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Zacks News
Mallinckrodt (MNK) Tops on Earnings in Transition Quarter
by Zacks Equity Research
Mallinckrodt Public Limited Company (MNK) reported positive results for the transition quarter (Oct 1, to Dec 30, 2016) beating both sales and earnings expectations.
Auris (EARS) Expands Pipeline with Intranasal Betahistine
by Zacks Equity Research
Auris (EARS) announced that it has strengthened its pipeline by the addition of AM-125 as the third clinical-stage program, which allowed it to expand into the field of vestibular disorders.
Portola, HealthCare Royalty Partners Ink $150 Million Deal
by Zacks Equity Research
Portola (PTLA) announced that it has signed a royalty agreement with HealthCare Royalty Partners (HCR) for $150 million.
AMAG Down Despite Positive Data on Makena Auto-Injector
by Zacks Equity Research
AMAG Pharmaceuticals (AMAG) announced positive top-line results from its pharmacokinetic (PK) study on Makena, subcutaneous auto-injector.
Novartis (NVS) Votubia Gets EU Approval for Label Expansion
by Zacks Equity Research
Novartis (NVS) wins EU approval for label expansion of Votubia in refractory partial-onset seizures in patients with tuberous sclerosis complex.
Catabasis Hits 52-Week Low on Poor DMD Drug Study Data
by Zacks Equity Research
Catabasis (CATB) announced disappointing top-line safety and efficacy data from part B of the MoveDMD study (phase I/II) on edasalonexent (CAT-1004).
Eli Lilly (LLY) Misses on Q4 Earnings, Beats on Revenues
by Zacks Equity Research
Eli Lilly (LLY) reported fourth quarter earnings of 95 cents on revenues of $5.76 billion.
Mylan (MYL) Gets Favorable Verdict for Copaxone in the US
by Zacks Equity Research
Mylan N.V. (MYL) announced that the United States District Court for the District of Delaware has issued a decision in favor of the company pertaining to claims related to Teva Pharmaceutical's (TEVA) Copaxone 40mg/mL.
Exelixis Inks Partnership with Takeda for Cabometyx in Japan
by Zacks Equity Research
Exelixis (EXEL) and Takeda (TKPYY) entered into an exclusive licensing agreement for the commercialization and clinical development of Cabometyx in Japan.
Endo (ENDP) Restructures Branded Pharmaceutical Unit (revised)
by Zacks Equity Research
Endo International plc (ENDP) announced that it has begun restructuring its corporate and branded pharmaceutical R&D functions in Malvern, PA and Chestnut Ridge, NY.
Celgene (CELG) Gets Favorable CHMP Opinion for Revlimid
by Zacks Equity Research
Celgene Corporation (CELG) announced that the EMA's CHMP has rendered a positive opinion for oncology drug Revlimid as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma.
Ironwood/Astellas Report Positive Phase III Data on Linzess
by Zacks Equity Research
Ironwood (IRWD) and partner Astellas reported positive top-line data from a phase III study on Linzess in adults with chronic constipation.
AbbVie (ABBV) Q4 Earnings Meet Estimates, Revenues Lag
by Zacks Equity Research
AbbVie (ABBV) reported earnings of $1.20 in the fourth-quarter of 2016, with revenues coming in at $6.80 billion.
Endo (ENDP) Restructures its Branded Pharmaceutical Unit
by Zacks Equity Research
Endo International plc (ENDP) announced that it has begun restructuring its corporate and branded pharmaceutical R&D functions in Malvern, PA and Chestnut Ridge, NY.
Celgene (CELG) Misses on Earnings & Revenues, Keeps View
by Zacks Equity Research
Celgene (CELG) reported fourth-quarter 2016 earnings of $1.41 per share (including share-based compensation expense and tax adjustments), missing the Zacks Consensus Estimate of $1.43.
Roche (RHHBY) Arthritis Drug Actemra sBLA Accepted by FDA
by Zacks Equity Research
Roche's (RHHBY) supplemental Biologics License Application (sBLA) for arthritis drug, Actemra, accepted for review by the FDA for giant cell arteritis (GCA).
Novartis (NVS) Beats Q4 Earnings, Might Spin-Off Alcon
by Zacks Equity Research
Novartis' (NVS) fourth-quarter 2016 results were mixed with the company beating earnings estimates but missing on revenues. The company has been facing challenging conditions for the past few quarters.
Sunesis Offers Updates on SNS-062 and Qinprezo Programs
by Zacks Equity Research
Sunesis (SNSS) provided updates on two of its lead programs: SNS-062, and Qinprezo (vosaroxin).
Eagle Pharmaceuticals Wraps Up Ryanodex NDA Submission
by Zacks Equity Research
Eagle (EGRX) announced that it has completed the submission of its 505(b)(2) NDA in the U.S. for Ryanodex for the treatment of exertional heat stroke.
Gilead (GILD) HCV Therapy Application Validated in Europe
by Zacks Equity Research
Gilead Sciences, Inc. (GILD) announced that its MAA for once-daily, single tablet regimen of Sovaldi, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for HCV treatment has been fully validated.
Bristol-Myers Settles Litigation with Merck for Keytruda
by Zacks Equity Research
Bristol-Myers Squibb Company (BMY) along with partner Ono Pharmaceutical Company, Ltd. announced that both the companies have signed a global patent license agreement with Merck & Co., Inc. (MRK) to settle all litigation related to Keytruda.
Prima Biomed Initiates Randomized Study for Breast Cancer
by Zacks Equity Research
Prima (PBMD) dosed the first patient in the enlarged randomized phase of the phase IIb study -- AIPAC -- on IMP321 for the treatment of metastatic breast cancer.
Synergy (SGYP) Trulance Wins FDA Approval for Constipation
by Zacks Equity Research
Synergy Pharmaceuticals Inc. (SGYP) announced that the FDA has approved one of its lead pipeline candidates, Trulance (plecanatide), for the treatment of adults suffering from chronic idiopathic constipation (CIC).
Allergan (AGN) Rhofade Cream for Rosacea Approved in U.S.
by Zacks Equity Research
Allergan plc (AGN) announced that the FDA has approved Rhofade (oxymetazoline hydrochloride) cream for topical treatment of persistent facial erythema (redness) associated with rosacea in adults.
Apricus (APRI) Stock Gains on Vitaros' Approval in Mexico
by Zacks Equity Research
Apricus (APRI) announced that Vitaros was approved in Mexico for the treatment of patients with erectile dysfunction.