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
Devices
FDA has cleared an STS Medical 510(k) for its composite sinus stent. The device is intended to reduce recurrent surgeries after functional endoscopic sinus surgery, which is often performed to increase airflow within the nose and sinuses, improve drainage, and remove diseased tissue. The company says that up to
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
FDA Policy/General
Absorbable Perirectal Spacer Into Class 2 Federal Register notice: FDA classifies the absorbable perirectal spacer into Class 2 (special controls). 01/05/2018 Cervical Intraepithelial Neoplasia Tests Put Into Class 2 Federal Register notice: FDA classifies the cervical intraepithelial neoplasia (CIN) test system into Class 2 (special controls). 01/04/
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
Devices
BioCardia has filed an IDE for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with refractory angina. The device uses a patient’s own cells for treating CMI. “This therapeutic approach of focused implantation of the right combination of bone marrow-derived cells delivered intramyocardially for the treatment
Devices
FDA has approved Roche’s cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. Previously, plasma viral load results required blood samples to be cooled during transport to the lab. The new device allows quantitative testing of patients with HIV living in remote areas affected
Devices
FDA has cleared a Mevion Medical Systems 510(k) clearance for the Mevion S250i Proton Therapy System that uses its Hyperscan pencil beam scanning (PBS) technology. The technology uses energy layer switching and automated collimation systems to deliver faster, sharper, and more robust PBS proton radiation treatments, the company says.
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’
FDA Policy/General
Federal Register notice: FDA has classified the absorbable perirectal spacer into Class 2 (special controls). The action is in response to a 10/14 de novo classification request by Augmenix, Inc. for its SpaceOAR System. The agency has named the generic type of device absorbable perirectal spacer, and it is
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
Drugs
The Justice Department says it obtained more than $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2017, with $2.4 billion of the total involving the health care industry. A department news statement says that the health sector
FDA Policy/General
A Washington Legal Foundation (WLF) Legal Pulse online post says a proposal to eliminate the tax exemption for direct-to-consumer drug advertising “is misguided, likely unconstitutional, counter-productive, and would result in worse healthcare outcomes for millions of Americans.” The suggestion to end the tax exemption was included in
Drugs
A 7/17-7/26/17 FDA inspection at American CryoStem Corp., Monmouth Junction, NJ, documented that the firm receives and processes adipose tissue for autologous use, according to a 1/3 Warning Letter. The firm reportedly isolates cellular components from the adipose tissue and processes the tissue into stromal
Drugs
The next FDA Grand Rounds Web cast is scheduled for 1/11 from 12 noon to 1 p.m. on the topic “Ethnicity- and Gender-Related Differences in Alzheimer’s Disease. Presenting will be National Center for Toxicological Research research psychologist Sherry Ferguson and research biologist Vijayalakshmi Varma. “Better understanding
Drugs
iTeos Therapeutics, a biotech firm developing cancer immunotherapies, has regained exclusive worldwide rights from Pfizer to develop EOS200271, a highly selective, clinical-stage indoleamine 2,3-dioxygenase (IDO1) inhibitor. A recent Phase 1 study by Pfizer did not demonstrate the therapy’s efficacy as a single agent in patients with