Drugs
Alcon is asking FDA to require only in vivo bioequivalence testing for ANDAs that cite its Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension as the reference-listed drug. It also asks that the agency revise its product-specific guidance on ciprofloxacin and dexamethasone. Specifically, the petition
Drugs
One in 13 investigational diabetes drugs receive FDA marketing approval, compared to one in eight of all drugs, making diabetes drugs the riskiest drugs to develop, according to a Tufts Center for the Study of Drug Development Impact Report analysis (subscription required). The analysis finds that investment in drug development
Drugs
A briefing document prepared for a joint advisory committee meeting that voted 10-9 to recommend removal of a Boxed Warning for Pfizer’s Chantix relating to potential psychiatric risks, including suicide and suicidal ideation, raised CDER medical reviewer concerns that data from a company post-marketing study were biased
Drugs
FDA has accepted for review a Puma Biotechnology NDA for its lead product candidate PB272 (neratinib), indicated for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy. The submission is based on data from the ExteNET
Drugs
CDER director Janet Woodcock had made up her mind to approve (see earlier story) Sarepta’s controversial Duchenne drug Exondys 51 (eteplirsen) well before the Center review team had completed its review — in fact, she had written an approval memo before reviewers even submitted their review memo and summary. This
Drugs
KemPharm has decided to file a formal dispute resolution request over a June FDA complete response letter on an NDA label claim of abuse deterrence for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The company expects it could take
Drugs
FDA has announced a Naloxone App Competition, a public contest focused on developing a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone – the antidote for an opioid overdose. The contest builds on work announced in the agency’s Opioids
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FDA has told Teva Pharmaceutical Industries that a previously agreed to Special Protocol Assessment (SPA) has been rescinded for the Phase 3 CONCERTO clinical trial evaluating laquinimod in relapsing remitting multiple sclerosis (MS). Earlier this year, Teva and its development partner Active Biotech confirmed that the highest dose arms in
Drugs
After surviving an internal staff challenge adjudicated in her favor by FDA commissioner Robert Califf, CDER director Janet Woodcock made final her decision to approve Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen) under the agency’s accelerated approval process 9/19. It’s unprecedented for such a
Drugs
FDA has posted an International Conference on Harmonization draft guidance on “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers” that is intended to help sponsors implement the S9 Guideline to reduce/replace the use of animals in preclinical studies. For example, where a therapeutic increases survival, “no additional general
Drugs
HHS has issued a new rule and the National Institutes of Health (NIH) has issued a new policy, both of them intended to increase the availability of clinical trial information and data on clinicaltrials.gov, which is run by NIH. The final rule applies to “responsible parties,” a clinical trial
Drugs
FDA is working with stakeholders to revisit criteria used for determining whether a patient is eligible to participate in a trial, according to Oncology Center of Excellence (OCE) acting director Richard Pazdur in a new blog posting. “Modifying the eligibility criteria could expand the number of people who qualify and
Drugs
Metabolic Therapy Inc. has filed a petition asking FDA to amend the Over-the Counter Acne Drug Products monograph for active ingredients to indicate that chromium is safe and effective for acne treatment. The petition says that when glucose levels and insulin levels rise, the liver responds to the higher
Drugs
Members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 10-9 on 9/14 to recommend that FDA remove a Boxed Warning from labeling for Pfizer’s smoking-cessation drug Chantix (varenicline). The Boxed Warning contains statements about the risk of serious
Drugs
FDA has published a guidance, Qualification of Biomarker—Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients with Chronic Obstructive Pulmonary Disease, to provide a qualified context of use for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease at
Drugs
Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ) and Rep. Jan Schakowsky (R-IL) have introduced the FAIR Drug Pricing Act as “the first step in addressing skyrocketing prescription drug prices by requiring transparency for pharmaceutical corporations that plan to increase drug prices.” A statement issued by Sen.
Drugs
FDA has approved an Aralez Pharmaceuticals NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. “Secondary prevention with aspirin may be recommended in patients who have had a myocardial infarction or unstable angina pectoris, chronic
Drugs
FDA has extended by three months its review of a Lexicon Pharmaceuticals NDA for telotristat etiprate, an oral drug for treating carcinoid syndrome. In response to an information request from the agency, additional clinical data analyses have been submitted and the extension will provide additional time to review it. The
Drugs
Virtus Pharmaceuticals has recalled seven batches of hyoscyamine sulfate (0.125mg) due to both superpotent and subpotent test results. All of the affected batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the U.S. and Puerto Rico. See a press release for a listing of affected batch
Drugs
According to a just-released FDA summary, patients with Alpha-1 Antitrypsin Deficiency (AATD) said at a 9/29/15 FDA public meeting that while significant treatment advances have occurred, much remains to be done and they would like to see a cure, through gene therapy or a lung or
Drugs
FDA has released a guidance on “Qualification of Biomarker Total Kidney Volume (TKV) in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease” that provides a qualified context of use (COU) for the biomarker TKV in such studies. The document also describes the experimental conditions and constraints for which this
Drugs
Investors and Duchenne muscular dystrophy patients and their families are cheering the departure of CDER Division of Neurology Products clinical team leader Ronald Farkas, who joined clinical research organization Parexel 9/9. Farkas was one of the harshest critics of Sarepta’s NDA for Duchenne drug eteplirsen during an April