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The Real Test for Gardasil: Money, not Morals

 
• By Kate Rawson

The real test for Gardasil isn't FDA approval or the Advisory Committee on Immunization Practices' recommendation for universal vaccination. In the long run, Gardasil's commercial success will be depend more on the future of the Vaccines for Children Act--and how long the government wants to continue to sign blank checks for childhood vaccinations.

Merck & Co. Inc. ’s human papilloma virus vaccine Gardasil sailed through FDA’s Vaccines and Related Biological Products Advisory Committee during a May 18 review. Despite lingering questions about whether HPV causes cervical cancer—generally an undisputed scientific finding—the committee unanimously recommended FDA approval of the three-dose vaccine series in female patients 9 to 26 years of age.

Now all eyes are on the Centers for Disease Control & Prevention’s Advisory Committee on Immunization Practices’ final review of...

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‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

More from Pink Sheet

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 
• By Sarah Karlin-Smith

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.