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Zacks News
Insys' Cannabidiol Gets Fast Track Designation in the U.S.
by Zacks Equity Research
The FDA grants a fast track status to Insys' (INSY) cannabidiol oral solution for Prader-Willi syndrome. The company also plans to move the candidate into clinical development in first-quarter 2018.
Agios (AGIO) Files NDA for Leukemia Candidate in the U.S.
by Zacks Equity Research
Agios (AGIO) submits new drug application to the FDA for ivosidenib for relapsed or refractory acute myeloid leukemia and IDH1 mutation. The company has also filed request for a priority review.
Why is Corcept's Stock Up More Than 150% So Far This Year?
by Zacks Equity Research
We take a look at the factors that drove the phenomenal growth in share price of Corcept (CORT) in 2017.
Alexion's (ALXN) Soliris Label Expansion Approved in Japan
by Zacks Equity Research
Alexion's (ALXN) announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan approved the label expansion of Soliris for the treatment of patients with generalized myasthenia gravis (gMG).
Merck's Diabetes Drugs Get FDA Nod as Adjunct Therapies
by Zacks Equity Research
Merck's (MRK) three diabetes drugs get FDA approval as adjunct treatment to diet and exercise to improve glycemic control in patients with diabetes mellitus.
BioMarin's (BMRN) Pegvaliase Review Period Extended by FDA
by Zacks Equity Research
BioMarin (BMRN) extended the review period of its biologics license application (BLA) for pegvaliase by three months to May 25, 2018.
Portola's (PTLA) AndexXa BLA Review Period Extended by FDA
by Zacks Equity Research
The FDA extends the review period of Portola's (PTLA) biologics license application for AndexXa by 90 days. Its response is now deferred to May 4, 2018 instead of the earlier Feb 3 deadline.
Strength Seen in Corcept Therapeutics (CORT): Stock Soars 10.8%
by Zacks Equity Research
Corcept Therapeutics (CORT) was a big mover last session, as the company saw its shares rise more than 10% on the day amid huge volumes.
Jazz Submits NDA to FDA for JZP-110 to Cure Sleep Disorder
by Zacks Equity Research
Jazz submits a new drug application to the FDA for JZP-110 (solriamfetol) for treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.
Allergan/Paratek's Acne Candidate NDA Filing Accepted by FDA
by Zacks Equity Research
Allergan (AGN) and partner Paratek announces that its new drug application for Seysara has been accepted for review by the FDA for moderate to severe acne vulgaris.
Achillion's Renal Disease Candidate Gets Orphan Drug Status
by Zacks Equity Research
Achillion Pharmaceuticals' (ACHN) factor D inhibitor, ACH-4471, gets orphan drug designation for treating C3G, a renal disease.
Regeneron in Strategic Immuno-Oncology Collaboration With ISA
by Zacks Equity Research
Regeneron Pharmaceuticals (REGN) and ISA Pharmaceuticals inked an agreement to advance ISA101 in combination with cemiplimab.
Alnylam/Sanofi Submit MAA in Europe for RNAi Candidate
by Zacks Equity Research
Alnylam (ALNY) and partner Sanofi have submitted a Marketing Authorization Application to the European Medicines Agency for patisiran for the treatment adults with hereditary ATTR amyloidosis with polyneuropathy.
Novartis (NVS) Oncology Head Strigini to Step Down by Dec. 31
by Zacks Equity Research
Novartis (NVS) is at a transitional stage as the CEO of its oncology segment will step down by the end of year. The company's CEO is also going to step next year.
Radius Health to Get Third Day-180 List of Outstanding Issues
by Zacks Equity Research
Radius Health (RDUS) will get a third Day-180 List of Outstanding Issues from the CHMP for its marketing authorisation application of abaloparatide-SC leading to a further delay in tentative approval.
Spectrum Pharma Dismisses CEO, Makes Leadership Changes
by Zacks Equity Research
Spectrum Pharma (SPPI) terminates Rajesh Shrotriya and appoints its present COO, Joseph Turgeon, as the new CEO.
Shire's New Formulation of Oncaspar Gets Approval in Europe
by Zacks Equity Research
Shire's (SHPG) marketing authorization application for a new (dried) formulation of its leukemia drug, Oncaspar receives approval from the European Commission.
Regeneron, Sanofi Report Positive Top Line Skin Cancer Data
by Zacks Equity Research
Regeneron (REGN) and partner Sanofi announced positive top-line results from a pivotal phase II study of skin cancer candidate cemiplimab.
Allergan Inks Deal to Buy Texas-Based Repros Therapeutics
by Zacks Equity Research
Allergan (AGN) signs a definitive contract to acquire Texas-based Repros Therapeutics, which is focused on developing new drugs to treat hormonal and reproductive system disorders.
Glaxo's Nucala Label Expansion Application Gets FDA Approval
by Zacks Equity Research
GlaxoSmithKline's (GSK) application to include treatment of eosinophilic granulomatosis with polyangiitis in Nucala's label was approved by the FDA.
Proteostasis Stock Surges on Positive Data From CF Studies
by Zacks Equity Research
Proteostasis (PTI) stock skyrockets on positive results from early and mid-stage studies on its cystic fibrosis pipeline candidates.
Merck's Keytruda Gets FDA Priority Review for Rare Lymphoma
by Zacks Equity Research
Merck (MRK) informs that the FDA grants a priority review to its supplemental biologics license application looking for its marketed drug Keytruda's label expansion for a rare lymphoma indication.
Spark Therapeutics Stock Plunges on Hemophilia Therapy Data
by Zacks Equity Research
Spark Therapeutics (ONCE) plunged 35% as investors were not impressed by the data from a phase I/II study on its Hemophilia A candidate, SPK-8011.
Lilly Reports Mixed Results from Late-Stage Cyramza Study
by Zacks Equity Research
Lilly's (LLY) gastric cancer drug, Cyramza, meets primary endpoint of progression free survival in a phase III study in first-line advanced gastric cancer patients. However, it failed to improve overall survival.
Roche Reports Tecentriq/Avastin Lung Cancer Study Data
by Zacks Equity Research
Roche (RHHBY) announced interim results from the phase III IMpower150 study of Tecentriq and Avastin plus chemotherapy in people with advanced form of lung cancer.