FDA: Page 41
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Louisiana launching 'Netflix model' in Medicaid for hep C drugs
The state is looking for a pharmaceutical partner on a project that will cap state spending for the expensive liver disease treatments.
By Les Masterson • Jan. 14, 2019 -
FDA to beef up Sentinel postmarket safety system
The agency unveiled a new plan to expand and strengthen the system by adding new data types and recruiting more collaborators to the network.
By Susan Kelly • Jan. 11, 2019 -
J&J raises prices as Dems introduce bills aimed at lowering drug costs
Drug pricing reform has bipartisan support, but that hasn't stopped pharma from enacting hikes — in part because such moves have been vital to growth.
By Jacob Bell • Jan. 11, 2019 -
Akorn's drug pipeline 'held hostage' with FDA warning letter
The agency detailed numerous violations against the generic manufacturer's plant in Decatur, Illinois.
By Kristin Jensen • Jan. 10, 2019 -
FDA warns it won't be long before user fee funding runs dry
With no end in sight to the shutdown, Commissioner Scott Gottlieb said drug and medical device user fee programs have one to two months of funding left.
By Jacob Bell • Jan. 9, 2019 -
Portola boosted by FDA nod for new Andexxa manufacturing
Roll-out of the reversal agent has been hampered by supply issues. Portola hopes its second-generation production process can give Andexxa a lift.
By Suzanne Elvidge • Jan. 2, 2019 -
Our 10 best stories of 2018
Pharma boards, cell therapy, AI and cancer drug ads feature in BioPharma Dive's top articles of the past 12 months.
By Ned Pagliarulo • Dec. 21, 2018 -
Courtesy of Merck & Co.
Merck's Keytruda faces delay in first-line approval decision
Keytruda already owns three approvals in frontline lung cancer, but will now have to wait three more months to find out the FDA's decision on a fourth.
By Suzanne Elvidge • Dec. 21, 2018 -
Lynparza boosted by key approval, trial success
An FDA OK for Lynparza as a first-line maintenance therapy in ovarian cancer should give AstraZeneca and Merck a leg up in the PARP inhibitor market.
By Suzanne Elvidge • Dec. 20, 2018 -
AstraZeneca's China push boosted by anemia drug OK
China's approval of AstraZeneca and Fibrogen's roxadustat flips the script on the usual path to market for new drugs, which almost always hit in Western countries first.
By Ned Pagliarulo • Dec. 18, 2018 -
Novartis, Pfizer withdraw drug applications in Europe
Novartis pulled canakinumab, with regulators leaning against approval, and Pfizer withdrew its Humira biosimilar.
By Andrew Dunn • Dec. 17, 2018 -
FDA approves another Herceptin biosimilar in blow to Roche
Herceptin is one of three top-selling Roche cancer drugs threatened by looming biosimilar competition.
By Suzanne Elvidge • Dec. 17, 2018 -
Supernus epilepsy drug secures label expansion
The approval opens Oxtellar XR to a much larger market, but a potentially slow ramp up could dull investor excitement.
By Suzanne Elvidge • Dec. 17, 2018 -
FDA turns down Mallinckrodt application for reformulated oxycodone
The specialty drugmaker offered few details on the Complete Response Letter issued by the regulator — the second Mallinckrodt's received this year.
By Suzanne Elvidge • Dec. 13, 2018 -
Pear's digital treatment for opioid abuse gets FDA nod
The app is a medication-assisted treatment that provides cognitive behavioral therapy to increase care retention rates for adults with opioid use disorder.
By Maria Rachal • Dec. 11, 2018 -
Brexit 'no deal' could mean 6 months of disruption for pharma
The warning comes as the prime minister postponed a crucial vote on an exit plan that had been set for this week.
By Suzanne Elvidge • Dec. 10, 2018 -
J&J's Actelion pays out $360M to resolve kickback claims
The Justice Department claimed the pharma donated to a charity to help pay Medicare patients' copays for its drugs.
By Suzanne Elvidge • Dec. 10, 2018 -
FDA guide unveils vision for cancer diagnostics
The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory-developed tests.
By David Lim • Dec. 6, 2018 -
Hospital docs weigh in on CAR-T reimbursement: 'It's very complicated'
Looming over clinical victories seen at ASH was a problematic question: How exactly will health systems pay for these powerful yet pricey therapies?
By Jacob Bell • Dec. 5, 2018 -
Bipartisan bill introduced in Senate to penalize pharma Medicaid gaming
The incoming leaders of the Senate Finance Committee want to set monetary penalties for drugmakers that misclassify products within Medicaid.
By Andrew Dunn • Dec. 5, 2018 -
Mylan expands valsartan recall as investigation continues
Mylan will expand a recall to cover all lots of the heart medication, the latest in a series of recalls following discovery of an impurity in the active ingredient.
By Suzanne Elvidge • Dec. 5, 2018 -
UK and EU inch toward regulatory cooperation after Brexit
As a March leave date looms, a political declaration notes the bloc will explore the possibility of cooperation by U.K. authorities with groups like the European Medicines Agency.
By Suzanne Elvidge • Dec. 3, 2018 -
US widens recognition of EU drug plant inspections
Health authorities in five more EU countries are now recognized by the FDA under an international deal aimed at streamlining global GMP inspections.
By Suzanne Elvidge • Nov. 29, 2018 -
Deep Dive
Memorial Sloan Kettering scandal raises questions for pharma's biggest corporate boards
A review of corporate board membership found about two-thirds of the largest drugmakers had at least one director who also had a leadership role in a nonprofit healthcare organization.
By Andrew Dunn • Nov. 29, 2018 -
CREATES Act looks likely to pass in Congress, policy analyst predicts
Height Securities highlighted eight drugmakers that would be particularly hit by the legislation, including big names like J&J, Gilead and Celgene.
By Andrew Dunn • Nov. 28, 2018
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