Latest Headlines

Latest Headlines

Roche snags FDA CLIA waiver for rapid Strep A test

Roche got an FDA CLIA waiver for its rapid Strep A test, opening the door to expanded use of the product months after the agency signed off on the test.

Illumina slaps Roche's Ariosa with a prenatal testing IP suit

San Diego's Illumina announced that it is filing a patent infringement suit against Roche's Ariosa Diagnostics and its microarray-based Harmony Prenatal Test. The gene sequencing company accuses Ariosa of violating its '794 patent, called "Multiplex Nucleic Acid Reactions."

Early ASCO winners? Roche and Pfizer, and to a lesser extent, BMS

The curtain is up on the first act of the annual cancer drug lollapalooza at ASCO. The first round of abstracts spotlights a series of early winners--including Roche--and at least one big loser: Puma Biotechnology.

FDA approves Roche's cancer diagnostic as a guide to use of Amgen, Lilly meds

The FDA approved Roche's diagnostic for the KRAS mutation in metastatic colorectal cancer patients, saying it needed to identify those without the mutation, for whom treatment with Eli Lilly's Erbitux or Amgen's Vectibix may be effective.

Roche scores FDA approval for colorectal cancer test

Roche snagged FDA approval for its KRAS mutation test for metastatic colorectal cancer (mCRC), chalking up a regulatory win as the company continues to gain ground in cancer R&D and expand its diagnostic offerings.

Tiny drugmakers top list of most profitable, but Shire and Gilead are there, too

Who are the most profitable companies in healthcare? Drug companies, with 7 out of 10 slots on a ranking by profit margin. Who are the most profitable drug companies? You might scratch your heads at all but a couple of names.

Roche presses pause on PTC's SMA drug over a safety scare

Roche has suspended dosing in a Phase II trial of PTC Therapeutics' in-development spinal muscular atrophy trial, cautious of a potential safety problem stemming from a preclinical study.

From the pharma C-suite: Notable, quotable remarks on Asia, emerging markets for Q1

FiercePharmaAsia combs earnings calls by major drug companies for notable and quotable nuggets on emerging markets and Asia to track the latest sales trends and insight into business outlooks in markets as diverse as China, India and Japan to Southeast Asia.

Roche's $100M Alzheimer's study could shift the balance in R&D

Despite all the excitement over Biogen's recent Phase I success in Alzheimer's, the question of whether attacking protein buildups in the brain can in fact treat the disease remains the subject of intense debate in the neurology world. And Roche, at work on a $100 million trial, is out to find out once and for all.

Roche, Amgen, Novo top the ranks in biologics sales, with AbbVie, Sanofi close behind

The world's top sellers of the world's top biologic meds haven't changed much in the last few years. Ranked by 2014 sales, it's your usual suspects--Roche, Amgen, Novo Nordisk, AbbVie. But as PMLiVE notes in its annual ranking, times are a-changing.