FDA: Page 72
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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 -
UK cost watchdog says Pfizer's Ibrance too pricey
NICE issued draft guidance last week judging the breast cancer drug to not be cost effective, even with data showing a progression free survival benefit.
By Suzanne Elvidge • Feb. 6, 2017 -
Prescribed Reading: A week dominated by politics and earnings
Pharma's sit down with President Trump was a hot topic in earnings calls this week as markets tried to gauge the new administration's approach to the industry.
By Lisa LaMotta • Feb. 3, 2017 -
Teva wins FDA approval for Advair copy
But the Israeli generics giant lost a Copaxone patent case in U.S. district court the same day, spelling trouble ahead for the company's most lucrative drug.
By Judy Packer-Tursman • Jan. 31, 2017 -
Amgen's Humira biosim clears EMA regulatory hurdle
The EMA also disclosed in its monthly update that Novartis had withdrawn an application for approval of its Neulasta biosimilar.
By Jacob Bell • Jan. 30, 2017 -
Regulus hits further setbacks as clinical hold upheld
Stock dropped by 20% after hours on Friday following an FDA request for more data on the microRNA-targeting drug RG-101.
By Suzanne Elvidge • Jan. 30, 2017 -
Regeneron drops $720M to buy New York HQ
The biotech has leased the space for years, but will now cement its presence in the state by buying the property outright.
By Judy Packer-Tursman • Jan. 26, 2017 -
FDA
FDA report stresses importance of Phase 3 testing
Several rumored candidates for FDA chief under President Trump have previously criticized the FDA approval process as being too slow.
By Judy Packer-Tursman • Jan. 25, 2017
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