Epizyme moves forward with cancer drug, eyes 2020 launch

The biotech is seeking an accelerated approval from the FDA for tazemetostat, an experimental treatment for a rare, aggressive tissue cancer.

By Andrew Dunn • May 30, 2019

How to survive in pharma's payer-empowered world

Success in the new payer-empowered world of value and affordability requires two fundamental changes in pharma companies’ corporate decision-making.

By Ed Schoonveld • May 30, 2019

Amarin wins speedy FDA review for Vascepa heart label

Regulators will rule on a new indication for the fish oil-based pill by late September instead of early 2020, but it's still unclear if the drug will face an advisory panel.

By Andrew Dunn • May 29, 2019

BioMarin readies hemophilia gene therapy for FDA submission

But the debate over valrox's durability has not dissipated, as factor expression continued to decline in clinical trial patients.

By Jonathan Gardner • May 28, 2019

Pay-for-delay deals disappearing, FTC says

The federal agency conceded branded and generic makers may be striking non-monetary deals that impede price competition on off-patent drugs.

By Jonathan Gardner • Updated May 24, 2019

Could Novartis' gene therapy have more than one price?

Indication-based pricing may be possible for less severe patients, who would receive a smaller dose. Lower manufacturing costs would lessen the blow to Novartis too.

By Jonathan Gardner • May 23, 2019

Medicare decides against tighter management of HIV drugs

A finalized regulation codifies step therapy and prior authorization practices in five of the Medicare Part D "protected" drug classes, but spares HIV.

By Jonathan Gardner • May 17, 2019

Gilead CEO pressured on PrEP pricing at House hearing

Critics of Gilead contend it had little to do with the research behind Truvada's use as a preventive therapy — a charge CEO Daniel O'Day rebutted Thursday.

By Ned Pagliarulo • May 17, 2019

FDA highlights manufacturing quality efforts after recalls, regulatory criticism

An agency report found the industry's average inspection score didn't change much over the last two years, though there remain concerns about quality control in China and India.

By Kristin Jensen • May 16, 2019

FDA schedules Aimmune's peanut allergy drug for September expert review

Set to convene earlier than analysts had expected, the advisory committee will discuss what would be the first-ever drug approval for a food allergy.

By Ned Pagliarulo , Andrew Dunn • May 16, 2019

Cost-effectiveness agency clears Biogen's Spinraza for UK patients

Private meetings between Biogen and NICE last week cleared way for a "managed access agreement" that will allow time to assess effectiveness data.

By Jonathan Gardner • May 15, 2019

Generics price-fixing lawsuit focuses on Teva's role as catalyst

A ranking system of competitors' willingness to follow price increases was one piece of evidence offered by 44 state attorneys general in a sweeping lawsuit. 

By Jonathan Gardner • May 13, 2019

FDA finalizes interchangeable biosimilar advice, with insulin focus

The agency will generally require switching studies for biologic copycats seeking a valuable interchangeable license.

By Andrew Dunn • May 13, 2019

Fibrogen confuses as it tries to explain blood-boosting drug data

The company claims roxadustat is as safe as Epogen when used to treat anemia in kidney-disease patients, but can't say whether the FDA will agree.

By Jonathan Gardner • May 10, 2019

Biopharma happily takes the tax cuts, but the jobs are harder to find

The tax burden of U.S.-based drugmakers shrank by nearly one-quarter following the 2017 Republican tax bill, but jobs edged up only slightly, a BioPharma Dive analysis found.

By Jonathan Gardner • May 9, 2019

Approval of $225,000-a-year tafamidis comes early for Pfizer

The FDA sped up approval by months, and surprised Pfizer by giving an OK to two formulations of the rare disease drug. 

By Jonathan Gardner • May 6, 2019

Rebate ban not a magic balm, federal budget forecasters say

The Trump administration plan to eliminate certain rebates would increase federal spending by $177 billion over a decade, the CBO found.

By Jonathan Gardner • May 3, 2019

Sanofi's dengue vaccine wins limited FDA approval

The French pharma is eyeing a 2020 launch but will face a challenging U.S. market given restrictions on the vaccine's use.

By Andrew Dunn • May 2, 2019

FDA rejects Heron, Nabriva drug applications, citing manufacturing concerns

Both biotechs expected approval of their respective pain and anti-infective drugs, but wound up with disappointment and delays.

By Andrew Dunn • May 2, 2019

CMS reopens coverage determination on next-gen sequencing for cancer patients

The agency responded to pressure from healthcare organizations in reopening the coverage determination for next-generation sequencing.

By Susan Kelly • April 30, 2019

Alexion, AstraZeneca secure backing of EMA panel for key drugs

The CHMP's recommendation for Ultomiris aids Alexion's Soliris switching strategy, while AstraZeneca's Lynparza aims to move up another treatment line.

By Jonathan Gardner • April 29, 2019

Praluent scores heart label, matching Amgen's rival Repatha

The cholesterol drug from Sanofi and Regeneron is now approved for prevention of cardiovascular events like heart attack or stroke.

By Ned Pagliarulo • April 29, 2019

Roche's takeout of Spark not working like a Swiss watch

Antitrust review drags on, forcing the two parties to withdraw and refile paperwork and extend the tender offer by another month.

By Jonathan Gardner • April 26, 2019

Lilly to withdraw FDA-approved cancer drug after clinical failure

Lartruvo showed no survival benefit in Phase 3 study results disclosed in January, leading Lilly to suspend promotion and pull the drug from market. 

By Andrew Dunn • April 25, 2019

Medicare proposes raising CAR-T pay, but reimbursement solution years away

As new technologies nip at CAR-T's heels, CMS could take three years to gin up a separate reimbursement category for Novartis' Kymriah and Gilead's Yescarta.

By Jonathan Gardner • April 24, 2019