Biography for Carly Helfand
Carly Helfand, News Editor
Carly Helfand is a news editor with Fierce's life sciences group, writing for FiercePharma, FiercePharmaMarketing and FierceVaccines. Carly got her start covering pharma while earning her master’s at Northwestern University’s Medill School of Journalism, where she concentrated in business reporting. She has completed journalism projects on four continents, and her work has appeared in various outlets such as The Boston Globe, The Washington Post’s “Wonkblog” and Cape Town’s Weekend Argus. Carly prefers watching pro hockey to nearly everything. She also plays the Irish fiddle. You can contact her at firstname.lastname@example.org and follow her on Twitter at @CarlyHFierce.
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Articles by Carly Helfand
Earlier this month, U.K. politicians asked Prime Minister David Cameron to explain why Novartis' Bexsero, approved as an addition to the country's childhood immunization schedule 8 months back, had yet to be covered by the National Health Service. Now, Cameron has asked Health Secretary Jeremy Hunt to do the same--and Hunt is pointing the finger at the Swiss pharma.
As Pfizer's Trumenba rolls out in the U.S., it may get a head start on Novartis' Bexsero, which is still awaiting FDA approval. But the drug giant still doesn't yet have what it needs to build a considerable lead: a recommendation from the CDC's Advisory Committee on Immunization Practices.
Ongoing price negotiations between the U.K. government and Novartis have so far kept the meningitis B vaccine Bexsero out of the public's reach, and now members of Parliament are asking where it is.
Analysts have said Sanofi's dengue vaccine, once approved, could rake in €1 billion, or $1.31 billion, a year. According to a report from Brandeis University, the number of dengue cases in the India is almost 300 times higher than government figures.
It's been a long road for Shan5, the low-cost pentavalent from Sanofi-owned Shantha Biotechnics. Now, after manufacturing tie-ups four years ago cost the company a $340 million contract to supply the vaccine, it's finally rolling out the product in India.
Ever since Dendreon's lackluster Provenge launch, the Washington-based biotech's failures have cast a pall over the troubled cancer vaccine field. And the company's bankruptcy won't help with that.
Expanded results from Sanofi's Latin American Phase III dengue vaccine trial are here, and the pharma giant says they confirm the high efficacy against severe dengue and the reduction in hospitalization the jab posted in its first Phase III study. And with these in tow, the company says it could have the vaccine to market by the second half of next year.
A couple of flu vaccine makers have new patient populations to target, thanks to a pair of recent FDA approvals in older adults.
Right now, the U.S. government is in search of an H7N9 vaccine that can reach the market to help prevent against a potential pandemic. And a new FDA fast-track designation for Novavax's candidate might help it get there a little sooner.
The SEC is investigating whether officials at the Center for Medicare and Medicaid Services tipped off a policy research group about the agency's review of Dendreon's cancer vaccine, Provenge, The Wall Street Journal reports.