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.
Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.
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.
The generics maker says an adalimumab biosimilar would anchor its immunology portfolio.
The governor says it is too early to legislate on drugs the FDA is still deliberating over.
Sales may be rising, but a new study finds current psoriasis therapies leave room for improvement. Over half of patients said they want better options.
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.
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.
Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.
European regulators said they're not satisfied that the information they have on hand is enough to let the drug go forward.
Having finally accepted that external R&D is the future, big pharmas are snapping up earlier-stage biotechs and biologics, but they're not betting the farm on them, thanks to pre-nup-like earnout deals.
Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars.
AstraZeneca cuts a deal with OCB to test unnamed cancer drug; an Enbrel biosimilar launches in India; BMS and Santaris seal an mRNA tech deal; Merck expands its China presence; Alzheimer's advocacy group parents a spin-off.
Sales hit $17.5 billion, an 8.5% increase compared to the same period last year.
Gwee exchanges Edelman offices for Chandler Chicco's, Pfizer can't shake Celebrex lawsuits, FDA issues draft guidance for biosimilars meetings, Dainippon Sumitomo acquires Edison Pharmaceuticals, CDC reports on growing ADHD diagnoses.
Novo's weight-loss news fails to lift investor mood; GAO wants FDA to do more biologics topped 2012 sales.
A buyout offer upsets Elan's post-Tysabri plans, Takeda and Affymax recall Omontys.
Biologics are making their way through the FDA approval process at a much faster clip than small molecule drugs these days, and just might unclog pharmas' slow-moving pipelines
The FDA gave green lights on two drugs days before the long weekend, and Novartis said Phase III COPD trials are shaping up to lead to regulatory filings.
New online and print DTC advertising targeting US patients with lupus will appear "within weeks," said executives from Human Genome Sciences. Can the campaign revive blockbuster fortunes for Benlysta?
When co-marketers Human Genome Sciences and GlaxoSmithKline launch newly approved lupus drug Benlysta later this month, reps will be able to tout a broad label.
Sanofi-Aventis said US sales of anti-thrombotic Lovenox were cut nearly in half by the launch of generic competition, an indication hospitals are showing little hesitation in using the copycat version.
Amgen has deployed "500 to 1,000" reps in support of Prolia (denosumab), a biologic osteoporosis treatment that received FDA approval on June 1. The drug was approved in the European Union on May 28.
A report predicting that Humira will become the world's biggest product in two years' time generated positive news for the Abbott Labs arthritis drug. Several factors are driving the bullish forecast.
One is a sales aid, and one is a consumer brochure, but both ads -- for CSL Behring's Zemaira and for Talecris' Prolastin -- are false or misleading, FDA said in a pair of untitled letters.
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