Drugs
CDER is planning a guidance document on the modernization of clinical trial conduct that is rooted in challenges to the clinical trial ecosystem brought on by the Covid-19 public health emergency. While Covid-19 disrupted traditional clinical trial infrastructures and operational activities, it also accelerated the adoption of modern
Drugs
FDA has released the FDA-483 that was at the center of an Alvotech-received complete response letter (see earlier story) on its biosimilar BLA for AVT02, a monoclonal antibody that was being evaluated for biosimilarity and interchangeability to Abbott’s Humira (adalimumab). The letter cited inspection deficiencies at Alvotech&
Drugs
A 10/18/21-11/2/21 FDA inspection at Texas Longhorn RX’s Vita Pharmacy, doing business as Talon Pharmacy of Boerne, Boerne, TX, found “serious deficiencies” in the company’s practices for producing drug products intended or expected to be sterile. An 8/29 Warning Letter cites these
Drugs
FDA has awarded a $2 million grant to Marker Therapeutics to support its Phase 2 ARTEMIS trial of MT-401, its lead multi-tumor associated antigen T-cell product candidate, in patients with post-transplant acute myeloid leukemia (AML). The company says the grant will support the treatment arm evaluating
Drugs
The Alliance for Pharmacy Compounding (APC) has submitted a letter to FDA signed by about 2,000 prescribers of compounded hormones asking that the agency assure continued patient access to compounded hormone therapy. The letter is an effort to counter what APC says is a “flawed 2020 report FDA commissioned
Drugs
FDA has issued a final rule specifying the deadline and content for submitting an annual summary of investigational drugs supplied under the Right to Try Act of 2017 and the uses for which the investigational drugs were supplied. The rule implements a provision in the Right to Try Act that
Drugs
FDA says it has launched a new Web page to highlight the most recent research activities of CDER’s Office of New Drugs (OND). The Web page says OND created its research program in 2019 to foster regulatory science research (RSR). “OND-led RSR projects are designed to address knowledge
Drugs
FDA has published a report estimating cost savings from the 2,400 new generic drug approvals in 2018, 2019, and 2020. It says generic drugs approved in 2018 yield annual savings of $17.8 billion, with $4 billion from first-generic approvals. Savings from 2019 approvals amount to $24.8
Drugs
Liaisons from CDER will be part of a new In Vitro Pharmacology Working Group being assembled by Pistoia Alliance, a global not-for-profit that says it advocates for greater collaboration in life sciences research and development. The alliance says the working group also will have representatives from biopharmaceutical companies,
Drugs
FDA has denied a Braintree citizen petition that asked it not to approve any NDA or ANDA for a tablet-based or tablet-containing colonoscopy preparation unless it contains a specification ensuring that the tablet formulation will not inhibit or interfere with the colonoscopy procedure. The petition said Braintree’s
Drugs
FDA has approved a Bristol Myers Squibb NDA for Sotyktu (deucravacitinib), which is said to be a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approval is based on data
Drugs
Teva is urging the U.S. Supreme Court to dismiss a GlaxoSmithKline (GSK) argument that the high court should not hear Teva’s appeal of a “skinny label” case involving GSK’s heart drug Coreg (carvedilol). In its appeal, Teva framed the question for the high court as: If a
Drugs
FDA has approved a Spectrum Pharmaceuticals BLA for Rolvedon (eflapegrastim-xnst) injection for decreasing the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The approval of the long-acting granulocyte
Drugs
FDA has accepted for review a Pfizer NDA for baldness drug ritlecitinib for treating adults and adolescents 12 years of age and older with alopecia areata. The agency is expected to make a decision in the second-quarter next year. Pfizer says the submission was based on previously announced topline
Drugs
FDA has published a final guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products, encouraging sponsors and applicants to identify in their submission cover letters certain uses of real-world data (RWD) and real-world evidence (RWE). The document says that
Drugs
In a filing with the National Stock Exchange of India, Panacea Biotec says it has been informed by FDA that the classification of the agency’s 5/30-6/8 inspection at the Panacea facility in Baddi, Himachal Pradesh, India, is “Official Action Indicated.” The filing says the classification means
Drugs
FDA has published a draft guidance, Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products, with labeling recommendations intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products. The document says labeling for
Drugs
FDA has released the form FDA-483 issued following an 8/12-8/20/21 inspection at the Hugel drug substance and drug product manufacturing facility in Chuncheon, Gangwon, Korea. The seven inspection observations were: * Clostridium botulinum spore containment in the drug manufacturing areas is inadequate to mitigate spore cross-
Drugs
FDA has published a draft guidance, General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products, to assist sponsors of INDs, Section 505 NDAs, BLAs, and supplements to those applications who are planning to conduct clinical studies in pediatric populations. The document also is intended to assist clinical
Drugs
CDER and CBER have accepted the first submission for the Innovative Science and Technology Approaches for New Drugs pilot program for developing drug development tools (DDTs). An FDA post says the first accepted letter of intent submission is for a tool that proposes to evaluate off-target protein binding for
Drugs
Ionis Pharmaceuticals and AstraZeneca plan to submit an NDA for eplontersen later this year for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) based on new study results announced 9/7. ATTRv is a severe, progressive, and life-threatening disease caused by the abnormal formation of the transthyretin
Drugs
While praising FDA efforts to develop guidances and standards to implement the Drug Supply Chain Security Act, four industry stakeholders are seeking changes to a draft guidance on the interoperable exchange of information for tracing of certain human, finished prescription drugs. The American Pharmacists Association (APhA) says the information guidance