Breakthrough Therapy Designation

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


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


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


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


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


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


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


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

Business briefs: Takeda, Sangamo, Catalyst, plus seniors and insurance

Takeda moves an Alzheimer's treatment to Phase III; Sangamo acquires Ceregene; Catalyst gets breakthrough designation for auto-immune disorder drug; study says seniors likely to opt out of health insurance

Novartis breakthough designation hat trick


The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.

Business briefs: Glaxo, Teva, Johnson & Johnson

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.

GA101 looks more like a franchise-extender for Roche


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


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.

Business briefs: Arena, Takeda, Teva, Cubist

Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status.

Business briefs: Sanofi, Allergan, Otsuka, Genmab, NIH, Novartis, DOJ

Lantus cushions Sanofi's quarterly sales; Allergan holds back on Eylea competitor; FDA limits use of Otsuka drug; Genmab lands Breakthrough label; NIH finds a link among cancers; and Novartis offers lunch with a side of medical information; DOJ appeals Plan-B Ruling.

Business Briefs: Manhattan Research, KPMG, Scioderm and GSK

Health-seeking consumers continue social-media push; Scioderm scores FDA's "Breakthrough" designation for bullosa agent; and GSK files NDA for airway treatment.

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