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

FDA's Woodcock: 'The clinical trial system is broken'

The CDER director said the current system doesn't serve the interests of patients and noted support for trials capable of answering multiple clinical questions at once. 

By Andrew Dunn • Nov. 20, 2018

FDA clears new Adcetris use in speedy review

Through an experimental real-time process, the regulator approved Seattle Genetics' application for the drug in just two weeks.

By Suzanne Elvidge • Nov. 19, 2018

Roche pulls EU application for Tecentriq in kidney cancer

The immunotherapy delivered positive results back in February, but Roche no longer believes that data to be supportive of a label extension.

By Suzanne Elvidge • Nov. 19, 2018

CMS approves Michigan Medicaid drug value-based payment plan

Administrator Seema Verma also previewed forthcoming agency action on protected classes of drugs in Medicare Part D, hinting that CMS plans to further open the space to private negotiation.

By David Lim • Nov. 14, 2018

UK calls Vertex on contentious Orkambi negotiations

A key committee has asked for more information from Vertex on its case for the cystic fibrosis drug, including the price offered to NHS.

By Suzanne Elvidge • Nov. 12, 2018

Coherus biosimilar to launch in US at 33% discount to Neulasta

Udenyca will be the second biosimilar in the U.S. to challenge Amgen's Neulasta when it hits markets in early January.

By Suzanne Elvidge • Nov. 9, 2018

Morgantown restructuring costs weigh on Mylan

High restructuring costs and reduced manufacturing at the West Virginia plant have poked a hole in Mylan's finances.

By Suzanne Elvidge • Nov. 8, 2018

5 election takeaways for pharma

Democrats took back the House on Tuesday, raising the prospect of more scrutiny on drug pricing. Experts, however, don't expect a major deal with President Trump.

By Ned Pagliarulo • Nov. 7, 2018

Sage depression drug to cost between $20K and $35K, if approved

Zulresso is currently under review by the FDA for postpartum depression, with a decision expected in December.

By Suzanne Elvidge • Nov. 7, 2018

Beleaguered Akorn hit with lengthy FDA inspection report

Already under fire for data integrity issues, Akorn has been issued a Form 483 detailing a slate of quality control violations. 

By Suzanne Elvidge • Nov. 6, 2018

Another opioid approval incites questions, criticism

The chairman of an FDA advisory committee has warned Dsuvia's approval will lead to diversion, abuse and death.

By Andrew Dunn • Nov. 5, 2018

Pfizer extends cancer drug approval streak with OK for Lorbrena

Lorbrena is Pfizer's third oncology therapy to be cleared by the FDA within the past two months, following Vizimpro and Talzenna.

By Suzanne Elvidge • Nov. 5, 2018

FDA panel vote lifts approval prospects for Sage's Zulresso

A key question, though, centers on how Sage's drug should be administered if approved. A strict REMS requirement could limit commercial prospects.

By Suzanne Elvidge • Nov. 5, 2018

9 state healthcare battles to watch Tuesday

It's not just Congress up for grabs in today's midterm elections. From Medicaid expansion to dialysis treatments, here's a snapshot of key votes, the odds and what they could mean for the industry.

By David Lim , Tony Abraham , Rebecca Pifer , Samantha Liss • Nov. 2, 2018

Alkermes depression drug approval odds slim after negative FDA panel vote

An agency advisory panel voted 21-2 against recommending approval for ALKS-5461, sending shares in the company sliding. 

By Ned Pagliarulo • Nov. 2, 2018

HHS proposes start date for 340B ceiling price after hospital suit

After delaying the start date five times, the department has proposed enforcing ceilings for the drug pricing program beginning Jan. 1. 

By Tony Abraham • Nov. 1, 2018