FDA: Page 64
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Coherus cuts staff after FDA red light
The California-based company will lay off employees after getting handed a rejection from the FDA for its Neulasta biosimilar.
By Lisa LaMotta • June 28, 2017 -
Novartis scores second biosimilar approval in two weeks
With several biosimilar approvals in Europe and the U.S., Sandoz is poised to make inroads into the blockbuster immunology drug market.
By Barbara Boughton • June 28, 2017 -
FDA's first steps in drug competition plan: get more generics approved
The agency rolled out a new list highlighting branded medicines that lack generic competition and updated protocols so copycat drugs can move to market faster.
By Jacob Bell • June 28, 2017 -
SEC charges ex-Ariad employees with insider trading
Two former senior staffers allegedly sold company stock, or tipped relatives to do the same, ahead of announcements about Ariad's drug Iclusig.
By Ned Pagliarulo • June 28, 2017 -
Esperion locks down regulatory pathway for cholesterol combo
The company is mapping out a late-stage bridging study for a pairing of its bempedoic acid with ezetimibe.
By Jacob Bell • June 27, 2017 -
Clarus resubmits oral hormone therapy to FDA
The small biotech again filed its testosterone replacement drug for approval, with the hope that new data will clear a path to market.
By Jacob Bell • June 27, 2017 -
Despite setbacks, Portola snags FDA OK for Bevyxxa
Although the anticoagulant missed its endpoint in a Phase 3 study, Portola was able to secure FDA backing with a second analysis.
By Suzanne Elvidge • June 26, 2017 -
CHMP decisions: Novartis locks up backing for Kisqali
A key committee of the EU regulator also recommended approval for a liver cancer drug from Aveo Oncology.
By Ned Pagliarulo • June 23, 2017 -
FDA surprises with rejection of Pfizer's Epogen biosimilar
Manufacturing issues at a Kansas site tripped up approval of the copycat biologic.
By Ned Pagliarulo • June 23, 2017 -
FDA says yes to rapid-acting Rituxan
A thumbs-up from the FDA could help the Swiss pharma stave off a sales slowdown for its oncology and immunology drug.
By Suzanne Elvidge • June 23, 2017 -
Novo's Victoza wins backing of FDA panel on CV benefit
A vote in favor of Victoza's cardiovascular benefit moves the Danish drugmaker closer to winning an expanded label for the important GLP-1 drug.
By Suzanne Elvidge • June 22, 2017 -
Can too many safety warnings overwhelm consumers?
Two FDA experiments will test whether repetition of safety warnings in DTC ads negatively affects consumers’ attention to drug risks.
By Barbara Boughton • June 21, 2017 -
Shire's ADHD drug secures FDA OK
The Irish pharma expects to start commercializing Mydayis in the third quarter.
By Jacob Bell • June 21, 2017 -
Deep Dive
FDA targets regulatory 'gaming' to boost generic competition
While the FDA has no direct role in drug pricing, agency head Scott Gottlieb hopes his planned actions could help address rising costs — at least in part.
By Ned Pagliarulo • June 21, 2017 -
FDA approves new antibiotic for skin infections
Antibiotic drug development has lagged, even as mounting evidence of antimicrobial resistance points to an emerging and serious health threat.
By Ned Pagliarulo • June 20, 2017 -
Novartis secures fourth biosimilar approval in Europe
The Swiss pharma's Sandoz unit secured EU market authorization for a biosimilar version of Roche's Rituxan, highlighting the growing threat to Roche's top sellers.
By Suzanne Elvidge • June 20, 2017 -
FDA
Hospira recalls add to drug shortages
The Pfizer subsidiary is recalling a number of drug products, potentially exacerbating drug shortages for key products like injectable sodium bicarbonate solution.
By Suzanne Elvidge • June 19, 2017 -
Prescribed Reading: ADA, Mylan, and an executive order?
The SGLT-2 category heats up at ADA, Mylan faces pressure from all sides, and President Trump might put his stamp on drug pricing.
By Lisa LaMotta • June 16, 2017 -
FDA chief Gottlieb maps out new digital health plan
The agency's plans could include a pilot program for third-party certification of low-risk digital products, aimed at laying out a faster path to market.
By Suzanne Elvidge • June 16, 2017 -
Bristol-Myers Squibb recalls mislabeled Eliquis medications
One lot of the blood thinner Eliquis distributed nationwide included bottles with 2.5 mg tablets, mislabeled as Eliquis 5 mg.
By Barbara Boughton • June 15, 2017 -
FDA
FDA approves Teva's generic copy of Truvada
But Gilead's patent defenses and a legal settlement mean it is not clear when a lower-cost version of the HIV prophylactic might launch in the U.S.
By Barbara Boughton • June 14, 2017 -
Pfizer, Roche, Aspen under investigation for cancer drug pricing
South African's Competition Commission is looking into the "excessive pricing" of Herceptin, Xalkori and a few generic medications.
By Jacob Bell • June 14, 2017 -
Despite CV benefit, Amgen still facing challenges over Repatha cost
Cost-effectiveness watchdog ICER plans to issue a lower value-based price benchmark for Repatha as part of an update to its 2015 review of the PCSK9 class.
By Suzanne Elvidge • June 14, 2017 -
Coherus' Neulasta biosimilar knocked back by FDA
The regulator's complete response letter left the California biotech's stock reeling, setting back hopes for a 2017 approval and launch of the copycat biologic.
By Suzanne Elvidge • June 13, 2017 -
A new wave of gene therapies ready to hit US shores
After decades of setbacks, a slew of next-gen gene therapies are ready to hit the U.S. market, prompting questions about manufacturing and pricing.
By Malorye Allison Branca • June 12, 2017
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