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More than 5,000 pregnant women in Colombia have Zika virus: government

HealthReuters2016-02-15 16:05 Read   226

More than 5,000 pregnant Colombian women are infected with the mosquito-borne Zika virus, the country's national health institute said on Saturday, as the disease continues its rapid spread across the Americas.

Chinese immunotherapy biotech BeiGene sets terms for $127 million IPO

EVENTSNasdaq2016-01-22 09:33 Read   200

BeiGene, a Chinese biotech developing immunotherapies based on kinase inhibitors, announced terms for its IPO on Tuesday.

Two Indian states halt sales of Roche's Avastin drug

Regulatorreuters2016-01-20 10:03 Read   203

Two Indian states have put sales of Swiss drugmaker Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat.

U.S. FDA accepts for priority review sNDA for Eisai’s anticancer agent lenvatinib seeking approval for renal cell carcinoma

RegulatorEisai2016-01-19 11:36 Read   250

Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai’s in-house developed novel anticancer agent lenvatinib mesylate (generic name, “lenvatinib”) for use in the treatment of advanced or metastatic renal cell carcinoma, and granted the sNDA Priority Review status.

FDA outlines cybersecurity recommendations for medical device manufacturers

RegulatorFDA2016-01-18 09:37 Read   766

The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.

FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk

RegulatorFDA2016-01-18 09:27 Read   316

The U.S. Food and Drug Administration today cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.

FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

RegulatorBioMarin2016-01-15 09:14 Read   404

BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.

In a win for LivaNova, the FDA approves the world's only sutureless aortic valve

RegulatorFDA2016-01-14 14:42 Read   949

London's LivaNova ($LIVN) can now sell the only sutureless surgical aortic valve in the U.S., thanks to the FDA's PMA approval of its Perceval device. The company is hoping the device can overcome the strong trend toward implantation of transcatheter aortic valve replacements, which are procedurally (as opposed to surgically) installed using a delivery catheter and guidewire.

Federal judge enters consent decree against Downing Labs

RegulatorFDA2016-01-12 09:02 Read   185

On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.

The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation

RegulatorFDA2016-01-07 13:21 Read   166

The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States.

US Marshals seize dietary supplements containing kratom

RegulatorFDA2016-01-07 10:30 Read   186

The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

CommentsFDA2016-01-06 09:22 Read   269

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina.