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Roche Holding AG (RHHBY.PK)

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Latest Key Developments (Source: Significant Developments)

ImaginAb Inc Says It Entered Non-Exclusive License And Collaboration Agreement With Roche
Tuesday, 9 Jul 2019 

July 9 (Reuters) - :IMAGINAB INC SAYS IT ENTERED INTO NON-EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT WITH ROCH; FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED..IMAGINAB INC SAYS ROCHE WILL USE IMAGINAB'S NOVEL MINIBODY CD8 T CELL IMAGING AGENT IN IMMUNO-ONCOLOGY CLINICAL TRIALS FOR MULTIPLE TYPES OF CANCERS.  Full Article

Roche Presents Data For Hemlibra At ISTH 2019 Congress
Tuesday, 9 Jul 2019 

July 9 (Reuters) - Roche Holding AG ::NEW ANALYSES FROM PHASE III HAVEN STUDIES SUPPORT HEMLIBRA'S SUSTAINED EFFICACY, SAFETY AND QUALITY OF LIFE BENEFIT IN PEOPLE WITH HAEMOPHILIA A, WITH AND WITHOUT FACTOR VIII INHIBITORS.FIRST DATA OF PHASE IIIB STASEY STUDY REINFORCES SAFETY PROFILE OF HEMLIBRA SEEN IN PIVOTAL HAVEN 1 CLINICAL TRIAL.NEW ANALYSIS OF PIVOTAL DATA SUGGESTS ADDITIONAL FACTOR TREATMENT MAY NOT BE NEEDED FOR PEOPLE ON HEMLIBRA UNDERGOING CERTAIN MINOR SURGERY.  Full Article

Chugai Obtains Approval Of FoundationOne CDx Cancer Genomic Profile As A Companion Diagnostic For Rozlytrek
Thursday, 27 Jun 2019 

June 27 (Reuters) - Chugai Pharmaceutical Co Ltd <4519.T>::CHUGAI PHARMACEUTICAL - CHUGAI OBTAINS APPROVAL OF FOUNDATIONONE CDX CANCER GENOMIC PROFILE AS A COMPANION DIAGNOSTIC FOR ROZLYTREK.  Full Article

Enzo Biochem Says CO Considering All Available Options For Challenging Federal Circuit Panel's Decision
Saturday, 22 Jun 2019 

June 21 (Reuters) - Abbott Laboratories ::ENZO BIOCHEM - U.S. COURT OF APPEALS ISSUED OPINION AFFIRMING LOWER COURT JUDGMENTS OF PATENT INVALIDITY FOR U.S. PATENT NOS. 6,992,180 & 8,097,405.ENZO BIOCHEM INC - COMPANY IS CONSIDERING ALL AVAILABLE OPTIONS FOR CHALLENGING FEDERAL CIRCUIT PANEL'S DECISION.  Full Article

Exelixis Says No New Safety Signals Were Identified With Combination Of Cobimetinib And Atezolizumab
Friday, 21 Jun 2019 

June 20 (Reuters) - Exelixis Inc ::EXELIXIS - ON JUNE 19 INFORMED BY GENENTECH, IMSPIRE170, PHASE 3 TRIAL EVALUATING COMBINATION OF COBIMETINIB & ATEZOLIZUMAB DID NOT MEET PRIMARY ENDPOINT.EXELIXIS - IMSPIRE170 SHOWED COMBINATION OF COBIMETINIB & ATEZOLIZUMAB DID NOT REDUCE RISK OF DISEASE PROGRESSION OR DEATH COMPARED TO PEMBROLIZUMAB.EXELIXIS INC - SAFETY PROFILE OBSERVED IN TRIAL WAS CONSISTENT WITH KNOWN SAFETY PROFILES OF INDIVIDUAL MEDICINES.EXELIXIS INC - NO NEW SAFETY SIGNALS WERE IDENTIFIED WITH COMBINATION OF COBIMETINIB AND ATEZOLIZUMAB.EXELIXIS INC - GENENTECH INFORMED EXELIXIS THAT GENENTECH INTENDS TO PRESENT RESULTS FROM TRIAL AT AN UPCOMING MEDICAL MEETING.  Full Article

Amgen Wins FDA Approval For Kanjinti Injection For Treatment Of Breast Cancer, Gastroesophageal Junction Adenocarcinoma - FDA
Thursday, 13 Jun 2019 

June 13 (Reuters) - U.S. FDA::AMGEN WINS FDA APPROVAL FOR KANJINTI INJECTION FOR TREATMENT OF BREAST CANCER, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA - FDA WEBSITE.U.S. FDA SAYS KANJINTI (TRASTUZUMAB-ANNS) IS BIOSIMILAR TO HERCEPTIN (TRASTUZUMAB).U.S. FDA SAYS KANJINTI COMES WITH A BOXED WARNING FOR CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, PULMONARY TOXICITY.  Full Article

BRIEF-Roche Says Xofluza Is Effective At Preventing Influenza
Tuesday, 4 Jun 2019 

Corrects spelling of Roche drug in headline to Xofluza:PHASE III STUDY SHOWED XOFLUZA (BALOXAVIR MARBOXIL) IS EFFECTIVE AT PREVENTING INFLUENZA INFECTION.COMPARED WITH PLACEBO, XOFLUZA TREATMENT SIGNIFICANTLY REDUCED LIKELIHOOD OF PEOPLE DEVELOPING FLU AFTER EXPOSURE TO INFECTED HOUSEHOLD MEMBER.PHASE III BLOCKSTONE STUDY, CONDUCTED BY SHIONOGI, MET ITS PRIMARY ENDPOINT.  Full Article

Synlogic Announces Collaboration To Evaluate Synb1891 In Combination With Pd-L1 In Patients With Advanced Solid Tumors
Wednesday, 22 May 2019 

May 22 (Reuters) - Synlogic Inc ::SYNLOGIC ANNOUNCES CLINICAL COLLABORATION TO EVALUATE SYNB1891 IN COMBINATION WITH PD-L1 CHECKPOINT INHIBITOR IN PATIENTS WITH ADVANCED SOLID TUMORS.SYNLOGIC - COLLABORATION WITH ROCHE TO EXPLORE CO'S SYNTHETIC BIOTIC MEDICINE, SYNB1891 IN COMBINATION WITH ROCHE'S PD-L1-BLOCKING CHECKPOINT INHIBITOR ATEZOLIZUMAB.SYNLOGIC INC - EXPECTS TO FILE INVESTIGATIONAL NEW DRUG APPLICATION WITH FDA IN SECOND HALF OF 2019 FOR SYNB1891.  Full Article

Parvus Therapeutics Enters Into Collaboration & License Agreement With Genentech To Develop Navacim Therapeutics For Treatment Of Autoimmune Diseases
Thursday, 16 May 2019 

May 16 (Reuters) - Roche Holding AG ::PARVUS THERAPEUTICS ENTERS INTO COLLABORATION & LICENSE AGREEMENT WITH GENENTECH TO DEVELOP NAVACIM THERAPEUTICS FOR TREATMENT OF AUTOIMMUNE DISEASES.PARVUS THERAPEUTICS - PARVUS ELIGIBLE TO RECEIVE UPFRONT AND MILESTONE PAYMENTS EXCEEDING $800 MILLION PLUS ROYALTIES ON NET SALES.PARVUS THERAPEUTICS - GENENTECH WILL BE RESPONSIBLE FOR CLINICAL DEVELOPMENT FROM PHASE II AND BEYOND.PARVUS - WILL RECEIVE UNDISCLOSED UPFRONT PAYMENT AND IS ELIGIBLE TO RECEIVE RESEARCH, DEVELOPMENT AND COMMERCIALIZATION MILESTONE PAYMENTS.PARVUS - ALSO ELIGIBLE TO RECEIVE CERTAIN ADDITIONAL MILESTONE PAYMENTS IN OTHER DISEASE AREAS, AS WELL AS ROYALTIES ON NET SALES OF PRODUCTS.  Full Article

Roche to include new SMA drug data in U.S., Europe filings set for H2 2019
Tuesday, 7 May 2019 

May 7 (Reuters) - Roche Holding AG ::SAYS IN THE DOSE-FINDING PART 1 OF FIREFISH STUDY, INFANTS WITH TYPE 1 SPINAL MUSCULAR ATROPHY SURVIVED AND ACHIEVED MILESTONES BEYOND THOSE EXPECTED IN NATURAL HISTORY OF DISEASE.SAYS IN FIREFISH STUDY, 10 OUT OF 17 INFANTS IN THE THERAPEUTICALLY DOSED GROUP ACHIEVED A CHOP-INTEND TOTAL SCORE OF 40 POINTS OR MORE, MEDIAN CHANGE FROM BASELINE TO MONTH 12 IN CHOP-INTEND WAS 17.5 PTS.SAYS PLANS TO INCLUDE NEW DATA PRESENTED AT THE AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING IN REGULATORY FILINGS IN U.S., EUROPE DURING THE SECOND HALF OF 2019.  Full Article

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Pfizer's Avastin biosimilar wins FDA approval

Pfizer Inc said on Friday that the U.S. Food and Drug Administration had approved its biosimilar to Roche Holding AG's blockbuster cancer treatment Avastin.