Zika made the FDA headlines this month, with two more tests receiving emergency use authorization: Thermo Fisher Scientific's TaqPath Zika Virus Kit for the qualitative detection of Zika virus RNA … [Read more...]
NEWS
FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
August 14, 2017
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a tumor's genomic features rather than its location in the … [Read more...]
NEWS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
July 31, 2017
After a relatively slow March and April, business has picked up noticeably in May, June and July with deal volume increasing across all transaction model sectors. Here are the highlights from the past … [Read more...]
NEW PRODUCTS
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
July 26, 2017
Thermo Fisher, HTG Molecular Diagnostics and Roche were among the large lab companies with product launches over the past 4 weeks. Here's a rundown of other key new products that came out. NEWLY … [Read more...]
LEGISLATION
FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster
July 10, 2017
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and pharma companies pay to … [Read more...]
NEWS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
June 26, 2017
Deal volume in May and June was noticeably higher, especially in terms of M&A activity. There was more global activity over the current than at any other point in 2017, particularly in Asia. Here … [Read more...]
FDA
FDA Speeding Approval Process, Continued User Fees Needed
June 26, 2017
The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and criticism over how long the agency takes to issue approvals. And the new … [Read more...]
FDA WATCH
FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees
June 5, 2017
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by $103 million, $4.665 billion in total. That includes $2.759 billion for … [Read more...]
NEWS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
May 22, 2017
The big story of April wasn't any particular new deal but the apparent resolution of an old one—the Abbott-Alere merger. Deal volume remained brisk, particularly in the alliance arena. But for those … [Read more...]
NEW PRODUCTS
The Dx Pipeline
A roundup of the month’s key new product launches
May 9, 2017
As usual, genome and sequencing products dominated the diagnostics pipeline last month. Exceptions included rapid diagnostic testing products from Alere, oncology lung testing kits from IncellDx, … [Read more...]
