$NVS (Novartis AG)

$NVS {{ '2015-11-10T16:05:31+0000' | timeago}} • Announcement

$PRGO received U.S. FDA approval for generic version of Upsher-Smith Labs' KlorCon (potassium chloride) extended-release tablets (600 mg & 750 mg), which are marketed by $NVS. KlorCon is indicated for treatment of hypokalemia (low levels of potassium in blood). The U.S. market for the both generic and branded offerings of KlorCon is about $81MM.

$AMGN {{ '2017-07-25T22:44:31+0000' | timeago}} • Announcement

$AMGN increased its 2017 earnings guidance to between $10.79 per share and $11.37 per share on GAAP basis, and between $12.15 per share and $12.65 per share on adjusted basis. Sales guidance was revised to a range of $22.5-23Bil.

$AMGN {{ '2017-07-25T22:43:15+0000' | timeago}} • Announcement

$AMGN reported a 15% YoY earnings growth in 2Q17 to $2.2Bil, or $2.91 per share, driven by a 4.9 percentage points increase in operating margin. Adjusted for one-time items, the company reported per-share earnings of $3.27. Revenue rose 2% to $5.8Bil.

$VRTX {{ '2017-07-25T21:51:58+0000' | timeago}} • Announcement

$VRTX and $CNCE completed an asset purchase agreement, under which $VRTX gained worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis. $CNCE received $160MM in cash upon closing and is eligible to receive up to $90MM in additional milestones.

$AMGN {{ '2017-07-25T20:50:47+0000' | timeago}} • Infographic

$AMGN Amgen Earnings AlphaGraphic: Q2 2017 highlights

$BIIB {{ '2017-07-25T15:15:33+0000' | timeago}} • Announcement

$BIIB named Alisha Alaimo as SVP of US Therapeutic Operations. In this position, Alaimo will lead $BIIB's sales and marketing, market access, patient services and commercial operations and strategy. Alaimo will join the company from $NVS, where she was VP and Head of its Cardiovascular Business Unit.

$BMY {{ '2017-07-25T15:05:20+0000' | timeago}} • Announcement

The FDA has accepted $BMY's supplemental Biologics License Applications to update Opdivo dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The applications are under review with an action date of March 5, 2018. Opdivo has become important treatment option across multiple cancers.

$BMY {{ '2017-07-24T16:32:02+0000' | timeago}} • Announcement

$BMY said the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older.

$ENDP {{ '2017-07-21T14:56:21+0000' | timeago}} • Announcement

$ENDP said it will be ceasing operations and closing its manufacturing and distribution facilities in Huntsville, Alabama. The closure is expected to take place over the next 12 to 18 months. These restructuring actions are expected to reduce $ENDP's workforce by about 875 positions and to result in pre-tax restructuring charges of about $325MM.

$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.

$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).

$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.

$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.

$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.

$BMY {{ '2017-07-10T11:35:22+0000' | timeago}} • Announcement

$BMY said the FDA accepted its supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel.

$ENDP {{ '2017-07-06T17:01:40+0000' | timeago}} • Announcement

Following FDA's June 2017 withdrawal request, $ENDP has decided to voluntarily remove OPANA ER, a painkiller, from the market, to prevent its misuse.  As a result, $ENDP expects to incur a pre-tax impairment charge of approx $20MM in 2Q17. Reported net sales of OPANA ER were $158.9MM for FY16 and $35.7MM for 1Q17.

$ENDP {{ '2017-07-05T12:36:12+0000' | timeago}} • Announcement

$ENDP today announced it has entered into a definitive agreement to sell Mexico City-based Grupo Farmacéutico SOMAR to Advent International for approximately $124MM subject to customary adjustments for cash, debt and working capital.

$ENDP {{ '2017-07-03T18:36:53+0000' | timeago}} • Announcement

$ENDP completed the divestiture of its South African based operations, Litha Healthcare Group, to Acino Pharma AG. At closing, the company received approx. $100MM in cash and may receive up to an additional $11MM in contingent consideration.

$AMGN {{ '2017-06-30T10:59:07+0000' | timeago}} • Announcement

$AMGN announced that the FDA has approved its Vectibix for patients with colorectal cancer, following successful Phase 3 trials.

$ACOR {{ '2017-06-29T20:59:19+0000' | timeago}} • Announcement

$ACOR submits New Drug Application (NDA) to FDA for Inbrija, a potential therapy for patients with Parkinson’s disease. Acorda Therapeutics plans to file a Marketing Authorization Application (MAA) in Europe for Inbrija by the end of 2017.

$BMY {{ '2017-06-26T11:44:11+0000' | timeago}} • Announcement

$BMY said, in its Phase 3 study, Empliciti plus lenalidomide/dexamethasone continued to demonstrate efficacy in patients with plasma cell cancer, compared to patients treated with lenalidomide/dexamethasone alone. The combination therapy demonstrated a sustained reduction in risk of progression/death of 29%.

Recent Transcripts

AMGN (Amgen Inc)
Tuesday, July 25 2017 - 9:00pm
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
CCXI (ChemoCentryx, Inc.)
Wednesday, May 10 2017 - 9:00pm
ARRY (Array BioPharma Inc.)
Wednesday, May 10 2017 - 1:00pm
VCEL (Vericel Corporation)
Wednesday, May 10 2017 - 12:00pm
ENDP (Endo International plc)
Tuesday, May 9 2017 - 12:30pm
PTLA (Portola Pharmaceuticals, Inc.)
Monday, May 8 2017 - 8:30pm
SYN (Synthetic Biologics Inc.)
Thursday, May 4 2017 - 8:30pm
ZTS (Zoetis Inc.)
Thursday, May 4 2017 - 12:30pm
ARQL (ArQule Inc.)
Wednesday, May 3 2017 - 1:00pm
BMY (Bristol-Myers Squibb Company)
Thursday, April 27 2017 - 2:30pm
ALKS (Alkermes plc)
Thursday, April 27 2017 - 12:30pm
ACOR (Acorda Therapeutics, Inc.)
Thursday, April 27 2017 - 12:30pm
AMGN (Amgen Inc)
Wednesday, April 26 2017 - 9:00pm
NVS (Novartis AG)
Tuesday, April 25 2017 - 12:00pm
CCXI (ChemoCentryx, Inc.)
Tuesday, March 14 2017 - 9:00pm
VCEL (Vericel Corporation)
Friday, March 10 2017 - 1:00pm
ARQL (ArQule Inc.)
Tuesday, March 7 2017 - 2:00pm

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