$UTHR (United Therapeutics Corporation)

$UTHR {{ '2016-02-19T10:43:29+0000' | timeago}} • Announcement

Biotechnology company $UTHR said it has announced receipt of a Paragraph IV Certification Notice Letter on Feb. 18, 2016 from Actavis advising that Actavis has submitted an ANDA to the U.S. Food and Drug Administration (FDA) requesting approval to market a generic version of the 2.5 mg strength of Orenitram (treprostinil) Extended-Release Tablets.

$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.

$PFE {{ '2017-07-24T15:56:36+0000' | timeago}} • Announcement

$PFE's REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin, met its primary objective. PF-06439535 is being developed by $PFE as a potential biosimilar to Avastin. Results demonstrate equivalence in objective response rate in patients with advanced non-squamous non-small cell lung cancer.

$GILD {{ '2017-07-24T13:41:56+0000' | timeago}} • Announcement

$GILD announced results from two Phase 3 studies evaluating the efficacy and safety of a fixed-dose combination of bictegravir (BIC) and emtricitabine/tenofovir alafenamide (FTC/TAF) for the treatment of HIV-1 infection in treatment-naïve adults. This regimen has been well tolerated with low rates of discontinuations due to adverse events.

$MCK {{ '2017-07-21T16:07:44+0000' | timeago}} • Announcement

Biologics, a unit of healthcare technology firm $MCK, said it will join the limited distribution network of $PBYI to promote the latter’s kinase inhibitor Nerlynx. The formulation is indicated for treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer.

$REGN {{ '2017-07-21T15:50:38+0000' | timeago}} • Announcement

$REGN and $SNY announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has given a positive opinion for the marketing authorization of Dupixent (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

$GSK {{ '2017-07-21T15:28:58+0000' | timeago}} • Announcement

$GSK and $INVA announced a submission to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta in patients with controlled asthma on an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA).

$MRK {{ '2017-07-21T15:21:07+0000' | timeago}} • Announcement

President Donald Trump announced that pharma giants $MRK and $PFE are collaborating with Gorilla Glass manufacturer Corning ($GLW) for manufacturing a new glass (Valor Glass), which is superior and reliable for the delivery of injectable drugs. Corning is planning to initially invest $500MM creating 1,000 jobs at 3 facilities in US.

$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.

$ABT {{ '2017-07-20T19:55:45+0000' | timeago}} • Webcast

For 3Q17, $ABT expects adjusted EPS of $0.64-0.66, with operational sales growth expected in the mid-single digits. At current exchange rates, the company expects operational sales growth to have a negative YoY impact of around 0.5%.

$ABT {{ '2017-07-20T19:45:56+0000' | timeago}} • Webcast

$ABT said that on a comparable operational basis, 3Q17 Established Pharmaceuticals sales growth is expected in the high double-digit, while in Nutrition, sales growth is expected in low single-digit. In Diagnostics, $ABT expects sales to increase mid-to-high single digits and in Medical Devices, sales is expected to increase double-digits.

$ABT {{ '2017-07-20T17:49:19+0000' | timeago}} • Announcement

$ABT raised its full year profit forecast backed by the intention of closing the Alere acquisition in 2017. The company raised its FY17 adjusted earnings from continuing operations guidance by $0.03 to a range of $2.43-2.53 per share. Reported EPS forecast was also raised from the range of $0.92-1.02 to $1.03-1.13, reflecting double-digit growth.

$ABT {{ '2017-07-20T17:36:53+0000' | timeago}} • Announcement

Declining operating earnings and rising costs and expenses hit $ABT 2Q17 earnings as much as 54%. Earnings plunged to $283MM or $0.15 from $615MM or $0.40 per share a year earlier. Sales, however, surged 24.4% on St. Jude Medical acquisition. On an adjusted basis, $ABT reported EPS above its previous guidance range at $0.62 per share.

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

$ABT Abbott Laboratories Earnings AlphaGraphic: Q2 2017 Highlights

$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.

$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).

$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.

Recent Transcripts

ABT (Abbott Laboratories)
Thursday, July 20 2017 - 1:00pm
MDT (Medtronic plc)
Thursday, May 25 2017 - 12:00pm
MCK (McKesson Corporation)
Thursday, May 18 2017 - 9:00pm
PTX (Pernix Therapeutics Holdings, Inc.)
Monday, May 15 2017 - 8:30pm
TEVA (Teva Pharmaceutical Industries Limited)
Thursday, May 11 2017 - 12:00pm
ENDP (Endo International plc)
Tuesday, May 9 2017 - 12:30pm
VRX (Valeant Pharmaceuticals International, Inc.)
Tuesday, May 9 2017 - 12:00pm
SYN (Synthetic Biologics Inc.)
Thursday, May 4 2017 - 8:30pm
REGN (Regeneron Pharmaceuticals, Inc.)
Thursday, May 4 2017 - 12:30pm
ZTS (Zoetis Inc.)
Thursday, May 4 2017 - 12:30pm
GILD (Gilead Sciences Inc.)
Tuesday, May 2 2017 - 8:30pm
PFE (Pfizer Inc.)
Tuesday, May 2 2017 - 2:00pm
VRTX (Vertex Pharmaceuticals Incorporated)
Thursday, April 27 2017 - 8:30pm
BMY (Bristol-Myers Squibb Company)
Thursday, April 27 2017 - 2:30pm
ALXN (Alexion Pharmaceuticals, Inc.)
Thursday, April 27 2017 - 2:00pm
AMGN (Amgen Inc)
Wednesday, April 26 2017 - 9:00pm
GSK (GlaxoSmithKline plc)
Wednesday, April 26 2017 - 1:00pm
UTHR (United Therapeutics Corporation)
Wednesday, April 26 2017 - 1:00pm
BIIB (Biogen Inc.)
Tuesday, April 25 2017 - 12:30pm
ABT (Abbott Laboratories)
Wednesday, April 19 2017 - 1:00pm

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