Drugs
The Justice Department says it obtained more than $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2017, with $2.4 billion of the total involving the health care industry. A department news statement says that the health sector
Drugs
A 7/17-7/26/17 FDA inspection at American CryoStem Corp., Monmouth Junction, NJ, documented that the firm receives and processes adipose tissue for autologous use, according to a 1/3 Warning Letter. The firm reportedly isolates cellular components from the adipose tissue and processes the tissue into stromal
Drugs
The next FDA Grand Rounds Web cast is scheduled for 1/11 from 12 noon to 1 p.m. on the topic “Ethnicity- and Gender-Related Differences in Alzheimer’s Disease. Presenting will be National Center for Toxicological Research research psychologist Sherry Ferguson and research biologist Vijayalakshmi Varma. “Better understanding
Drugs
iTeos Therapeutics, a biotech firm developing cancer immunotherapies, has regained exclusive worldwide rights from Pfizer to develop EOS200271, a highly selective, clinical-stage indoleamine 2,3-dioxygenase (IDO1) inhibitor. A recent Phase 1 study by Pfizer did not demonstrate the therapy’s efficacy as a single agent in patients with
Drugs
FDA has cleared a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use as an aid in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company says
Drugs
FDA has denied an 8/2017 Allergan petition asking it to refuse to approve any pending ANDA for cyclosporine ophthalmic emulsion for which its Restasis is the reference-listed drug that relies on in vitro or other non-clinical analyses, and does not rely on one or more appropriately designed
Drugs
FDA commissioner Scott Gottlieb says the agency has issued a draft guidance and a Manual of Policies and Procedures (MAPP) intended to help improve the efficiency and predictability of the agency’s generic drug review process to reduce the time it takes to get a new generic drug approved and
Drugs
A new HHS Office of Inspector General report found that from 2012 to 2016 Medicaid may have lost $1.3 billion in base and inflation-adjusted rebates for 10 potentially-misclassified drugs with the highest total reimbursement in 2016. “The vast majority of the approximately 30,000 drugs in the
Drugs
PharMEDium Services has recalled several lots of drug products to the hospital/user level due to a lack of sterility assurance. “PharMEDium conducted a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding
Drugs
FDA has released the FDA-483 issued following a 10/16-10/23/17 inspection at KRS Global Biotechnology, Boca Raton, FL, an outsourcing facility. The observations were: * equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its
Drugs
FDA has published online instructions for NDA and ANDA holders to use in submitting a one-time marketing status report required by the FDA Reauthorization Act of 2017. NDA and ANDA holders are to review information published in the Orange Book and submit a one-time report indicating that (1)
Drugs
An Illinois federal judge has overturned a $150 million verdict against AbbVie in a case that alleged the company fraudulently misrepresented the risks of its AndroGel testosterone replacement drug. According to Reuters, the judge found that the findings by a jury that rendered its verdict 7/2017 were “logically incompatible.
Drugs
FDA says it is seeking nominations to join the agency’s Patient Engagement Collaborative (PEC). An FDA Voice blog post says the PEC is looking for: * patients who have personal disease experience; * caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have
Drugs
FDA has approved Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), a new gene therapy to treat children and adults with an inherited form of vision loss that may result in blindness. An agency news release says that Luxturna is the first directly administered gene therapy approved in the U.S. that
Drugs
FDA says it will take a new risk-based enforcement approach to drug products labeled as homeopathic. “To protect consumers who choose to use homeopathic products,” an agency news release says, “this proposed new approach would update FDA’s existing policy to better address situations where homeopathic treatments are being
Drugs
Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) are asking FDA commissioner Scott Gottlieb whether the agency’s enforcement policies on prescription drugs imported from Canada has changed. The senators’ 12/21/17 letter follows an 11/20/17 Kaiser Health News report that FDA sent Office of
Drugs
CDER innovative drug approvals sharply rebounded in 2017 — more than doubling the 22 products approved in 2016, which was a significant down year for approvals. In all, the Center approved 46 innovative NDA/BLAs last year. In contrast, there were just 22 approved in 2016 and 45 in 2015, according
Drugs
FDA has published a final guidance and a draft guidance addressing communications between the agency and drug sponsors. The final guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, describes best practices and procedures for timely, transparent, and effective communication between IND sponsors and FDA at
Drugs
Washington Legal Foundation (WLF) says that a 3rd Circuit Court of Appeals decision in a patent reverse payment case involving Pfizer and Ranbxy “represents a major expansion of antitrust law” and directly conflicts with the Supreme Court’s Actavis decision. In a brief asking the high court to hear Pfizer’
Drugs
FDA has issued a final rule establishing that 24 active ingredients in over-the-counter antiseptic products for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital are not generally recognized as safe and effective. The agency says it issued the final rule after
Drugs
FDA says it has updated the labeling for Novartis’ cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. An agency news release says Tasigna was approved in 2007 and is indicated for treating patients with Philadelphia chromosome positive (Ph+) chronic myeloid
Drugs
In a draft guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases, FDA says it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases unless use of the drug in the pediatric subpopulation meets the regulatory for