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breakthrough designation

This page shows the latest breakthrough designation news and features for those working in and with pharma, biotech and healthcare.

BMS unveils long-term results for Opdivo in kidney cancer

respectively. Initial results from the CheckMate-025 study formed the basis of an FDA breakthrough designation for Opdivo in this setting, and the subsequent approval for the checkpoint inhibitor in advanced

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Clovis leapfrogs PARP rivals, filing Rubraca for prostate cancer

All three of the PARP inhibitors have been awarded a breakthrough designation from the FDA in prostate cancer, reflecting the urgent need for new therapies to treat the disease.
GSK files anti-BCMA drug for myeloma after second trial win

The ADC has been given a breakthrough designation by the FDA as well as PRIME designation from the EMA in Europe.
J&J and Bristol-Myers Squibb/Bluebird bio reveal rival CAR-T data

J&J’s CAR-T candidate – JNJ-4528 – impressed at the conference, as well as at the FDA, so much so that the drug has been granted a breakthrough therapy designation
Y-mAbs files breakthrough neuroblastoma drug in US

The Danish/US biotech is using the FDA’s rolling Biologics License Application (BLA) process to file naxitamab, an anti-GD2 antibody that has a breakthrough designation from the US regulator
Roche’s Tecentriq/Avastin combo improves survival in liver cancer

Merck is testing Keytruda alongside partner Eisai’s kinase inhibitor Lenvima (lenvatinib) – already-approved for first-line HCC – in the Leap-002 trial, picking up a breakthrough designation from the FDA

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Latest Intelligence

Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019

Nine US, four EU and one Japanese Orphan Drug designation. Four US Breakthrough Therapy designations. ... This determination may mean that instead of expedited review because of AR-101’s Breakthrough Therapy designation, the filing may be given a
Drug launches to watch in 2019

Analysts say the market could eventually be worth $4.8bn annually. The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy ... Upadacitinib is already in a phase 3 trial in
Bluebird Bio: on the cusp of a gene therapy revolution

Bluebird’s four breakthrough candidates. In addition to the two LentiGlobin-based treatments, the company also has its Lenti-D product for patients with cerebral adrenoleukodystrophy (CALD), a rare, serious and ... There is no question that these
Deal Watch February 2017

IMMU-132 has FDA Breakthrough Therapy designation for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and also has Fast Track status and orphan designation
Deal Watch January 2016

32, 000. Seres Therapeutics/ Nestle Health Science. Collaboration. Rights to market products including SER 262 (p1 for Clostridium difficile), 287, 301 and 109 (SER 109 has breakthrough therapy designation); includes $120m

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