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STRATEGIC ADVISORY GROUP OF EXPERTS ON IMMUNIZATION CONVENED BY THE WORLD HEALTH ORGANIZATION RECOMMENDS USE OF SANOFI PASTEUR'S DENGUE VACCINE IN ENDEMIC COUNTRIES

RegulatorSanofi2016-04-18 11:39 Read   76

Sanofi and its vaccines global business unit Sanofi Pasteur, announced today that the Strategic Advisory Group of Experts on Immunization (SAGE) has issued its recommendations to the WHO on the use of Dengvaxia® dengue vaccine.

Hundreds in China to be punished over tainted vaccines

Regulatormarketwatch2016-04-15 13:45 Read   86

BEIJING — China will punish 357 officials implicated in the sale of improperly handled vaccines, a scandal that has reignited drug safety fears and further eroded trust in the country’s public health system.

Continuous Manufacturing Has a Strong Impact on Drug Quality

RegulatorFDA2016-04-15 11:15 Read   127

If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant of today, it might be surprising to learn that they would already be very familiar with most of the processes and production techniques being used. That’s because not much has changed in pharmaceutical production over the last 50 or so years.

FDA approves folic acid fortification of corn masa flour

RegulatorFDA2016-04-15 08:55 Read   95

The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains.

Senator calls on Medtronic, FDA for bone graft injury data

Regulatorreuters2016-04-14 15:01 Read   121

U.S. Senator Al Franken asked federal regulators and Medtronic Inc for detailed information about injuries associated with the company's bone graft Infuse following a newspaper report that Medtronic hid thousands of adverse events linked to the product.

FDA panel says no to quick approval of Clovis' rociletinib

Regulatorpmlive2016-04-14 10:55 Read   92

An FDA advisory committee all but dashed any hopes that Clovis Oncology had for quick approval of its lung cancer drug rociletinib yesterday.

FDA advisors vote against Clovis' rociletinib

Regulatorpharmatimes2016-04-13 11:09 Read   103

It looks likely that Clovis Oncology’s non-small cell lung cancer drug rociletinib will hit a major setback in its quest for approval after failing to win the support of US Food and Drug Administration advisors.

Shock approval for Abiomed but big test to come

Regulatorepvantage2016-04-11 10:19 Read   117

After yesterday’s expanded FDA approval of its Impella line of heart pumps Abiomed is heading for an even more significant event. In a year or so a US study, Shield II, comparing Impella with St. Jude Medical’s HeartMate PHP pump during high-risk percutaneous coronary intervention (PCI) procedures will report data.

FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

RegulatorFDA2016-04-11 09:08 Read   131

Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.

FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients

RegulatorFDA 2016-04-08 12:35 Read   113

 The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.

AstraZeneca and Takeda DPP-4 inhibitors get another warning added to their labels

RegulatorFierce pharma 2016-04-07 14:15 Read   121

There is more bad news for DPP-4 inhibitor diabetes drugs saxagliptin and alogliptin from AstraZeneca ($AZN) and Takeda. The FDA has tightened its regulatory grip on the Type 2 diabetes meds, insisting their labels now include warnings of increased risks of heart failure.

FDA releases final rule to ensure food safety during transport

RegulatorFDA2016-04-06 09:02 Read   106

The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation.