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Based in New Haven, CT, Alexion Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of life-transforming drugs, for the treatment of patients with ultra-rare disorders. The company’s complement franchise consists of key growth driver, Soliris, which is approved for the treatment of two severe and ultra-rare disorders resulting from chronic uncontrolled activation of the complement component of the immune system — paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Soliris is also approved for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. The FDA also approved its long-acting C5 complement inhibitor, Ultomiris, for the treatment of adult patients with PNH, to be administered every eight weeks. In October 2019, the FDA approved the use of Ultomiris as a treatment for adult and pediatric (one month of age or older) patients with aHUS to inhibit complement-mediated TMA.
Pfizer Lung Cancer Drug's Overall Survival Data Unfavorable
by Zacks Equity Research
Pfizer (PFE) announced final overall survival data from a phase III study (PROFILE 1014), evaluating its cancer drug Xalkori for first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).
AstraZeneca's Lung Cancer Study Data Promising, Shares Spike
by Zacks Equity Research
AstraZeneca, (AZN) releases data from a late-stage study on Imfinzi which showed that the new cancer drug led to superior progression-free survival to standard of care in lung cancer patients.
Regeneron/Sanofi's Dupixent Asthma Study Meets Endpoints
by Zacks Equity Research
Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi's (SNY) Dupixent (dupilumab) met two primary endpoints in phase III study.
5 Top-Ranked Biotech Stocks to Buy Right Now
by Arpita Dutt
If you are looking to invest in the biotech sector, here is a peek at 5 buy-ranked biotech stocks including Regeneron Pharmaceuticals (REGN).
Lilly to Cut 3,500 Jobs to Invest in New Drugs and Growth
by Zacks Equity Research
Lilly (LLY) plans to reduce its global workforce by approximately 3,500 positions, which should save $500 million. Lilly plans to invest the savings in new drugs and overall growth of the company.
AstraZeneca's COPD Candidate Duaklir Reports Positive Data
by Zacks Equity Research
AstraZeneca Plc (AZN) announced encouraging results from the phase III AMPLIFY study for Duaklir being developed for the treatment of chronic obstructive pulmonary disease (COPD).
Aerie Initiates Phase III Study for Ophthalmic Drug Roclatan
by Zacks Equity Research
Aerie Pharmaceuticals, (AERI) announced that it has commenced phase III study -Mercury 3 in Europe for its pipeline candidate Roclatan 0.02%/0.005%.
ProQR's QRX-421 Gets Orphan Drug Designation from FDA and EMA
by Zacks Equity Research
ProQR Therapeutics's (PRQR) pipeline candidate, QRX-421, has received orphan drug designation from the FDA and European Medicines Agency.
VIVUS Gives Rights to Alvogen in Korea for Anti-Obesity Drug
by Zacks Equity Research
VIVUS, Inc. (VVUS) signed an agreement with Alvogen giving rights to the latter to market anti-obesity drug Qsymia in Korea for the treatment of chronic weight management or weight-related conditions.
Cellect Biotechnology (APOP) Soars: Stock Adds 10.2% in Session
by Zacks Equity Research
Cellect Biotechnology Ltd. (APOP) was a big mover last session, as the company saw its shares rise more than 10% on the day.
4 Biotech Stocks to Improve Your Portfolio's Health
by Zacks Equity Research
The biotech industry has posted a turnaround in the first half of the year, despite facing pricing issues in 2016.
The Zacks Analyst Blog Highlights: Regeneron Pharmaceuticals, Activision Blizzard, Intuit, Alexion Pharmaceuticals and Gilead Sciences
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Regeneron Pharmaceuticals, Activision Blizzard, Intuit, Alexion Pharmaceuticals and Gilead Sciences
Biotech Stocks Back in Favor: Will the Rally Continue?
by Arpita Dutt
Interest in the biotech sector has picked up with the Gilead (GILD)-Kite acquisition announcement. Will the rally continue?
AMAG's Filing for Feraheme's Label Expansion Accepted by FDA
by Zacks Equity Research
AMAG Pharmaceuticals (AMAG) announced that the FDA accepted its submission for the label expansion of Feraheme (ferumoxytol) and has set an action date of Feb 2, 2018.
Amgen Gets EU Nod to Expand Hyperparathyroidism Drug Label
by Zacks Equity Research
The European Commission approves Amgen's (AMGN) marketing application for Mimpara's pediatric formulation to heal secondary hyperparathyroidism (HPT).
5 Winning Stocks to Beat September Blues
by Tirthankar Chakraborty
Investing in stocks that have traditionally given consistent returns during the weakest month of the year seems judicious.
Teva Austedo Gets FDA Nod for Label Expansion in Dyskinesia
by Zacks Equity Research
Teva Pharmaceutical (TEVA) announced that the FDA has approved the label expansion of Austedo to include tardive dyskinesia in adults. Shares are up since announcement.
Roche's (RHHBY) Actemra Gets FDA Nod for Label Expansion
by Zacks Equity Research
Roche Holding AG's (RHHBY) drug Actemra got FDA approval for label expansion.
BioMarin's Pegvaliase BLA Granted Priority Review by the FDA
by Zacks Equity Research
BioMarin Pharmaceutical (BMRN) announced that the FDA has accepted and granted priority review to the BLA for phenylketonuria candidate, Pegvaliase with a decision expected in February 2018.
Juno Therapeutics (JUNO) Soars: Stock Adds 20.1% in Session
by Zacks Equity Research
Juno Therapeutics (JUNO) saw a big move last session, as its shares jumped over 20% on the day amid huge volumes.
Advanced Accelerator Gets Action Date for Lutathera from FDA
by Zacks Equity Research
The FDA granted an action date for Lutathera after the company resubmitted the New Drug Application (NDA) for the candidate.
Novo Nordisk's Tresiba Gets Canadian Nod
by Zacks Equity Research
Novo Nordisk's (NVO) Tresiba is approved by Health Canada for the once-daily treatment of adults with diabetes mellitus to improve glycemic control.
Kamada (KMDA) Gets FDA Approval for Rabies Vaccine
by Zacks Equity Research
Kamada Ltd. (KMDA) and partner Kedrion Biopharma and announced that FDA has approved Kedrab [rabies immune globulin (Human)] for post-exposure prophylaxis against rabies infection.
Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.
by Zacks Equity Research
Vertex Pharmaceuticals' (VRTX) regulatory applications for tezacaftor/ivacaftor (Kalydeco) combination have been accepted by the FDA and EMA for review.
Array BioPharma (ARRY) Looks Good: Stock Adds 5.9% in Session
by Zacks Equity Research
Array BioPharma (ARRY) shares rose nearly 6% in the last trading session, amid huge volumes.