Biologics
Former CBER Office of Vaccines Research and Review (OVRR) deputy director Philip Krause has joined Adjuvance Technologies as a strategic consultant. The privately-held clinical-stage biopharmaceutical company says it is focused on developing next-generation saponin adjuvants and vaccines for infectious disease and immuno-oncology. Saponin adjuvants are described
Biologics
CBER has released a list of 13 guidance topics it is considering for development this calendar year. The 13 guidances are divided into three categories: Blood and Blood Components (six guidances), Tissues and Advanced Therapies (six guidances), and Vaccines (one guidance).
Biologics
FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as a first-line treatment in advanced non-small cell lung cancer (NSCLC). The user fee review action target date is 9/19. Libtayo was approved last year as
Biologics
FDA says it has revised the Janssen Covid-19 vaccine fact sheet for healthcare providers administering vaccines and the fact sheet for recipients and caregivers. The agency says the revisions are in response to new safety information about the serious risk of immune thrombocytopenia, a disorder that can cause easy
Biologics
FDA issued 1/7 a new guidance with recommendations to healthcare providers and investigators on the use of Covid-19 convalescent plasma under the emergency use authorization or investigational convalescent plasma under an IND during the current public health emergency. The document supersedes a 2/2021 guidance and has recommendations
Biologics
An FDA review of a Web site and YouTube channel maintained by Aspen Institute for Regenerative Medicine and Anti-Aging determined that the firm markets cellular products derived from umbilical cord blood or adipose tissue to treat diseases or conditions such as congestive heart failure, ischemia, chronic obstructive pulmonary disease
Biologics
FDA has amended the Pfizer/BioNTech emergency use authorization for their Covid-19 vaccine to: * expand the use of a single booster dose to include those ages 12-15; * shorten the time between the completion of primary vaccination with the product and a booster dose to at least five months;
Biologics
Novavax says it will apply for an FDA emergency use authorization for its Covid-19 vaccine this month, extending slightly the 12/31/21 deadline it previously announced. Reuters reports the company has delayed its U.S. submission multiple times due to development and manufacturing issues. The company released data
Biologics
FDA has published a draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other interested parties on the use of digital health technologies for remote data acquisition from participants in clinical investigations evaluating medical products. The document defines a digital health
Biologics
Former FDA Office of Vaccines Research and Review deputy director Philip Krause and former FDA acting chief scientist Luciana Borio say the Biden administration has made recent vaccine decisions without consulting outside scientific experts, reversing what had been standard practice. Writing in a Washington Post op-ed, the two cite
Biologics
FDA says there are revisions to two fact sheets for the Janssen (Johnson & Johnson) Covid-19 vaccine. An agency announcement says the Fact Sheet for Healthcare Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers now include a Contraindication to the administration of the Janssen Covid-19
Biologics
A 7/8-7/19 FDA inspection at Cooper Institute for Advanced Reproductive Medicine, Houston, TX, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 12/15 Warning Letter says specific deviations were: * failing to test a specimen from an anonymous or
Biologics
FDA has granted Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and older. The booster dose is intended to be administered at least six months after completing a two-shot primary vaccination series. The companies say they
Biologics
FDA’s limited experience in approving seven gene therapies to date has provided some valuable “lessons learned,” according to CBER Office of Tissues and Advanced Therapies director Wilson Bryan. Speaking at a 12/6 online update for the Alliance for a Stronger FDA, Bryan said all seven products were approved
Biologics
FDA has issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prevention of Covid-19 in certain adults and pediatric patients. An agency notice says the monoclonal antibody product is only authorized for those individuals who are
Biologics
Former FDAers Joshua Sharfstein and Peter Lurie say a recent agency draft guidance on benefit/risk assessment indicates that FDA “intends to embrace the broader view of its authority in certain circumstances, a promising alignment of the tools of regulation with the agency’s mission to protect public health.” Writing
Biologics
CBER’s Office of Tissues and Advanced Therapies (OTAT) is swamped with new product submissions to the extent that the office is considering restructuring and revamping processes to help move products along the regulatory pathways. OTAT regulates cell therapies, gene therapies, as well as plasma derived products, such as immunoglobulins
Biologics
Theratechnologies has submitted a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous (IV) push form of administration for treating, in combination with other antiretrovirals, human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults. The company recently announced results from the TMB-302 study, which it
Biologics
FDA has issued a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the company’s Covid-19 vaccine candidate, BBV152, which is known as Covaxin outside the U.S. The company is awaiting formal written communication from the agency that will outline the deficiencies. Earlier this
Biologics
A 4/5-4/16 FDA inspection at Surgenex, Scottsdale, AZ, determined that it manufactures cellular products for allogenic use that are distributed to third-party distributors, some under private label, and directly to healthcare professionals and medical facilities. An 11/15 Warning Letter says the products are intended for
Biologics
Pfizer has asked a California federal court for an injunction against former employee Chun Xiao (Sherry) Li, claiming she uploaded over 12,000 files from her company laptop to a personal account and/or device. In its court filing, Pfizer says Li resigned effective 11/24 and reportedly accepted a
Biologics
The House Select Committee on the Coronavirus Crisis is asking former FDA commissioner Stephen Hahn for information relating to possible political interference from the Trump administration in the pandemic response. In an 11/22 letter, the committee asks Hahn for all documents and communications in his possession, custody, or control