FDA: Page 58
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Celltrion biosimilars plant hit with FDA warning letter
The South Korean drugmaker doesn't expect the warning to impact its ability to supply Pfizer with Inflectra, the companies' Remicade copy.
By Ned Pagliarulo • Feb. 1, 2018 -
India's Semler sues FDA for $50M over suspicious spreadsheet
Semler is taking on the FDA over actions the CRO says were spearheaded by a disgruntled employee.
By Suzanne Elvidge • Feb. 1, 2018 -
FDA adds black box warning to Intercept's Ocaliva
Shares in the New York biotech rose on relief the FDA's caution did not broadly limit use of the drug in patients with mild or moderate liver disease.
By Ned Pagliarulo • Feb. 1, 2018 -
How Amazon, JPM and Berkshire could disrupt healthcare (or not)
"News of three corporate giants forming an independent healthcare company proves every business is a healthcare business," said David Vivero, CEO of digital health startup Amino.
By Shannon Muchmore, Daphne Howland & Jeff Byers • Jan. 31, 2018 -
Patient death, clinical hold sink Bellicum shares
Three patients treated with the biotech's BPX-501 developed encephalopathy, causing the FDA to halt all U.S.-based trials of the drug.
By Jacob Bell • Jan. 31, 2018 -
CutisPharma wins FDA approval of oral liquid vancomycin
The company's version of the antibiotic is designed to reduce the burden on pharmacists who compound the drug into liquid formulations.
By Suzanne Elvidge • Jan. 30, 2018 -
Deep Dive
Industry awaits FDA on rules for real-world evidence
Top FDA officials talk up data from outside the clinic, but the agency has yet to give the industry concrete guidance for best practices.
By Lisa LaMotta • Jan. 29, 2018 -
Aradigm stung by FDA rejection of inhaled antibiotic
In a Complete Response Letter to the biotech, the regulator asked for another costly Phase 3 study to further prove Linhaliq's efficacy.
By Ned Pagliarulo • Jan. 29, 2018 -
FDA approves Novartis-acquired Lutathera for certain gut cancers
Novartis' new acquisition won an FDA OK for gastroenteropancreatic neuroendocrine tumors.
By Suzanne Elvidge • Jan. 29, 2018 -
FDA
FDA changes biologics inspections from biennial to risk-based
"While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase," FDA chief Scott Gottlieb said.
By David Lim • Jan. 26, 2018 -
Prescribed Reading: Art of the deal, pharma dines with Trump
Just a few weeks into the year, M&A showed signs of life. Meanwhile, pharma execs schmoozed in Davos and Q4 earnings were all about the art of the deal.
By Lisa LaMotta • Jan. 26, 2018 -
Azar confirmed as HHS secretary in bipartisan vote
The former Eli Lilly executive, attacked by some critics as too cozy with the pharmaceutical industry, has said he will make drug prices a top priority.
By David Lim • Jan. 24, 2018 -
EMA frets drug shortages ahead of Brexit
The European regulatory agency is surveying U.K. manufacturers to prepare for drug shortages after the U.K.'s departure from the EU.
By Lisa LaMotta • Jan. 24, 2018 -
FDA debuts paper on quality standards, aiming to decrease review times
The Office of Pharmaceutical Quality is aiming to give manufacturers clarity on standards, in line with other FDA initiatives to increase efficiency.
By David Lim • Jan. 24, 2018 -
UPDATED: Shutdown ends after half of HHS furloughed
With government agencies operating at a diminished capacity, the FDA had been set to stop routine establishment inspections, as well as certain compliance and enforcement activities.
By David Lim • Jan. 22, 2018 -
Braeburn hits setback with CRL for opioid disorder
One analyst says the delay could push back approval by four to eight months.
By Suzanne Elvidge • Jan. 22, 2018 -
FDA to speed public notification of product recalls
The move is part of the FDA's efforts to strengthen its enforcement of potentially unsafe food and medical products.
By Ned Pagliarulo • Jan. 19, 2018 -
Prescribed Reading: Murmurs of M&A, backlash over CRLs
Celgene may make another acquisition, while the FDA Commissioner gets his first negative marks for reneging on a promise.
By Lisa LaMotta • Jan. 19, 2018 -
FDA issues PRV guidance for medical countermeasures
A new PRV program looks to reward drugmakers for developing products that address diseases tied to biological, nuclear and other threats, as well as emerging infectious diseases.
By Suzanne Elvidge • Jan. 19, 2018 -
Pharma, payers clash over CMS Part D drug rebate plan
The drug, PBM and insurance industries differ on a CMS proposal to require Part D sponsors to pass on a percentage of rebates to consumers.
By David Lim • Jan. 18, 2018 -
Shire's latest approval won't save it from Hemlibra
The EC thumbs up for Adynovi should bolster Shire's hemophilia business, yet Roche's new drug still threatens bottom lines.
By Jacob Bell • Jan. 17, 2018 -
FDA, Pentagon work to speed review of products for military use
The two government agencies reached an agreement to maintain FDA oversight, while accelerating approval of certain medical products for military use.
By Lisa LaMotta • Jan. 17, 2018 -
FDA roadmap highlights opioids, gene therapy, biosimilars
On the agency's to-do list is broadening access to biologics and calling out pharma for impeding generics.
By Suzanne Elvidge • Jan. 12, 2018 -
Biotech CEOs unfazed by Brexit
During a panel moderated by BioPharma Dive, biotech executives sounded off about the upcoming Brexit and what it means for them.
By Lisa LaMotta • Jan. 11, 2018 -
FDA slaps down Amneal bid to stop Forteo generics
The agency has rejected a citizen petition from the copycat drugmaker.
By Jacob Bell • Jan. 10, 2018
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