Devices
FDA has cleared a Medivis 510(k) for its SurgicalAR, an augmented reality technology platform for surgical applications and its clinical use in the operating room. The company says the device “integrates the latest advancements in augmented reality, artificial intelligence, and computer vision to advance surgical visualization, thereby decreasing surgical
Devices
FDA has granted Resolution Bioscience a Breakthrough Device Designation for the Resolution HRD liquid biopsy assay, a qualitative in vitro diagnostic to detect sequence variations in key genes related to homologous recombination deficiency for single nucleotide variants, indels, and copy number variants. The company says it plans to seek device
Drugs
The Justice Department says Almirall (formerly Aqua Pharmaceuticals) will pay $3.5 million to resolve a whistleblower’s allegations that it used illegal kickbacks to incentivize doctors to prescribe the company’s dermatology drugs. A department statement says the settlement resolves allegations that between 2012 and 2017 Aqua knowingly paid
Devices
Terumo Medical has recalled its Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to the potential for the tip to dislodge from the outer rim of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface
Drugs
Epizyme has submitted an NDA seeking accelerated approval of tazemetostat for treating patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The company describes Tazemetostat is an oral, first-in-class, EZH2 inhibitor that it discovered and is developing for various cancers and treatment settings. The
Drugs
GlaxoSmithKline says a draft FDA guidance on quality considerations for continuous manufacturing is “a good first step toward establishing current Good Manufacturing Practices around emerging continuous manufacturing technology.” The company says it expects that once the International Conference on Harmonization Q13 guideline on continuous manufacturing of drug substances and drug
Drugs
Merck says it would be helpful if FDA would include in a draft guidance on bioavailability studies submitted in NDAs or INDs the reason or trigger for revising the 3/2014 draft guidance and a summary of key changes from the 2014 document. Pharmaceutical Research and Manufacturers of America (PhRMA)
Drugs
FDA has opened a public docket to receive comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain solid, oral dosage forms of immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging for outpatient dispensing. A
FDA Policy/General
Federal Register notice correction: FDA is correcting a 5/10 notice entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability” that was published with the incorrect docket number. The correct docket is
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” (OMB Control Number 0910-0641). FDA’s regulations require that the label of a
Drugs
Heritage Pharmaceuticals has recalled one lot of amikacin sulfate injection, USP, 1g/4 mL (250mg/mL) and one lot of prochlorperazine edisylate injection, USP, 10mg/2mL (5mg/mL) due to microbial growth having been detected in each lot. The drug products are manufactured by Emcure Pharmaceuticals and distributed by Heritage.
Drugs
An FDA 5/13 public meeting on the future of insulin biosimilars heard from stakeholders representing many different perspectives. Mylan head of global clinical research Abhijit Barve said any “additional requirements not based on risk or clinical relevance will only be a barrier to development” of biosimilar insulins. “In fact,
Drugs
A recent updated Justice Department guidance intended to help department prosecutors evaluate corporate compliance programs in the context of investigations of business entities confirms that three fundamental issues are relevant to any such evaluation. Attorneys Gregory Brower and Stanley Garnett (Brownstein Hyatt Farber Schreck) write in a Washington Legal Foundation
Drugs
FDA has released two documents relating to its work on regenerative medicine therapies. The first, Standards Development for Regenerative Medicine Therapies, says the agency is working with the National Institute of Standards and Technology and stakeholders to facilitate efforts to coordinate development of standards for regenerative medicine therapies as required
Drugs
A 5/20 Supreme Court decision in a Merck Fosamax case involving the company’s alleged failure to warn about atypical femur fractures “will change the dynamics of litigation involving the impossibility defense, and will introduce new litigation uncertainty due to a shift in the decision maker for impossibility preemption.
Drugs
FDA has accepted for priority review an Amarin supplemental NDA for Vascepa (icosapent ethyl) capsules, indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides, an important indicator of cardiovascular disease. Vascepa is currently indicated as an adjunct to diet to reduce
Drugs
The Supreme Court has rejected a request that it reconsider a 7th Circuit Court of Appeals ruling throwing out a $3 million jury verdict in the death of an Illinois attorney who committed suicide in 2010, six days after starting to take GlaxoSmithKline’s Paxil (paroxetine) for depression. An Illinois
Drugs
FDA has granted Bayer a Breakthrough Therapy Designation for Aliqopa (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin’s lymphoma (iNHL)and accounts for about 10% of all non-
Devices
FDA has cleared a Medtronic 510(k) for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing. The device features a deflectable, out-of-plane curve to reach the bundle of His and is designed to “enable enhanced range maneuverability, fixation and implant success
Drugs
FDA has approved a Celgene supplemental NDA for Revlimid (lenalidomide) in combination with rituximab for treating adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma. The company says that this is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’
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: AMMD Labs Pompano Beach, FL (5/2): FDA inspected the firm 9/2018 and cited significant GMP violations for finished pharmaceuticals. For
Drugs
Researchers say that confirmatory trials for only 20% of cancer drug indications approved under the FDA accelerated approval pathway demonstrated improvements in overall patient survival. Writing in JAMA Internal Medicine the researchers say that reassessment of the requirements for confirmatory trials may be necessary to obtain more clinically meaningful information.