All GLG News Analyses Filed Under: Infectious Disease

Frank MalinoskiPresidentTD Consultancy, LLC

GSK Boost an indication of Merck's Deeper Problem?

August 20, 2009

Analysis of:Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply Vaccine Approved as a Hib Booster Dose | www.fda.gov

 The Hib vaccine shortage that began in 2007 when Merck voluntarily recalled PedVAXHib and COMVAX Hib products, has resulted in inadequate immunization of children (recommendation to stop 4th dose) Clusters of disease have been reported since the shortage began The accelerated approval of GSK's Hib vaccine for booster will help prevent the return of this deadly disease

Frank MalinoskiPresidentTD Consultancy, LLC

Top Line Is Not Enough

August 19, 2009

Analysis of:Sinovac Reports Top-Line Preliminary Results of H1NI Vaccine Clinical Trials | www.pipelinereview.com

This seemly positive news is incomplete and cannot be analyzed properly until greater detail regarding the formulation, trials, subjects, and results are made available publicly. 

How much store to put on Sinovac press release?

August 4, 2009

Analysis by: GLG Expert Contributor

Analysis of:Sinovac Provides Update On Clinical Trial For H1N1 Vaccine Trials | www.medicalnewstoday.com

In their press release Sinovac don't make any mention of their swine flu vaccine trial design or how the vaccine is madeAccording to their dates, they started their clinical trial on exactly the same day as CSL in Australia, which would if correct place them equal second in the race to the clinic with Australian company Vaxine Pty Ltd, with which I am associated, coming a clear first by 2 days using recombinant protein technology developed by US company Protein Sciences Corporation!

Sex - we can chemically get it up and now last longer?

August 2, 2009

Analysis by: GLG Expert Contributor

Analysis of:Sciele Pharma And Plethora Solutions Announce Positive Results Of Final Phase III Pivotal Trial For PSD502 For Premature Ejaculation | www.medicalnewstoday.com

?? breakthrough

Frank MalinoskiPresidentTD Consultancy, LLC

Pandemic Influenza Vaccine for 2009: More to Consider

July 31, 2009

Analysis of:CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1 | www.cdc.gov

  1.  ACIP recommends 5 target groups & prioritization if shortage occurs 2.  Elderly will be added once vaccine supply for other groups is established. 3.  5 companies are supplying H1N1 vaccine:  CSL, Novartis, sanofi-Pasteur, GSK, and MedImmune, AstraZeneca 4.  Supply in September is unrealistic. 5.  FDA approval will not require clinical data except for MedImmune. 6.  Use of adjuvants will require clinical data & may use of emergency use.

A useful advance

July 28, 2009

Analysis by: GLG Expert Contributor

Analysis of:Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today | www.medscape.com

This test will enable quicker diagnosis of C. difficile colitis in suspicious cases, thus allowing more timely and appropriate therapy

Rush to production

July 28, 2009

Analysis by: GLG Expert Contributor

Analysis of:Swine-Flu Vaccine Production Hits a Snag | online.wsj.com

The current vaccine-manufacturing process is time consuming and cumbersome, as is the pre-licensing clinical study process.

Clostridium difficile PCR-based test may gain quick adoption

July 26, 2009

Analysis by: GLG Expert Contributor

Analysis of:Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today | www.medscape.com

 The FDA has approved a new assay which utilizes the GeneXpert platform and detects Toxin B DNA in less then an hour. The test is very sensitive and specific, and allows precise use of appropriate anti-C. diff. antibiotics early in care. 

A GREAT STEP FORWARD IN RX OF C.DIFFICILE

July 25, 2009

Analysis by: GLG Expert Contributor

Analysis of:Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today | www.medscape.com

A new test was approved by the FDA for the B toxin of C. difficile which caused severe diarrhea and dehydration. The test is 93% sensitive and 94% specific and only takes 45 minutes to complete versus the gold standard culture which takes 3 days.

A Difficult Pathogen Meets its Match

July 23, 2009

Analysis by: GLG Expert Contributor

Analysis of:Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today | www.medscape.com

C. difficile is one of the most pervasive hospital-acquired pathogens. Existing techniques for detecting C. difficile are fraught with problems, including a high incidence of false negatives and false positives. PCR-based testing is a game-changer because it practically eliminates false negatives. Thus, the added cost of PCR testing is recouped many times over.

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