23:07 , Aug 15, 2019 |  BC Innovations  |  Product Development

Adaptive is surfing a wave of enthusiasm in disease detection, betting on the immune system

Adaptive’s float to more than $5 billion after its June IPO is largely based on its ambition to compete with the likes of Grail and Guardant in early diagnosis of cancer and other diseases by...
23:17 , Aug 7, 2019 |  BC Extra  |  Politics & Policy

CMS broadens coverage of CAR T therapies

After receiving 146 comments across two comment periods, CMS has opened up its coverage criteria for CAR Ts. In a final National Coverage Determination issued Wednesday, the Centers for Medicare & Medicaid Services said it...
00:44 , Aug 6, 2019 |  BC Extra  |  Politics & Policy

How CMS plans to retool payments for antibiotics

CMS updated its payment system last week to make it easier for antibiotic companies to turn a profit, but the changes improve an already-established pathway rather than implementing an innovative subscription-based model as called for...
00:35 , Jul 13, 2019 |  BioCentury  |  Product Development

Why Merck is in infectious disease for the long haul

Merck is bucking the trend of its biopharma peers by continuing to invest in and build its infectious disease pipeline. With new regulatory pathways in play and novel funding mechanisms for antibiotics starting to take...
23:53 , Jul 10, 2019 |  BC Extra  |  Politics & Policy

CMS’s new CKD payment models could be mixed bag for drug companies

A set of five different payment models announced by the Centers for Medicare & Medicaid Services for patients with chronic kidney disease or end-stage renal disease could be a boon for companies that have taken...
23:04 , Jun 6, 2019 |  BC Extra  |  Politics & Policy

New antibiotic treatments focus of reintroduced Senate bill

A bill that would advance research into new treatments for drug-resistant infections, the DISARM Act of 2019, was reintroduced in the Senate this week. The Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act (...
00:17 , May 18, 2019 |  BioCentury  |  Politics, Policy & Law

Cutting through the noise: the handful of pricing proposals the Trump administration or Congress may enact

Scores of proposals for reducing the cost of drugs are swirling around Congress, the White House and the U.S. Department of Health and Human Services, but only a few merit attention outside the beltway. Eliminating...
23:07 , May 16, 2019 |  BC Extra  |  Politics & Policy

CMS drops Trump administration proposal to negotiate protected class coverage

CMS will not implement a proposed change to Medicare Part D that would have allowed plans to exclude some drugs in six protected therapeutic classes from their formularies, but will allow for broader use of...
19:43 , May 2, 2019 |  BC Extra  |  Politics & Policy

May 2 P&P Quick Takes: ICER, CMS, FDA, House

ICER seeking input on value assessment framework  The Institute for Clinical and Economic Review is accepting public comments until June 10 for suggestions on how to modify its value assessment framework for 2020, including cost-effectiveness...
22:34 , May 1, 2019 |  BC Extra  |  Politics & Policy

CMS to reexamine coverage of germline sequencing tests

CMS said it will reopen its analysis of the National Coverage Determination for next-generation sequencing tests for cancer patients. The agency is only reconsidering evidence for tests of germline mutations to identify those with hereditary...