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Zacks News
Concert's (CNCE) CTP-656 Gets Orphan Drug Status in U.S.
by Zacks Equity Research
Concert Pharmaceuticals, Inc. (CNCE) announced that the FDA has granted orphan drug designation to its candidate CTP-656 for the treatment of cystic fibrosis.
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.
Minerva Presents Additional Data from Schizophrenia Drug
by Zacks Equity Research
Minerva Neurosciences, Inc. (NERV) announced the results of additional data analyses from phase IIb clinical trial of MIN-101, as monotherapy in patients with negative symptoms of schizophrenia.
Shire's (SHPG) ADHD Candidate's NDA Accepted by FDA
by Zacks Equity Research
Shire plc (SHPG) announced that the FDA has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for pipeline candidate, SHP465.
Bristol-Myers to Not Seek Accelerated Approval for Opdivo+Yervoy
by Zacks Equity Research
Bristol-Myers (BMY) won't seek an accelerated approval in the U.S. for the combination of its two immuno-oncology treatments Opdivo plus Yervoy for the first-line lung cancer.
Aduro (ADRO) Inks License Agreement with Stanford University
by Zacks Equity Research
Aduro Biotech, Inc. (ADRO) announced that it has inked an exclusive license agreement with Stanford University for state-of-the-art neo-antigen identification technology.
Mallinckrodt to Pay $100M Fine to FTC for Questcor Matter
by Zacks Equity Research
Mallinckrodt plc (MNK), will have to pay a fine of $100 million to the U.S. Federal Trade Commission (FTC) to resolve the latter???s investigation into the acquisition of Synacthen Depot by its Questcor division.
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.
Teva's (TEVA) Pain Drug Vantrela ER Receives FDA Approval
by Zacks Equity Research
Teva Pharmaceutical Industries Ltd. (TEVA) announced that the FDA has approved Vantrela ER for the treatment of pain which is severe enough to require daily, around-the-clock, long-term opioid treatment.
Bioblast (ORPN) SCA3 Drug Favorable in Phase IIa Study
by Zacks Equity Research
Bioblast (ORPN) announced results from a phase IIa study on trehalose for the treatment of patients with spinocerebellar ataxia type 3.
Allergan's Uterine Fibroids Candidate Positive in Phase III
by Zacks Equity Research
Allergan Plc (AGN) and European specialty pharma company Gedeon Richter reported encouraging results from a phase III study on their pipeline candidate, ulipristal acetate, in women with abnormal bleeding due to uterine fibroids.
Concert Offers Update on Cystic Fibrosis Drug, Stock Down
by Zacks Equity Research
Concert Pharmaceuticals, Inc. (CNCE) provided update on the development plan of its next generation CFTR potentiator, CTP-656, for the treatment of cystic fibrosis in the U.S. and Europe.
Sanofi Diabetes Drug Suliqua Wins EU Marketing Approval
by Zacks Equity Research
Sanofi (SNY) announced that the European Commission has granted marketing authorization to its once-daily injection, Suliqua a combination of diabetes drugs Lantus and lixisenatide for the treatment of diabetes.
Jazz Begins Phase III Study for Label Expansion of Defitelio
by Zacks Equity Research
Jazz Pharmaceuticals Public Limited Company (JAZZ) announced the initiation of a phase III clinical study on its marketed drug, Defitelio (defibrotide), for the potential prevention of veno-occlusive disease.
AstraZeneca Offers Update on Immuno-Oncology Program
by Zacks Equity Research
AstraZeneca (AZN) provided an update on its late-stage immuno-oncology program for first-line NSCLC.
Agenus, NCI Ink Deal to Evaluate Prophage-Keytruda Combo
by Zacks Equity Research
Agenus (AGEN) entered into a clinical trial collaboration with the National Cancer Institute to evaluate Prophage, in conjunction with Merck's (MRK) Keytruda.
Kura Oncology Starts Dosing Patients in Phase II CMML Study
by Zacks Equity Research
Kura Oncology (KURA) dosed the first patient in a phase II study on tipifarnib for the treatment of chronic myelomonocytic leukemia.
Benitec Stock Up on Orphan Drug Status for BB-301 in EU
by Zacks Equity Research
Benitec (BNTC) announced that its proposed candidate, BB-301, received Orphan Drug Designation in the EU for the treatment of ocularpharyngeal muscular dystrophy.
Biogen to Pay $1.25B to Forward Pharma in Tecfidera Lawsuit
by Zacks Equity Research
Biogen Inc. (BIIB) recently entered into a settlement and license agreement with Danish biotech, Forward Pharma A/S (FWP) with respect to an ongoing patent dispute for Tecfidera.
Biogen's Multiple Sclerosis Franchise to Drive Growth in 2017
by Zacks Equity Research
We issued an updated research report on Biogen Inc. (BIIB) on Jan 16.
What's Behind Clovis' (CLVS) One-Year Rally of 146.3%?
by Zacks Equity Research
In December, Clovis received the FDA nod for its first product, Rubraca, which sent its shares soaring.
Novartis to Conduct Trial on Obese, Type II Diabetes Patients
by Zacks Equity Research
In a recent announcement, MorphoSys AG mentioned that its partner Swiss major Novartis AG (NVS) will conduct a phase II clinical trial on pipeline candidate bimagrumab in obese patients with type II diabetes.
Pluristem (PSTI) Intermittent Claudication Study Enrolled
by Zacks Equity Research
Pluristem Therapeutics (PSTI) has completed patient enrollment in a phase II study on PLX-PAD cells for the treatment of intermittent claudication.
Incyte/Merck to Start More Epacadostat-Keytruda Studies
by Zacks Equity Research
Incyte (INCY) and Merck (MRK) announced that they have decided to initiate additional pivotal studies on epacadostat, in combination with Merck's Keytruda.
AMAG, Palatin Ink Deal to Focus on Female Sexual Disorder
by Zacks Equity Research
AMAG (AMAG) announced that it has entered into an agreement with Palatin (PTN) for the exclusive U.S. rights to develop and commercialize Rekynda.