Vanessa Doctor, RN

A growing number of studies show that though natural immunity can work, hybrid immunity through vaccination could be better. They urge faster vaccination drives.
Skin health logged major wins this week after two companies announced positive clinical trial results.
The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
FDA
The U.S. FDA approved the use of Moderna’s and Janssen’s COVID-19 vaccines as a booster dose after their primary versions are completed.
Surgeons hit a major milestone in transplantation science after successfully attaching a pig’s kidney to a human patient and it worked for several hours.
The entire lot of CUBICIN (daptomycin), numbered 934778, which has an expiry date of June 2022, will be recalled from the user level, including administering institutions and hospitals.
SURPASS-4 is part of the Phase III trial evaluating tirzepatide as a possible treatment for type 2 diabetes.
FDA
Zimhi is indicated for use in both adults and children in the event of an emergency. It is to be given right away and does not take the place of emergency care.
It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
Read about TFF Pharmaceuticals and Augmenta Bioworks’ dry powder COVID-19 antibody formula, the world’s first gene editing clinical trial for PKU, Bayer’s COVID-19 vaccine and other key developments in life sciences research.
The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
Transition Bio named Gregory Miller as chief executive officer, Prof. Tuomas Knowles as chief technology officer and Martin Kulander as chief operating officer, among several others.
FDA
The FDA gave Ardelyx a CRL on the NDA but did not mention anything about clinical pharmacology or biopharmaceutics, safety, or any related non-clinical concerns.