Drugs
The Association for Accessible Medicines (AAM) says it applauds FDA for taking a bold step in developing a guidance on quality-related controlled correspondence “to mitigate duplicative work for both the industry and the agency.” FDA defines a controlled correspondence as a correspondence submitted to the agency by a generic
Drugs
Both the Biosimilars Forum and Pharmaceutical Research and Manufacturers of America (PhRMA) have communicated to FDA their overall support for the BsUFA 3 biosimilars user fee agreement. The Biosimilars Forum says that improvements to the biosimilar review program negotiated under BsUFA 3 “will help bring biosimilars to the market as
Drugs
Teligent Pharma has recalled two lots of lidocaine HCl topical solution USP 4%, 50ml in screw cap glass bottles, due to internal testing determining the product is super potent. The company made its determination based on out-of-specification (OOS) results obtained at the nine-month (Lot 16345) and 18-
Drugs
Gilead Sciences has recalled two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of glass particulates. Administrating an injectable product that contains glass particulates may result in blocked blood vessels in the heart, lungs or brain which can cause stroke and even lead
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Former FDAers Joshua Sharfstein and Peter Lurie say a recent agency draft guidance on benefit/risk assessment indicates that FDA “intends to embrace the broader view of its authority in certain circumstances, a promising alignment of the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
Drugs
FDA has issued two draft guidances for individualized antisense oligonucleotide drug products for severely debilitating or life-threatening diseases. The first draft contains clinical recommendations for sponsors developing such drug products. Its focus is to describe important clinical considerations for IND submissions to support initial and continued administration, dosing, and
Drugs
The Natural Products Association (NPA) has filed suit against FDA to make the agency cease its “unlawful retroactive application of the Federal Food, Drug, and Cosmetic Act against N-acetyl-L-cysteine (NAC).” NPA says it is “defending the industry’s right to provide a product with an exceptional 30-
Drugs
The Senate Health, Education, Labor & Pensions Committee has announced a 12/14 hearing on the nomination of Robert Califf to be the next FDA commissioner. The times have changed in the past five years since Califf served as FDA commissioner at the end of the Obama Administration, and prresumably
Drugs
As FDA continues to use alternative inspectional tools, such as remote interactive evaluations, the prolonged Covid-19 pandemic will likely see the agency “continue to adapt and utilize new strategies for accomplishing oversight activities that were previously conducted primarily through FDA in-person inspections,” according to a Kleinfeld, Kaplan &
Drugs
Writing in a MedCity News “influencers” online post, Susan Dallabrida and Craig Gravina say that while researchers have been talking about the potential benefits of using real-world data (RWD) in clinical trials, it has been difficult to accomplish. “The primary reason is that RWD has been largely unavailable to
Drugs
FDA reviewers have cast doubt on the effectiveness of Reata Pharmaceuticals’ bardoxolone to slow the loss of kidney function in Alport syndrome (AS) patients and reduce the risk of kidney failure with chronic use. In a briefing document released ahead of a 12/8 Cardiovascular and Renal Drugs Advisory Committee
Drugs
An FDA-ordered drug class warning (see earlier story) has begun appearing in labels of Janus kinase (JAK) inhibitors — Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib). In September, the agency ordered the warning after reviewing a recent clinical trial that showed an increased
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage 2B or 2C melanoma following complete resection. Additionally, the agency expanded the anti-PD-1 therapy’s indication to include adjuvant treatment for Stage 3 melanoma following complete
Drugs
FDA has approved Genentech’s Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Approval was based on data from the Inter-
Drugs
FDA has revised an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patients than previously authorized for treating mild to moderate Covid-19. Previously, the monoclonal antibodies’ combination use was authorized for pediatric patients 12 years of age and older, and the
Drugs
An FDA online consumer post updates agency efforts to provide more drug information to women who are pregnant or breastfeeding. “When a prescription medication is approved by FDA for adults, it is also approved for pregnant patients,” FDA says. “But information about medication dosing during pregnancy and breastfeeding is often
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on investigator responsibilities for safety reporting for investigational drugs and medical devices “will help further ensure a consistent approach to safety and safety reporting throughout the entire medical product development process.” In its 11/29 comment letter, the
Drugs
FDA officials told an 11/30 meeting of the National Industrial Hemp Council that the agency still believes it needs additional CBD (cannabidiol) research and safety data before it can be considered for uses beyond prescription drugs such as a food additive or dietary supplement. CDER deputy director for regulatory
Drugs
The Justice Department says the former chief financial officer and former head of corporate communications for a $21 billion biopharmaceutical company have been arrested for their role in an insider trading scheme. (While the Justice Department statement did not identify the company, the Associated Press reports that a Securities and
Drugs
FDA has accepted for review a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for preventing invasive pneumococcal disease in children six weeks through 17 years of age. The agency has set a user fee review action target date of 4/1/2022. “Vaxneuvance has the potential to
Drugs
FDA has issued a complete response letter for the BeyondSpring Pharmaceuticals NDA seeking approval of plinabulin in combination with granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia (CIN). The company says the agency indicated the NDA cannot be approved at this time because the results of the single registrational
Drugs
FDA has approved Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The company says the safety profile of Darzalex Faspro plus carfilzomib