Archives for July 2016

2 plead guilty in connection with compounding pharmacy case

The majority owner of the New England Compounding Center, the Framingham pharmacy blamed for a 2012 meningitis outbreak that left more than 60 people dead and hundreds ill, pleaded guilty Friday to trying to conceal financial transactions from federal regulators.

Compounding Pharmacy Recalls Lots of HCG and Sermorelin

Texas-based Talon Compounding Pharmacy (TCP) recently issued a voluntary recall of all lots of lyophilized HCG and sermorelin amid FDA concerns about sterility assurance.

So far no complaints have been filed regarding illness or injury stemming from use of the product, but nevertheless a potential lack of sterility may increase the risk of infection and other complications.

Talon Compounding Pharmacy Issues Recall

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

Talon Compounding Pharmacy (San Antonio, TX) announced on July 21, 2016 that it was recalling all lots of lyophilized HCG and sermorelin because of a lack of sterility assurance. The affected lots were distributed nationwide between January 18 and July 18, 2016.

Why Change Is Inevitable In Aseptic Manufacturing

Aside from the usual challenges of traditional blockbuster drugs, on which patents provided a crucial period of exclusivity and protection, the new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs. The largest number of ongoing clinical studies focus on cancer treatments and half of the newly developed anti-cancer drugs are injectable. Additionally, bio-pharma research is generating new higher value/lower volume drugs, many of which are highly ac-tive.

FDA Staff Split Over Suicide Risk of Valeant’s Psoriasis Drug

U.S. regulators had differing opinions on the risk of Valeant Pharmaceuticals International Inc.’s experimental psoriasis treatment and recommended, if approved for sale, that it possibly include a warning that it may be linked to suicidal thoughts and behavior or that the company conduct new clinical trials to better understand the risks.

After 3 patient deaths, FDA halts immunotherapy trial

‘This is a humbling experience,’ Juno CEO says

FDA has temporarily halted a Juno Therapeutics clinical study that used genetically engineered cells to treat cancer after three participants died, the company announced on Thursday.

The patients, all in their 20s, died from swelling in the brain. Two of the patients died two weeks ago, while the third died

FDA to Restrict Compounders from Making Copies of Commercially Available Drugs

The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.