:22 pm
The change comes as part of Disney's effort to instill greater inclusion — which joins safety, courtesy, show and efficiency as a fifth company value.
Posted: April 16, 2021, 2:11 pm
With public interest in diversity and inclusion increasing, experts say now is the time for employers to act.
Posted: April 16, 2021, 2:06 pm
The training will impact 2 million employees at the chain's 39,000 restaurants worldwide regardless of whether they work at corporate-owned or franchisee-operated locations, CEO Chris Kempczinski announced Wednesday.
Posted: April 16, 2021, 1:11 pm
The tool allows users to practice their interviewing skills, interact with HR professionals and hear from workers who have found employment after incarceration.
Posted: April 15, 2021, 2:29 pm