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Zacks News
Glaxo (GSK)/ Vir Biotech COVID-19 Antibody Under Review in EU
by Zacks Equity Research
The EMA starts review of Glaxo (GSK) and partner Vir Biotech's antibody candidate, VIR-7831, for the treatment of adults and adolescents with COVID-19 infection.
Pharma Stock Roundup: JNJ's COVID-19 Vaccine Woes, MRK Ends COVID-19 Drug Development
by Kinjel Shah
FDA & CDC temporarily halt J&J's (JNJ) COVID-19 vaccine use. Merck (MRK) ends development of COVID-19 drug.
Will Solid Pharma Unit Performance Drive J&J (JNJ) Q1 Earnings?
by Zacks Equity Research
In J&J's (JNJ) Pharma segment, its oncology drugs, Imbruvica and Darzalex as well as psoriasis treatment drug, Stelara, are likely to have driven sales growth.
Regeneron (REGN) Posts Positive Data on COVID-19 Antibody Cocktail
by Zacks Equity Research
Regeneron (REGN) announces encouraging data on antibody cocktail, REGEN-COV, from two phase III studies.
Dynavax (DVAX) Up on Positive COVID-19 Vaccine Study Data (Revised)
by Zacks Equity Research
Dynavax's (DVAX) partner Valneva, developing a COVID-19 vaccine using Dynavax's adjuvant, reports 100% seroconversion rates from a phase I/II study.
Dynavax (DVAX) Up on Positive COVID-19 Vaccine Study Data
by Zacks Equity Research
Dynavax's (DVAX) partner Valneva, developing a COVID-19 vaccine using Dynavax's adjuvant, reports 100% seroconversion rates from a phase I/II study.
SpringWorks (SWTX) Begins Dosing in Multiple Myeloma Study
by Zacks Equity Research
SpringWorks (SWTX) doses the first patient in a phase Ib study evaluating nirogacestat in combination with teclistamab for the treatment of relapsed or refractory multiple myeloma.
Biotech Stock Roundup: BLUE/BMY's CAR T Therapy Nod, KLDO's COVID-19 Study News & More
by Zacks Equity Research
The biotech sector gains prominence with new product approvals from bluebird (BLUE)/Bristol Myers Squibb (BMY) and other coronavirus updates.
Merck's (MRK) Breast Cancer sBLA for Keytruda Gets CRL (Revised)
by Zacks Equity Research
FDA issues a complete response letter to Merck's (MRK) sBLA seeking label expansion of Keytruda as neoadjuvant and adjuvant treatment for patients with triple-negative breast cancer. A phase III study in this indication is ongoing.
Merck (MRK) Keytruda Gets CHMP Nod for First-Line Bladder Cancer
by Zacks Equity Research
Merck (MRK) is seeking approval for label expansion of Keytruda in Europe to include first-line treatment of certain patients with advanced or metastatic urothelial carcinoma.
Akebia (AKBA) Files NDA for Vadadustat for Anemia Due to CKD
by Zacks Equity Research
Akebia (AKBA) submits new drug application for vadadustat to treat anemia due to chronic kidney disease in adult patients who are on dialysis as well as who are not on dialysis.
Novartis (NVS) Gets EC Nod For Kesimpta in Relapsing Forms of MS
by Zacks Equity Research
The European Commission approves Novartis' (NVS) Kesimpta for the treatment of adult patients with relapsing forms of multiple sclerosis.
Merck's (MRK) Breast Cancer sBLA for Keytruda Gets CRL
by Zacks Equity Research
FDA issues a complete response letter to Merck's (MRK) sBLA seeking label expansion of Keytruda as neoadjuvant and adjuvant treatment for patients with triple-negative breast cancer. A phase III study in this indication is ongoing.
Lilly/Vir's Cocktail COVID-19 Therapy Meets Study Endpoint
by Zacks Equity Research
Eli Lilly (LLY), Vir Biotechnology and Glaxo are developing a combination of their respective monoclonal antibodies as a potential treatment for mild-to-moderate COVID-19 patients.
Kaleido (KLDO) Reports Positive Results from COVID-19 Study
by Zacks Equity Research
Kaleido (KLDO) announces impressive results from a study on KB109 in patients with mild-to-moderate COVID-19.
Regeneron (REGN) Announces Positive Data on COVID-19 Cocktail
by Zacks Equity Research
Regeneron (REGN) announces positive data from a phase III study on its antibody cocktail for COVID-19.
Merck (MRK) Gets FDA Nod for Keytruda in Esophageal Cancer
by Zacks Equity Research
The FDA approves Merck's (MRK) anti-PD-1 therapy, Keytruda in combination with chemotherapy, for the first-line treatment of esophageal and gastroesophageal junction carcinoma.
Glaxo (GSK) Begins Late-Stage Severe Eosinophilic Asthma Study
by Zacks Equity Research
Glaxo (GSK) is developing an anti-IL-5 monoclonal antibody candidate, GSK3511294 - engineered for high affinity and long-acting suppression of IL-5 function - for treating severe asthma patients.
Pharma Stock Roundup: J&J, AZN COVID-19 Update, FDA Delays Decision on ABBV's sNDA
by Kinjel Shah
WHO gives EUL to J&J's (JNJ) COVID-19 vaccine. FDA pushes back review on AbbVie's (ABBV) sNDA
Biotech Stock Roundup: REGN's Cancer Drug Positive, COVID-19 Updates From NVAX & More
by Zacks Equity Research
The biotech sector was in focus last week with vaccine and antibody updates from quite a few companies like Novavax (NVAX) and Vir (VIR), among others.
Gilead (GILD), Merck Collaborate for Long-Acting HIV Treatments
by Zacks Equity Research
Gilead (GILD) collaborates with Merck for developing long-acting treatments for HIV patients.
Sanofi (SNY)/Translate Bio COVID-19 Vaccine in Clinical Stage
by Zacks Equity Research
The phase I/II clinical study on Sanofi (SNY)/Translate Bio's (TBIO) COVID-19 vaccine candidate will assess its safety, immune response and reactogenicity.
Vir Biotech (VIR)/Glaxo COVID-19 Drug Cuts Hospitalization Risk
by Zacks Equity Research
Vir Biotechnology (VIR) and partner Glaxo's, antibody candidate, VIR-7831, reduces hospitalization and risk of death in early treatment of adult patients with COVID-19.
Pharma Stock Roundup: EU Nod for J&J COVID-19 Vaccine, Updates From LLY, GSK, MRK
by Kinjel Shah
Europe clears J&J's (JNJ) COVID-19 vaccine. Eli Lilly (LLY), Merck (MRK) and Glaxo (GSK) give update on their COVID-19 antibody/antiviral candidates.
GlaxoSmithKline (GSK) Stock Sinks As Market Gains: What You Should Know
by Zacks Equity Research
GlaxoSmithKline (GSK) closed at $35.55 in the latest trading session, marking a -0.14% move from the prior day.