$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.

$LGND {{ '2018-01-19T15:51:19+0000' | timeago}} • Announcement

$LGND announced initiation of a program to develop contrast agents with reduced renal toxicity. Contrast agents are injectable solutions used during diagnostic imaging procedures. $LGND plans to advance products toward proof-of-concept, followed by selling or out-licensing them for further development and commercialization.

$AMGN {{ '2018-01-19T13:28:13+0000' | timeago}} • Announcement

The European Commission (EC) has granted marketing authorization for MVASI from $AMGN and $AGN. MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers.

$GILD {{ '2018-01-18T17:34:32+0000' | timeago}} • Announcement

Kite, a $GILD company, has entered into a clinical trial collaboration with Pfizer, Inc. to evaluate the safety and efficacy of the combination of Yescarta and Pfizer's utomilumab, in patients with refractory large B-cell lymphoma. A multi-center Phase 1/2 study sponsored by Kite is expected to begin in 2018.

$AGN {{ '2018-01-17T13:14:16+0000' | timeago}} • Announcement

$AGN and $IRWD reached an agreement with Indian pharma company Sun Pharma to resolve a patent litigation for the generic version of constipation drug Linzess in the U.S. As per the agreement, Sun Pharma will be able to market the generic version of Linzess in the U.S. from Feb. 1, 2031. All the litigations related to Linzess were dismissed.

$MDT {{ '2018-01-16T17:16:57+0000' | timeago}} • Announcement

$MDT received FDA clearance of the Riptide Aspiration System, adding a valuable tool to the Acute Ischemic Stroke (AIS) product portfolio. This is designed to retrieve thrombus (or blood clot) through the Arc Catheter and restore blood flow in patients experiencing blockage of an artery in the brain, known as an ischemic stroke.

$LGND {{ '2018-01-11T17:54:53+0000' | timeago}} • Announcement

Pharma company $LGND has signed a license agreement with Glenmark Pharmaceuticals, allowing the latter to use the OmniAb platform for discovery of antibodies. For products incorporating OmniAb antibodies, Ligand will receive annual platform access payments and royalties, while the programs will be entirely funded by Glenmark.

$MDT {{ '2018-01-10T14:44:35+0000' | timeago}} • Announcement

The FDA has approved an innovative clinician programmer for the SynchroMed-II Intrathecal Drug Delivery system developed by medical technology company $MDT, for chronic pain and spasticity. SynchroMed-II, an implantable pump, delivers medication directly to the fluid around the spinal cord. It is an app that facilitates simple, guided workflows.

$AGN {{ '2018-01-09T15:46:35+0000' | timeago}} • Announcement

$AGN, which announced its plan to give pink slips to 1,000 of its employees and cut down 400 open positions earlier this year, provided FY18 financial outlook. In 2018, Allergan plans to sell its remaining position of 10% stake in $TEVA through Forward Sale Agreements and/or open market sales.

$AMGN {{ '2018-01-05T14:22:45+0000' | timeago}} • Announcement

$AMGN gets US FDA's approval for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

$LGND {{ '2018-01-03T14:25:12+0000' | timeago}} • Announcement

$LGND's partner HanAll Biopharma out-licensed antibody projects that were discovered by HanAll using $LGND’s OmniAb antibody discovery platform. The licensing events triggered $6MM of payments to $LGND. Including these payments, $LGND now anticipates total revenue for full year 2017 to be approx. $140MM with adjusted EPS to be $3.13-3.16.

$ACET {{ '2018-01-02T20:11:33+0000' | timeago}} • Announcement

$ACET's finished dosage form generics subsidiary Rising Pharmaceuticals launched the first generic for Efavirenz Capsules. This is an FDA-approved generic version of the reference listed drug, Sustiva from $BMY, which in combination with other drugs is indicated for the treatment of HIV-1 infection in adults and pediatric patients.

$AGN {{ '2017-12-26T12:22:55+0000' | timeago}} • Announcement

$AGN said that the Federal Circuit confirmed that a proposed generic version of Combigan eye drug from Sandoz, a unit of $NVS, did not infringe Allergan's two patents. The Federal Circuit also reversed the district court's decision that Sandoz's proposed generic product infringes Allergan's 3rd patent. Allergan plans to file for rehearing within 30 days.

$AGN {{ '2017-12-21T14:38:43+0000' | timeago}} • Announcement

$AGN and its partner $PRTK announced that FDA accepted to review Seysara, an investigational drug for treating acne. Allergan, which has the U.S. rights of developing and marketing Seysara, expects FDA to take action on this in 2H18. Paratek retains the non-U.S. rights. In March 2017, Allergan announced positive results from Seysara Phase 3 trials.

$ZBH {{ '2017-12-19T14:31:26+0000' | timeago}} • Announcement

$ZBH appointed Bryan Hanson as President and CEO and a member of the BoD, effective Dec. 19, 2017. Daniel Florin, who has served as Interim CEO since July 11, 2017, will continue in his role as SVP and CFO. Most recently, Hanson served as a $MDT's Executive Committee member and as EVP and President of Medtronic's Minimally Invasive Therapies Group.

$MDT {{ '2017-12-19T14:11:39+0000' | timeago}} • Announcement

$MDT has named Bob White, previously SVP and President of APAC Region, as EVP and President of Minimally Invasive Therapies Group. The company also announced Chris Lee, SVP and President of Greater China Region, will assume the position of APAC Region President. These leadership changes are effective immediately.

$AGN {{ '2017-12-18T22:26:29+0000' | timeago}} • Announcement

Robert Stewart, COO of $AGN will resign from his role. He has been named as the CEO of the newly formed Amneal Pharmaceuticals, effective Jan. 25, 2018. Following Rob's departure, Wayne Swanton, SVP, Global Operations has been promoted as EVP, Global Operations of Allergan.

$AGN {{ '2017-12-18T22:14:14+0000' | timeago}} • Announcement

$AGN and its development partner Gedeon Richter Plc reported positive results from phase 3 study of cariprazine, which is used to treat the bipolar depression. Allergan plans to file the New Drug Application to the FDA in 2H18.

$IPXL {{ '2017-12-18T13:05:53+0000' | timeago}} • Announcement

Amneal Pharmaceuticals LLC and $IPXL said Robert Stewart will join Amneal as President, effective Jan. 25, 2018. Stewart most recently served as COO of $AGN. After completion of combination of Amneal and $IPXL, Stewart will become President and CEO of the combined company, to be named Amneal Pharmaceuticals Inc., and will become a BoD member.

$BMY {{ '2017-12-18T12:54:53+0000' | timeago}} • Announcement

$BMY announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of Yervoy for pediatric patients 12 years of age and older who have unresectable or metastatic melanoma. The CHMP recommendation will now be reviewed by the European Commission.

$GILD {{ '2017-12-15T12:38:30+0000' | timeago}} • Announcement

$GILD announced that Executive Chairman John Martin will transition from his current role of Executive Chairman to Chairman of the Board of Directors effective March 9, 2018.

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