FDA: Page 69
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FDA
Control over production data still tripping up foreign drug manufacturers with FDA
Warning letters sent to two drugmakers in India and China show a lack of data controls and failure to investigate test results are still common problems with foreign suppliers.
By Ned Pagliarulo • March 23, 2017 -
FDA bans Divi's Labs plant, dealing another blow to India's quality credibility
Efforts by the Indian drugmaker to right manufacturing violations clearly haven't been enough to keep it off the agency's bad side.
By Jacob Bell • March 23, 2017 -
Who stands to benefit from Mylan's EpiPen recall?
A voluntary recall of Mylan's EpiPen could mean trouble for the drugmaker and a boon for its competitors.
By Suzanne Elvidge • March 23, 2017 -
Trial restart approval brings back DMD hope for Akashi
The biotech rejoins the ranks of companies following the rocky road of drug development for Duchenne muscular dystrophy.
By Suzanne Elvidge • March 23, 2017 -
PTC comes under fire from Congress for Emflaza
After buying the embattled drug, PTC is now getting inquiries about how it intends to price the DMD treatment.
By Lisa LaMotta • March 22, 2017 -
Esperion says FDA okay with approval path for key drug
Amgen's FOURIER results had sunk Esperion's stock Friday. But clarity on the regulatory path for the biotech's cholesterol drug has investors feeling chipper.
By Suzanne Elvidge • March 21, 2017 -
Prescribed Reading: CRISPR, Trump and FOURIER. Oh my!
CRISPR technology is moving into new therapeutic areas; we finally know the skinny on Repatha's CV effects; and potential budget cuts could hammer the industry.
By Lisa LaMotta • March 17, 2017 -
Seres rekindles once-failed microbiome study
Under the FDA’s direction, the microbiome pioneer hopes its redesigned trial for a therapeutic treating C. diff. qualifies as a pivotal study.
By Judy Packer-Tursman • March 17, 2017 -
FDA hands AstraZeneca's ZS-9 another setback
The agency issued a complete response letter to AstraZeneca for its hyperkalemia drug, giving it a second rejection.
By Jacob Bell • March 17, 2017 -
FDA warns of Viberzi pancreatitis risk
Allergan's irritable bowel syndrome drug gets slapped with a safety warning.
By Suzanne Elvidge • March 17, 2017 -
Trump budget to cost pharma industry
The budget proposed by the Trump administration cuts funding to HHS and NIH, while increasing fees for companies to the FDA.
By Lisa LaMotta • March 16, 2017 -
FDA advisory panel votes against Endo's opioid painkiller
After the panel concluded the risks associated with Opana ER outweigh its benefits, the FDA will now have to decide what reforms to take for the prescription opioid.
By Jacob Bell • March 15, 2017 -
CBO: 24 million more uninsured by 2026 under AHCA
The score of the ACA replacement bill from the Congressional Budget Office was worse for the GOP than many expected, but Republicans responded by saying the report was flawed.
By Shannon Muchmore • March 14, 2017 -
Novartis locks up Kisqali approval, eyes Pfizer's lead
With approval of its CDK 4/6 inhibitor, Novartis hopes to catch Pfizer's Ibrance in a soon-to-be hotly contested field.
By Ned Pagliarulo • March 13, 2017 -
Deep Dive
Investors have high expectations for cannabinoids
The pipeline is moving forward for cannabis-mimicking pharmaceuticals as investors' interest grows and new clinical data spark approval hopes.
By Jacob Bell • March 13, 2017 -
FDA puts partial hold on Karyopharm's cancer drug
The pharma stresses that the FDA’s hold, while halting new patient enrollment until it’s lifted, is due to errors on written materials, not safety problems.
By Judy Packer-Tursman • March 12, 2017 -
FDA
Trump taps Scott Gottlieb to head FDA
The former FDA deputy commissioner, widely seen as a more traditional pick than other unorthodox names put forward, will likely push for deregulation and speedier review of drugs and devices.
By Ned Pagliarulo • March 10, 2017 -
Prescribed Reading: More backlash to drug pricing
Negotiating Medicare prices is now on the table, lawmakers are not happy with Marathon, and PTC is pushing back at the FDA.
By Lisa LaMotta • March 10, 2017 -
FDA
Radius shares slide after FDA delays decision on bone drug
In a surprise, the regulator extended its review of Radius' osteoporosis drug by three months, with a target action date now set for the end of June.
By Ned Pagliarulo • March 10, 2017 -
Nicox resubmits eye drug to FDA after manufacturing setback
Issues with an API contractor tripped up Nicox's new drug application for Zerviate last year. With that now resolved, Nicox hopes to win secure approval.
By Ned Pagliarulo • March 9, 2017 -
Trump 'enthusiastic' about drug price negotiation, lawmakers say
Two Democratic congressmen met with President Donald Trump yesterday to discuss a draft bill that would allow the government to directly negotiate prices with drugmakers.
By Ned Pagliarulo • March 9, 2017 -
GOP ACA bill has massive Medicaid changes, no CBO score
The bill still faces significant opposition, not only with Democrats but also Republicans who feel the tax credits are too generous, as well as some GOP governors who dislike the changes to Medicaid.
By Ana Mulero , Shannon Muchmore • March 8, 2017 -
Serenity wins FDA nod on frequent nighttime urination treatment
The company secured approval for its nocturnal nasal spray, but gets a boxed warning as well.
By Judy Packer-Tursman • March 8, 2017 -
FDA lifts trial holds for Seattle Genetics' cancer med
The agency is allowing two early-stage trials testing the treatment in patients with AML to continue, but the company is not continuing a Phase 1/2 study.
By Jacob Bell • March 7, 2017 -
PTC files DMD drug in spite of earlier rejection
The company employed a rarely used tactic to force the FDA to review Translarna for approval.
By Jacob Bell • March 6, 2017
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