Hello, everyone. Nice to see you again. As promised, we have returned. We trust you had a pleasant and productive week while we were away. And we want to say thanks for the nice send-off notes so many of you posted. Much appreciated. As always, though, the time has now come to reach for that favored cup of stimulation as we gear up for another week. Here goes...
Glaxo Starts Final Clinical Trials For Shingles Vaccine (Reuters)
Roche Buys Imaging Company For $100 Million (SwissInfo)
Pfizer Tries To Remediate Former Upjohn Site (North Haven Citizen)
Archimedes Pharma Sets Up Shop (The Star-Ledger of NJ)
Genzyme Shareholder Sues To Block Deal That Hasn't Happened (Boston Globe)
Taiwan Seeks To Remove Non-Tariff Barriers To China (Focus Taiwan)
Jailed Psychiatrist Pleads Guilty Over Paxil Trials (Associated Press)
Primal Claims Regulatory Price Cut Fixed To Help Rival (Economic Times)
Merck Sues Impax Over Vytorin Patent (Allentown Morning Call)
Switching From Lipitor To A Generic Raises Risks: Study (Bloomberg News)
Lilly's ImClone Shuts Facility Affecting 140 Jobs (MyCentralJersey)
India's Prime Minister Renews Patent Debate (Business Standard)
Doctors Question Cost Of Herceptin (PharmaTimes)
Sweden Probes Glaxo Flu Vaccine And Narcolepsy (Agence France Presse)
4 Comments
As has been said beofre, "He's Baaaack!!" You were missed, Ed, but hopefully you had a great vacation.
Can someone please explain to me why a second shingles vaccine is under development, when the first one, Zostavax is doing so poorly? Or as Warden Norten said to Andy Defresne in the movie The Shawshank Redemption, "am I being obtuse?".
Would the new shingles vaccine be easier to use than the current one? If the new one is easier to use than it might be more popular than the current vaccine. Doctor's offices do not want to carry the vaccine here locally and some offices charge patients up to $70.00 in handling costs to store the vaccine for 24 hours (or less) in the required conditions before administration to the patient.
The current vaccine has special requirements that make it really difficult to handle and administer. These handling and administration requirements often add to out of pocket costs (nonreimbursable costs) for patients or the provider who administers the vaccine.
Anne is correct. These are the most convoluted handling instructions (Zostavax) that I have ever seen. Two roadblocks from my IND experiences with other temperature-sensitive drugs: 1) most doctors don't have refrigerators these days. For the most part these went out with autoclaves. 2) even when we supplied investigators with small refrigerators, it was virtually impossible to keep the temperature within prescribed limits, which were looser than for Zostavax. Out of 40 investigators we had an average of 170 temperature alarms go off/week. Ultimately we discontinued the study because we could not guarantee the stability of the drug product over the course of the study. With the constant expiry/re-supply activity, I felt like more of an air traffic controller than a medical monitor.
http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi.pdf