Regulatory Affairs
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
Posted: June 16, 2021, 9:03 pm
The Pharmaceutical Inspection Cooperation Scheme (PIC/S) this week announced plans to incorporate the EU good manufacturing practice (GMP) Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim is to have non-EU/European Economic Area (EEA) members incorporate Annex 16 into their regulatory systems.
Posted: June 16, 2021, 8:43 pm
Recon: US buys another 200M doses of Moderna vaccine; First patient receives Biogen Alzheimer's drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: June 16, 2021, 6:33 pm
With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applications.
Posted: June 16, 2021, 3:00 pm
Biotechnology
Tiziana Life Sciences plc announces that it has submitted a grant to the United Kingdom COVID Therapeutics Advisory Panel to support further clinical development of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, as an innovative ‘Take Home’ approach for treatment of non-hospitalized patients with COVID-19.
Posted: June 17, 2021, 12:00 am
Targovax ASA, a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, announces that the ONCOS-102 and durvalumab trial in patients with advanced peritoneal malignancies has completed enrollment in the colorectal cancer cohort.
Posted: June 17, 2021, 12:00 am
Core One Labs Inc. advises that in preparation of a potential listing of its common shares on the Capital Market tier of The Nasdaq Stock Market LLC (“Nasdaq” or the “Exchange”), the Company is planning a share consolidation of its outstanding common share capital on the basis of eight (8) pre-Consolidation shares for every one (1) post-Consolidation share.
Posted: June 16, 2021, 12:00 am
Moderna, Inc., (Nasdaq: MRNA) today announced that the U.S. government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline.
Posted: June 16, 2021, 12:00 am
Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced that Kevin Cook will join as the Company’s Chief Financial Officer, effective June 21, 2021.
Posted: June 16, 2021, 12:00 am
Pharmaceuticals
Health care in the U.S. won’t get better if people don’t demand it, as they did during the pandemic.
Posted: June 17, 2021, 8:35 am
“Whatever they decide, it will have significance around the world," said Priti Krishtel, co-executive director of I-MA.
Posted: June 17, 2021, 8:30 am
American Medical Association delegates voted to support a controversial proposal to temporarily waive IP protections for Covid-19 vaccines.
Posted: June 16, 2021, 8:39 pm
A Regeneron monoclonal antibody treatment saved lives among hospitalized Covid-19 patients who had not mounted their own immune response.
Posted: June 16, 2021, 1:22 pm
In a special two-part "First Opinion Podcast" this week, guests Dennis Selkoe and Jason Karlawish talk individually about the tempest over Aduhelm, a newly approved drug for Alzheimer's disease.
Posted: June 16, 2021, 11:00 am
Human Resources
Internet ridicule of AmaZen took shots at the company's business practices, but it also may speak to problems employers face in evaluating their wellness efforts.
Posted: June 16, 2021, 7:36 pm
The agency last updated the overtime threshold in 2019, when it finalized a $35,568 minimum salary for overtime exemptions.
Posted: June 16, 2021, 2:09 pm
These popular companies are making good on their Juneteenth 2020 promises.
Posted: June 16, 2021, 2:05 pm
Labor efforts in the space are demystifying the idea that all tech workers have good working conditions.
Posted: June 16, 2021, 2:03 pm
By establishing guidelines around how any new practice will be tested, tracked or modified, companies ensure adaptability.
Posted: June 16, 2021, 1:59 pm