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Zacks News
Glaxo's Nucala Label Expansion Application Gets FDA Approval
by Zacks Equity Research
GlaxoSmithKline's (GSK) application to include treatment of eosinophilic granulomatosis with polyangiitis in Nucala's label was approved by the FDA.
Proteostasis Stock Surges on Positive Data From CF Studies
by Zacks Equity Research
Proteostasis (PTI) stock skyrockets on positive results from early and mid-stage studies on its cystic fibrosis pipeline candidates.
Merck's Keytruda Gets FDA Priority Review for Rare Lymphoma
by Zacks Equity Research
Merck (MRK) informs that the FDA grants a priority review to its supplemental biologics license application looking for its marketed drug Keytruda's label expansion for a rare lymphoma indication.
Spark Therapeutics Stock Plunges on Hemophilia Therapy Data
by Zacks Equity Research
Spark Therapeutics (ONCE) plunged 35% as investors were not impressed by the data from a phase I/II study on its Hemophilia A candidate, SPK-8011.
Lilly Reports Mixed Results from Late-Stage Cyramza Study
by Zacks Equity Research
Lilly's (LLY) gastric cancer drug, Cyramza, meets primary endpoint of progression free survival in a phase III study in first-line advanced gastric cancer patients. However, it failed to improve overall survival.
Roche Reports Tecentriq/Avastin Lung Cancer Study Data
by Zacks Equity Research
Roche (RHHBY) announced interim results from the phase III IMpower150 study of Tecentriq and Avastin plus chemotherapy in people with advanced form of lung cancer.
Revance's Neuromodulator Injection Positive in Phase III
by Zacks Equity Research
Revance (RVNC) releases positive top-line data from two pivotal phase III trials, evaluating RT002 for reducing wrinkles between the brows. The studies meet both primary and secondary endpoints.
Here's Why Sarepta Stock is Up More Than 70% in 6 Months
by Zacks Equity Research
Sarepta's (SRPT) key product, Exondys 51, and lead pipeline candidate, golodirsen, have put up a good show in the past six months.
AstraZeneca's COPD Drug Succeeds in Label Expansion Study
by Zacks Equity Research
AstraZeneca (AZN) releases positive top-line data from a phase IV study, evaluating label expansion of Tudorza for chronic obstructive pulmonary disease with cardiovascular risk factors.
Ironwood Succeeds in Diabetic Hypertension Phase II Study
by Zacks Equity Research
Ironwood Pharmaceuticals' (IRWD) pipeline candidate, IW-1973, reduces blood pressure and improves metabolic parameters in type II diabetes with hypertension patients in a phase IIa study.
Pfizer Wins China & Asia-Pacific Rights to Anti-Fungal Drug
by Zacks Equity Research
Pfizer (PFE) inks a deal to buy exclusive rights to develop and commercialize Basilea Pharmaceutica's anti-fungal treatment, Cresemba, in the Asia-Pacific region and China.
Bristol-Myers' Opdivo's Lung Cancer Study Meets Early Success
by Zacks Equity Research
Bristol-Myers' (BMY) phase III study evaluating Opdivo versus docetaxel was stopped earlier than expected as it met the primary endpoint.
Celldex Begins Phase I Trial on Cancer Candidate CDX-1140
by Zacks Equity Research
Celldex (CLDX) commences a phase I study on CDX-1140 for patients with advanced solid tumors. The study is designed to evaluate the safety and tolerability of the candidate at different dose levels.
Glaxo Submits NDA for Anti Relapse Malaria Medicine to FDA
by Zacks Equity Research
Glaxo (GSK) and partner Medicines for Malaria Venture filed a new drug application (NDA) with the FDA for single-dose anti relapse medicine for malaria.
AstraZeneca's Tagrisso Label Expansion Filing Accepted by EMA
by Zacks Equity Research
AstraZeneca's (AZN) Marketing Authorisation Application for label expansion of Tagrisso has been accepted by the European Medicines Agency.
Valeant Closes Senior Note Offering, Reprices Term Loan
by Zacks Equity Research
Valeant (VRX) offered new debt and restructured old debt. The company is making efforts to repay its huge level of debt.
Can Valeant (VRX) Turn Around on Rebuilding Initiatives?
by Zacks Equity Research
Valeant (VRX) has performed much better so far in 2017 compared to last year on the back of rebuilding initiatives.
Mallinckrodt (MNK) Down 55% Year to Date: What Lies Ahead?
by Zacks Equity Research
Mallinckrodt plc (MNK)'s stock lost 55% in the year so far due to ongoing investigations and weakness in Acthar and Inomax.
Roche Reports Positive Data From Tecentriq Combination Study
by Zacks Equity Research
Roche (RHHBY) announced encouraging results from IMpower150 study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel), with or without Avastin.
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.
Incyte (INCY) Initiates Essential Thrombocythemia Trial
by Zacks Equity Research
Incyte (INCY) announced that the first patient has been treated in the essential thrombocythemia trial on ruxolitinib. A potential label expansion of the drug will boost sales.
Valeant (VRX) Announces Pricing of Senior Secured Notes
by Zacks Equity Research
Valeant (VRX) prices its senior secured notes. The proceeds of the notes will be used to pay down its existing debt.
Roche (RHHBY) Receives FDA Clearance for Ventana MMR Test
by Zacks Equity Research
Roche's (RHHBY) diagnostic portfolio gets a further boost with FDA's clearance for Ventana tests.
Pacira's Exparel sNDA to be Reviewed by FDA Advisory Committee
by Zacks Equity Research
Pacira (PCRX) announced that the FDA has asked for an Advisory Committee Meeting to review the supplemental New Drug Application for expanded indication of Exparel in the nerve block setting.
Cardinal Health (CAH) to Divest Assets to Shanghai Pharma
by Zacks Equity Research
Cardinal Health (CAH) will streamline its Chinese operations by disposing pharmaceutical and medical products distribution business in China.