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Quality by Design: A Regulatory Initiative No More?


A speaker at last week’s AIChE annual meeting joked about the nitty-gritty, technical nature of the conference’s Quality by Design topical track. QbD talks at some shows are a bit like Las Vegas, he said—more superficial than substantial—whereas at AIChE they were “more like M.I.T.”

From 'On Pharma'

Can a Cannabis-based Drug Gain Approval in the U.S.?


While there is increasing acceptance of the idea of cannabis-based drugs and the use of marijuana for medicinal purposes (particularly in California), there is still political resistance across much of the U.S. Britain's GW Pharma continues to push ahead with Sativex, which was approved in Canada five years ago for neuropathic pain associated with MS. MHRA has now also approved its use related to spasticity in MS patients (see press release in italics below).

From 'On Pharma'

Lilly: Breaking Down Silos in Building 88


Eli Lilly announced that it will be moving 1,000 key employees from its (leased) Faris facilities in Indy to its (owned) downtown corporate center, where it is renovating Building 88 and establishing its Development Center of Excellence, aimed at getting drugs to market faster.

From 'On Pharma'

View from Academia: "Scale Is Not Going to Do It" for Pharma's Future


University of Pennsylvania's Wharton School regularly publishes insights into how the pharmaceutical industry is faring, and its most recent article is the naively titled, "Rx for the Pharmaceutical Industry: Focus on Innovation, Not Marketing." As you'll read, the article does not offer any revelations, but affirmations that the blockbuster model is dead and that marketing practices will have to change.

From 'On Pharma'

An Indictment of Scientists: The Drug Development Challenge is Productivity, Not Funding


Are we spending our drug development dollars wisely? It's not a new debate, but a new study from U.S. medical researchers suggests no. Industry funding of drug R&D is aligned with the needs of high-income countries, the report says (no big surprise), and that funding is not producing the results we should all expect.

From 'On Pharma'

Have Microreactors Made the Mainstream?


Drug manufacturers have had their eyes on micro-scale flow reactors and related technologies for some time now. (Here’s a big picture overview of microreactors in pharma from several years back, and here’s one discussing the benefits of microreactors vs.

From 'On Pharma'

Pfizer's Wicks: “We are beginning to move into the unsustainable cycle."


The above is a quote from Pfizer's Steve Wicks, VP of Worldwide Pharmaceutical Sciences, as told on Nature's "The Great Beyond" blog. We've heard about the end of the blockbuster era and the need for the industry to remake itself, but I find Wicks' phrasing of it intriguing.
--PWT

From 'On Pharma'

Who Is Manufacturing the H1N1 Vaccine?


It's a matter of weeks now until we begin to see: a) to what degree the H1N1 pandemic will again ramp up; b) which manufacturers will have developed vaccines in time to address the need; and c) if those vaccines will work against the dominant strain that develops.

From 'On Pharma'

Cancer Drugs: Are Manufacturers Still Dedicated to "Finding a Cure"?


In its ongoing series of articles about the struggle to defeat cancer, the New York Times yesterday chronicled Pfizer's headlong dive into the cancer drug market. There are two major trends that are pushing Pfizer and other manufacturers to invest heaviliy in oncology.

From 'On Pharma'

Is Swine Flu Vaccine Development Schedule "Immutable"?


An excellent article from the Center for Infectious Disease Research and Policy (CIDRAP) outlines the key hurdles in developing a swine flu vaccine and quotes WHO and CDC authorities as saying that any acceleration of development is unlikely, thanks to myriad hurdles and challenges, particularly the inefficiency of producing seed strain via embryonated chicken eggs.

From 'On Pharma'