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.
Drugs
Two FDAers involved in the agency’s development and implementation of a benefit-risk framework throughout a drug’s lifecycle told a 5/16 public meeting held in conjunction with the Duke-Margolis Center for Health Policy that stakeholders should be thinking about benefit-risk at each stage of drug
Drugs
Four senators — Ted Cruz (R-TX), Mike Braun (R-IN), Rand Paul (R-KY), and Mike Lee (R-UT) — are asking FDA to expand the agency’s Parallel Track provision from HIV/AIDS to other critical diseases as a way to bring life-saving drugs to patients faster. In a
Devices
Integra LifeSciences has recalled its LimiTorr and MoniTorr Drainage Systems due to complaints on “piece breaking off at connection point,” “broken manifold-stopcock,” “stopcock problem,” “connection where the external transducer is attached to the transducer holder bracket broke off,” and “transducer attachment on the LimiTorr/MoniTorr has cracked and was
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540,329.100,514.80, 600.80, 1271.350, and Part 803” (OMB Control Number 0910-0645). FDA requires that product sponsors
Drugs
The Biotechnology Innovation Organization (BIO) says FDA should highlight and recognize that its draft guidance on natural history studies for rare disease drug development can apply to a wider range of stakeholders, such as advocacy and patient organizations. It says the guidance should encourage patient organizations to consider the guidance
Drugs
A 9/10-9/14/18 FDA inspection at AMMD Labs, Pompano Beach, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A 5/2 Warning Letter says the violations were: * failing to perform, for each batch of drug product, appropriate laboratory
Drugs
Pharm D Solutions has recalled all sterile compounded drug products due to FDA inspection concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. “Administration of a non-sterile product that is intended to be sterile by
Drugs
FDA has placed a clinical hold on Newron Pharmaceuticals’ proposed Phase 2-3 pivotal studies with evenamide for treating schizophrenia due to agency concerns about central nervous system events found during a recently completed study in rats as well as another at high doses in dogs, and the potential implication
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Review and Update of Device Establishment Inspection Processes and Standards.” Comments are now due by 6/27. To view the notice, click here.
FDA Policy/General
Regulatory Review Period for Edwards Aortic Valve Federal Register notice: FDA determines that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days. 05/24/2019 Final Guide on Compounding Bulks List Federal Register notice: FDA makes available a final guidance entitled “Section 503A
Drugs
DEVICES FDA has cleared a Cynosure 510(k) for the SculpSure, a hyperthermic laser treatment for lipolysis of the flanks. The device works by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body, according to the company. SculpSure,
Drugs
Allergan has submitted a citizen petition asking FDA to refuse to receive and approve any ANDA that references the company’s NDA for Viberzi (eluxadoline) tablets, indicated for treating adults with irritable bowel syndrome with diarrhea, if the ANDA does not include comparative clinical endpoint data to demonstrate it is
Drugs
New FDA “regulatory tools” were used to approve a Novartis NDA for Piqray (alpelisib) tablets, indicated for treating postmenopausal women and men with a certain type of breast cancer. These tools helped streamline the review without compromising the quality of our assessment, the agency said in a release. “This drug
Biologics
FDA has approved an AveXis BLA for Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), a severe form of SMA and a leading genetic cause of infant mortality. FDA says that the rare genetic disease