Snowdrift Farm Chek-it Kit: Microlab in a Box

Did you know that the FDA has rules about filth and sterility in your water-based solutions, such as lotions, creams and sprays? See how simple it is to test your formulations at home, for about $4 per test.

Centric Health Resources Participates in Specialty Pharmacy News’ Webinar: Integrating FDA Risk Evaluation and …

Centric Health Resources Participates in Specialty Pharmacy News’ Webinar: Integrating FDA Risk Evaluation and …
CHESTERFIELD, Mo.—-With an ongoing dedication to improving the calibre of life for people nationwide with rare, orphan, ultra-orphan, and chronic genetic disorders, Centric Health Resources, Inc. , will participate in the upcoming Specialty Pharmacy News’ Webinar, Wednesday, June 2, 2010, 1–2:30 p.m.

Read more on Business Wire via Yahoo! Finance

Pro-Pharmaceuticals plans to submit Phase III trial design for DAVANAT to FDA

Pro-Pharmaceuticals plans to submit Phase III trial design for DAVANAT to FDA
Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, this day announced plans to submit a Phase III trial design for DAVANAT to the U.S. Food and Drug Administration during the second half of 2010. The Company has added the talent of Peter G. Traber, M.D., to its FDA approval strategy and trial design team.

Read more on News-Medical-Net

JHP Pharmaceuticals Announces Successful Completion of FDA and EMEA GMP Audits

JHP Pharmaceuticals Announces Successful Completion of FDA and EMEA GMP Audits
PARSIPPANY, N.J., Might 10 /PRNewswire/ — JHP Pharmaceuticals’ sterile manufacturing site based in Rochester, Michigan finished a successful GMP (Good Manufacturing Practices)/Pre Approval Audit by the U.S. Food and Drug Administration (FDA) drug division (CDER).

Read more on redOrbit

Prescription Drugs–Me-Too Drugs, 2/7

www.encognitive.com Angell disputes the industry’s reputation as an “engine of innovation,” arguing that the top US drug makers spend 2.5 times as much on marketing and administration as they do on research. At least a third of the drugs marketed by industry leaders were discovered by universities or small biotech companies, writes Angell, but they’re sold to the public at inflated prices. She cites Taxol, the cancer drug discovered by the National Institutes of Health, but sold by Bristol-Myers Squibb for $20000 a year, reportedly 20 times the manufacturing cost. The company concurred to pay the NIH only 0.5 percent in royalties for the drug. The majority of the new products the industry puts out, states Angell, are “me-too” drugs, which are nearly same to current treatments but “no superior than drugs already on the market to treat the same condition.” Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they’re more effective than a placebo, they can get the regulatory green light. http

Next Page »