Roche Holding AG (ROG.S)
Tue, Jun 18 2019
A federal judge has dismissed a lawsuit accusing Roche Holding AG of misleading investors by announcing the results of a study examining how a combination of medications fared in treating breast cancer without disclosing that a key researcher had a conflict of interest.
(This June 10 story deletes paragraph 9 to clarify that retreatment with Polivy has not been studied.)
June 10 The U.S. Food and Drug Administration on Monday granted earlier-than-expected approval to Roche Holding AG's antibody- Polivy for treatment of patients with advanced lymphoma.
* PHASE III PEMPHIX STUDY SHOWED THAT MABTHERA/RITUXAN (RITUXIMAB) IS SUPERIOR TO STANDARD OF CARE IN ACHIEVING SUSTAINED REMISSION IN PATIENTS WITH PEMPHIGUS VULGARIS
* FDA GRANTS PRIORITY REVIEW TO GENENTECH’S RITUXAN (RITUXIMAB) IN CHILDREN WITH TWO RARE BLOOD VESSEL DISORDERS
BRIEF-Roche Holding Announces Positive Phase II Lupus Nephritis Study Results For Genentech's Gazyva (Obinutuzumab)
* GENENTECH’S GAZYVA (OBINUTUZUMAB) DELIVERS POSITIVE TOPLINE RESULTS FOR PHASE II LUPUS NEPHRITIS STUDY
* SAYS U.S. LIST PRICE FOR 4-MONTH COURSE OF POLIVY IS $90,000 ON AVERAGE; POLIVY DOSAGE BASED ON PATIENT WEIGHT Further company coverage:
June 10 The U.S. Food and Drug Administration granted accelerated approval to Roche Holding AG's combo lymphoma treatment for previously treated patients, the company said on Monday
* ROCHE AND SPARK THERAPEUTICS, INC. RECEIVE REQUEST FOR ADDITIONAL INFORMATION FROM FTC UNDER HART-SCOTT-RODINO ACT AND ANNOUNCE EXTENSION OF TENDER OFFER FOR SHARES OF SPARK THERAPEUTICS, INC.
* PIVOTAL PHASE III CLL14 RESULTS FOR VENCLEXTA/VENCLYXTO IN COMBINATION WITH GAZYVA/GAZYVARO FOR CHRONIC LYMPHOCYTIC LEUKAEMIA PRESENTED AT ASCO 2019 AND PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE