Strategic alliance rather than M&A remains the preferred form of strategic interaction in the lab industry. M&A The preference of diagnostic companies to work with rather than digest each … [Read more...]
ACQUISITIONS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
September 26, 2017
NEWS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
August 30, 2017
It's been a relatively quiet month on the diagnostic front in terms of both deal volume and impact. Here's a rundown of the deals that did come down. M&A CRO acquisitions were the M&A … [Read more...]
NEW PRODUCTS
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
August 30, 2017
Abusy month in product launches included a new CE-marked IVD version of Invivoscribe Technologies' LeukoStrat CDx FLT3 Mutation Assay, which the company describes as the first companion diagnostic for … [Read more...]
NEWS
FDA Watch: Two More Zika Tests Get Emergency Use Authorization
August 28, 2017
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...]
