Industry News (RSS)

Regulatory Affairs

FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH
The US Food and Drug Administration (FDA) revealed Thursday that it’s offering a proposal to the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs.
 
Posted: October 18, 2018, 3:26 pm
Democrats Grill Drugmakers Over Tax Savings
In letters to the CEOs of five top US drugmakers, 16 House Democrats question the companies’ actions on pricing, investment in research and development, employment, stock buybacks and executive compensation in light of tax savings as a result of the 2017 Tax Cuts and Jobs Act (TCJA).
Posted: October 17, 2018, 8:33 pm
21st Century Cures Act and Acceleration of Device Approval
This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past.
Posted: October 17, 2018, 6:57 pm
EU Releases Working Plan to Implement MDR/IVDR

The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR).

Posted: October 17, 2018, 6:48 pm
Cybersecurity: FDA Spells Out Updated Premarket Policies
With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective.
Posted: October 17, 2018, 6:09 pm

Biotechnology

Amgen Invests £50 Million ($66 Million) In Oxford Nanopore Technologies
Amgen (NASDAQ:AMGN) and Oxford Nanopore Technologies today announced Amgen's equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology.
Posted: October 18, 2018, 12:00 am
CytoSorbents to Showcase CytoSorb® at Two Key European Medical Conferences
CytoSorbents, Inc. (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that it will showcase CytoSorb at the 32nd European Association for CardioThoracic Surgery Conference (EACTS) in Milan, Italy from October 18-20, 2018, and the 31st European Society of Intensive Care Medicine Congress (ESICM) in Paris, France from October 20-24, 2018.
Posted: October 18, 2018, 12:00 am
Immune Design Abandons Cancer Vaccine Program, Drops 20% of Workforce at Two U.S. Locations
The company, with sites in Seattle and South San Francisco, focuses on next-generation oncology therapeutics. It recently completed a portfolio review and decided to focus its energies and existing capital on G100 and abandoned its CMB305 program.
Posted: October 18, 2018, 12:00 am
MiNA Therapeutics Announces Sosei Will Not Exercise Acquisition Option
MiNA Therapeutics remains on track with current development plans for small activating RNA medicines including clinical development of MTL-CEBPA drug candidate
Posted: October 18, 2018, 12:00 am
UCB Accelerates Anti-FcRn Rozanolixizumab in Myasthenia Gravis Into Confirmatory Development Phase
Positive outcomes in proof-of-concept study with subcutaneous rozanolixizumab in patients with myasthenia gravis (MG): clinically meaningful improvement in multiple disease-related endpoints
Posted: October 18, 2018, 12:00 am

Pharmaceuticals

STAT Plus: Pharmalittle: Pfizer offers early retirement ahead of layoffs; Novartis buys Endocyte for $2.1 billion
Novartis agreed to pay $2.1 billion to acquire Endocyte in order to gain access to a new treatment being developed for prostate cancer.
Author: Ed Silverman
Posted: October 18, 2018, 1:14 pm
STAT Plus: A new device aimed at improving sleep is generating excitement — and questions
There’s a new device out today that promises to help you sleep better. But whether people will actually use the device — and whether doctors will trust it — is…
Author: Kate Sheridan
Posted: October 18, 2018, 12:00 pm
Novartis buys Endocyte for $2.1 billion, causing an outspoken critic to admit he was badly wrong
Novartis buys Endocyte for $2.1 billion, causing an outspoken critic to admit he was badly wrong.
Author: Adam Feuerstein
Posted: October 18, 2018, 10:57 am
STAT Plus: How 23andMe thinks about genetic privacy in the age of forensic genealogy and Facebook’s woes
How 23andMe thinks about genetic privacy in the age of forensic genealogy and Facebook’s woes.
Author: Rebecca Robbins and Damian Garde
Posted: October 18, 2018, 8:40 am
Opinion: Mental health patients, with nowhere else to go, are overwhelming emergency departments
When patients with mental health crises arrive in my emergency department, I'd love to have a way to get them the higher-level care they need for their psychiatric issues.
Author: Anne Zink
Posted: October 18, 2018, 8:35 am

Human Resources

Tesla is 2018's 'hottest' company among Indeed applicants

The automaker's presence in the list — despite controversies — speaks to the necessity and power of an authentic brand presence in recruiting.

Posted: October 18, 2018, 2:09 pm
DOL extends violation self-reporting program — but should employers bite?

At least nine employers have participated in PAID, and their names are already public. Two attorneys weigh in on the program's risks and rewards.

Posted: October 18, 2018, 1:53 pm
Neither employees nor managers know what work is being done

A lack of communication and transparency will remain problems for the workplace unless employers step in with a fix, a new study claims.

Posted: October 18, 2018, 1:26 pm
Employer to offer jobs to 150 women to settle EEOC suit

Sherwood Food Distributors will pay $3.6 million to resolve claims it discriminated against female applicants at warehouses in Cleveland and Detroit.

Posted: October 18, 2018, 1:03 pm
4 key leadership skills to drive your digital transformation

Successfully driving a digital transformation at your organization requires rethinking your leadership talent. Here are 4 digital leadership skills you’ll need to cultivate in today’s leaders.

 

Posted: October 18, 2018, 12:00 pm