Industry News (RSS)

Regulatory Affairs

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.
Posted: December 11, 2017, 12:00 am
France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.
Posted: December 11, 2017, 12:00 am
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: December 11, 2017, 12:00 am
The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.
Posted: December 11, 2017, 12:00 am
The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments.
Posted: December 8, 2017, 12:00 am

Biotechnology

ProMetic Life Sciences announced today that its orally-active drug candidate, PBI-4050, has been issued a Promising Innovative Medicine designation by the UK MHRA as add-on treatment to nintedanib in patients with idiopathic pulmonary fibrosis.
Posted: December 11, 2017, 12:00 am
The regulatory process entails an on-site inspection by the FDA and a BLA review period that is approximately 12 months, suggesting potential approval of ADMA’s third plasma facility by the end of 2018.
Posted: December 11, 2017, 12:00 am
Cardiome plans to submit regulatory filings for Trevyent in Europe and Canada shortly following SteadyMed's NDA resubmission to the FDA.
Posted: December 11, 2017, 12:00 am
If approved, would be the first treatment for deadly smallpox.
Posted: December 11, 2017, 12:00 am
PharmaCyte Biotech announced that it recently met with its Oncology Advisory Board, which was formed to assist in optimizing and finalizing the clinical protocol and other clinical trial-related matters.
Posted: December 11, 2017, 12:00 am

Pharmaceuticals

Three more drug makers allegedly relied on schemes in which nurses were used to illegally promote its diabetes medicines to physicians, according to recently unsealed lawsuits. The documents describe how…
Author: Ed Silverman
Posted: December 11, 2017, 8:56 pm
Although sales do not constitute usage, the data is closely watched over concerns that humans are becoming increasingly resistant to antibiotics that are given to food-producing livestock.
Author: Ed Silverman
Posted: December 11, 2017, 7:12 pm
Adawia Alousi, for whom the scholarship is named, helped develop a pioneering drug treatment for congestive heart failure in the 1980s.
Author: Associated Press
Posted: December 11, 2017, 3:48 pm
The American Society of Hematology annual meeting was bit like playing in a children’s soccer tournament: Everyone got a congratulatory trophy just for showing up. Well … not everyone.
Author: Adam Feuerstein
Posted: December 11, 2017, 2:14 pm
Avondale Pharmaceuticals raised the price of Niacor, a prescription version of Niacin, by 809 percent last month.
Author: Ed Silverman
Posted: December 11, 2017, 2:14 pm

Human Resources

The move leaves a split among the federal appeals courts, but experts say employers should still include LGBT workers in nondiscrimination policies.

Posted: December 11, 2017, 3:51 pm

It’s in every company’s best interest to promote and encourage healthy attitudes toward work flexibility, says Workfront's president and CEO. So where do you start?

Posted: December 11, 2017, 3:30 pm

Since uncovering a pay gap in July, the company vowed to close it by year's end.

Posted: December 11, 2017, 3:20 pm

Over 60% of employers plan to switch up to one-third of their full-time permanent positions to contingent jobs.

Posted: December 11, 2017, 3:11 pm

Other survey results show that U.S. companies anticipate automation accounting for, on average, 17% of work during the next three years.

Posted: December 11, 2017, 2:56 pm