FDA: Page 47
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AstraZeneca settles Texas suits claiming it mismarketed Crestor, Seroquel
The British drugmaker will pay $110 million to resolve the charges — far less than the $5 billion Texas originally sought in its 2013 claim.
By Ned Pagliarulo • Aug. 8, 2018 -
CMS to allow step therapy in Medicare Advantage plans
A CMS senior adviser said the move could save 15-20% of the $12 billion spent annually by MA plans on pricey Part B drugs. Not all analysts buy that estimate.
By David Lim • Aug. 8, 2018 -
Gemphire stock drops to all-time low as lead drug delayed
Phase 3 studies of gemcabene can't begin until a partial clinical hold on the drug's class is lifted — something Gemphire now needs more data to do.
By Andrew Dunn • Aug. 7, 2018 -
Jacob Bell/BioPharma Dive
Pain Therapeutics reorganizing as abuse-deterrent opioid rejected again
CEO Remi Barbier called the FDA's decision "bizarre ... especially during a time of staggering human and economic toll created by opioid abuse and addiction."
By Jacob Bell • Aug. 6, 2018 -
Elizabeth Regan/BioPharma Dive
Latest PRV sale further evidence of sliding value
Ultragenyx and Kyowa Kirin sold a PRV for just $81 million, reinforcing the downward trend in prices commanded by the regulatory "fast passes."
By Ned Pagliarulo • Aug. 2, 2018 -
FDA makes new moves to cut veterinary drug use in AMR fight
A new blueprint builds on existing guidance, including establishing appropriate durations of use of medically-important antimicrobials.
By Suzanne Elvidge • Aug. 2, 2018 -
EMA faces higher staff losses ahead of move to Amsterdam
The regulator is putting business continuity plans in place, as it expects to lose up to a third of its staff.
By Suzanne Elvidge • Aug. 2, 2018 -
FDA approves Shionogi's thrombocytopenia drug
Mulpeta was cleared for patients with chronic liver disease-associated thrombocytopenia undergoing medical or dental procedures.
By Barbara Boughton • Aug. 1, 2018 -
Gencaro back from the brink as FDA gives Phase 3 go-ahead
Regulators have told Arca a single Phase 3 study could be sufficient to support an NDA for the heart medicine.
By Suzanne Elvidge • Aug. 1, 2018 -
Gottlieb teases guidance on continuous trials, touts surrogate endpoints
In a self-described "tweetorial," the FDA chief said modernizing clinical trials could help cut costs.
By Lisa LaMotta • July 30, 2018 -
FDA rejects Insys opioid pain spray
Regulators cited concerns about the safety and efficacy of Buvaya, a form of the opioid buprenorphine.
By Barbara Boughton • July 30, 2018 -
With CHMP thumbs up, Alynlam's RNAi moves a step closer to EU market
The drugs committee of the EU regulator this month recommended a slate of new drugs for approval, including the newly named Onpattro from Alnylam.
By Suzanne Elvidge • July 30, 2018 -
FDA increases regulation on compounded drugs, issues new warning
The agency continues to increase its oversight of compounding, alerting the public to the risk of using cesium chloride as a bulk drug substance.
By Andrew Dunn • July 26, 2018 -
GSK secures US approval of new malaria drug
The pharma also plans to secure regulatory OKs in malaria-endemic countries, where it says it will sell the treatment at a "not-for-profit" price.
By Ned Pagliarulo • July 25, 2018 -
Courtesy of AbbVie
AbbVie's new endometriosis drug to cost $10K per year
The FDA OK'd the women's health treatment Tuesday, setting up AbbVie for a first-to-market entry.
By Lisa LaMotta • July 24, 2018 -
Courtesy of Eli Lilly
Lilly divests Elanco, focuses on capital allocation strategy
The Trump administration's drug pricing blueprint, business development and share repurchases were a few of the topics that overshadowed the divestiture of the animal health business.
By Lisa LaMotta • July 24, 2018 -
GSK faces scrutiny for Nucala in COPD
FDA briefing documents questioned the drug's clinical outcomes and mechanism of action ahead of a Wednesday advisory committee meeting.
By Suzanne Elvidge • July 24, 2018 -
Bayer to stop selling Essure birth control implant in US
The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.
By Susan Kelly • July 23, 2018 -
Agios gets to prove its marketing abilities with new approval
The biotech expects that its time helping Celgene roll out Idhifa will benefit the commercialization of Tibsovo, Agios' first wholly-owned product.
By Jacob Bell • July 23, 2018 -
Merck makes price pledge, but targets insignificant to bottom line
Six of the seven drugs identified for cuts are so minor the pharma doesn't even break out sales. The seventh is past its prime.
By Lisa LaMotta • July 20, 2018 -
CDER announces sweeping structural changes in letter from Woodcock to staff
Transformation is planned at the Center for Drug Evaluation and Research, with structural changes within four of its offices.
By Suzanne Elvidge • July 20, 2018 -
Regulators recall valsartan after finding impurity tied to cancer risk
EU authorities linked the impurity to manufacturing changes made six years ago by a Chinese producer of the drug's active pharmaceutical ingredient.
By Suzanne Elvidge • July 19, 2018 -
Drug lobby aims to shake up how medicines are paid for
PhRMA wants PBMs to be compensated on a fee-for-service basis, rather than from a percentage cut of a drug's list price.
By Ned Pagliarulo • July 18, 2018 -
Antibiotic overprescribing underestimated, CDC study says
Incorrect prescribing was prevalent in other outpatient settings, including emergency departments, medical offices and retail clinics.
By Rebecca Pifer • July 18, 2018 -
Jacob Bell/BioPharma Dive
FDA seeks to make more drugs available over the counter
Drugs eyed for potential changes in classification include cholesterol meds and the opioid-overdose reversal drug naloxone.
By Barbara Boughton • July 18, 2018
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