Drugs
FDA says it is investigating a possible increased risk of death with TG Therapeutics’ Ukoniq (umbralisib), approved to treat two specific lymphomas. An agency drug safety communication says FDA has determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible
Drugs
FDA has published a proposed rule, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers, as required by the Drug Supply Chain Security Act. When finalized, the proposed rule would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription
Drugs
Four Hogan Lovells attorneys say an 11th Circuit Court of Appeals 1/28 mandate upholding orphan exclusivity for Catalyst Pharmaceuticals’ Firdapse (amifampridine phosphate) “appears to undermine FDA’s indication-specific approach to orphan exclusivity, providing exclusivity holders (and those on deck for approval) potentially broader exclusivity than previously expected.” In
Drugs
FDA has published a draft guidance, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format, to assist applicants with incorporating immunogenicity information into the labeling of human prescription biological products, specifically therapeutic protein products and of select drug products that have immunogenicity assessments. The
Drugs
Eli Lilly is delaying a planned BLA accelerated approval submission for its Alzheimer’s investigational antibody therapy donanemab due to uncertainties related to a Center for Medicare and Medicaid Services (CMS) decision (see earlier story) to propose restricting Medicare coverage of Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Lilly was
Drugs
The White House says President Joe Biden is reenergizing the Cancer Moonshot he launched in 2016 when he was vice president and setting ambitious new goals that he says will “end cancer as we know it today.” A White House online statement says the new goals are to: * cut today’
Drugs
FDA has published a draft guidance, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, with recommendations to industry on formal meetings between FDA and sponsors or requestors of nonprescription drugs without approved NDAs, known as over-the-counter (OTC) monograph drugs. The document specifies
Drugs
Two Hogan Lovells attorneys say companies operating in the telemedicine and electronic health records (EHR) spaces should expect increased False Claims Act (FCA) enforcement going forward and take steps to minimize their risk. The attorneys’ views are expressed in a white paper, “Healthcare Digitization Creates New FCA Risk.” “In recent
Drugs
FDA has approved a Janssen Pharmaceutical expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for treating HIV-1 in virologically suppressed adults with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. Cabenuva was approved 1/2021
Drugs
FDA has placed a clinical hold on LogicBio Therapeutics’ Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia (MMA). According to the company, four patients have been dosed in the SUNRISE trial with LB-001, a single-administration, adeno-associated virus (AAV) genome editing
Drugs
Jazz Pharmaceuticals has submitted a Supplemental BLA for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) and its use as a component of a multi-agent chemotherapeutic regimen for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one
Drugs
An FDA review of a Web site and Internet address maintained by Applied Health Solutions, Scottsdale, AZ, determined that the firm markets branded products that are considered to be drugs based on claims made for them at the Web site. A just-released 10/22/21 Warning Letter gives pages
Drugs
Medable, described as a patient-centered drug development cloud platform, says a Tufts Center for the Study of Drug Development analysis found that, on average, decentralized clinical trials are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 14 times for Phase 2
Drugs
FDA has issued its 2021 Drug Safety Priorities report detailing CDER safety programs and activities and “highlighting the depth and versatility of drug safety initiatives across CDER and FDA.” The report is said to explain CDER’s efforts to manage drug safety through modernized safety surveillance methods and innovative responses
Drugs
Associations representing the innovative and generic drug industries say the U.S. should be using its trade policy to defend and protect American inventions. The Association for Accessible Medicines (AAM) and Pharmaceutical Research and Manufacturers of America (PhRMA) made the plea in comments to the United States Trade Representative on
Drugs
FDA has approved a Kite labeling update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment
Drugs
The Department of Justice says Ohio-based Cardinal Health has agreed to pay $13,125,000 to resolve whistleblower allegations that it violated the False Claims Act by paying “upfront discounts” to physician customers in violation of the Anti-kickback law. The department says the HHS Inspector General has advised
Drugs
CDER has released its guidance agenda for new and revised draft guidance documents it plans to publish in 2022. The list contains 98 documents shown in 17 categories: Animal Rule (1), Biosimilars (1), Clinical/Antimicrobial (2), Clinical/Medical (12), Clinical Pharmacology (6), Compounding (7), Drug Development Tools (1), Drug Safety
Drugs
The Department of Justice says Blackstone Labs founder Aaron Singerman, Delray Beach, FL, was sentenced by a Florida federal judge to 54 months in prison and ordered to forfeit $2.9 million for conspiring to sell illegal anabolic steroids and other products marketed as dietary supplements. A department statement says
Drugs
FDA has released four draft guidances on the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making, specifically covering topics related to data sources, data standards, and regulatory considerations. The draft guidance on Real-World Data: Assessing Electronic Health Records and Medical Claims Data
Drugs
FDA has issued sterile drug product maker Johnson Memorial Cancer Center a Form FDA-483 after a 10/2021 inspection cited GMP deficiencies. For example, the inspection observations said the firm produced hazardous drugs without providing adequate cleaning of work surfaces to prevent cross-contamination. They also cited the company
Drugs
Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active systemic lupus erythematosus based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II). “In SLE-BRAVE-I, the baricitinib 4-mg oral dose