Analysis of:
FDA Advisers Endorse Childhood Vaccine (users1.wsj.com)
- Pentacel is Sanofi's entry into the new multiple-antigen market- The space is already occupied by Glaxo's Pediarix, which covers almost the same diseases but was approved in the US 2 years ago.- There's room for both, but both will need successors as desire grows for a single all-in-one "supershot"...
Analysis of:
FDA Approves New Indication for Yaz to Treat Acne (www.pharmalive.com)
- Several OCPs are approved for use to treat acne; the first (Ortho Tri-Cyclen) was approved for this indication in 1997. In addition, most OCPs using the newer progestins have the same effect, even if not specifically labeled for this use.-Yaz and its parent compound Yazmin are and will remain very...
Analysis of:
New Vaccine for Cervical Cancer Could Prove Useful in Men, Too (www.nytimes.com)
- Gardasil, approved for females age 9-27 for prevention of HPV, has been tested overseas in males to prevent the same virus from causing anal cancer.- The FDA is unlikely to get the chance to approve Gardasil for this indication because Merck is unlikely to do the research that proves whether or not...
Analysis of:
Vaccine Makers Receive Immunity From the U.S. (online.wsj.com)
-Action was taken this week to remove the potential of lawsuits over side effects from drug companies developing avian flu vaccines-This is one of the few inducements that Washington can give that matters to pharmaceutical makers that may encourage them to either get into research for flu drugs or to...
Analysis of:
Texas governor orders anti-cancer vaccine for schoolgirls (www.usatoday.com)
-HPV vaccine is a groundbreaking advance in cancer prevention. As states realize that mandating its use will save dollars in cancer treatment starting in the next 10 years, it will be required more and more (thank goodness!)-Insurance companies and individuals, not individual state governments shoulder...
Analysis of:
FDA Approves MedImmune's Refrigerated Formulation of FluMist (phx.corporate-ir.net)
- MedImmune's FluMist has been approved in a new form that will allow storage in a standard medical refrigerator for next flu season (the current product must be stored in a cumbersome box in a freezer).-Along with the pending application for age down to 1 year, FluMist's prospects are improving.
Analysis of:
New River Pharmaceuticals And Shire Receive Approvable Letter For VYVANSE™ (lisdexamfetamine Dimesylate) For The Treatment Of ADHD (www.medicalnewstoday.com)
-Vyvanse, a novel prodrug for ADHD will be approved in the next few months according to both its developers and the FDA. -Shire and New River had been hoping for relaxed "scheduling" compared to traditional stimulants.-The DEA is unlikely to go along with this and is leaning...
Analysis of:
Retail Medical Clinics Draw Patients & Payers (www.managedcaremag.com)
Retail Medical Clinics (RMCs) will succed where they have a perceived advantage over a physician's office in price, wait time, or in furthering a patient's agenda. If they offer a no-wait visit for a sore throat while a spouse shops at Wal-Mart, many will be likely to use them. The...
Analysis of:
New Study Supports Low Abuse Potential Of Leading ADHD Medication, CONCERTA® (methylphenidate HCl) (www.medicalnewstoday.com)
Concerta's low(er) abuse potential vs. straight Ritalin is well-known. At its introduction several years ago this was a big selling point, as it was the only approved ADHD drug that was hard to crush and sniff.As other harder-to-abuse drugs come to market (Shire has one that is awaiting approval)...
Analysis of:
FDA approves Zostavax, Merck's new vaccine for preventing shingles in adults 60 and older (www.therapeuticsdaily.com)
-Zostavax is being touted as a "homer" by some in this thread. Although clearly beneficial, other more important vaccines that are supposedly "universal" are already routinely not given to a large fraction of the elderly.-Vaccines for special populations are only as universal as the care that delivers...