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August 7, 2014
09:03 EDTBAXBaxter opens biologics facility in Singapore
Baxter International announced the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite. The current suite supports the processing of ADVATE.The second suite will initially process RIXUBIS, a recombinant factor IX protein for the treatment of adults with hemophilia B and, when operational, will be the primary global commercial processing facility. It will also support production of the company’s investigational extended half-life recombinant FVIII treatment BAX 855 upon regulatory approval. The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE2. This allows the facility to process and supply ADVATE to the European Union, Iceland and Norway. The biologics facility in Singapore currently employs more than 400 production staff and expects to reach 450 by 2015 to support the second processing suite.
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June 25, 2015
07:06 EDTBAXMerrimack's MM-398 NDA granted priority review by FDA
Merrimack (MACK) and Baxalta Incorporated, a wholly-owned subsidiary of Baxter (BAX) announced that the New Drug Application for MM-398 has been accepted for review by the FDA. Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. In addition, the FDA has classified the NDA as having Priority Review status. The FDA has set a goal of October 24 to take action under the Prescription Drug User Fee Act. The European Medicines Agency has also accepted for review a Marketing Authorization Application for MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The acceptance of the MAA marks the beginning of the review process in the European Union for MM-398 in this indication.
June 23, 2015
18:07 EDTBAXBaxter initiated with a Buy at Goldman
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June 22, 2015
06:32 EDTBAXKamada collaborates with Baxter on clinical trial with Alpha-1 antitrypsin
Kamada (KMDA) reports that the company has entered into a collaboration with Baxalta International, a wholly-owned subsidiary of Baxter (BAX) on a Phase 1/2 clinical trial of Kamada’s proprietary alpha-1 antitrypsin treatment for the prevention of lung transplant rejection. Under the agreement, Baxalta will collaborate in the development and funding of the study, which will be conducted in Israel. The study is expected to initiate in the first half of 2016, with more details on trial design to be provided at a later date. Kamada’s proprietary, highly-purified, liquid form of human AAT has shown positive interim results in a proof-of-concept Phase II study in Graft-versus-Host-Disease conducted at the Fred Hutchinson Cancer Research Center in cooperation with Baxalta. Based on those results, preclinical data published in Blood, and at the American Society of Hematology meeting, and a similar mechanism of action, the companies now plan to expand the AAT indication to the prevention of lung transplant rejection and may use this data to support clinical development worldwide. Baxalta has distribution rights to intravenous AAT for all indications in the U.S., Canada, Australia and New Zealand, while Kamada has rights in all other territories and all other formulations.
June 19, 2015
18:12 EDTBAXS&P announces changes to S&P 100, 400, 500, and 600 indices
S&P Dow Jones Indices will make the following changes to the S&P 100, S&P 500, S&P MidCap 400 and S&P SmallCap 600 indices: S&P 500 constituent The Priceline Group (PCLN) will replace Baxter International (BAX) in the S&P 100, Baxalta (BXLT) will replace QEP Resources (QEP) in the S&P 500, QEP Resources will replace Itron (ITRI) in the S&P MidCap 400, and Itron will replace Arch Coal (ACI) in the S&P SmallCap 600 after the close of trading on Tuesday, June 30. Baxter International is spinning off Baxalta in a transaction expected to be completed on that date. Baxter International will remain in the S&P 500 following the distribution, but its post spin market capitalization will no longer make it appropriate for the S&P 100. QEP Resources, Itron and Arch Coal are all ranked near or at the bottom of their current indices. Skechers USA (SKX) will replace Rock-Tenn Co. (RKT) in the S&P MidCap 400, and MiMedx Group (MDXG) will replace Skechers USA in the S&P SmallCap 600 after the close of trading on Tuesday, June 30. S&P 500 constituent MeadWestvaco Corp. (MWV) is combining with Rock-Tenn in a transaction expected to be completed on or about that date. The combined company will remain in the S&P 500 and will change its name to WestRock Co. HealthEquity (HQY) will replace Zep Inc. (ZEP) in the S&P SmallCap 600 after the close of trading on Thursday, June 25. Private equity firm New Mountain Capital is acquiring Zep in a transaction expected to be completed on or about that date pending final approvals.
17:19 EDTBAXPriceline to replace Baxter in S&P 100 as of 6/30 close
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