Roche’s proposal to acquire the remaining shares in the biopharmaceutical company Genentech for $43.7 billion is a strong statement on Big Pharma’s strategy to adjust its pipelines and product portfolios to biopharmaceuticals. Read more

As an animal lover—and especially a dog lover—I can understand where PETA, People for the Ethical Treatment of Animals, is coming from when they condemn FDA for not putting an end to toxicity testing on animals.  But as a consumer of medication, I also understand the need to test certain things on animals before subjecting humans to potential serious adverse effects. And here lies the challenge that has been around for decades, if not longer, sparking disputes between scientists and those who back ethical treatment across the board. Read more

About six years ago, I wrote an editorial describing my skepticism over FDA's plans to incorporate more science into its regulatory oversight. At that time, the industry had just been introduced to the concepts of the new risk-based initiative, and Pharm Tech received regular inquiries about "this PAT we keep hearing about." Companies complained that good science was being suppressed by strict adherence to traditional processing and analytical methods. "Alternative" methods were definately discouraged, even if it was well known that the technologies were more efficient. I had my doubts about the agency's promises to let good science lead the lead to greater regulatory flexibility.Now I'm happy to eat my words. Read more

Normally, I don't think much about research and development. I usually leave that subject to our sister magazine, Applied Clinical Trials. I do think about patient safety, though, and today an announcement on the website of the US Department of Health and Human Services (DHHS) got my attention.DHHS's Office for Human Research Protections (OHRP) is soliciting public comment about a proposal to issue guidance recommending training for personnel who conduct, review, or oversee human clinical trials. I was surprised that such training was not already formalized.When I read a little more, I was even more surprised. Read more

The Japanese pharmaceutical company Daiichi Sankyo’s pending move to buy a controlling stake in the Indian pharmaceutical company Ranbaxy Laboratories for up to $4.6 billion took a rocky turn this week. Read more

When I was in school, HIV/AIDS education was part of the health curriculum. I sat with my middle-, and then, high-school classmates and we learned about AIDS prevention, wore red ribbons, watched the made-for-TV movie The Ryan White Story, and attended school-wide AIDS awareness presentations by people living with HIV. All the time knowing scientists were hard at work finding a cure. Read more

Last week, I blogged about FDA’s requirement to add black-box warnings to certain antibiotics such as "Levaquin" and other flouroquinoline antimicrobial-based drugs. We were inundated with reader responses as many patients have had adverse reactions to these antibiotics leading to serious tendon rupture and tendonitis.

On July 10, an FDA advisory committee considered adding black-box warnings to certain epilepsy medications due to reported suicidal thoughts and behaviors associated with those drugs.
Read more

Regardless of how much I may agree with the general objectives of a professional organization, there are times when I just have to question the effectiveness of its tactics. Last week, the Pharmaceutical Research and Manufacturers of America revised its PhRMA Code on Interactions with Healthcare Professionals. The document is an updated list of the original 2002 edition describing what constitutes as the "highest ethical standards" for pharmaceutical marketing professionals when communicating with healthcare providers. Read more

Success can be a mixed blessing, as the pharmaceutical industry well knows. Drug companies have prospered by developing and marketing new medicines that improve patients' lives. But the industry's impressive profits also bring public scrutiny and criticism. Sometimes the criticism is warranted, sometimes it's unwarranted. Read more

“If you can’t beat them, join them,” is the operative phrase for describing the business model for the newly launched company, Enlight Biosciences. Funded by Merck & Co., Pfizer, Eli Lilly, and the Boston-based venture capital firm PureTech Ventures, Enlight Biosciences’ plan is to be a collaborative entrepreneurial engine for drug discovery and development. Read more