|Bid||0.00 x 0|
|Ask||0.00 x 0|
|Day's range||37.02 - 37.60|
|52-week range||37.02 - 37.60|
|Beta (5Y monthly)||0.41|
|PE ratio (TTM)||24.11|
|Forward dividend & yield||N/A (N/A)|
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted a NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours. The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation. The FDA is expected to make a decision on these approvals by November 23, 2020.
AbbVie's (ABBV) blood cancer drug, Venclexta, in combination with azacitidine, achieves statistically significant improvement in overall survival and composite complete remission rate in treatment-naive AML patients.
Schwan was responding to a question about testing being made available for everyone in the United States, including people without symptoms of the COVID-19 disease, which has infected more than 32,000 people and killed over 415 people in the United States. "The industry is increasing capacities, but at the same time infection rates are even increasing faster," Schwan said.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta® (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta plus azacitidine appeared consistent with the known safety profile of these medicines.
Pfizer (PFE) is set to jointly develop BioNTech's potential coronavirus vaccine. Regeneron/Sanofi (SNY) and Roche will study their RA drugs, Kevzara & Actemra, respectively to treat severe COVID-19 infection.
The Zacks Analyst Blog Highlights: Roche, Thermo Fisher Scientific, Becton, Dickinson and Teladoc Health
Intel, Royal Caribbean Cruises, Roche, Thermo Fisher and Quest Diagnostics highlighted as Zacks Bull and Bear of the Day
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is working with the U.S. Food & Drug Administration (FDA) to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
Lilly (LLY) signs deal with AbCellera to co-develop antibody therapies to treat COVID-19. AbbVie (ABBV) supports studies evaluating Kaletra for treating COVID-19.
Roche's (RHHBY) cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the virus that causes the COVID-19 disease, gets EUA from the FDA.
Puma Biotech (PBYI) focuses on improving sales of its only marketed drug Nerlynx, which is approved for treating breast cancer. High dependence on Nerlynx for growth remains a woe.
Roche has won fast-track review status in the United States for a new diagnostic approach the Swiss drugmaker hopes will support its push into treating liver cancer with drugs including its immunotherapy Tecentriq. The company said on Wednesday that its Elecsys GALAD score, which combines factors including age, gender and biomarker results to more quickly and accurately diagnose early stage hepatocellular carcinoma (HCC), was awarded U.S. Food and Drug Administration's (FDA) Breakthrough Device Designation. "The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of HCC patients as they can receive a more timely diagnosis and treatment," said Roche Diagnostics head Thomas Schinecker.
China will use a Roche Holding AG arthritis drug to treat some coronavirus patients in severe conditions, health authorities said on Wednesday, as the country seeks to build up treatment regimens to help the infected recover. Tocilizumab, sold by the Swiss pharma giant under the trade name Actemra, can be prescribed to coronavirus patients who show serious lung damage and show elevated level of a protein called Interleukin 6, which could indicate inflammation or immunological diseases, the National Health Commission said in the latest version of its treatment guidelines published online. Actemra can help contain inflammation related to Interleukin 6, according to Roche.