San Diego Biotech

Biotech Directory

Aug
31

Sanofi, Regeneron point to potential heart benefit in PCSK9 data dump

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll
Aug
30

Novartis’ LCZ696 kindles megablockbuster projections with impressive PhIII heart data

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll
Aug
29

Pro-GMO Labeling Business Faces Own Labeling Dilemma

Posted under and Cosmetic Act, Blog, Companies, Diagnostics, Dr. Bronner's Magic Soaps, Drug, Farmer Gene, FDA, Federal Food, Food And Agriculture, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, The Center for Consumer Freedom, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization) Farmer Gene

 “Dr. Bronner’s should spend more time worrying about their own labels.”

The Center for Consumer Freedom recently published an interesting piece on Dr. Bronner’s Magic Soaps and his run in with the FDA.  You may know that Dr. Bronner’s Magic Soaps is an outspoken advocate of the scientifically suspect “GMO labeling” movement. 

In a warning letter to the company, the FDA states: “Based on our review of the product label, we have determined that your product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act…”

New drugs need FDA approval — they have to be safe and actually work — before they can be put on the market, and the coconut oil never received this authorization.

The label also suggests that the product is intended “for use in mitigating, treating, or preventing…coronary heart disease.” But according to the FDA, these conditions are “not amendable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended use.” The feds allege that this makes the product “misbranded.”

This is a divine irony, because Dr. Bronner’s claims to be a champion of “accurate” consumer information. Specifically, the company has bankrolled campaigns to legislate mandatory labels on products containing genetically improved foods (GIFs). The company ostentatiously supports these pro-label initiatives as means of providing transparency and defending consumers’ so-called “right to know.”

 

Aug
29

ThromboGenics spins out cancer R&D, scales down staff amid lackluster Jetrea sales

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, ThromboGenics, Universities, Videos by Emily Mullin

Disappointing sales of ThromboGenics' only marketed product, Jetrea, have taken their toll on the company's profits this year. To get back in the black, the Belgian company now says it's spinning out its cancer R&D activities to focus on the struggling eye drug.