Biologics

Amgen releases Humira biosimilar data

The company says ABP 510 hit its primary endpoint in an adalimumab comparison.

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

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Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

Investors want end to biosim trash talk

A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.

Senators ask FDA for biosimliar naming rules

Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.

Sandoz wades into Humira biosimilars

The generics maker says an adalimumab biosimilar would anchor its immunology portfolio.

Calif. governor vetoes biosimilars bill

The governor says it is too early to legislate on drugs the FDA is still deliberating over.

Rampant dissatisfaction with psoriasis drugs: study

Rampant dissatisfaction with psoriasis drugs: study

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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.

GA101 looks more like a franchise-extender for Roche

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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.

Roche's son-of-Rituxan scores priority review

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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.

EU backs Remicade biosimilars; anti-TNFs at risk

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CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.

Study shows old-school meds as effective as Enbrel

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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.

AbbVie reports first-ever quarter, downplays Pfizer impact

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Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.

Europe halts Xeljanz progress

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European regulators said they're not satisfied that the information they have on hand is enough to let the drug go forward.

Pharmas to biotechs: let's make a deal

Pharmas to biotechs: let's make a deal

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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.

Amgen sales up for the quarter, but biosimilars grab buzz

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Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars.

Business Briefs: AstraZeneca, Amgen, BMS and Merck

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.

Recall rebound boosts J&J quarterly results

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Sales hit $17.5 billion, an 8.5% increase compared to the same period last year.

Business briefs: Chandler Chicco, Pfizer, FDA, Dainippon, CDC

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.

Business Briefs: Novo, FDA, Biologics

Novo's weight-loss news fails to lift investor mood; GAO wants FDA to do more biologics topped 2012 sales.

Business briefs: Élan, Teva

A buyout offer upsets Elan's post-Tysabri plans, Takeda and Affymax recall Omontys.

"I just want to say one word to you: biologics"

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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

FDA nods for Teva, J&J signal pipeline progress

FDA nods for Teva, J&J signal pipeline progress

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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.

Branded Benlysta DTC campaign ready to roll out

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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?

GSK, HGS cleared to launch lupus drug with unrestricted label

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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.

Generic Lovenox drags down Sanofi sales

Generic Lovenox drags down Sanofi sales

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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 deploys up to 1,000 reps on Prolia approval

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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.

What's behind Humira's bullish forecast?

What's behind Humira's bullish forecast?

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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.

FDA says competing biologic ads both misled

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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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