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The Latest Breaking News from Roche Holdings AG

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…

Why Mereo BioPharma Shares Are Jumping Today

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…

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

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…

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…

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).

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

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…

FDA Warns Against Relying On Screening Tests For Prenatal Diagnosis

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…

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

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…

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

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…

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

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…

Roche And AstraZeneca Settle Ultomiris Patent Lawsuit

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

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

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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