Drugs
FDA has granted Akari Therapeutics an orphan drug designation for coversin, a recombinant protein inhibitor of complement factor 5 for treating Guillain Barr Syndrome. The company says the second-generation complement inhibitor is intended to act on complement component-C5, preventing release of C5a and formation of C5b-9 (also
Drugs
FDA has told Tetraphase Pharmaceuticals that it will need positive data from an additional Phase 3 trial for its lead candidate, eravacycline, in order to support an NDA for the antibiotic. The drug has shown potent activity against drug-resistant bacteria, including multidrug-resistant pathogens, the company says. Based on
Drugs
In issuing a 5/12 drug safety communication on fluoroquinolones when they are used systemically, the agency also simultaneously denied a 2014 petition seeking to change the professional labeling for Johnson & Johnson’s Levaquin (levofloxacin) to warn about possible mitochondrial toxicity. The petition denial letter says that an agency
Drugs
FDA says that so far there is no indication that counterfeit drug product labeled as BiCNU (carmustine for injection) 100 mg has entered the legitimate U.S. drug supply chain, or that any U.S. patients have received any of the suspect product. Earlier this week, Heritage Pharmaceuticals said (see
Drugs
FDA has granted fast-track designation to Edge Therapeutics for its EG-1962 for treating aneurysmal subarachnoid hemorrhage (aSAH). The company describes it as a novel polymeric nimodipine microparticle containing nimodipine suspended in a diluent of sodium hyaluronate that uses the company’s Precisa development platform and that is designed
Drugs
FDA this week granted breakthrough therapy status to a Duke University-based company’s new therapy that cured recurrent brain gioblastoma in three patients and extended life for others in a clinical trial from 10 to 15 months, according to a CBS 60 Minutes report to be aired Sunday and
Drugs
Former FDA commissioner Margaret Hamburg and former NIH director Elias Zerhouni say that global drug regulatory harmonization is a public health imperative. Writing in an online Science Translational Medicine editorial, the two argue that “in this world of growing public health needs, limited resources, and incessant demand for more, faster,
Drugs
FDA has cleared an Xtant Medical Holdings 510(k) for a posterior cervical screw indication on the Certex Spinal Fixation System, which the company says can be linked to the Fortex Pedicle Screw System and the Xpress Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
Drugs
FDA says that the serious side effects associated with fluoroquinolone antibiotics generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. An agency drug safety communication says that an FDA safety review found that when fluoroquinolones are used systemically, they are
Drugs
Aegerion Pharmaceuticals has reached preliminary agreements with the Department of Justice and the Securities and Exchange Commission involving a settlement of ongoing investigations by the feds into the company’s sales activities and disclosures related to Juxtapid (lomitapide). Under the agreement, the company will pay both agencies over five years
Drugs
FDA has granted AstraZeneca an orphan drug designation for the investigational MEK 1/2 inhibitor, selumetinib, indicated for adjuvant treatment of patients with Stage III or IV differentiated thyroid cancer. The condition is diagnosed in about 60,000 people in the U.S. each year, the company says. Some patients
Drugs
Rep. Mia Love (R-UT) has introduced the Over-the-Counter Contraceptives Act of 2016 (H.R. 5138) to “allow women greater access to safe and effective contraceptives.” Under the measure, FDA would be required to give priority review to any supplemental application for a contraceptive drug that (1) involves
Drugs
A Harvard School of Public Health poll finds that a majority of Americans don’t favor some key provisions of the 21st Century Cures Act and its companion Senate legislation. The poll also found that few people think FDA does a good job of regulating prescription drugs and medical devices.
Drugs
A citizen petition filed by Hyman, Phelps & McNamara on behalf of an unnamed client asks FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. The petition says the drugs are being marketed in violation of the Federal Food, Drug, and
Drugs
The Personal Care Products Council says that while it supports the FDA intent to harmonize requirements for prescription and OTC products and make them consistent with long-standing agency policy, it has some concerns about the agency’s proposed rule on fixed-combination and co-packaged drugs covering applications for
Drugs
A petition from two Yale University School of Medicine professors of endocrinology and metabolism asks FDA to reconsider labeling changes relating to the Contraindications and Precautions sections of labeling for metformin. The petition asks that the Precautions section specifically recommend use of a lower dose of the drug (up to
Drugs
CDER director Janet Woodcock says there is a knowledge chasm in translational science that CDER is helping to fill. Speaking on a Director’s Corner podcast, she says that every disease should have its own translational program and natural history studies that look at disease progression over time. (Woodcock defines
Drugs
FDA has accepted from H3 Biomedicine an IND application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800. The oral and selective small molecule modulator of splicing factor 3b subunit 1 is being developed as an anticancer therapeutic agent for treating select hematologic malignancies. “Mutations
Drugs
Allergan andGedeon Richter have announced positive results from Venus I, one of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study included 157 patients, with 101 randomized to ulipristal acetate 5 and 10 mg and 56 to placebo.
Drugs
Sen. Ron Johnson (R-WI) has introduced legislation to prevent the federal government from interfering with implementation of state “Right to Try” laws that allow terminally ill patients, under a doctor’s direction, to access treatments that are being safely used in clinical trials but may be years away from
Drugs
Heritage Pharmaceuticals says it has become aware of the existence of a counterfeit drug product labeled as BiCNU (carmustine for injection) 100 mg, that is being sold and distributed outside of the U.S. BiCNU is primarily used for chemotherapy to treat several types of brain cancer, multiple myeloma, and
Drugs
FDA says it will hold a 6/10 public meeting to hear stakeholder input on the potential development of a user-fee program for nonprescription over-the-counter monograph drugs. A Federal Register notice says that such a program would provide funding to supplement congressional non-user-fee appropriations, and