$GALE (Galena Biopharma, Inc.)

$GALE {{ '2016-08-09T20:41:12+0000' | timeago}} • Announcement

$GALE's non-operating income for 2Q16 was $17.57MM compared to an expense of $4.39MM last year. This was due to significant decrease in estimated fair value of warrants accounted for as liabilities on lower stock price, and significant fall in fair value of contingent purchase price liability for NeuVax given decision to terminate PRESENT study.

$AGN {{ '2017-09-22T21:53:16+0000' | timeago}} • Announcement

$AGN received a Refusal to File letter from the US FDA on its Supplemental New Drug Application (sNDA) for Vraylar for treatment of negative symptoms associated with schizophrenia in adult patients. VRAYLAR is an oral antipsychotic approved in the US to treat schizophrenia. The FDA said the sNDA was not sufficient to permit a substantive review.

$A {{ '2017-09-22T21:43:23+0000' | timeago}} • Announcement

$A said its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by the US FDA to aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by $MRK. These approvals mean these patients have the possibility of receiving a targeted anti-PD-L1 immunotherapy.

$AGN {{ '2017-09-22T14:30:34+0000' | timeago}} • Announcement

$AGN announced top-line results from new data for the Centaur Phase 2b study which supports the anti-fibrotic efficacy and safety of Cenicriviroc (CVC) for the treatment of liver fibrosis in adults with NASH. $AGN is currently enrolling patients in a 2,000 patient phase 3 clinical trial of CVC called the Aurora trial.

$REGN {{ '2017-09-18T10:59:56+0000' | timeago}} • Announcement

Pharma company $REGN and healthcare firm $SNY said a study showed that Dupixent, which is indicated for the treatment of atopic dermatitis, significantly improved overall disease severity. It also met the primary end point - the proportion of patients that achieved a 75% or greater improvement at 16 weeks from baseline.

$AMGN {{ '2017-09-14T19:26:48+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi for the treatment of five types of cancer. Amgen and Allergan's bevacizumab biosimilar is also undergoing review by the European Medicines Agency, following a Marketing Authorization Application submitted in December 2016.

$AMGN {{ '2017-09-14T19:26:21+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi (bevacizumab-awwb) for the treatment of five types of cancer. The approval was based on totality of evidence from global development program showing Mvasi is highly similar to Avastin. Mvasi is the first anti-cancer biosimilar, as well as first bevacizumab biosimilar, approved by the FDA.

$COO {{ '2017-09-11T20:51:49+0000' | timeago}} • Announcement

Medical devices company $COO has signed an agreement with pharma firm $TEVA to acquire the global rights and business of Teva’s Paragard Intrauterine Device for $1.1Bil in cash. The transaction, which is likely to close prior to the end of the calendar year, is expected to be accretive to Cooper's earnings by $0.7-0.75 per share in the first year.

$TEVA {{ '2017-09-11T20:47:29+0000' | timeago}} • Announcement

Israeli drugmaker $TEVA appointed Kare Schultz as its CEO replacing the current acting CEO Yitzhak Peterburg, who will continue as acting CEO until Schultz joins. Schultz, who will move to Israel and be based at Teva's headquarters, recently served as CEO of Denmark-based H. Lundbeck A/S. Prior to this job, he held the post of COO in Novo Nordisk.

$MRK {{ '2017-09-11T17:08:33+0000' | timeago}} • Announcement

$MRK announced that Keytruda is the only programmed death (PD-1) drug with data to show it can improve overall survival rate in the second-line bladder cancer. Phase 3 results show that patients whose disease had progressed following platinum chemo treatment, Keytruda demonstrated an OS advantage vs. chemo with median follow-up of 22.5 months.

$AGN {{ '2017-09-08T19:54:30+0000' | timeago}} • Announcement

$AGN transferred all patents for its dry eye treatment drug Restasis to the St. Regis Mohawk tribe to protect the drug patents. The tribe has granted Allergan back an exclusive license for the drug. As per the agreement, the tribe will get $13.75MM as one-time payment, and potentially $15MM annually in royalties.

$AMGN {{ '2017-09-07T12:11:23+0000' | timeago}} • Announcement

$AMGN announced results from the PATHWAY Phase 2b trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a novel anti-thymic stromal lymphopoietin monoclonal antibody being developed by $AZN in collaboration with $AMGN.

$MRK {{ '2017-08-29T14:59:23+0000' | timeago}} • Announcement

$MRK and Oxford University's Clinical Trial Service Unit announced the REVEAL study results of anacetrapib, the company's investigational cholesteryl ester transfer protein (CETP) inhibitor. Anacetrapib reduced the risk of major coronary events by 9% relative to placebo. $MRK is reviewing the results with external experts for filing NDA with FDA.

$AGN {{ '2017-08-29T10:53:21+0000' | timeago}} • Announcement

$AGN and its subsidiaries reached a settlement regarding its litigation with Famy Care Ltd. relating to the company's patent covering Restasis (Cyclosporine Ophthalmic Emulsion). All Famy Care litigation regarding Restasis patents will be dismissed and Famy Care will terminate its pending petitions for Inter Parties Review.

$MDCO {{ '2017-08-28T12:09:36+0000' | timeago}} • Announcement

$MDCO and $ALNY announced positive data from the ORION-1 Phase II study of Inclisiran, an investigational, drug for the treatment of high cholesterol. The companies added that there were no deaths or serious adverse events during the extended observation period.

$MRK {{ '2017-08-18T15:18:52+0000' | timeago}} • Announcement

Lynparza, which is developed and marketed by AstraZeneca and $MRK, announced that it got approval for a two-tablet regimen, regardless of whether patients test positive for BRCA genetic mutations associated with high risk for the cancer. This helps Lynparza to compete with Tesaro’s Zejula and Clovis Oncology's Rubraca.

$MRK {{ '2017-08-18T13:37:46+0000' | timeago}} • Announcement

Lynparza has received FDA approval to include the drug in ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. Lynparza (olaparib) claims to be the world's first poly (ADP-ribose) polymerase [PARP] inhibitor. The drug is jointly developed and sold by AstraZeneca and $MRK.

$VRX {{ '2017-08-08T18:56:32+0000' | timeago}} • Webcast

$VRX cuts FY17 revenue guidance by $200MM to about $8.70-8.90Bil. This reflects the loss of approx. $170MM of Dendreon revenues. The overall reduced outlooks is mostly due to the revised expectation of the struggling Dermatology business.

$VRX {{ '2017-08-08T18:56:03+0000' | timeago}} • Webcast

During 2Q17, $VRX announced the use of cash on hand to redeem $500MM of outstanding senior notes due 2018. Since 1Q16, the company reduced total debt to $4.8Bil. $VRX expects to exceed the commitment of paying down $5Bil of debt from divestiture proceeds and free cash flow before February 2018.

$VRX {{ '2017-08-08T18:54:54+0000' | timeago}} • Webcast

$VRX's dermatology business continues to underperform. To address the challenges, the company has stabilized Derm ASP and have rebranded the business unit as Ortho Dermatologics during 2Q17. The company launched SILIQ on July. 27, 2017 as the new product under this business unit.

$ZTS {{ '2017-08-08T18:36:56+0000' | timeago}} • Webcast

$ZTS stated that its key markets in Europe performed well in 2Q17, the UK and Germany leading with 12% and 8% operational growth respectively. The growth was driven primarily by strong Apoquel sales.

Recent Transcripts

IMUC (ImmunoCellular Therapeutics, Ltd.)
Wednesday, August 23 2017 - 9:00pm
ONVO (Organovo Holdings, Inc.)
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ALNY (Alnylam Pharmaceuticals, Inc.)
Wednesday, August 9 2017 - 8:30pm
IONS (Ionis Pharmaceuticals, Inc.)
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ZTS (Zoetis Inc.)
Tuesday, August 8 2017 - 12:30pm
VRX (Valeant Pharmaceuticals International, Inc.)
Tuesday, August 8 2017 - 12:00pm
TXMD (TherapeuticsMD, Inc.)
Thursday, August 3 2017 - 8:30pm
SYN (Synthetic Biologics Inc.)
Thursday, August 3 2017 - 12:30pm
AGN (Allergan plc)
Thursday, August 3 2017 - 12:30pm
TEVA (Teva Pharmaceutical Industries Limited)
Thursday, August 3 2017 - 11:30am
TRXC (TransEnterix, Inc.)
Wednesday, August 2 2017 - 8:30pm
MRK (Merck & Co. Inc.)
Friday, July 28 2017 - 12:00pm
AZN (AstraZeneca PLC)
Thursday, July 27 2017 - 12:30pm
GSK (GlaxoSmithKline plc)
Wednesday, July 26 2017 - 1:00pm
SRPT (Sarepta Therapeutics, Inc.)
Wednesday, July 19 2017 - 8:30pm
NVS (Novartis AG)
Tuesday, July 18 2017 - 12:00pm
ONVO (Organovo Holdings, Inc.)
Wednesday, June 7 2017 - 9:00pm
PTN (Palatin Technologies Inc.)
Tuesday, May 16 2017 - 3:00pm
TEVA (Teva Pharmaceutical Industries Limited)
Thursday, May 11 2017 - 12:00pm
IONS (Ionis Pharmaceuticals, Inc.)
Tuesday, May 9 2017 - 3:30pm

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