FDA draws fine line between health and wellness apps; Colorado gives biosimilar swap law another look; ZMapp is set to start human trials of its Ebola vaccine.
The committee is slated to rule on Sandoz's Zarzio Jan 7.
As courts sort out lawsuits over two Sandoz biosimilars, the Novartis unit reports a study showing its BLA candidate has similar efficacy to Neupogen.
The company says ABP 510 hit its primary endpoint in an adalimumab comparison.
Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.
A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.
A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.
Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.
Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.
Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.
A three-year, $1 million project seeks an equation for generics and biosimilars.
A London court knocked down two Roche/Genentech patents, making a clearer path for biosimilars of the breast cancer drug. The primary patent lapses in July.
Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.
A court in India ruled biosimilar drug makers will not be able to cite the drug's name, efficacy or safety profile in its marketing.
Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.
The generics maker says an adalimumab biosimilar would anchor its immunology portfolio.
Biogen Idec and JV partner Samsung are going into the biosimilars business.
Lantus-like rivals can expect a wary reception from endocrinologists, even if these biosimilars reach market, researchers predict.
The governor says it is too early to legislate on drugs the FDA is still deliberating over.
Biogen extend Isis relationship for six years and $100M; HHS readies healthcare reform TV push; Medivir ends hep. B clinical trial; FDA approves Celgene cancer drug; Baxter seeks Enbrel biosimilar
FDA is concerned state biosimilar legislation could make consumers uneasy about the category, J&J hands $75 million milestone payment for ibrutinib, Consumer Reports gets into drug apps
Medtronic buys up Cardiocom, Novo will file liraglutide to battle obesity, HHS navigates cutback and looks into anti-psychotic prescription rates, Amgen's Neulasta to compete against Teva's Lonquex.
Glaxo shakes up China division, Teva and Lonza break up their biosimilars pact, and FDA's breakthrough designation speeds review but not international and payer uptake.
The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.
The FDA's priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.
CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.
The drug maker says it expects to use the Phase III clinical trial data to back applications in the EU and the US (when it gets a pathway setup).
A cocktail of older meds works as well as Enbrel, a study found, but docs are already comfortable with prescribing the biologic and aren't likely to switch therapies.
Genentech's blockbuster follow-up shows promise in preliminary Phase III data
Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.
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