$SHPG (Shire plc)

$SHPG {{ '2016-09-19T11:12:30+0000' | timeago}} • Announcement

Biotechnology company $SHPG said the US District Court for the District of Delaware has ruled that Zydus Cadila's proposed generic version of Lialda does not infringe US Patent No. 6,773,720. Lialda is used to treat mild to moderate ulcerative colitis and for maintenance of ulcerative colitis remission.

$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.

$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.

$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.

$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.

$LIVN {{ '2017-07-12T12:45:32+0000' | timeago}} • Announcement

$LIVN appointed Keyna Skeffington as SVP and General Counsel. Skeffington most recently served as Vice President of Legal – Corporate and Securities, Deputy General Counsel and Assistant Secretary at $MDT.

$AGN {{ '2017-07-10T16:14:16+0000' | timeago}} • Announcement

$AGN announced additional results of a prespecified prospective pooled subgroup analysis from the two Phase 3 studies, which evaluated the efficacy and safety of Viberzi to treat the symptoms associated with irritable bowel syndrome with diarrhea, abdominal pain and diarrhea.

$MDT {{ '2017-07-10T15:43:07+0000' | timeago}} • Announcement

$MDT announced the expanded FDA approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

$BIIB {{ '2017-07-10T12:58:24+0000' | timeago}} • Announcement

$BIIB appointed Amy Chevalier Efantis as VP of Government Affairs, effective July 17. Efantis brings more than two decades of legislative, public policy, and advocacy experience in the biopharma industry and the public sector. She will lead the company's federal and state government affairs activities from $BIIB's Washington, D.C., office.

$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.

$BIIB {{ '2017-06-28T12:10:03+0000' | timeago}} • Announcement

Pharma company $BIIB has appointed Catherine Steele as SVP of Corporate Affairs, effective July 17, 2007. Most recently, Steele served Novartis Pharmaceuticals as Global Head of Communications and Patient Relations. She began her biopharma career with Roche, where she worked more than a decade.

$AGN {{ '2017-06-27T13:15:55+0000' | timeago}} • Announcement

Pharma company $AGN launched Refresh Optive Mega-3, an over-the-counter artificial tear under the company’s Refresh portfolio. The formulation protects tears from evaporating while nourishing the damaged lipid layer and providing essential hydration to the tear film layers in patients suffering from ‘dry eye’.

$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%.

$MDT {{ '2017-06-23T12:04:14+0000' | timeago}} • Announcement

$MDT has announced a 7% increase in its quarterly cash dividend, raising the amount to $0.46 per ordinary share. The dividend is payable on July 26, 2017, to shareholders of record as of July 7, 2017.

$REGN {{ '2017-06-22T14:02:42+0000' | timeago}} • Announcement

$REGN provided details of the royalty it receives on any sales of canakinumab (ACZ885). $REGN received a royalty on worldwide net sales of canakinumab; the royalty rate starts at 4% and reaches 15% when canakinumab annual sales exceed $1.5Bil.

$BMY {{ '2017-06-21T11:54:13+0000' | timeago}} • Announcement

$BMY announced expiration on June 20 of its cash tender offer for any and all of certain of its outstanding debt securities. About $337MM of the notes were validly tendered and not validly withdrawn on or prior to June 20, 2017, and an additional $106,000 of the notes had been submitted pursuant to a Notice of Guaranteed Delivery.

$LGND {{ '2017-06-20T13:57:42+0000' | timeago}} • Announcement

$LGND's partner Melinta Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved the delafloxacin drug Baxdela, indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria.

$MDT {{ '2017-06-20T13:54:51+0000' | timeago}} • Announcement

$MDT said data from a recent study showed that its cardiac resynchronization therapy devices reduced healthcare system costs and improved therapy delivery in heart failure patients. A European health-economic analysis indicated that Medtronic’s AdaptivCRT extended life expectancy of patients by about four months, while lowering healthcare costs.

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