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Zacks News
Inovio (INO) Initiates Phase I Study on Hepatitis C Vaccine
by Zacks Equity Research
Inovio Pharmaceuticals (INO) and Korean partner GeneOne Life Science dose the first patient in a phase I study, which will assess its hepatitis C vaccine GLS-6150.
AstraZeneca's Lupus Drug Misses Primary Endpoint in Study
by Zacks Equity Research
AstraZeneca's (AZN) phase III study, evaluating anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus, does not meet primary endpoint.
Bayer's (BAYRY) Jivi Gets FDA Approval to Treat Hemophilia A
by Zacks Equity Research
Bayer's (BAYRY) Jivi gets FDA approval for the treatment of hemophilia A in previously-treated adults and adolescents aged 12 years and older.
Alnylam Gets European Nod for First-Ever RNAi Therapeutic
by Zacks Equity Research
Alnylam's (ALNY) Onpattro, the first ever RNA interference (RNAi) therapeutic, has been granted marketing authorization by the European Commission.
Merck (MRK) Receives FDA Approval for Two HIV Medicines
by Zacks Equity Research
Merck's (MRK) two new HIV-1 medicines, Delstrigo and Pifeltro, get approval in the United States.
Bristol-Myers' Sprycel Seeks Label Expansion in the U.S.
by Zacks Equity Research
The FDA accepts Bristol-Myers' (BMY) sBLA for label expansion of Sprycel for the treatment of pediatric patients with newly diagnosed Ph+ ALL.
Glaxo's Asthma Drug Gets EU Nod for Pediatric Population
by Zacks Equity Research
Glaxo (GSK) gains EU approval for asthma drug Nucala as an add-on treatment for severe refractory eosinophilic asthma in children.
Vertex Inks Deal With Genomics to Make Serious Disease Drugs
by Zacks Equity Research
Vertex (VRTX) signs a three-year collaboration contract with Genomics to develop novel drug targets for advancing discovery of precision medicines.
Gilead Sciences (GILD) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Gilead Sciences (GILD) closed the most recent trading day at $76.29, moving +0.9% from the previous trading session.
Gilead Sciences (GILD) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Gilead Sciences (GILD) closed the most recent trading day at $76.29, moving +0.9% from the previous trading session.
Affimed (AFMD) Surges on Collaboration Contract with Roche (revised)
by Zacks Equity Research
Affimed (AFMD) inks a strategic collaboration deal with Roche to develop a host of immunotherapies for treating different types of cancer.
Bausch (BHC) Resubmits NDA for Duobrii for Plaque Psoriasis
by Zacks Equity Research
Bausch Health Companies Inc. (BHC) resubmits its NDA for plaque psoriasis drug, Duobrii to the FDA and the agency has set a PDUFA action date of Feb 15, 2019.
Ultragenyx to File NDA for LC-FAOD Candidate on Existing Data
by Zacks Equity Research
Ultragenyx (RARE) plans to submit an NDA for UX007 for the treatment of LC-FAOD on existing data, as per agreement with the FDA.
Amgen's Leukemia Drug Blincyto Gets EU Nod for Pediatric Use
by Zacks Equity Research
Amgen's (AMGN) leukemia drug, Blincyto gets approval in EU for use in pediatric patients aged one year or older.
Affimed (AFMD) Surges On Collaboration Contract With Roche
by Zacks Equity Research
Affimed (AFMD) inks a strategic collaboration deal with Roche to develop a host of immunotherapies for treating different types of cancer.
Biotech Stock Roundup: GILD Gets EC Nod for Yescarta, AMGN Submits Kyprolis sNDA
by Zacks Equity Research
Regulatory and pipeline updates comprise some of the key developments in the biotech sector this week. These include Gilead's Yescarta approval in Europe.
Ultragenyx's Rare Disease Drug Mepsevii Gets EU Approval
by Zacks Equity Research
Ultragenyx's (RARE) Mepsevii gets European approval for the treatment of Mucopolysaccharidosis VII.
Bayer's Blood Thinner Xarelto Fails in Line Extension Studies
by Zacks Equity Research
Bayer (BAYRY) and partner Johnson & Johnson's drug, Xarelto shows no significant difference when compared with placebo in two late-stage phase III studies.
Amgen Files for Once-Weekly Regimen for Myeloma Drug Kyprolis
by Zacks Equity Research
Amgen (AMGN) submits a supplemental new drug application to the FDA, seeking an approval for once-weekly dosage of its multiple myeloma drug, Kyprolis, combined with dexamethasone (Kd).
Gilead's CAR-T Therapy Yescarta Gets Approval in Europe
by Zacks Equity Research
Gilead's (GILD) CAR-T therapy, Yescarta gets approval in Europe for adult patients suffering from relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy.
Bausch (BHC) Gets FDA Approval for Altreno for Acne Vulgaris
by Zacks.com
Bausch (BHC) advances its dermatology portfolio with the FDA approval of Altreno for acne vulgaris.
Novartis' CAR-T Therapy Kymriah Gets Approval in Europe
by Zacks Equity Research
Novartis (NVS) gets EC approval for CAR-T therapy, Kymriah, for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia.
Novo Nordisk's Ozempic Lowers Risk of Cardiovascular Events
by Zacks Equity Research
Novo Nordisk (NVO) announces post hoc results from SUSTAIN 6 study demonstrating that Ozempic consistently reduces the risk of major cardiovascular (CV) events across type II diabetes population.
Why Is Gilead (GILD) Down 6.2% Since Last Earnings Report?
by Zacks Equity Research
Gilead (GILD) reported earnings 30 days ago. What's next for the company? We take a look at earnings estimates for some clues.
Shire's Takhzyro Gets FDA Nod for Hereditary Angioedema
by Zacks Equity Research
Shire???s (SHPG) Takhzyro gets approval from the FDA for the treatment of hereditary angioedema in patients 12 years of age and older. It is the first-of-its-kind mAb preventive treatment for the same.