Roche Gets FDA Nod for Emergency Use of Zika Virus Test
Zacks Equity Research - Zacks Investment Research - Mon Aug 29, 7:41AM CDT
Roche Holdings (RHHBY) announced that the FDA has issued an Emergency Use Authorization (EUA) for its LightMix Zika rRT-PCR Test.
ANIP: 59.74 (-1.12), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Novartis (NVS) Reports Positive Phase III Results on MS Drug
Zacks Equity Research - Zacks Investment Research - Fri Aug 26, 9:20AM CDT
Novartis AG (NVS) announced positive results from the phase III EXPAND study on its multiple sclerosis candidate BAF312.
TEVA: 50.39 (-0.17), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45), NVS: 78.77 (-0.57)
Mallinckrodt to Divest Nuclear Imaging Business for $690M
Zacks Equity Research - Zacks Investment Research - Thu Aug 25, 7:22AM CDT
Mallinckrodt plc (MNK) announced that it has entered into a definitive agreement to sell its Nuclear Imaging business to IBA Molecular for $690 million.
MNK: 74.54 (-0.51), MDCO: 39.17 (-0.97), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Cempra's Application for Pneumonia Drug Validated in EU
Zacks Equity Research - Zacks Investment Research - Wed Aug 24, 4:02PM CDT
Cempra, Inc. (CEMP) announced that the EMA has validated its MAA for the oral capsule and intravenous (IV) formulations of pipeline candidate solithromycin, for the treatment of community-acquired bacterial pneumonia.
AGN: 234.54 (-2.45), CEMP: 21.94 (+0.50), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
J&J (JNJ) Seeks EU Approval for Darzalex's Expanded Use
Zacks Equity Research - Zacks Investment Research - Wed Aug 24, 8:10AM CDT
Johnson & Johnson's (JNJ) seeks label expansion for Darzalex in combination with standard-of-care regimens for relapsed multiple myeloma patients.
JNJ: 119.34 (-0.13), AMGN: 170.06 (-0.70), CORT: 5.33 (-0.08)
Novartis Licenses Anti-PCSK9 Antibody to Cyon Therapeutics
Zacks Equity Research - Zacks Investment Research - Wed Aug 24, 7:50AM CDT
Novartis AG (NVS) entered into a license agreement with privately held Cyon Therapeutics Inc. for its anti-PCSK9 antibody, LGT-209.
XNCR: 21.13 (-0.66), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45), NVS: 78.77 (-0.57)
Gilead (GILD) Truvada Gets EU Approval for Label Expansion
Zacks Equity Research - Zacks Investment Research - Tue Aug 23, 9:02AM CDT
Gilead Sciences (GILD) once-daily Truvada gains EU approval for reducing the risk of sexually acquired HIV-1 infection.
GILD: 78.38 (+0.46), GERN: 2.69 (unch), CORT: 5.33 (-0.08), ANIK: 47.24 (-0.21)
Roche Launches Accu-Chek Blood Glucose Monitoring System
Zacks Equity Research - Zacks Investment Research - Tue Aug 23, 8:47AM CDT
The launch of new systems will help Roche (RHHBY) offset the sales decline in the diabetes care business due to pricing pressure in the U.S. and reimbursement issues
ANIP: 59.74 (-1.12), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Supernus' Trokendi XR Gets FDA Nod for Migraine in Adults
Zacks Equity Research - Zacks Investment Research - Mon Aug 22, 8:52AM CDT
Supernus Pharmaceuticals, Inc. (SUPN) announced that the FDA has granted a tentative approval to the company's sNDA for a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults.
ANIP: 59.74 (-1.12), SUPN: 21.38 (-0.49), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
What Falling Estimates & Price Mean for Merus Labs International (MSLI)
Zacks Equity Research - Zacks Investment Research - Mon Aug 22, 7:43AM CDT
One such stock that you may want to consider dropping is Merus Labs International Inc. (MSLI), which has witnessed a significant price decline in the past four weeks
MSLI: 1.01 (+0.03), CORT: 5.33 (-0.08)
Insys Therapeutics Starts Enrollment in Cannabidiol Trial
Zacks Equity Research - Zacks Investment Research - Fri Aug 19, 4:32PM CDT
Insys Therapeutics, Inc. (INSY) announced that it has enrolled the first patient in a phase II trial on its pharmaceutical cannabidiol (CBD) product candidate.
INSY: 14.27 (-0.06), GWPH: 81.75 (-0.02), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Horizon (HZNP) Rayos Receives USPTO Notice of Allowance
Zacks Equity Research - Zacks Investment Research - Fri Aug 19, 9:22AM CDT
Horizon Pharma (HZNP) announced that it has received a notice of allowance from the U.S. Patent and Trademark Office with claims covering Rayos.
ANIP: 59.74 (-1.12), GERN: 2.69 (unch), HZNP: 18.80 (-0.21), CORT: 5.33 (-0.08)
Valeant Stock Down on Lawsuit by T. Rowe, Alters Credit Loan
Zacks Equity Research - Zacks Investment Research - Fri Aug 19, 9:21AM CDT
Valeant Pharmaceuticals International, Inc. (VRX) announced that it has received the requisite lender approval for an amendment to its credit facility which is scheduled to close next week.
VRX: 29.03 (-1.22), TROW: 69.54 (-0.36), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Glaxo/Pfizer ViiV Healthcare Starts HIV Drug Combo Study
Zacks Equity Research - Zacks Investment Research - Wed Aug 17, 8:59AM CDT
GlaxoSmithKline (GSK) announced that its HIV-focused company, ViiV Healthcare has initiated a phase III program to support regulatory filings for a two-drug regimen of Tivicay and Epivir for the treatment for HIV-1 infection.
PFE: 34.80 (-0.08), GSK: 43.46 (+0.10), CORT: 5.33 (-0.08)
OncoGenex Down on Poor Phase III Data on Lead Cancer Drug
Zacks Equity Research - Zacks Investment Research - Wed Aug 17, 8:57AM CDT
Shares of OncoGenex Pharmaceuticals, Inc. (OGXI) were down 41% after the company announced disappointing data from its late-stage trial, AFFINITY, on custirsen in men with metastatic castrate-resistant prostate cancer.
OGXI: 0.54 (-0.03), ANIP: 59.74 (-1.12), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Endo (ENDP) Withdraws Label Expansion Filing for Opana ER
Zacks Equity Research - Zacks Investment Research - Tue Aug 16, 3:48PM CDT
Endo International (ENDP) announced that after discussions with the FDA the company has decided to withdraw its supplemental new drug application for Opana ER.
ENDP: 20.70 (-0.19), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Aurinia (AUPH) Stock Falls on Poor Phase II Lupus Study Data
Zacks Equity Research - Zacks Investment Research - Tue Aug 16, 10:08AM CDT
Shares of Aurinia Pharmaceuticals Inc. (AUPH) crashed 55% after the company reported mixed results from a phase IIb study, AURA-LV, on its pipeline candidate, voclosporin.
AUPH: 1.94 (-0.01), ANIP: 59.74 (-1.12), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Bristol-Myers to Reacquire Rights to Oncology Drug in Asia
Zacks Equity Research - Zacks Investment Research - Mon Aug 15, 8:26AM CDT
Bristol-Myers Squibb Company (BMY) will reacquire the rights to BMS777607 from Aslan Pharmaceuticals.
ANIP: 59.74 (-1.12), BMY: 57.39 (+0.15), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Mallinckrodt (MNK) to Buy Stratatech for Undisclosed Value
Zacks Equity Research - Zacks Investment Research - Fri Aug 12, 11:24AM CDT
Mallinckrodt plc (MNK) announced that it will acquire privately held regenerative medicine company, Stratatech Corporation.
MNK: 74.54 (-0.51), MDCO: 39.17 (-0.97), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45)
Adverum (ADVM) Reports Narrower-than-Expected Q2 Loss
Zacks Equity Research - Zacks Investment Research - Thu Aug 11, 8:31AM CDT
Adverum (ADVM) reported a narrower-than-expected loss in the second quarter. The company also decided to discontinue the development of lead candidate.
ADVM: 3.58 (-0.16), CORT: 5.33 (-0.08), PCRX: 39.63 (-1.45), REGN: 392.55 (-2.67)