Biologics

Five things for pharma marketers to know: Thursday, April 2

Five things for pharma marketers to know: Thursday, April 2

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Celltrion expects its Remicade biosimilar to hit the US this year; Vivus cuts its sales force; BMJ accuses Novartis of interfering with clinical trials

Doctors want specifics on biosimilar labels

An Alliance for Safe Biologic Medicines survey shows what doctors mean by biosimilar transparency.

Biosimilar uptake will require companies to tell a trustworthy backstory

Biosimilar uptake will require companies to tell a trustworthy backstory

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Reactions to the first biosimilar approval show that marketing and education will be essential for the new category to take market share.

FDA hands Amgen a biosimilar competitor

FDA hands Amgen a biosimilar competitor

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The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.

Tufts: biosimilars will not be an instant hit

A study by the nonprofit research group found resistance to drug switching.

Five things for pharma marketers to know: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

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Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.

Pfizer's Hospira deal shores up established product division

Pfizer's Hospira deal shores up established product division

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Pfizer said the $17-billion decision to acquire Hospira will not affect the timeline of its divide-or-stay-whole decision.

Five things for pharma marketers to know: Wednesday, February 4

Five things for pharma marketers to know: Wednesday, February 4

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One in three adults would rather not take a pill and have a shorter life span; Pfizer's next-gen breast-cancer drug nabs an early approval; Amgen's Humira biosimilar demonstrates clinical equivalence.

Novartis psoriasis drug approval could upend market

Novartis psoriasis drug approval could upend market

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A novel psoriasis treatment approved today, which demonstrated superiority to TNF inhibitors, could unseat entrenched competitors like Amgen's Enbrel and J&J's Stelara.

Five things for pharma marketers to know: Monday, January 5

Five things for pharma marketers to know: Monday, January 5

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Severe flu season to test Roche's Tamiflu; Novartis gains nod for psoriasis drug; Amgen and Kite collaborate on immunotherapy.

MM&M's top reads of 2014

MM&M's top reads of 2014

A look at the content that grabbed most reader interest over the past year.

FDA plans review of Sandoz's Neupogen biosimilar

As courts sort out lawsuits over two Sandoz biosimilars, the Novartis unit reports a study showing its BLA candidate has similar efficacy to Neupogen.

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.

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