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6014 items
3:27 PM, Oct 19, 2018  |  BC Extra | Politics & Policy

FDA asks peers to globalize generic drug development

FDA is calling on international regulatory authorities to develop harmonized guidelines on scientific and technical standards for generic drugs that would allow manufacturers to use the same data and applications to gain approval across multiple...
3:37 PM, Oct 18, 2018  |  BC Extra | Politics & Policy

CMS’s Verma outlines new drug payment options

CMS Administrator Seema Verma Thursday outlined three types of payment arrangements the agency is considering for new, expensive medicines, such as gene therapies. Speaking at the Brookings Institution, Verma said CMS may modify its regulations...
4:13 PM, Oct 16, 2018  |  BC Extra | Politics & Policy

FDA mandates pediatric trials for 200 cancer targets

In a move to spur development of drugs for pediatric populations and require more studies of pediatric cancers, FDA published Tuesday a list of 200 molecular targets for which companies developing directed compounds must conduct...
4:20 PM, Oct 15, 2018  |  BC Extra | Politics & Policy

ICER weighing issuing advice on trial design

The Institute for Clinical and Economic Review is evaluating whether to collaborate earlier than it now does with drug companies by offering advice on clinical trial designs. ICER spokesperson David Whitrap said the institute is considering...
3:10 PM, Oct 15, 2018  |  BC Extra | Politics & Policy

FDA guides on minimal residual disease endpoint in hematologic cancer trials

FDA Commissioner Scott Gottlieb highlighted minimal residual disease (MRD)'s potential as a surrogate endpoint in clinical trials when he unveiled FDA's draft guidance on using MRD in hematologic malignancy drug development in a statement Monday. As...
12:33 PM, Oct 15, 2018  |  BC Extra | Politics & Policy

CMS, PhRMA release dueling plans on price disclosures in ads

The Trump administration released a proposed regulation that would mandate disclosure of prices in DTC television advertisements for products paid for by Medicare or Medicaid. Earlier Monday, PhRMA preempted the announcement by releasing its own...
2:53 PM, Oct 11, 2018  |  BC Extra | Politics & Policy

Inter Partes Review to be more favorable to biotech

The U.S. Patent and Trademark Office (PTO) finalized a rule requiring higher standards for invalidating patents through inter partes review (IPR) petitions, a victory for biopharma companies and other industries that depend on strong patent...
7:51 AM, Oct 11, 2018  |  BC Extra | Politics & Policy

FDA approves record number of generics in FY18

FDA approved 971 generic drugs during FY18, the most the agency has ever approved in a fiscal year. The figure rose from 937 during FY17, and 835 in FY16. The agency issued 781 final approvals and...
4:21 PM, Oct 10, 2018  |  BC Extra | Politics & Policy

U.S. to scrutinize foreign biotech investments

The U.S. government will scrutinize foreign investments in biotech companies and block those it deems threats to national security under interim regulations released Wednesday. Biotech is included among 27 “critical technology” areas included in a pilot...
2:44 PM, Oct 10, 2018  |  BC Extra | Politics & Policy

China adds insurance coverage for 17 cancer therapies

China's National Medical Insurance Administration added 17 cancer drugs to the National Reimbursement Drug List (NRDL) for coverage by the country's medical insurance program. The prices will go into effect by the end of October and...