Drugs
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat all stages of diabetic retinopathy. Approval was based on data from the PANORAMA trial which showed that “20% of untreated patients developed proliferative diabetic eye disease, and Eylea reduced this risk by 85% to 88% when administered using an every
Drugs
Connecticut attorney general William Tong has led a 44-state lawsuit against Teva Pharmaceuticals and 19 generic drug manufacturers that alleges a “broad conspiracy to artificially inflate and manipulate prices, reduce competition and unreasonably restrain trade for more than 100 different generic drugs.” The lawsuit, filed in Connecticut federal court,
Drugs
For the second time in a week, FDA finds itself defending its medical product oversight after a New York Times opinion piece questions the safety and quality of the products. Last week, the paper’s editorial board published a scathing critique of medical device regulatory oversight, urging FDA to abolish
Drugs
FDA reviewers are questioning the robustness of data submitted in a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive, as detected by an FDA-approved test. In a briefing document released before a 5/14 Oncologic
Drugs
FDA has released a final guidance entitled “Considerations in Demonstrating Interchangeability With a Reference Product” to help sponsors navigate the pathway for “interchangeable” biologics/biosimilars, which may be substituted without prescriber involvement. Although the 351(k) biosimilar pathway applies generally to biological products, the guidance focuses on therapeutic protein products
Drugs
The quality of the U.S. drug supply is the best it has ever been, says CDER Office of Pharmaceutical Quality director Michael Kopcha. This FDA assurance comes on the heels of a 5/10 CBS News report about allegations of widespread fraud associated with generic drugs made overseas and
Drugs
FDA has granted Sunovion Pharmaceuticals and PsychoGenics a breakthrough therapy designation for SEP-363856, a novel agent for treating people with schizophrenia. The companies say that SEP-363856 does not bind to dopamine 2 or serotonin 2A receptors, which are thought to mediate the effects of currently available antipsychotic medicines.
Drugs
The Federal Trade Commission (FTC) has reiterated its opposition to an FDA proposed convention for naming non-proprietary biological products, saying the plan’s “disparate treatment and differentiated naming of certain biosimilar products will reduce biosimilar competition in the U.S.” FTC called on FDA to abandon its proposal to
Drugs
FDA has published a guidance, Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations, with recommendations for conducting in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the-
Drugs
FDA has published a guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application, to help applicants determine which of the abbreviated approval pathways is appropriate for submission of a marketing application to the agency. The document says that many potential drug product developers are not familiar
Drugs
A Supreme Court decision expected in June could lead to an increase in False Claims Act cases according to some attorneys contacted by Bloomberg Law. The report says that defense attorneys “resoundingly believe [the ruling] will give whistleblowers more time to act on behalf of the government and sue companies
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to clarify a draft guidance on principles of premarket pathways for combination products. The association says that while it appreciates the agency’s efforts to clarify the premarket pathways for combination products and implement provisions of the 21st Century Cures
Drugs
The International Council for Harmonization has released for public comments a revised draft guideline entitled “General Considerations For Clinical Studies E8(R1).” The document focuses on designing quality into clinical studies and it is intended to: * Describe internationally accepted principles and practices for designing and conducting clinical studies that will
Drugs
Bristol-Myers Squibb says its Phase 3 CheckMate-498 trial evaluating Opdivo (nivolumab) plus radiation versus temozolomide plus radiation in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme did not meet its primary endpoint of overall survival at final analysis. The drug’s safety profile was consistent
Drugs
FDA has issued a guidance, Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations, to assist sponsors in evaluating reproductive toxicity (mainly for effects on embryo-fetal development, or EFD) for oncology pharmaceuticals. The document also is intended to provide recommendations for product labeling on duration of contraception following cessation of
Drugs
FDA has published a draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics, to encourage sponsors and applicants who are using real-world data to generate real-world evidence (RWE) as part of their regulatory submission to
Drugs
FDA is issuing two draft guidances that, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information on drugs used during pregnancy or lactation. The first draft, Clinical Lactation Studies: Considerations for Study Design, gives agency recommendations for sponsors on
Drugs
FDA has just released the Establishment Inspection Report (EIR) from an 8/6-8/14/18 inspection at Immunomedics, Morris Plains, NJ. The EIR says a 13-item FDA-483 was issued to the company at the close of the inspection with these observations: * the quality control unit lacks authority
Drugs
The Biotechnology Innovation Organization (BIO) says it is pleased that FDA has included in a draft guidance on nonproprietary naming of biological products use of a four-letter distinguishable suffix for biological products. “BIO shares FDA’s view that a distinguishable nonproprietary naming convention will best facilitate robust pharmacovigilance, promote
Drugs
The House has passed two bipartisan bills that would make updates to FDA’s Orange Book and Purple Book to improve accuracy and transparency of the two databases that guide development decisions for generic and biosimilar manufacturers. They are: H.R. 1503, the Orange Book Transparency Act of 2019, from
Drugs
Pharmaceutical recalls decreased 7.8% to 94 in the first quarter of 2019, higher than 19 of the last 21 quarters, according to the Stericycle 2019 Q1 index. The report says that recalled units decreased 75.3% to just under 13 million, lower than six of the last nine quarters.
Drugs
A 9/17-9/21/18 FDA inspection at Laboratoires Clarins, Pontoise, France, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 4/23 Warning Letter lists specific violations as: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of