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Zacks News
Emergent BioSolutions Acquires Sanofi's Smallpox Vaccine Unit
by Zacks Equity Research
Emergent BioSolutions (EBS) announced that it has acquired FDA-licensed smallpox vaccine's business of Sanofi (SNY) ??? ACAM2000.
Roche (RHHBY) Receives FDA Approval For Cobas Zika Test
by Zacks Equity Research
The approval of cobas Zika will expands Roche's industry-leading donor screening portfolio for blood-borne diseases.
ACADIA's Antipsychotic Drug Gets Breakthrough Therapy Status
by Zacks Equity Research
ACADIA Pharmaceuticals' (ACAD) Nuplazid granted Breakthrough Therapy Designation for dementia-related psychosis. A phase III study for the same was also initiated.
Ligand (LGND) Signs Deal to Acquire Crystal Bioscience
by Zacks Equity Research
Ligand (LGND) inked a deal to acquire Crystal Bioscience, a leader in chicken-derived fully-human antibody generation, for $25 million in cash.
Celsion's Immunotherapy Candidate Impresses, Stock Surges
by Zacks Equity Research
Celsion's (CLSN) pipeline candidate, GEN1, controls ovarian cancer in all patients in the phase Ib study and achieves a historical improvement in progression free survival.
Emergent Completes Acquisition of Anthrax Drug Raxibacumab
by Zacks Equity Research
Emergent BioSolutions Inc. (EBS) completes the acquisition of anthrax monoclonal antibody, raxibacumab, from GlaxoSmithkline.
Allergan Authorizes New $2B Share Buyback Plan, Stock Up
by Zacks Equity Research
Allergan plc (AZN) sanctions a new stock repurchase program. The company also reiterates its commitment toward annual hike of quarterly cash dividend.
Glaxo-Innoviva's Triple Combo Inhaler Positive in Phase III
by Zacks Equity Research
GlaxoSmithKline plc (GSK) along with partner Innoviva reports positive results from a phase III study, evaluating a single inhaler triple therapy in patients with COPD.
Supernus Drops SPN-810's Lower Dose Test in Phase III Trials
by Zacks Equity Research
Supernus (SUPN) decides to stop evaluating the lower dose option of SPN-810 for treatment of impulsive aggression. However, the company will carry on with the study of higher dose arm or placebo.
Glaxo/Innoviva's Triple Combo Therapy Gets FDA Nod for COPD
by Zacks Equity Research
The FDA approves GlaxoSmithKline (GSK) and Innoviva's triple combination therapy, FF/UMEC/VI, for COPD. The drug will be accessed as Trelegy Ellipta in the U.S. market.
BioMarin Says FDA Not Planning an AdCom for Pegvaliase BLA
by Zacks Equity Research
The FDA currently shows no intent to hold an AdCom to discuss the BLA for BioMarin's (BMRN) pipeline candidate, pegvaliase.
GTx's (GTXI) Enobosarm Positive in Phase II, Shares Down
by Zacks Equity Research
GTx (GTXI) posts positive data from a phase II study of enobosarm for treating women with stress urinary incontinence. However, shares dip possibly with the release falling below market estimates.
Alexion (ALXN) Reports Interim Results for Soliris Study
by Zacks Equity Research
Alexion (ALXN) announced results from an interim analysis of an ongoing phase III REGAIN study of Soliris. The study showed sustained treatment benefits of Soliris treatment for patients with refractory generalized myasthenia gravis.
Perrigo's Stock Up, Starboard's CEO Calls it a Key Pick
by Zacks Equity Research
Perrigo's (PRGO) shares rise with Jeff Smith, CEO of Starboard Value, certifying the company as a top investment pick, courtesy its highly potential generic business.
Marinus Stock Surges on Successful Phase II Epilepsy Study
by Zacks Equity Research
Marinus (MRNS) announced positive top-line data from a phase II study on its epilepsy candidate, ganaxolone, for treating CDKL5 disorder.
Ultragenyx's Burosumab Positive in Phase II for XLH and TIO
by Zacks Equity Research
Ultragenyx's (RARE) burosumab passes the test with positive data from two phase II studies. The candidate gets evaluated for X-linked hypophosphatemia and tumor-induced osteomalacia.
BioMarin Presents Interim Data on BMN 250 from Phase I/II
by Zacks Equity Research
BioMarin's (BMRN) interim data from a current dose escalation phase I/II study on BMN 250 shows improvement signs in cognitive Development Quotient.
Merck (MRK) Opts for Buying German Immuno-Oncology Biotech
by Zacks Equity Research
Merck (MRK) to acquire Germany-based Rigontec, a leader in retinoic acid-inducible gene I (RIG-I), a novel immuno-oncology treatment approach targeting therapeutics.
The Medicines Company's Infection Drug Vabomere Gets FDA Nod
by Zacks Equity Research
The Medicines Company's (MDCO) infection-resistant antibiotic Vabomere secures a fast FDA approval for urinary tract diseases. The drug is likely to hit the market in fourth-quarter 2017.
FDA's Refusal-to-File Letter for Inbrija Pushes Acorda Down
by Zacks Equity Research
Acorda (ACOR) receives a refusal to file (RTF) letter from the FDA in connection with Inbrija's NDA.
The Medicines Co's Inclisiran Positive in Extension Study
by Zacks Equity Research
The Medicines Company (MDCO) and partner Alnylam publish new one-year safety and efficacy data from phase II extension study of Inclisiran for hypercholesterolemia.
Anthera's Blisibimod Positive in Phase II Extension Study
by Zacks Equity Research
Anthera's (ANTH) blisibimod passes test in an extended phase II study to prove efficacy for IgA nephropathy treatment. The study also shows a trend toward preservation of renal function.
J&J's (JNJ) Xarelto/Aspirin Regimen Positive in Phase III
by Zacks Equity Research
J&J's (JNJ) blood thinner Xarelto shows a significant risk reduction in major cardiovascular events in patients with stable coronary and peripheral artery disease.
Minerva-J&J's Amendment of MIN-202 Contract Wins EU Approval
by Zacks Equity Research
The EU approves of Minerva's (NERV) amendment of MIN-202 license agreement with Janssen. Per the deal, Minerva will receive an upfront payment from Janssen.
Adamas (ADMS) Dyskinesia Drug Gets FDA Approval, Stock Soars
by Zacks Equity Research
Adamas Pharmaceuticals' (ADMS) Gocovri was approved by the FDA for treating dyskinesia in patients with Parkinson's disease. This led to an upside in shares.