21:09 , May 24, 2019 |  BC Extra  |  Company News

AveXis says label makes Zolgensma gene therapy ‘treatment of choice’ for newly diagnosed SMA

Gene therapy Zolgensma from Novartis’ AveXis unit received a label from FDA that will allow it to become the “treatment of choice” for newly diagnosed spinal muscular atrophy patients, according to the company, as well...
19:16 , Apr 26, 2019 |  BioCentury  |  Product Development

For patients’ sake, collaborate already

Cancer immunotherapy companies must stop squandering the most precious stakeholder, patients, and collaborate now on platform trials to test new combination regimens. A straightforward platform trial design that tests different combo partners with PD-1/PD-L1 agents...
20:12 , Apr 23, 2019 |  BC Extra  |  Politics & Policy

Biopharma battling drug price regulations in Massachusetts

The Massachusetts House of Representatives is set to vote this week on a bill that would regulate the prices of the highest-cost drugs purchased by the state’s MassHealth Medicaid program. Massachusetts biopharma companies are fighting...
21:56 , Feb 22, 2019 |  BioCentury  |  Politics, Policy & Law

Azar’s IPI: socialist or capitalist?

The Trump administration’s plan for an international reference pricing scheme for Medicare Part B drugs has provoked vituperative opposition from BIO, PhRMA and their allies who have branded it as an attempt to impose socialism....
23:51 , Jan 29, 2019 |  BC Extra  |  Politics & Policy

Senate to ‘compel’ pharma CEO testimony

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and ranking member Ron Wyden (D-Ore.) said at the start of a hearing Tuesday they will demand that pharma CEOs testify publicly about drug pricing after several companies...
20:17 , Jan 18, 2019 |  BC Extra  |  Politics & Policy

CMS aims to spread risk of catastrophic coverage

On Friday, CMS unveiled the Medicare Part D Payment Modernization model that seeks to share the costs of catastrophic coverage for Medicare patients whose drug costs exceed the limits of the donut hole. The five-year...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
17:55 , Dec 7, 2018 |  BC Week In Review  |  Clinical News

Legend reports 15 months PFS for anti-BCMA CAR; questions over trial sites linger

Data presented on the most advanced Chinese CAR product at the American Society of Hematology (ASH) meeting don't shed much light on outstanding questions related to the company's data reports from the trial, but do...
21:49 , Dec 4, 2018 |  BC Extra  |  Clinical News

Legend reports 15 months PFS for anti-BCMA CAR; questions over trial sites linger

Data presented on the most advanced Chinese CAR product at the American Society of Hematology (ASH) meeting on Monday don't shed much light on outstanding questions related to the company's data reports from the trial,...
19:53 , Nov 9, 2018 |  BioCentury  |  Politics, Policy & Law

Buckle-up, turbulence ahead in Washington

The midterm elections’ outcome will create deafening political noise about drug prices and great discomfort for pharmaceutical company executives. The effects on the biopharma industry will be tangible, but far more modest than the fiery...