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Zacks News
BioMarin's Hemophilia Candidate Included in PRIME Initiative
by Zacks Equity Research
BioMarin Pharmaceutical Inc. (BMRN) announced that BMN 270, being evaluated for the treatment for severe hemophilia A, has been granted access to Priority Medicines (PRIME), a regulatory initiative by the European Medicines Agency (EMA).
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).
AbbVie (ABBV) HCV Regimen Gets Priority Review in Canada
by Zacks Equity Research
AbbVie Inc. (ABBV) announced that its New Drug Submission (NDS) for an investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) received priority review in Canada for treatment of HCV.
Endo's (ENDP) Ephedrine Sulfate Injection Gets FDA Approval
by Zacks Equity Research
Endo International plc (ENDP) announced that Par Pharmaceutical has received final approval from the FDA regarding its New Drug Application (NDA) for ephedrine sulfate injection.
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.
Allergan (AGN) Avycaz Label to Include New Phase III Data
by Zacks Equity Research
Allergan plc (AGN) announced that its supplemental new drug application (sNDA) for antibiotic Avycaz has been approved by the FDA. Allergan is looking to include new data from two phase III trials, RECAPTURE and REPRISE, in the drug???s label.
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.
Novo Nordisk Inks Diabetes Deal with University of Oxford
by Zacks Equity Research
Novo Nordisk A/S (NVO) and University of Oxford announced a landmark research collaboration for the treatment of type II diabetes.
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.
AstraZeneca's Symbicort Granted Pediatric Exclusivity by FDA
by Zacks Equity Research
AstraZeneca (AZN) announced that the FDA has granted six months of pediatric exclusivity to its Symbicort inhalation aerosol.
Immunogen Doses First Patient in Ovarian Cancer Drug Study
by Zacks Equity Research
ImmunoGen, Inc. (IMGN) announced that the first patient has been dosed in FORWARD I, the company's phase III study, assessing mirvetuximab soravtansine, as a single-agent therapy for the treatment of platinum-resistant ovarian cancer.
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.
Pfizer (PFE) C. Difficile Vaccine Positive in Phase II Study
by Zacks Equity Research
Pfizer Inc. (PFE) announced positive top-line results from a phase II study on its investigational vaccine candidate, PF-06425090, for the prevention of clostridium difficile infection.
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.
J&J to Acquire Actelion for $30B: Is It a Strategic Fit?
by Zacks Equity Research
Johnson & Johnson (JNJ) entered into a definitive agreement to acquire Actelion (ALIOF) for $280 per share, as of Jan 25, 2017, in an all-cash transaction.
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.
Bristol-Myers (BMY) Misses on Q4 Earnings, Beats on Sales
by Zacks Equity Research
Bristol-Myers (BMY) reported fourth quarter earnings of 63 cents on revenues of $5.23 billion.
Vertex Pharma's (VRTX) Q4 Earnings & Sales Beat; Stock Up
by Zacks Equity Research
Vertex Pharmaceuticals Inc. (VRTX) reported fourth-quarter 2016 earnings of 11 cents per share (including the impact of stock-based compensation expenses). The Zacks Consensus Estimate was of a loss of 1 cent per share.
Lilly's Elanco Unit & Aratana Launch Veterinary Pain Drug
by Zacks Equity Research
Eli Lilly and Company's (LLY) animal health subsidiary, Elanco and partner Aratana Therapeutics, Inc. (PETX) together announced the availability of Galliprant for the management of pain and inflammation associated with canine osteoarthritis (OA).
AbbVie's HCV Regimen Okayed for Accelerated Assessment
by Zacks Equity Research
AbbVie Inc. (ABBV) recently announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P).
Endo (ENDP) Settles Disputes with Federal Trade Commission
by Zacks Equity Research
Endo International plc (ENDP) announced that it has resolved all disputes with the U.S. Federal Trade Commission (FTC).
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.
Marinus Releases Positive Preliminary Data from CDKL5 Study
by Zacks Equity Research
Marinus Pharmaceuticals, Inc. (MRNS), announced positive preliminary data from the initial CDKL5 pediatric patients enrolled in its ongoing phase II study assessing pipeline candidate, ganaxolone, for the treatment of orphan, genetic disorders.