Drugs
FDA has approved a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Approval is based
Drugs
The White House Council of Economic Advisors (CEA) says that H.R. 3, the Lower Drug Costs Now Act of 2019, could keep as many as 100 new lifesaving drugs off the market. The CEA also estimates that by limiting access to lifesaving drugs, the bill would reduce Americans’ average
Devices
FDA has granted RightEye a breakthrough device designation for the RightEye Vision System and its use in diagnosing Parkinson’s Disease. Currently, no single test is capable of definitively diagnosing Parkinson’s disease and physicians instead rely on a variety of neurological examinations designed to confirm the clinical diagnosis, and
Drugs
Aquestive Therapeutics has completed a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters. Libervant is administered from inside the cheek in selected, refractory patients with epilepsy on stable regimens who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive says it is
Devices
AdvaMed says FDA should “adopt a practice of full transparency regarding its plans for submissions by electronic format.” In comments to an agency draft guidance on providing regulatory submissions for medical devices in electronic format, the association says that information technology systems are complex and costly, and new systems require
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: American Contract Systems, Houston, TX (11/9): FDA inspected the firm in September and found Quality System Regulation violations with various surgical
Drugs
The House Energy and Commerce Oversight and Investigations Subcommittee has planned a 12/10 hearing entitled “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program.” It will be held at 10 am in the John D. Dingell Hearing Room, 2123 Rayburn House Office Building. “Over
Drugs
FDA has released the FDA-483 issued following a 9/9-9/19 inspection at AnazaoHealth, a Las Vegas, NV, outsourcing facility. The three inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions; * the flow of
Drugs
At the 11/16-11/10 International Council on Harmonization (ICH) meeting in Singapore, the ICH management committee reelected CDER associate director for strategic initiatives Theresa Mullin to a one-year term as the committee chair. A meeting report also indicates that the assembly regulatory members adopted the new ICH
Devices
A 9/9-10/4 FDA inspection at the American Contract Systems medical device operations in Houston, TX, found Quality System Regulation violations in the firm’s work as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. A just-released 11/9 Warning
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Amgen’s Aimovig (erenumab-aooe), indicated for preventing migraines in adults. The regulatory review period is 2,042 days, which includes 1,675 days that occurred during the testing phase and 367 days during the
FDA Policy/General
Two weeks after sailing though his confirmation hearing (see earlier story), the Senate Health, Education, Labor & Pensions Committee 12/3 voted 18 to 5 to advance Stephen Hahn’s nomination to serve as FDA commissioner to the full Senate for consideration. “Dr. Hahn has extensive medical and research experience
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides recommendations on the appropriate use of adaptive designs for drug clinical trials. It describes important principles for designing, conducting, and reporting the results from an adaptive clinical
Devices
A bipartisan congressional group has written to HHS and its Centers for Medicare and Medicaid Services supporting a recommendation that the device identifier portion of unique device identifiers (UDIs) be added to the standard information on electronic health insurance claims forms. Signing the letters were Sens. Chuck Grassley (R-IA)
Drugs
FDA has released the FDA-483 issued following an 8/26-9/26 inspection at Nubratori, Inc., a Torrance, CA, outsourcing facility. The inspection observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * disinfectant contact time and coverage of the item
Drugs
Immunomedics has resubmitted its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In January, FDA issued a complete response letter on the original submission. “The issues related to approvability in
FDA Policy/General
A Ropes&Gray legal analysis says that a recent Supreme Court decision on deference to agencies such as FDA that are interpreting their own regulations has changed the landscape and empowered plaintiffs. “Although FDA will often continue to receive deference in cases involving application of its specialized scientific knowledge
Drugs
Citing a May Supreme Court ruling outlining the standard for a federal preemption defense in drug warning claims, the 3rd Circuit Court of Appeals has remanded to a New Jersey federal court hundreds of Fosamax bone fracture lawsuits, asking that court to decide whether the failure-to-warn cases are
Devices
FDA has cleared a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain. NeuroOne believes that the device is the first cortical electrode to receive FDA 510(k) clearance that
Drugs
Immunomedics has resubmitted its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In January, FDA issued a complete response letter on the original submission. “The issues related to approvability in
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy as monotherapy for treating patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or
Drugs
FDA’s Office of New Drugs has denied a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for adults with Type 1 diabetes in combination with insulin. Without disclosing FDA’s concerns, the company says the agency