Drugs
FDA has approved a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis. Expanded approval was based on data from a Phase 3 trial in scalp psoriasis patients where Cosentyx demonstrated superior efficacy compared to placebo, the company says. The human interleukin-
Devices
FDA has cleared a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the company’s polymerase chain reaction testing platform, which is designed for point-of-care infectious disease diagnosis. The test provides a qualitative result in about 30 minutes. It is indicated
Devices
Attorney Elizabeth Minerd (Reed Smith) says an Illinois federal court took the time to sort through a number of novel plaintiff allegations in a case involving a Mentor silicone breast implant and determined that almost all of them were either expressly or impliedly preempted. Minerd writes in an online post
Drugs
Washington Legal Foundation (WLF) is asking the Supreme Court to review and then overturn an appeals court decision authorizing private individuals to sue drug companies for government-contracting fraud based on technical violations of federal regulations, even if FDA approved the drugs and government officials continue to buy them after
Drugs
FDA has updated a public listing of “Pharmacogenomic Biomarkers in Drug Labeling.” The listing details the data in labeling that can help identify responders and non-responders to medications, avoid adverse events, and optimize drug doses. “The labeling for some, but not all, of the products includes specific actions to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Kaken Pharmaceutical Co.’s Jublia (efinaconazole) is 2,521 days. Of this time, 1,840 days occurred during the testing phase and 681 days during the approval phase. Jublia is indicated for the topical
Drugs
Four stakeholders are praising FDA’s 1/16 notification of an indefinite delay in the effective date of a final rule setting forth a new method for determining the intended use of medical products. The stakeholders say the delay is warranted given the controversy over a provision in the rule
Drugs
FDA has posted online “Considerations for Applicants Deciding When to Submit Elemental Impurity Data to FDA” recommending that any applicant who has not fully addressed elemental impurities in their applications in their current form submit the information as soon as possible. “If the application is currently under review,” the post
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for AstraZeneca’s Farxiga (dapagliflozin) is 3,673 days. Of this time, 2,565 days occurred during the testing phase and 1,108 days during the approval phase. Farxiga is indicated as an adjunct to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Gilead Sciences’ Genvoya (cobicistat, emtricitabine, elvitegravir, and tenofovir alafenamide fumarate) is 5,031 days. Of this time, 4,665 days occurred during the testing phase and 366 days during the approval phase. Genvoya is
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Scott Laboratories’ Sedasys System is 2,816 days. Of this time, 950 days occurred during the testing phase and 1,866 days during the approval phase. The device is indicated for intravenous administration of
Drugs
FDA will soon unveil a comprehensive plan to promote more competition and availability of biosimilars, according to commissioner Scott Gottlieb. During a 2/6 address to the Alliance for a Stronger FDA, Gottlieb expressed the agency’s dissatisfaction with how its biosimilars program has progressed and its small impact on
Devices
The DC federal court has granted in part and denied in part Medtronic’s motion for summary judgment in a case involving a mechanical pump and associated infusion set used to administer insulin to a diabetic woman. The woman, a college sophomore in 2007, experienced severe hypoglycemia in her dorm
Devices
FDA says Pentax has recalled all of its ED-3490TK duodenoscopes to replace the forceps elevator, O-ring seal, and distal end and cap, and to update the operation manual to recommend annual maintenance. An agency post says the design changes are intended to reduce the potential for leakage of
Drugs
A New York federal court has finally ruled on a 2012 motion to dismiss a suit based on earlier Supreme Court rulings in Mensing and Bartlett. Attorney Michelle Yeary (Dechert) writes in an online blog post that the suit alleged the plaintiff suffered from Stevens Johnson Syndrome as a result
Devices
FDA has released the FDA-483 issued following a 10/2-10/16/17 inspection at Zimmer Biomet’s manufacturing facility in Warsaw, IN. Specific observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately establish procedures to control product that does not conform to
Drugs
As required under the 2012 FDA Safety and Innovation Act, FDA has submitted to Congress its report on the Governing Antibiotic Incentives Now (GAIN) law addressing the public health threat of antibacterial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. The document describes these
Drugs
FDA has issued a guidance on “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation.” The document provides agency recommendations on the overall microbiology development program needed to support clinical development and approval of antibacterial drugs administered systemically as well as microbiology information collected after approval. It replaces the
Devices
FDA has cleared an Empatica 510(k) for Embrace, a smart watch that monitors for seizures known as “grand mal” or “generalized tonic-clonic” seizures. Once detected, the watch sends an alert to summon a caregiver for help. The device measures multiple seizure indicators. It uses “electrodermal activity,” a signal
Drugs
Bristol-Myers Squibb (BMS) says that its ongoing Phase 3 CheckMate-227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high tumor mutation
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Celltrion, Inc. Incheon, Republic of Korea (1/26): FDA inspected the firm 6/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Amgen’s Blincyto (blinatumomab) is 2,850days. Of this time, 2,774 days occurred during the testing phase and 76 days during the approval phase. Blincyto is indicated for treating Philadelphia chromosome-negative relapsed