FDA Policy/General
Eli Lilly has signed an agreement to acquire CoLucid Pharmaceuticals $960 million. The acquisition would boost the company’s existing portfolio in pain management for migraine and also add a potential near-term launch to its late-stage pipeline. “Lasmiditan is a novel, first-in-class molecule that could represent
Drugs
BIOLOGICS Draft Guide on Biosimilar Interchangeability Federal Register Notice: FDA has made available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the
Drugs
After a flurry of end-of-the year enforcement letters and new guidance documents this month on product communications, it appears a dramatic shift in CDER’s Office of Prescription Drug Promotion (OPDP) enforcement approach is underway, according to an analysis posted on FDAlawblog.com. “After a string of First
Devices
FDA has cleared an OssDsign 510(k) for the OssDsign Cranial PSI, a patient-specific medical implant intended for reconstruction of cranial defects (cranioplasty). Such procedures have traditionally been performed by neurosurgeons using a patient’s own bone or by using implants made from inert plastic or metal materials, such
Devices
FDA has cleared a Bone Index Ltd. 510(k) for its second generation Bindex point-of-care device model to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a “Density Index,” a parameter which estimates bone mineral density at the
FDA Policy/General
In his last role as FDA commissioner, Robert Califf has penned a JAMA online article calling for a harmonized risk-benefit assessment across the medical product Centers. “Realization of a harmonized benefit-risk framework across the agency will require firm commitment to evaluating cultural and scientific reasons for variation in
Drugs
FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) for treating adults with chronic idiopathic constipation (CIC). The company says Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal peptide that is thought to stimulate fluid secretion which results
Drugs
FDA has granted Concert Pharmaceuticals an orphan drug designation for CTP-656, a next-generation CFTR (cystic fibrosis transmembrane conductance regulator) potentiator being developed for treating cystic fibrosis. Last month, Concert initiated a Phase 2 trial in the U.S. evaluating the drug in cystic fibrosis patients with gating mutations.
Drugs
FDA has named deputy commissioner for foods and veterinary medicine Stephen Ostroff acting commissioner after former commissioner Robert Califf resigned 1/20 as the Trump Administration assumed government responsibilities. Ostroff has served as deputy commissioner since 5/2016. He previously served as acting commissioner from 4/2015 to 2/2016.
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
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance for “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.” The guidance provides answers to common questions on communicating health care economic information about approved prescription drugs by medical product manufacturers, packers, distributors, and
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.” The document provides information for manufacturers, packers, and distributors of drugs and medical devices for humans, including those that are licensed as biological products, and
FDA Policy/General
Federal Register Notice: FDA has canceled a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting that was announced in the 12/27/2016 Federal Register. Panel members were scheduled to review a Neurocrine Biosciences NDA for valbenazine 40 milligram (mg) capsules, indicated for treating Tardive Dyskinesia. To view the notice,
FDA Policy/General
Federal Register Notice: FDA has reopened the comment period concerning its comprehensive review of regulations and policies governing manufacturer communications about unapproved uses of approved or cleared medical products. The agency has also made available “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses
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.
Devices
A 10-week FDA inspection at Zimmer Biomet from 9/12/16 to 11/22/16 led to a 58-page FDA-483 detailing 14 inspection observations, some of which were repeated from earlier inspections. The just-released document shows these violations: * failing to adequately validate according to established procedures
FDA Policy/General
FDA says it is abandoning a controversial embargo policy directed at reporters that came to light last year by New York University journalism professor Charles Seife. In a lengthy analysis for Scientific American, Seife said that by holding embargoed briefings for select reporters on major issues conditional that the reporters
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
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension for its “Adverse Event Program for Medical Devices (Medical Product Safety Network — MEDSUN).” FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A related to medical devices and
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