$UTHR (United Therapeutics Corporation)

$UTHR {{ '2016-04-28T19:33:58+0000' | timeago}} • Announcement

$UTHR said Roger Jeffs has stepped down as its President and Co-CEO and David Zaccardelli has stepped down as its EVP and COO. These departures will become effective June 26. Also, Jeffs will not stand for re-election to its BoD when his current term expires at the 2016 Annual Meeting. Jeffs will become a Senior Advisor to the company.

$ABT {{ '2017-07-20T12:52:57+0000' | timeago}} • Infographic

$ABT Abbott Laboratories Earnings AlphaGraphic: Q2 2017 Highlights

$TBPH {{ '2017-07-20T12:32:48+0000' | timeago}} • Announcement

$TBPH and $MYL announced positive results from a 12-month Phase 3 safety study of revefenacin in patients with chronic obstructive pulmonary disease (COPD). The study of 1,055 patients with COPD demonstrated that revefenacin was generally well-tolerated, and no new safety issues were identified.

$AKRX {{ '2017-07-19T21:41:28+0000' | timeago}} • Announcement

Specialty generic pharmaceutical company $AKRX said that its shareholders have voted to approve the merger for the acquisition of Akorn by Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA. The companies expect the acquisition to close by early 2018.

$AGN {{ '2017-07-19T15:54:53+0000' | timeago}} • Announcement

$AGN appointed Joseph Boccuzi to its BoD, effective immediately. Boccuzi recently retired as a Partner in the Global Life Sciences, Board and Chief Executive Officer Practices at Spencer Stuart, following 24 years of service with the global executive search and leadership consulting firm.

$GILD {{ '2017-07-18T20:14:00+0000' | timeago}} • Announcement

$GILD said the US FDA has approved Vosevi tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults previously treated with or without an NS5A inhibitor-containing regimen. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies.

$AMGN {{ '2017-07-18T15:11:19+0000' | timeago}} • Announcement

$AMGN and $ARRY collaborates for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered through Array's proprietary platform. Amgen, responsible for clinical development & commercialization, will make upfront and milestone payments for rights to Array's preclinical program.

$VRX {{ '2017-07-17T14:04:54+0000' | timeago}} • Announcement

$VRX has entered into an agreement to sell its Obagi Medical Products business for $190MM in cash to Haitong International Zhonghua Finance Acquisition Fund I, L.P. The transaction is expected to close in second half of 2017. $VRX intends to use the proceeds from the sale to permanently repay term loan debt under its Senior Secured Credit Facility.

$PRGO {{ '2017-07-17T13:30:02+0000' | timeago}} • Announcement

$PRGO received final approval from the FDA for its AB rated Abbreviated New Drug Application referencing $ABBV's Androgel Topical Gel, 1.62% packets. The gel is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

$ABT {{ '2017-07-17T12:36:21+0000' | timeago}} • Announcement

$ABT is commencing a tender offer to purchase for cash all outstanding shares of Series B Convertible Perpetual Preferred Stock of Alere Inc. at a price of $402 per share of Preferred Stock. The offer will expire at 11:59 pm, NYC time, on Aug 11, 2017. There is no financing condition to the offer.

$AMGN {{ '2017-07-14T16:06:47+0000' | timeago}} • Announcement

$AMGN announced the submission of a supplemental New Drug Application to the FDA and a variation to the marketing application to the European Medicines Agency to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS (carfilzomib).

$MYL {{ '2017-07-14T12:05:52+0000' | timeago}} • Announcement

Pharma firm $MYL said the FDA Oncologic Drugs Advisory Committee has recommended approval of the biosimilar trastuzumab developed by Mylan along with India-based Biocon Ltd. for  treatment of breast cancer. The committee determined no clinically meaningful differences exist between the biosimilar product and cancer drug Herceptin.

$GILD {{ '2017-07-13T13:10:29+0000' | timeago}} • Announcement

$GILD said its Marketing Authorization Application for an investigational, once-daily single tablet regimen containing bictegravir and emtricitabine/tenofovir alafenamide, formulations for treatment of HIV-1 infection in adults, has been fully validated. Currently, they are under evaluation by the European Medicines Agency.

$VRTX {{ '2017-07-13T12:31:35+0000' | timeago}} • Announcement

$VRTX announced that the Italian Medicines Agency has agreed to reimburse ORKAMBI (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older who have two copies of the F508del mutation. Effective immediately, hundreds of eligible patients in Italy will have access to this medicine.

$AMGN {{ '2017-07-13T12:24:26+0000' | timeago}} • Announcement

$AMGN and $AGN announced they will discuss data supporting the ABP 215 Biologics License Application (BLA) with FDA's Oncologic Drugs Advisory Committee. ABP 215 is a biosimilar candidate to Avastin (bevacizumab) and is the first bevacizumab biosimilar candidate to be considered by the FDA.

$ABT {{ '2017-07-13T12:23:21+0000' | timeago}} • Announcement

$ABT and Bigfoot Biomedical agreed to develop and commercialize diabetes management systems, integrating $ABT's FreeStyle Libre glucose sensing technology with Bigfoot's insulin delivery solutions in the United States. $ABT will provide Bigfoot with the next generation of its FreeStyle Libre glucose sensing technology.

$PFE {{ '2017-07-13T12:13:49+0000' | timeago}} • Announcement

The FDA has accepted $PFE's filing of supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis. The FDA has provided an anticipated Prescription Drug User Fee Act action date in March 2018 for the sNDA.

$AMGN {{ '2017-07-12T20:58:00+0000' | timeago}} • Announcement

$AMGN said the final analysis of its phase-3 ASPIRE trial involving myeloma patients met the key secondary endpoint of overall survival. The study demonstrated Kyprolis reduced the risk of death by 21%, compared to lenalidomide and dexamethasone. The data will be submitted to regulatory agencies to support a potential label update.

$PFE {{ '2017-07-12T11:41:14+0000' | timeago}} • Announcement

$PFE said the FDA's Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favorable risk benefit profile for Mylotarg on days 1, 4 and 7 added to chemotherapy for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML).

$AMGN {{ '2017-07-12T11:38:47+0000' | timeago}} • Announcement

$AMGN said the FDA has approved the supplemental Biologics License Application for Blincyto to include overall survival data from the Phase 3 Tower study. This also included data from Phase 2 Alcantara study supporting treatment of Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

$PFE {{ '2017-07-11T20:58:23+0000' | timeago}} • Announcement

The US FDA's Oncologic Drug Advisory Committee (ODAC) voted in favor of $PFE's MYLOTARG (gemtuzumab ozogamicin), an antibody-drug conjugate used to treat acute myeloid leukemia. The role of the ODAC is to provide recommendations to the FDA. The FDA decision on whether or not to approve MYLOTARG is anticipated by Sept. 2017.

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