Drugs
At an FDA/Untragenyx end-of-Phase-2 meeting for the DTX301 ornithine transcarbamylase (OTC) deficiency gene therapy program, the parties reached an agreement on the design and endpoints for a Phase 3 study. The company says the study will include a 64-week primary efficacy analysis period and enroll
Drugs
Eli Lilly and and Incyte say they plan to file in the second half of this year a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a second Phase 3 trial (BRAVE-AA1). They say the data are consistent with findings from the first Phase 3
Drugs
FDA has granted accelerated approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR as determined by an FDA-approved test.
Drugs
FDA says there were 10 section 505(j) ANDAs subject to priority review approved in the second quarter of FY 2021 (January-March) and six approved in the first quarter (October-December). A report, required under the FDA Reauthorization Act of 2017, also shows 58 awaiting FDA action in the
Drugs
In an unprecedented move, FDA has released an inspection report less than 24 hours after it completed an inspection of Emergent BioSolutions’ Baltimore manufacturing plant that shows troubling findings which led to an agreement to shut down operations until corrections are implemented (see earlier story). The plant is key to
Biologics
A California Law Review article by two Yale Law School professors makes the case that FDA should “reboot” its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. The professors
Drugs
The International Council for Harmonization (ICH) management committee has released a draft version of the ICH E6 good clinical practice guideline that continues to be developed by an expert working group. ICH says it determined that sharing the draft of the principles “would facilitate transparency and common understanding. Although public
Drugs
FDA has placed a clinical hold on a proposed KalVista Pharmaceuticals Phase 2 clinical trial of KVD824 for preventing hereditary angioedema attacks. The agency has requested further information and analysis on certain KVD824 preclinical studies submitted to support the planned trial, the company says. Modifications were also proposed for the
Drugs
FDA and industry negotiators met 1/21 and 1/27 to continue discussions on proposals from each side to enhance the review process. The sides acknowledged the need to continue discussing overall proposed resource requests at future negotiation meetings. The 1/21 meeting summary lists these topics that were discussed:
Drugs
Reps. Vern Buchanan (R-FL), Elaine Luria (D-VA), Nancy Mace (R-SC), Mikie Sherrill (D-NJ), and Brendan Boyle (D-PA) have introduced H.R. 2565, the FDA Modernization Act, to lift requirements for animal testing for any new drug development and to enable FDA to require the most
Drugs
Y-mAbs Therapeutics says it is collecting data from identified historical control groups sought by FDA for the company’s omburtamab, an investigational monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system administration. A company statement says the firm had a Type B meeting
Drugs
FDA has placed a clinical hold on an Anixa Biosciences ovarian cancer chimeric antigen receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (MCC), requesting additional information before allowing the trial to begin. Within the next 30 days, the company and MCC expect FDA will
Drugs
The DC Circuit Court of Appeals has affirmed in a 4/16 decision a district court decision that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug. At issue in Genus Medical Technologies v. FDA was that having a product
Drugs
FDA’s decision earlier this month to recommend a pause on Johnson & Johnson Covid-19 vaccinations was more a move to cover agency rear ends than to protect public health, according to an opinion piece by Pacific Research Institute senior fellow and former FDA’s Office of Biotechnology director
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. An agency release says this is the first FDA-approved immunotherapy for the first-line treatment of gastric
Drugs
Eli Lilly has requested that FDA revoke its Emergency Use Authorization for bamlanivimab (LY-CoV555) 700 mg alone due to the growing prevalence of Covid-19 variants in the U.S. The company says it will now only provide bamlanivimab and etesevimab together for treating Covid-19. Lilly says it
Drugs
Three Harvard University professors and two Zuckerman attorneys who used to work at HHS say FDA should use the GDUFA 3 reauthorization negotiations to “balance the need to ensure sustainability with the goal of providing a level playing field for competition among firms of all sizes.” Writing in Health Affairs,
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP), Critical Path Innovation Meetings, to delineate the roles and responsibilities of CDER staff and outline the procedures to be followed for a critical path innovation meeting (CPIM). The MAPP defines a critical path innovation meeting as a nonbinding scientific dialog
Drugs
Merck says it is stopping development of MK-7110 (formerly known as CD24Fc) for treating hospitalized patients with Covid-19 due to additional FDA data requests. Merck received the therapy in a 12/2020 acquisition of OncoImmune. Previously, the company and the U.S. government penned a $356 million deal
Drugs
FDA has granted priority review status to a BioMarin NDA for vosoritide, an analog of C-type natriuretic peptide in children with achondroplasia, described as the most common form of short stature in humans. The agency granted priority review based on the serious pediatric indication the drug addresses, BioMarin says.
Drugs
FDA’s willingness to embrace technology-enabled tools to conduct remote inspections and trim the mounting inspection backlog during the Covid-19 pandemic “may transform FDA’s inspection approach for years to come.” That’s the projection made by Sheppard Mullin attorneys Allison Fulton and Eva Schifni in their analysis
Drugs
The operators of Genesis Herb, an Ohio dietary supplement manufacturing company, intend to plead guilty in federal court to charges of failing to register a food manufacturing facility and refusing an FDA inspection. A Department of Justice statement says Shane Cotterill, Monroeville, OH, was charged with three counts of failing