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Regulatory Affairs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: June 1, 2020, 5:08 pm
Some extended-release formulations of the diabetes drug metformin contained levels of a nitrosamine impurity falling above the US Food and Drug Administration’s (FDA’s) acceptable intake limit, according to recent testing conducted by the agency.
Posted: May 29, 2020, 8:54 pm
To further the establishment of a rare disease clinical trials network, the US Food and Drug Administration (FDA) is asking for input from the public and a broad array of stakeholders.
Posted: May 29, 2020, 8:48 pm
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the authorization of eight new medicines, including a new vaccine against Ebola virus, and says it is waiting for Gilead Sciences to submit an application for conditional marketing authorization for remdesivir to treat coronavirus disease (COVID-19).
Posted: May 29, 2020, 8:38 pm
Beginning in the mid-1980s and through the last decade, several scientific discoveries have paved the way for ultra-personalized therapeutics.
Posted: May 29, 2020, 8:06 pm

Biotechnology

Juvenescence Limited, a life sciences company focused on therapies to modify aging and increasing healthy human longevity, and G3 Therapeutics, a trailblazer biotechnology company leveraging biological big data for drug discovery and development, announced the formation of Juvenomics Limited, a joint venture between the two parent companies.
Posted: June 1, 2020, 12:00 am
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment, prevention, and diagnosis of cancer and infectious diseases, today announced that the Company, together with partner OntoChem GmbH, has synthesized four potential Covid-19 compounds that will advance to biological assay testing. Anixa and Ont
Posted: June 1, 2020, 12:00 am
SYNB1891 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors or lymphoma
Posted: June 1, 2020, 12:00 am
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
Posted: June 1, 2020, 12:00 am
Mateon Therapeutics Inc. (OTCQB:MATN) report several peer-reviewed publications derived from its R&D effort against COVID-19. Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3 Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in
Posted: June 1, 2020, 12:00 am

Pharmaceuticals

By taking America's marbles and going home, President Trump has created a leadership vacuum in the WHO that others will happily fill — to the detriment of the U.S. and…
Author: Ashish K. Jha
Posted: June 1, 2020, 5:28 pm
Key takeaways from this year's virtual #ASCO20 conference: AstraZeneca does a star turn, KRAS fizzles, and cell therapy shows progress.
Author: Adam Feuerstein
Posted: June 1, 2020, 4:15 pm
Anthony Fauci, director of NIAID, was not enthused about a decision by Moderna to issue snippets of early data from the Covid-19 vaccine trial his agency has been conducting.
Author: Ed Silverman
Posted: June 1, 2020, 1:38 pm
New data add to the evidence that remdesivir is at least somewhat effective treatment for Covid-19.
Author: Matthew Herper
Posted: June 1, 2020, 1:23 pm
It’s been extraordinarily difficult to design medicines that can target neurological illness because of the "blood-brain" barrier. But new science shows there may be a way.
Author: Meghana Keshavan
Posted: June 1, 2020, 11:37 am

Human Resources

Unless workers get training in their current jobs, they run the risk of their skills becoming obsolete in a cycle that is moving faster than ever.

Author: Aman Kidwai
Posted: June 1, 2020, 2:59 pm

Employers have paid high prices to settle similar charges of national origin and race discrimination.

Author: Lisa Burden
Posted: June 1, 2020, 2:51 pm

"Our commitment to inclusion and diversity at Twitter has never been stronger," a Twitter official said.

Author: Sheryl Estrada
Posted: June 1, 2020, 2:49 pm

Included are five installments of HR Dive's Back to Basics, a column dedicated to laying out the basics of federal employment laws. 

Posted: June 1, 2020, 2:40 pm

Among other things, the labs said they will offer on-site testing and employee health questionnaires.

Author: Kate Tornone
Posted: June 1, 2020, 1:47 pm