FDA: Page 70
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Prescribed Reading: Icahn stokes M&A flames
The billionaire activist investor makes a new biotech hire; the CAR-T space heats up; and the FDA cooperates with EMA to improve manufacturing.
By Lisa LaMotta • March 3, 2017 -
FDA touts own role in women's heart health
The agency highlighted its efforts to curb heart disease in women, an oft-overlooked area of healthcare.
By Judy Packer-Tursman • March 3, 2017 -
FDA gives go-ahead to Lexicon's rare disease drug
The company plans to price Xermelo, a drug for carcinoid syndrome diarrhea, similarly to Novartis' leading treatment for the condition.
By Jacob Bell • March 1, 2017 -
La Jolla surges on Phase 3 results for shock patients
The San Diego-based company says its synthetic formulation of a blood-pressure regulator offers a new level of treatment for shock patients who fail first- and second-line therapies in the ICU.
By Judy Packer-Tursman • Feb. 27, 2017 -
Why drug pricing seems so complicated
Experts say pharma companies need to get better at incorporating clinical value into pricing and communicating this value.
By Judy Packer-Tursman • Feb. 27, 2017 -
Prescribed Reading: Bristol M&A steals the show
Debate about the future of Bristol-Myers dominated news coverage this week, while several cancer drugs failed in late-stage trials.
By Lisa LaMotta • Feb. 24, 2017 -
Resverlogix gets FDA input, redesigns kidney trial
This is the Canadian biotech’s third announcement over the past month on studies related to the potential of its lead candidate, apabetalone.
By Judy Packer-Tursman • Feb. 24, 2017 -
Momenta's Copaxone generic delayed following Pfizer warning letter
The FDA is unlikely to determine the drug's approval status in the first quarter, the company said.
By Jacob Bell • Feb. 23, 2017 -
Dr. Reddy's hits roadblock in re-inspection of India plant
The India-based drugmaker said the FDA issued a Form 483 over problems at a manufacturing facility first flagged by U.S. regulators two years ago.
By Judy Packer-Tursman • Feb. 23, 2017 -
Bayer touts Xarelto strength on heels of COMPASS data
The blood thinner led the German company’s pharma growth last year, but Eylea, cancer drugs and a pulmonary hypertension treatment also played key roles.
By Judy Packer-Tursman • Feb. 23, 2017 -
DMC: little promise for Argos cancer therapy
Argos stock plummeted more than 66% on news that an independent data monitoring committee recommended stopping a Phase 3 study of its cancer drug.
By Jacob Bell • Feb. 22, 2017 -
Harvard Pilgrim bets on value-based drug payments with new deals
The New England insurer signed separate agreements with Amgen and Eli Lilly to link the cost of Enbrel and Forteo, respectively, to certain benchmarks.
By Ned Pagliarulo • Feb. 22, 2017 -
FDA
Amphastar shares tumble after FDA rejection
The California-based specialty pharma was hit with a complete response letter for its intranasal naloxone — an in-demand treatment for opioid overdoses.
By Suzanne Elvidge • Feb. 22, 2017 -
Pfizer's Xeljanz falls short in match-up with Humira
Xeljanz monotherapy failed to beat out a combination of Humira and methotrexate, crimping hopes the JAK inhibitor could stand on its own in the competitive class.
By Judy Packer-Tursman • Feb. 17, 2017 -
Prescribed Reading: Sage CEO embellishes, Merck stumbles
Plus, Valeant gets an approval, but is still in a tight spot; Allergan continues its deal spree; and PhRMA tries to deal with image issues.
By Lisa LaMotta • Feb. 17, 2017 -
FDA warns another Japanese drug manufacturer over GMP flaws
Tokyo-based Sato Pharmaceutical Co. is the third Japanese drugmaker in six months to run afoul of the FDA's inspectors.
By Ned Pagliarulo • Feb. 16, 2017 -
FDA
Are commercial prospects limited for Valeant's Siliq?
The FDA okayed Siliq (brodalumab) for plaque psoriasis, but the drug will carry a black box warning due to concerns over increased suicide risk.
By Ned Pagliarulo • Feb. 16, 2017 -
EMA reviews Actelion PAH drug after patient deaths
The agency is investigating the safety of Uptravi following the deaths of five patients taking the drug in France.
By Suzanne Elvidge • Feb. 15, 2017 -
Senators call on HHS' Price to fast track Canadian drug imports
Sens. Charles Grassley, Amy Klobuchar and John McCain are urging Trump's pick to consider an idea aimed at reducing the burden of high prescription drug costs.
By Jacob Bell • Feb. 14, 2017 -
Sanofi sells off OTC products to Ipsen
The divestiture will help Sanofi meet requirements set by the E.U. in exchange for approval of last year's asset swap with Boehringer Ingelheim.
By Suzanne Elvidge • Feb. 14, 2017 -
Marathon presses pause on Emflaza launch after pricing pushback
The abrupt about-face follows criticism from legislators over Marathon's decision to price the newly approved, but previously discovered, DMD drug at $89,000 per year.
By Ned Pagliarulo • Feb. 13, 2017 -
FDA
Marathon stokes drug pricing flames after DMD approval
Marathon Pharmaceuticals' approved drug is a corticosteroid already widely used off-label for Duchenne muscular dystrophy and a high price tag is already causing outrage.
By Judy Packer-Tursman • Feb. 10, 2017 -
Amgen secures FDA approval for hormone drug
The approval should help ease the threat Amgen faces as generics move in on the company's older drug for a similar indication.
By Jacob Bell • Feb. 8, 2017 -
Mylan to pay $96.5M to settle pay-for-delay lawsuit
Cozy pay-for-delay deals between branded drugmakers and their generic competitors have come under closer scrutiny in recent years.
By Judy Packer-Tursman • Feb. 7, 2017 -
Checkpoint inhibitors set to face off in bladder cancer
Bristol-Myer's Opdivo will soon challenge Roche's Tecentriq in bladder cancer, but rivals Merck and AstraZeneca are moving quickly to compete.
By Suzanne Elvidge • Feb. 7, 2017
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