$SHPG (Shire plc)

$SHPG {{ '2016-09-19T11:12:44+0000' | timeago}} • Announcement

Despite the court ruling, $SHPG believes the proposed Zydus product infringes its patent. Company will continue to defend its intellectual property rights. $SHPG has 30 days to file an appeal to the Court of Appeals. Zydus does not have a tentative or final approval of their ANDA, which is necessary for commercial introduction of a generic product.

$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.

$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.

$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

$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.

$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 {{ '2017-07-13T12:24:26+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.

$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.

$VRX {{ '2017-07-10T13:27:06+0000' | timeago}} • Announcement

$VRX pays down $811MM of senior secured term loans using the net proceeds of the sale of Dendreon Pharmaceuticals LLC. The company has now reduced its debt by more than $4.3Bil since the end of 1Q16. $VRX still expects to pay down $5Bil in debt from divestiture proceeds and free cash flow within 18 months of August 2016.

$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.

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