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Zacks News
AstraZeneca Gets CHMP Nod for Forxiga/Onglyza Combo Tablet
by Zacks Equity Research
The CHMP recommends AstraZeneca's (AZN) marketing application for Qtrilmet, a combination of Forxiga and Onglyza plus metformin, for treating patients with type-II diabetes.
FibroGen's Evrenzo Gets Nod in Japan for Anemia with CKD
by Zacks Equity Research
FibroGen's (FGEN) Evrenzo (roxadustat) wins a marketing approval in Japan for treating anemia caused by chronic kidney disease in dialysis-dependent patients.
Pharma Stock Roundup: FDA Approves Expanded Use of MRK/J&J's Drugs & Other Updates
by Kinjel Shah
FDA approves label expansion of Merck's (MRK) Keytruda and J&J's (JNJ) Erleada.
Ironwood Amends Linzess Agreement with AstraZeneca in China
by Zacks Equity Research
Ironwood (IRWD) announces amendment in collaboration agreement with AstraZeneca, granting the latter exclusive rights to develop, manufacture and commercialize Linzess in China.
AstraZeneca's Farxiga Gets Fast Track Tag for Heart Failure
by Zacks Equity Research
The FDA assigns a Fast Track status to AstraZeneca's (AZN) Farxiga to reduce the risk of cardiovascular death or worsening of heart failure in adult patients with HFrEF and HFpEF.
Biogen Stops Late-Stage Studies on Alzheimer's Candidate
by Zacks Equity Research
Biogen (BIIB) and its Japanese partner, Eisai receive another setback as they discontinue two late-stage studies evaluating elenbecestat in patients with Alzheimer's disease.
Breast Cancer Drugs May Inflame Lungs Per FDA Safety Alert
by Kinjel Shah
The FDA approves new warnings about inflammation risk to be added to labels of Pfizer's (PFE) Ibrance, Eli Lilly's (LLY) Verzenio and Novartis' (NVS) Kisqali.
Glaxo's Asthma Drug Nucala Gets FDA Nod for Pediatric Use
by Zacks Equity Research
Glaxo's (GSK) asthma medicine, Nucala gets FDA approval for use in pediatric patient population.
Pharma Stock Roundup: Pipeline/Regulatory Updates From GSK, PFE & Others
by Kinjel Shah
Glaxo's (GSK) Nucala gets FDA nod for use in kids. Pfizer (PFE), Allergan (AGN) & Roche (RHHBY) give regular pipeline/regulatory updates.
Roche Reports Positive Data on Tecentriq & NMOSD Drug (Revised)
by Zacks Equity Research
Roche's (RHHBY) immuno-oncology drug, Tecentriq, meets the primary goal in a late-stage study in NSCLC patients. Also, the company reports positive data on its NMOSD drug in a phase III study.
Roche (RHHBY) Reports Positive Data on Tecentriq & MS Drug
by Zacks Equity Research
Roche's (RHHBY) immuno-oncology drug, Tecentriq, meets the primary goal in a late-stage study in NSCLC patients. Also, the company reports positive data on its MS drug in a phase III study.
AVEO Surges on Favorable Updated OS Results on RCC Drug
by Zacks Equity Research
AVEO posts positive updated results from the second prespecified overall survival analysis of Fotivda for treating highly refractory metastatic renal cell carcinoma. Stock up more than 30%.
Bristol-Myers' (BMY) Opdivo Shows Long-Term Survival Benefit
by Zacks Equity Research
Bristol-Myers' (BMY) Opdivo continues to experience long-term OS benefit as demonstrated by the long-term pooled efficacy and safety results in patients with previously-treated NSCLC.
Lexicon (LXRX) Settles With Sanofi for $260M, Shares Rally
by Zacks Equity Research
Lexicon Pharmaceuticals (LXRX) settles with Sanofi related to termination of their alliance for development of Zynquista in type I and type II diabetes.
4 Big Drugmakers Boasting Impressive Oncology Pipelines
by Kinjel Shah
We discuss four pharma giants, which possess the industry's strongest oncology pipeline portfolios.
ACADIA Surges on Early Success of Nuplazid Dementia Study
by Zacks Equity Research
ACADIA Pharmaceuticals' (ACAD) Parkinson's psychosis drug, Nuplazid, meets primary endpoint earlier than expected in late-stage label expansion study evaluating it in patients with dementia-related psychosis.
Novartis' Capmatinib Gets Breakthrough Therapy Tag From FDA
by Zacks Equity Research
The FDA grants a Breakthrough Therapy status to Novartis' (NVS) capmatinib for the first-line treatment of patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer.
Pharma Stock Roundup: AGN's Opioid Settlement, Line Extension Nod in EU for MRK, JNJ Drugs
by Kinjel Shah
Allergan (AGN) settles with two Ohio plaintiffs for $5 million. Merck's (MRK) Keytruda, Roche's (RHHBY) Tecentriq and J&J's (JNJ) Stelara get EU approval for expanded use.
Roche's Tecentriq Combo Gets EU Nod for Difficult Lung Cancer
by Zacks Premium Research
The latest EU nod makes Roche's (RHHBY) immuno-oncology drug -- Tecentriq -- the first and only cancer immunotherapy approved for the initial treatment of ES-SCLC in Europe.
AstraZeneca's Tagrisso Gets Nod in China for First-Line NSCLC
by Zacks Equity Research
AstraZeneca's (AZN) Tagrisso gets a marketing approval in China for the first-line treatment of advanced or metastatic non-small cell lung cancer in patients with tumors having EGFR mutations.
Vertex (VRTX) Inks All-Cash Deal to Acquire Semma for $950M
by Zacks Equity Research
Vertex (VRTX) inks an all-cash deal to buy privately-held Semma Therapeutic. The acquisition will add pre-clinical type I diabetes candidates to its pipeline.
AstraZeneca's Lupus Drug Meets Primary Endpoint in Study
by Zacks Equity Research
AstraZeneca's (AZN) second phase III study evaluating anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus meets the primary endpoint.
Pharma Stock Roundup: JNJ's Opioid Lawsuit, Regulatory Nod for LLY, BMY, RHHBY Drugs
by Kinjel Shah
Oklahoma imposes fine of $572 million on J&J (JNJ). FDA gives nod to Lilly's (LLY) Taltz while EU approves Bristol-Myers' (BMY) Empliciti and Roche's (RHHBY) Tecentriq for expanded patient population.
Forget Pfizer, Add These Big Drugmakers to Your Portfolio
by Kinjel Shah
Buy these three large drug companies instead of Pfizer (PFE) as the stock is down this year.
AstraZeneca's Fasenra Gets Orphan Drug Status for New Disease
by Zacks Equity Research
AstraZeneca's (AZN) Fasenra gets Orphan Drug status for eosinophilic oesophagitis (EoE). A phase III COPD study on Breztri Aerosphere meets primary endpoint.