FDA: Page 67
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FDA cites Braun Medical for repeat GMP violations
Inspections in 2013, 2014, 2015 and 2016 all flagged similar issues with the medical product manufacturer's production processes, triggering a warning letter.
By Ned Pagliarulo • June 1, 2017 -
Novartis' Zykadia gets 1st-line nod in ALK+ lung cancer
The expanded approval cements Novartis’ position in the market for treatment of ALK-positive NSCLC patients.
By Barbara Boughton • May 31, 2017 -
Maryland Gov. allows drug price gouging bill to become law
The bill permits the state's Attorney General to request pricing information from generic drugmakers for some of their most essential medications.
By Jacob Bell • May 31, 2017 -
Drug rebates may shift costs to Medicare, study finds
While industry argues rebates lower drug and premium costs, a new paper suggests the practice leads to higher out-of-pocket spending and a heavier burden on Medicare.
By Ned Pagliarulo • May 31, 2017 -
HedgePath hogs time to chat with FDA
HedgePath and the FDA plan a Type C meeting to review the process of SUBA-Caps, its antifungal repurposed for basal cell carcinoma.
By Suzanne Elvidge • May 31, 2017 -
Pfizer secures European approval for MenB vaccine
The OK is a shot in the arm for Pfizer's vaccines division, which is headlined by the blockbuster Prevnar 13.
By Suzanne Elvidge • May 31, 2017 -
Hoped-for COPD approval fades with FDA rejection
Shares of Sumitomo Dainippon Pharma slumped as its COPD inhaler was knocked back by the FDA.
By Suzanne Elvidge • May 30, 2017 -
Novo Nordisk seeks expanded label for Tresiba
The DEVOTE study showed non-inferiority in cardiovascular safety and improvement in hypoglycemia — but will this be enough for the FDA?
By Suzanne Elvidge • May 30, 2017 -
Prescribed Reading: FDA on a roll, while pharma continues sell off
The regulatory agency continues its approval spree, just as big pharma sells off older assets in its ongoing restructuring.
By Lisa LaMotta • May 26, 2017 -
FDA
Problems at Sun Pharma plant trip up drug approval
The Indian drugmaker has struggled to bring its Halol facility into compliance with FDA standards, hurting its ability to win U.S. drug approvals.
By Ned Pagliarulo • May 25, 2017 -
FDA highlights threat bacteria poses to water-based products
A recent multi-state outbreak of the Burkholderia cepacia infection has the agency warning drugmakers to thoroughly clean their equipment and establish procedures to safeguard their products' quality.
By Jacob Bell • May 25, 2017 -
Puma gets adcomm OK ahead of FDA decision
A positive opinion from the Oncologic Drugs Advisory Committee has sent the biotech's share skyrocketing ahead of a potential approval.
By Suzanne Elvidge • May 25, 2017 -
CBO: Amended AHCA still leaves 23M uninsured
The agency found that premiums for single policyholders buying in the nongroup market would increase by an average of about 20% in 2018 and 5% in 2019.
By Shannon Muchmore • May 24, 2017 -
Merck may face financial fine for anti-competitive pricing
A U.K. regulator has issued a provisional ruling against Merck, Sharp & Dohme for engaging in anti-competitive pricing to defend Remicade sales from biosimilar competition.
By Barbara Boughton • May 24, 2017 -
Merck's Keytruda gets first nod in genetically-defective tumors
The anti-PD-1 drug locked down another indication, this time for solid tumors that have defective genetic code.
By Jacob Bell • May 24, 2017 -
Courtesy of Sanofi
Overcoming delay, Sanofi, Regeneron win US approval for RA drug
The two companies said Kevzara will be priced at a 30% discount to the leading TNF-alpha inhibitors Humira and Enbrel.
By Ned Pagliarulo • May 23, 2017 -
Investors claw for Puma shares despite questions from FDA adcomm
The biotech's stock leapt more than 80% Monday morning after the FDA released documents for an upcoming advisory committee meeting. Yet, it's unclear whether the panel experts will share investors' optimism.
By Jacob Bell • May 22, 2017 -
EMA recommends 11 drugs for approval in May meeting
The list of CHMP-backed new treatments included Sanofi's biosimilar Humalog, LEO Pharma's brodalumab and Gedeon Richter's cariprazine.
By Jacob Bell • May 22, 2017 -
Prescribed Reading: ASCO dominates, Icahn BMS interest just a rumor
The abstracts have arrived! Carl Icahn's first quarter holdings are released and J&J gets a black box warning.
By Lisa LaMotta • May 19, 2017 -
FDA
FDA warns of higher amputation risk for J&J's Invokana
Results from two clinical studies showed the risk of amputation was roughly double for the SGLT-2 inhibitor compared to placebo.
By Ned Pagliarulo • May 17, 2017 -
Concert trial on hold while FDA reviews tox studies
The biotech's baldness drug was put on clinical hold by the regulatory agency in order to assess non-clinical toxicology studies.
By Lisa LaMotta • May 17, 2017 -
Editas delays CRISPR move to human trials
The biotech announced a delay for its planned IND filing, giving competitors an opening to start trials in the closely watched field first.
By Lisa LaMotta • May 16, 2017 -
FDA
Taking office, Gottlieb keeps drug pricing front and center
The new FDA head told agency staff he hopes to speed lower cost generics to market and increase competition, particularly for complex drugs and biologics.
By Ned Pagliarulo • May 16, 2017 -
Minerva's schizophrenia drug heads to late stages
The central nervous system drug developer has completed an end-of-Phase 2 meeting with the FDA, and plans to kick off late-stage testing later this year.
By Jacob Bell • May 16, 2017 -
Deep Dive
Solutions to clinical trial adherence remain elusive
Making sure patients take their medications is crucial to clinical trial success, but exactly how to do that remains a daunting task for investigators.
By Jacob Bell • May 15, 2017
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