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

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

Teva launches EpiPen generic at same price as Mylan's version

The copycat's entry could be a threat to Mylan, though limited supply may hamper the commercial impact. 

By Suzanne Elvidge • Nov. 28, 2018

Loxo cancer drug wins US approval in advance for targeted therapy

Vitrakvi is notable both for its tissue-agnostic label and for a price that puts the cancer drug in the upper ranks of costly therapies.

By Ned Pagliarulo • Nov. 27, 2018

CMS aims to tackle drug costs by giving payers more bargaining power

Under the agency's proposal, Part D plans would be allowed to exclude protected drugs from their formularies in certain instances. 

By Samantha Liss • Nov. 27, 2018

Luxturna cleared for sale in Europe, but payer support uncertain

Spark and commercialization partner Novartis now face the battle of getting the pricey gene therapy covered in Europe. 

By Suzanne Elvidge • Nov. 26, 2018

Pfizer secures 4th cancer drug approval in 2 months

U.S. regulators cleared Daurismo for certain patients with acute myeloid leukemia, extending a recent streak of new approvals for the cancer type.

By Suzanne Elvidge • Nov. 26, 2018

Novartis confident in Gilenya despite FDA call out

Regulators identified 35 cases where patients experienced severely increased disability after going off Gilenya, spurring a label update about potential risks.

By Jacob Bell • Nov. 21, 2018

Mylan taken to task for manufacturing failings at key plant

A warning letter issued by the FDA is the first received by the drugmaker for its Morgantown, West Virginia facility since the site was established in 1966.

By Ned Pagliarulo • Nov. 21, 2018

FDA plan would ease regulations for prescription drug apps

The regulator proposes to treat software like dose calculators or symptom trackers as promotional labeling, aiming to boost development of digital tools.   

By Susan Kelly • Nov. 20, 2018

Sage faces delayed decision on postpartum depression drug

The FDA needs more time to review a REMS plan Sage proposed for Zulresso, resulting in a three-month extension to the drug's PDUFA date.

By Ned Pagliarulo • Nov. 20, 2018