Drugs
CDER director Janet Woodcock says the Center’s regulatory pathways that expedite the development and approval of new drugs received significant use in 2017. Writing in a report on new drug therapy approvals in 2017, Woodcock reviews usage of the fast track, breakthrough therapy, priority review, and accelerated approval expedited
Drugs
A Pennsylvania state judge has overturned a $27.8 million award approved by a jury for an Indiana couple who said Bayer and Johnson & Johnson failed to sufficiently warn about the risk of internal bleeding with their drug Xarelto (rivaroxaban). Reuters reports the judge ruled after a hearing on
Drugs
International Laboratories has recalled one lot of clopidogrel tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as clopidogrel tablets USP 75 mg, but it may contain clopidogrel 75mg or simvastatin tablets USP 10 mg. “Missed doses of
Drugs
A Tufts Center for the Study of Drug Development study with Veeva Systems finds that the volume and diversity of clinical data are presenting integration, compatibility, loading, and interoperability challenges that the drug industry must address to optimize drug development performance. The study (purchase or subscription required), reported in an
Drugs
Gilead has asked the Supreme Court to hear its appeal of a 9th Circuit Court of Appeals decision holding that whether False Claims Act allegations are material raises questions of proof that cannot be resolved through a motion to dismiss. Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in her
Drugs
Washington Legal Foundation (WLF) has asked the Supreme Court to overturn a 3rd Circuit Court of Appeals decision in Pfizer v. Rite Aid Corp because the decision dramatically expands antitrust law and prevents settling of patent litigation. WLF says the 3rd Circuit decision requires exacting antitrust scrutiny for virtually any
Drugs
FDA commissioner Scott Gottlieb says 2017 was “an inspiring year of advances in both medicine and public health for FDA, from groundbreaking medical products brought to market this year to a record number of generic drug approvals that will promote competition, and to the agency’s ongoing efforts to advance
Drugs
FDA has denied a 10/2017 Amneal Pharmaceuticals petition asking it not to approve any ANDAs for generic forms of its Forteo (teriparatide [rDNA origin]) injection that contain synthetically derived teriparatide active substance, and to only approve ANDAs for teriparatide injection products that contain recombinant human parathyroid hormone. The petition
Drugs
FDA has denied a 10/2017 Novo Nordisk petition asking it not to approve any ANDA referencing any of the company’s liraglutide-containing drugs as the reference-listed drug. Novo Nordisk identified the drugs in question as Victoza (liraglutide) injection, Saxenda (liraglutide) injection, or Xultophy (insulin degludec and liraglutide
Drugs
Federal Register notice: FDA has submitted to OMB an information collection extension for “Adverse Experience Reporting (AER) for Licensed Biological Products; and General Records — 21 CFR Part 600; OMB Control Number 0910-0308.” Evaluation of these safety issues enables FDA to take focused regulatory action. Such action may include, but
Drugs
pSivida Corp. has submitted an NDA for Durasert, a three-year sustained-release implant containing the corticosteroid fluocinolone acetonide for treating posterior segment uveitis. The submission includes data from two Phase 3 studies that achieved the primary efficacy endpoint, according to the company. The most recent study reported last year
Drugs
FDA has accepted for review two Merck NDAs for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor for treating HIV-1 infection in adults. The NDAs include data for doravirine as a once-daily tablet for use in combination with other antiretroviral agents, and for use of doravirine
Drugs
A new study suggests that pregnant women who take certain drugs for treating attention deficit hyperactivity disorder have a higher risk that their babies could be born with heart deformities and other birth defects. The study, which was published in the Journal of American Medicine Psychiatry, analyzed data on more
Drugs
FDA commissioner Scott Gottlieb says he expects a shortage of IV saline fluids related to the hurricane destruction in Puerto Rico will improve early this year, with continuing improvements in the weeks ahead. In an online update, he says Baxter, a leading producer of IV saline fluids, has indicated that
Drugs
FDA has approved an Amgen supplemental BLA for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors to include patients with multiple myeloma. The approval is based on data from a Phase 3 study that
Drugs
Johnson & Johnson Innovation LLC has entered into more than a dozen new product collaborations to address areas of high unmet medical need. Priority areas that Johnson & Johnson (J&J) says it is devoting resources to include the use of artificial intelligence to detect early signs of Alzheimer’
Drugs
HHS Office of Inspector General (OIG) has asked Pharmaceutical and Research Manufacturers of America (PhRMA) for its help finding companies to provide free drugs to patients who were receiving assistance from a charitable group that fell out of favor with the government. A 1/14 OIG letter to PhRMA says
Drugs
AuroMedics Pharma has recalled one lot of ampicillin and sulbactam for injection USP, 1.5 g in a single-dose vial due to the potential for vials to contain glass particles. AuroMedics shipped the entire lot to wholesalers and hospitals nationwide on 2/9/2017, according to a recall notice.
Drugs
FDA has released the Establishment Inspection Report from a 2/27-3/8/17 inspect at the Dr. Reddy’s manufacturing facility in Andhra Pradesh, India. The report says the facility continues to manufacture sterile injectable and tablet products for the U.S. market. At the end of the inspection,
Drugs
FDA has released the FDA-483 issued following a 9/25-9/29/17 inspection at SCA Pharmaceuticals, a Little Rock, AR, outsourcing facility. Specific inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * there is a failure to thoroughly review any unexplained discrepancy
Drugs
Federal Register notice or correction: FDA is correcting a notice that appeared 10/24/2017 that announced the withdrawal of 54 ANDAs. That notice inadvertently announced the withdrawal of approval for Watson Labs ANDA for chlorthalidone tablets 25 mg. FDA now confirms that the ANDA approval is still in effect.
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Good ANDA Submission Practices.” The document highlights common, recurring deficiencies that may delay ANDA approval. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for