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Zacks News
Protalix (PLX) Fabry Disease Candidate Gets Orphan Status
by Zacks Equity Research
Protalix BioTherapeutics's (PLX) pipeline candidate, PRX-102, gets orphan drug status in Europe which is being developed as a treatment for Fabry disease.
BioMarin's (BMRN) Gene Therapy Enters First Phase III Study
by Zacks Equity Research
BioMarin (BMRN) commences the first phase III study to evaluate the 6e13 vg/kg dose of its investigational gene therapy, valoctocogene roxaparvovec, for severe hemophilia A.
Why is Alnylam's (ALNY) Stock Up More Than 200% This Year?
by Zacks Equity Research
Alnylam's (ALNY) share price has increased year to date based on impressive progress of its pipeline candidates.
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.
Novo Nordisk's (NVO) Semaglutide Gets Positive CHMP Opinion
by Zacks Equity Research
Novo Nordisk (NVO) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorisation of semaglutide for the treatment of adults with type II diabetes mellitus.
Sanofi/Alnylam Say FDA Lifts Clinical Hold on Fitusiran
by Zacks Equity Research
Sanofi (SNY) and Alnylam announced that the FDA has lifted the clinical hold placed on all ongoing studies of its hemophilia candidate, fitusiran.
Mylan Announces IPR Proceedings for Sanofi's Lantus Patents
by Zacks Equity Research
Mylan (MYL) announced that interpartes review (IPR) proceedings has been initiated by PTAB regarding two Orange Book-listed patents, U.S. Patent Nos. 7,476,652 and 7,713,930 owned by Sanofi.
Cancer Space Update: Roche, Pfizer & Regeneron Make Data Presentations
by Zacks Equity Research
Several presentations at the annual meeting of the American Society of Hematology grab headlines in the cancer space.
Pharma Stock Roundup: Teva Announces Major Job Cuts, Lilly Provides 2018 Outlook
by Arpita Dutt
This week's pharma sector highlights include ASH data, Teva's restructuring announcement and Lilly's (LLY) 2018 outlook.
Lilly Issues Guidance for 2018, New Drugs to Drive Top Line
by Zacks Equity Research
Eli Lilly (LLY) issues financial guidance for 2018 and also reaffirms the previously issued 2017 projection as well as its long-term expectations.
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.
Intersect ENT (XENT) SINUVA Implant Receives FDA Approval
by Zacks Equity Research
Intersect ENT's (XENT) consistent focus on the chronic sinusitis market is likely to lend the company a competitive edge in the niche space.
Sanofi Wins FDA Approval for Biosimilar of Lilly's Humalog
by Zacks Equity Research
Sanofi's (SNY) Admelog, a follow-on biologic version of Lilly's Humalog, received FDA approval.
3 Stocks in Focus as Biotech M&A Hopes for 2018 Rise
by Arpita Dutt
With tax reform on the horizon, the biotech sector is expected to witness a surge in M&A deals. Here is a look at Juno (JUNO) and two other biotech stocks that could be on the acquisition radar.
Sanofi Begins Combo Studies on Multiple Myeloma Candidate
by Zacks Equity Research
Sanofi (SNY) starts two new phase III studies evaluating isatuximab in combination with other cancer medicines for the treatment of multiple myeloma, a rare blood cancer.
Pharma Stock Roundup: FDA Nod for NVO's Ozempic, Second Indication for Lilly's Taltz
by Arpita Dutt
FDA approval for Novo Nordisk's (NVO) type II diabetes drug, a second indication for Lilly's Taltz, and the approval of the first Herceptin biosimilar were the key highlights this week.
Novo Nordisk's Semaglutide Gets FDA Approval for Diabetes
by Zacks Equity Research
Novo Nordisk (NVO) announced that the FDA approved semaglutide, which is a once-weekly injection approved to improve glycaemic control in adults with type II diabetes mellitus.
Sanofi's Toujeo Meets Key Objective in Head-to-Head Study
by Zacks Equity Research
Sanofi's (SNY) head-to-head study comparing Toujeo long-acting insulin to Novo Nordisk's Tresiba long-acting insulin (insulin degludec) meets its objective.
Amgen's PCSK9 Inhibitor Gets FDA Nod for Stroke Prevention
by Zacks Equity Research
Amgen (AMGN) announced FDA approval of its regulatory application seeking approval to expand Repatha's label to prevent heart attacks and strokes in patients with established cardiovascular disease.
Alnylam's RNAi Candidate Gains Breakthrough Therapy Status
by Zacks Equity Research
Alnylam (ALNY) announced that the FDA has granted Breakthrough Therapy Designation for RNAi therapeutic candidate, patisiran.
Alnylam Starts Rolling NDA Submission for RNAi Candidate
by Zacks Equity Research
Alnylam (ALNY) has started rolling New Drug Application to the FDA for its RNAi candidate, patisiran.
Why is Alnylam's (ALNY) Stock Up More Than 200% this Year?
by Zacks Equity Research
Alnylam (ALNY) expects to achieve the profile of three marketed products by the end of 2020 and remains focused on development of its pipeline candidates.
Alnylam RNAi Drug Gets Accelerated Assessment Grant From EMA
by Zacks Equity Research
Alnylam's (ALNY) RNAi candidate, patisiran, has been granted accelerated assessment by the European Medicines Agency. The company expects to file new drug application by end of 2017.
Novo Nordisk & 4 Other Pharma Stocks in Focus on World Diabetes Day
by Arpita Dutt
Despite pricing pressure & competition, the diabetes market remains lucrative given the prevalence of the disease and demand for better treatments. Novo Nordisk (NVO) is a key player in this market.