Archives for January 2016

FDA approves first drug to show survival benefit in liposarcoma

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

Positive Findings May Lift FDA Hold On Zafgen’s Obesity Drug Trials

Biotech giant Zafgen Inc. feels hopeful in the possible revival of FDA review process of its controversial obesity drug after the release of positive report on the company’s experimental medication.

Following the deaths of two patients during its drug trials, the Food and Drug Administration (FDA) ordered a halt on experiments effectively leaving the regulatory approval process in limbo.

Compounding pharmacy recalls medications

Abbott’s Compounding Pharmacy in Berkeley, Calif., is voluntarily recalling all unexpired lots of sterile compounded products because of lack of sterility assurance.

The compounded medications include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.

3 Scorned Biotechs Destined to Rebound

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Utah fears thousands infected in hepatitis C outbreak after exposure to hospital nurse

More than 7,000 patients at a Utah hospital were potentially exposed to an “outbreak” of hepatitis C after coming into contact with an infected former nurse – but less than half have come in for free testing to find out if they have the disease.

Researchers Link FDA Actions to Decrease in LABA Use in Asthma Treatment

A recent study finds an association between regulatory actions by the US Food and Drug Administration (FDA) and the use of long-acting β2-agonists (LABA) commonly used to treat asthma.

Chipotle Outbreaks At Center Of FDA Investigation

MIAMI (CBSMiami) — Chipotle Mexican Grill has been served with a subpoena by a federal grand jury in connection to illnesses at one of its California restaurants.

The company announced Wednesday that U.S. Attorney’s Office and the Food and Drug Administration are investigating a norovirus outbreak that occurred over the summer in the state.

FDA issues safety alert for antifungal medication dosages, approves label revisions

The FDA issued a safety announcement today warning prescribers, pharmacists and patients that differences in dosing regimens between the two oral formulations of the antifungal Noxafil can lead to dosing errors.