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The Latest Breaking News from Roche Holdings AG

Merck's Keytruda Plus Chemo Regimen Shows Overall Survival Benefit In Recurrent Ovarian Cancer Patients

Merck Co. Inc. (NYSE:MRK) announced data from the Phase 3 KEYNOTE-B96 trial (ENGOT-ov65) of Keytruda (pembrolizumab) in combination with chemotherapy (paclitaxel) with or without Roche Holdings AG’s (OTC:RHHBY) Avastin (bevacizumab).

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Roche To Acquire 89bio For $2.4 Billion In Liver And Cardiometabolic Push

On Thursday, Roche Holdings AG (OTC:RHHBY) agreed to acquire 89bio, Inc. (NASDAQ:ETNB) for $2.4 billion. 89Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for liver and cardiometabolic diseases.

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Sarepta Reports One Heart Inflammation Case In Duchenne Gene Therapy Trial

Sarepta Therapeutics Inc (NASDAQ:SRPT) shared new functional data across multiple studies from the SRP-9001 (delandistrogene moxeparvovec) program for Duchenne muscular dystrophy. SRP-9001 is an investigational gene therapy under development in partnership with Roche Holdings AG (OTC:RHHBY). Results from Cohort 1 demonstrated a 3.8-point improvement and 3.2-point improvement on the Duchenne functional scale 52 weeks after…

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Why Mereo BioPharma Shares Are Jumping Today

AstraZeneca plc (NASDAQ:AZN) is rumored to be eyeing take over of Mereo BioPharma Group plc (NASDAQ:MREO), according to a report in The Times. The Times' report says that "Mereo would accept $5, equating to $500 million including American depositary receipts or ADRs. Evercore and Citigroup are said to be involved as advisers." Mereo's lead…

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Roche-AC Immune's Crenezumab Fails To Show Benefit In Sub-Set Of Alzheimer's Patients

Roche Holdings AG (OTC:RHHBY) said its Alzheimer's medicine crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation that causes early-onset disease. Crenezumab did not show a statistically significant clinical benefit in its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function. The…

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Seagen Posts Encouraging Data From Tucatinib Combo Trial In Colorectal Cancer

Seagen Inc (NASDAQ:SGEN) announced topline results from phase 2 MOUNTAINEER trial investigating Tukysa (tucatinib) in combination with trastuzumab in previously treated HER2-positive metastatic colorectal cancer (mCRC) patients. Trastuzumab is sold under the name Herceptin by Genentech, a unit of Roche Holdings AG (OTC:RHHBY). Data from this trial will form the basis of a planned supplemental…

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Teva Pharmaceutical Shares Real-World Data Of ProAir Digihaler In Asthma Patients

Teva Pharmaceutical Industries Ltd (NYSE:TEVA) announced new study findings based on newly established clinical thresholds on short-acting beta-agonist (SABA) use and real-world usage of ProAir Digihaler (albuterol sulfate) inhalation powder. ProAir Digihaler is a breath-actuated, digital SABA inhaler with built-in flow sensors that detect, record, and store objective data. 89% (319/359) of patients…

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Genentech's Tiragolumab/Tecentriq Fails On Progression Free Survival In PD-L1-High Metastatic Lung Cancer

Genentech, a unit of Roche Holdings AG (OTC: RHHBY), announced results from its Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab in PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Roche's CEO Warns Russia-Ukraine War Causing Problems For Multiple Sclerosis Trials

The development of Roche Holdings AG's (OTC: RHHBY) multiple sclerosis candidate fenebrutinib is negatively impacted by Russia's ongoing invasion of Ukraine.

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EMA' Advisory Committee Recommends Approval For Roche's Two Cancer Drugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL). The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies. The CHMP recommendation is based on…

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FDA Warns Against Relying On Screening Tests For Prenatal Diagnosis

The U.S. FDA is warning that noninvasive prenatal screening (NIPS) tests may provide false results, such as stating a fetus may have a genetic abnormality when the fetus was healthy. FDA issues warning on possible false results from noninvasive prenatal screening tests. The agency noted that these tests, also known as…

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FDA Extends Review Period For Regeneron's COVID-19 Antibody Therapy

The FDA has extended its review of Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) marketing application of REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use. Regeneron has submitted additional data from its completed prophylaxis trial that the…

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FDA Grants Priority Review To Roche's Actemra For Hospitalized COVID-19 Adults

The FDA has granted priority review to Roche Holdings AG's (OTC:RHHBY) Actemra/RoActemra (tocilizumab) for COVID-19 in hospitalized adults. "If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for treating COVID-19 in hospitalized patients," Roche said. The Compay also added that more than 1 million people hospitalized with COVID-19 had been treated with Actemra/RoActemra…

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Roche's Evrysdi Shows Long-Term Efficacy, Safety In Broader Spinal Muscular Atrophy Population

At the annual congress of the Muscular Dystrophy Association (MDA), Roche Holdings AG (OTC:RHHBY) announced new data for its spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is a novel survival motor neuron 2 (SMN2) splicing modifier, licensed from PTC Therapeutics Inc (NASDAQ:PTCT). At the annual MDA event, Roche’s presentations included new three-year data from the…

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Roche And AstraZeneca Settle Ultomiris Patent Lawsuit

Roche Holdings AG (OTC: RHHBY) has decided to close out a patent infringement lawsuit against AstraZeneca plc (NASDAQ: AZN), centering around the latter's newly acquired rare disease drug Ultomiris for a

Benzinga

Roche Expects Slower FY22 Sales Growth On Lower Demand For COVID-19 Tests

Roche Holdings AG's (OTC: RHHBY) FY21 sales increased 8% Y/Y (9% on a constant currency basis) to CH

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