Drugs
FDA has released a discussion paper entitled “22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results” to illustrate the challenges drug developers face and why about nine out of 10 drugs/biologics tested are never submitted for approval. The paper acknowledges the growing interest in recent
Drugs
The FY 2016 Health Care Fraud and Abuse Control (HCFAC) Program report issued by HHS and the Justice Department says that the FDA Prescription Fraud Program (PFP) operated by the agency’s Office of Criminal Investigations with funding from HCFAC opened 31 criminal investigations in the fiscal year, including: * two
Drugs
In one of his final acts as FDA commissioner, Robert Califf announced 1/19 that the agency is officially establishing the Oncology Center of Excellence, with Richard Pazdur as its director. “This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics, and devices
Drugs
Acting for FDA, the Justice Department filed action in a California federal court seeking a permanent injunction against VivaCeuticals, Inc., doing business as Regeneca Worldwide, and its CEO Matthew Nicosia. A department news release says the company and Nicosia have agreed to cease all operations as part of a settlement.
Drugs
FDA has approved an Allergan NDA for RhoFade (oxymetazoline hydrochloride) cream for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29. Data showed that the drug reduced persistent facial erythema
Drugs
In what is likely his last public statement as FDA commissioner, before leaving as part of the change in administrations, Robert Califf chose to focus on the nation’s opioid abuse crisis and to offer his perspective on what needs to be done in the future. Writing in an FDA
Drugs
CDER’s sixth annual Novel Drug Summary says the Center approved 22 novel drugs in calendar year 2016, either as new molecular entities (NMEs) under NDAs or as new therapeutic biologics under BLAs. “Novel drugs are often innovative products that serve previously unmet medical needs or otherwise significantly help to
Drugs
Symbiomix has submitted an NDA for Solosec (secnidazole oral granules) for treating bacterial vaginosis (BV). The company describes Solosec as a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. In clinical trials Solosec demonstrated efficacy for treating BV with only a single, oral, two-gram dose, it
Drugs
FDA says it has approved a Roxane Laboratories ANDA for the first generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution for treating cataplexy and excessive daytime sleepiness in patients with narcolepsy. The approval requires Roxane to implement strict safety controls on prescribing and dispensing under a Risk Evaluation
Drugs
FDA has accepted for review an Ezra Innovations NDA for investigational drug product EZR-104 for treating hypertension and heart failure. The agency has set a user fee review target date of 9/10. EZR-104 combines angiotensin receptor blocker valsartan with its Rubireten delivery technology. “This novel formulation is
Drugs
Mallinckrodt has agreed to pay $100 million to settle Federal Trade Commission charges that it violated antitrust laws when its subsidiary Questcor acquired the rights to a drug that threatened its monopoly in the U.S. market for adrenocorticotropic hormone (ACTH) drugs. Acthar is a specialty drug used as a
Drugs
Former Rep. Henry Waxman (D-CA) says that some of the financial incentives under the Orphan Drug Act and the Waxman-Hatch Act have resulted in financial windfalls for drug companies and may no longer be needed. Waxman offered his assessment in an online Kaiser Health News video interview. He
Drugs
FDA has denied an 8/18/16 Lilly petition asking that it open notice and comment rulemaking to revise the regulatory definition of “biological product” such that Forteo (teriparatide [rDNA origin] injection) would fall within the statutory definition under the Biologics Price Competition and Innovation Act. Specifically, the petition asked
Drugs
As part of FDA’s reexamination of its rules and policies relating to regulated industry communication on unapproved uses of approved or cleared medical products, the agency has submitted a memorandum to the docket “to provide additional background and seek input on the full range of issues to consider as
Drugs
HHS, FDA and 13 other federal agencies have issued a final rule updating regulations that safeguard individuals who participate in research. The agencies say that most provisions in the rule take effect in 2018. “The new rule strengthens protections for people who volunteer to participate in research, while ensuring that
Drugs
A small study of hematologists/oncologists found that nearly 80% of them who tweeted about drugs or medicines had financial conflicts of interest ranging from $100 to upwards of $1,000. Modern Healthcare says the study, which appeared in JAMA Internal Medicine, reports that Twitter gives doctors direct access to
Drugs
A Government Accountability Office (GAO) study says that FDA has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection, but has not assessed the contributions its foreign offices make to drug safety. “FDA has made progress in its strategic planning for its offices in
Drugs
FDA has denied an AbbVie 12/17/15 petition asking the agency to ensure that applicants seeking interchangeability determinations meet the “Safety Standards for Determining Interchangeability” in the Public Health Service Act for each condition of use for which the reference product is licensed, regardless of whether the applicant intends
Drugs
FDA will publish 1/19 a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers, to provide the agency’s answers to common questions about the communication of healthcare economic information (HCEI) about approved prescription drugs by medical product manufacturers, packers, distributors,
Drugs
Drug distributor McKesson Corp. has agreed to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act, the Justice Department announced 1/17. The nationwide settlement requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for multiple
Drugs
A 10/27-11/5/15 FDA inspection at Horizon Pharmaceuticals, Riviera Beach, FL, found significant violations of current good manufacturing regulations for finished pharmaceuticals, according to a just-released 12/23/16 Warning Letter from the agency’s Florida District Office. Specific violations included: * failing to establish and follow
Drugs
Efforts underway in the past year to build a National Medical Evidence Generation Collaborative (EvGen) aim at leveraging previously isolated data systems in a way that ensures that available information collected during healthcare-related activities such as medical research, medical product development, and clinical care, can be brought to bear