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Alnylam's RNAi Candidate Gains Breakthrough Therapy Status

3h zacks
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the FDA has granted Breakthrough Therapy Designation for lead candidate, patisiran. The candidate is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment adults with hereditary ATTR (hATTR) amyloidosis with polyneuropathy.  (24-1)

Can Valeant (VRX) Turn Around on Rebuilding Initiatives?

4h zacks
Shares of Valeant Pharmaceuticals International Inc. (VRX - Free Report) have rallied 7.2% year to date compared with the industry’s gain of 2.4%. (242-1)

Agios Posts New Data on Glioma Candidate from Dose Expansion

21h zacks
Agios Pharmaceuticals, Inc. (AGIO - Free Report) announced new data from the dose expansion part of a phase I study, evaluating its IDH1 mutant inhibitor, ivosidenib (AG-120), as a single agent for treating low grade isocitrate dehydrogenase-1 mutant (IDH1m) glioma. Data was presented at the annual meeting of the Society for Neuro-Oncology (“SNO”) in San Francisco. (115-0)

Mallinckrodt (MNK) Down 55% Year to Date: What Lies Ahead?

21h zacks
Shares of Mallinckrodt plc (MNK - Free Report) have tumbled 55.1% year to date, compared with the industry’s decline of 29.2%. (46-0)

Roche Reports Positive Data From Tecentriq Combination Study

2017-11-20 zacks
Roche Holding AG’s (RHHBY - Free Report) member, Genentech, announced that the phase III IMpower150 study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel), with or without Avastin has met its co-primary endpoint of progression-free survival (PFS). The study is being conducted  in people with stage IV non-squamous non-small cell lung cancer (NSCLC), who had not been treated with chemotherapy for their advanced disease. (51-0)

Ultragenyx's rhGUS Gets FDA Nod for Rare Genetic Disease

2017-11-17 zacks
Ultragenyx Pharmaceutical Inc. (RARE - Free Report) announced that the FDA has approved its genetic disorder drug, vestronidase alfa or rhGUS, for treatment of children and adults with mucopolysaccharidosis VII (MPS VII, also known as Sly syndrome). It is approved under the trade name, MEPSEVII. (43-0)

Alnylam Starts Rolling NDA Submission for RNAi Candidate

2017-11-17 zacks
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has initiated submission of a rolling New Drug Application (NDA) to the FDA for lead candidate patisiran. The candidate is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis.  The rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis. (49-0)

Your Daily Pharma Scoop: A Look At Sanofi, Ultragenyx Gets FDA Nod, Capricor Tumbles

2017-11-16 seekingalpha
This abridged “Daily Scoop” is published by Avisol Capital Partners, which runs the physician-managed Total Pharma Tracker healthcare investment research service on Seeking Alpha Marketplace. (381-4)

Valeant (VRX) Announces Pricing of Senior Secured Notes

2017-11-15 zacks
Valeant Pharmaceuticals International, Inc. (VRX - Free Report) announced that it has priced its previously announced offering of $750,000,000 aggregate principal amount of 5.500% senior secured notes due 2025. These will be additional notes and form part of the same series as the existing 5.500% senior secured notes due 2025.Valeant will sell the notes at a price of 100.0% of the principal amount thereof plus accrued interest from Oct 17, 2017. (201-0)

Pacira's Exparel sNDA to be Reviewed by FDA Advisory Committee

2017-11-15 zacks
Shares of Pacira Pharmaceuticals, Inc. (PCRX - Free Report) declined about 6.6% on Nov 14. This followed the FDA’s notice stating that the company’s supplemental New Drug Application (sNDA) for  label expansion of Exparel (bupivacaine liposome injectable suspension) in the nerve block setting will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (“AADPAC”) before a final decision. (49-0)

Ligand Pharmaceuticals' (LGND) Presents at Analyst Day (Transcript)

2017-11-15 seekingalpha
Welcome. Thank you, everyone, for joining us. Ligand's end-of-the-year Analyst Day 2018 and beyond. We appreciate the turnout. We got a nice group on the audience today. The attendees on the webcast that continue to add and we really do appreciate your attention here at the end of day and close to the end of the year. My name is John Higgins, I'm the CEO of Ligand. I'm joined by several of our colleagues. (115-0)

Theravance (TBPH) Submits NDA for COPD Candidate Revefenacin

2017-11-14 zacks
Theravance Biopharma, Inc. (TBPH - Free Report) and partner Mylan (MYL - Free Report) announced that the new drug application for the combined entity’s key pipeline candidate, revefenacin (TD-4208), has been submitted to the FDA for treatment of adults with chronic obstructive pulmonary disease (“COPD”). (74-0)

Merck (MRK) Gets CHMP Nod for Infection Candidate Prevymis

2017-11-14 zacks
Merck & Co., Inc. (MRK - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing approval of Prevymis (letermovir). (41-0)

Alnylam RNAi Drug Gets Accelerated Assessment Grant From EMA

2017-11-14 zacks
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has granted an accelerated assessment for patisiran. (72-0)

Shire Gets Positive CHMP Opinion for Hemophilia A Drug

2017-11-14 zacks
Shire plc (SHPG - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending approval  of Adynovi [Antihemophilic Factor (Recombinant), PEGylated]. (73-0)

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