Breakthrough Therapy Designation

Roche sclerosis drug granted Breakthrough Therapy status

Roche's Actemra is already approved for three forms of arthritis.

Study: 10 medications will cost US $50 billion over 10 years

Study: 10 medications will cost US $50 billion over 10 years

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An analysis by Avalere Health says 10 breakthrough therapy drugs will account for billions in spending.

FDA grants Breakthrough status to Niemann-Pick drug

Genzyme's experimental enzyme-replacement therapy olipudase alfa is being investigated for the Type B form of the condition.

AbbVie leukemia drug gets breakthrough status

AbbVie expected to submit chronic lymphocytic leukemia drug venetoclax to the FDA this year.

FDA grants Pfizer lung-cancer drug Breakthrough Designation

Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.

Bristol-Myers Squibb's Opdivo lassoes lung-cancer indication

Bristol-Myers Squibb's Opdivo lassoes lung-cancer indication

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The FDA granted the drug Priority Review status just last week.

Five things for pharma marketers to know: Wednesday, February 11

Five things for pharma marketers to know: Wednesday, February 11

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BMS loses breakthrough therapy status, Gilead's pricing comes under fire in Europe, and pharma fights Italy's off-label Avastin use.

FDA rescinds Merck HCV therapy's Breakthrough Designation

FDA rescinds Merck HCV therapy's Breakthrough Designation

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The drugmaker announced in its earnings call Wednesday that the FDA has rescinded the company's Breakthrough Therapy designation, which could delay Merck's HCV doublet therapy launch from early to mid-2016.

Pfizer urges parents to take the pledge against meningitis

Pfizer urges parents to take the pledge against meningitis

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Pfizer has kicked off a disease-awareness campaign, "Take Action Against Meningitis," urging parents to discuss vaccinations with their healthcare providers with paralympic snowboarder Amy Purdy.

FDA 2014 approvals outpace those of 2013

FDA 2014 approvals outpace those of 2013

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The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.

FDA approves Amgen leukemia immunotherapy

Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.

Five things for pharma marketers to know: Monday, November 24

Five things for pharma marketers to know: Monday, November 24

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BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.

Regeneron's Eylea scores Breakthrough label

The designation is for diabetic retinopathy for patients with diabetic macular edema.

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA labels AbbVie hep C drug Breakthrough

The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.

BMS, AbbVie land Breakthrough label

The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.

Latest Breakthrough nod goes to Novartis

The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

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The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Daclatasvir combo gets Breakthrough status

The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.

Tufts: Breakthrough Therapy progress TBD

Tufts: Breakthrough Therapy progress TBD

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Researchers say it's too early to declare the 2012 program a success but that the label will benefit drugs beyond those with orphan status.

UK seeks own Breakthrough Therapy program

Reports are that the UK wants an expedited process that will mirror the FDA's.

GSK's Taflinar pockets breakthrough label

It was granted based on data among patients with BRAF V600E mutation-positive non-small lung cancer who have undergone chemo.

FDA's 2013 so far: 26 approvals

FDA's 2013 so far: 26 approvals

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The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.

FDA greenlights Gilead's sofosbuvir

FDA greenlights Gilead's sofosbuvir

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The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.

FDA approves Imbruvica (ibrutinib) for MCL

FDA approves Imbruvica (ibrutinib) for MCL

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The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.

Gazyva's nod gives Roche a Rituxan successor

Gazyva's nod gives Roche a Rituxan successor

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The regulator approved the CLL medication Friday, giving the drugmaker time to create a marketing transition before Rituxan goes generic. The approval marks another milestone: the first drug approved with a Breakthrough Designation label, a tag that is now coming under scrutiny.

Business briefs: Merck, AbbVie, Roche, plus new FDA device rule

Complete Response letter slows Merck's suggamedex; AbbVie looks for next Humira; Roche drug gets breakthrough label; FDA effort to better track medical devices

Business briefs: Boehringer Ingelheim, Sanofi, GSK, Teva

BI cancer drug lands breakthrough therapy designation; Sanofi tallies two European MS drug approvals; GSK terminates testing for a Crohn's drug; and Teva joins cancer collaboration

FDA expedites two GlaxoSmithKline treatments

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GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.

Business briefs: Biosimilars, Johnson & Johnson, Consumer Reports

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

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As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.


The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.