An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue. read more
Stryker completes acquisition of Physio-Control International, Inc
Stryker Corporation (NYSE: SYK) announced today the completion of its previously announced acquisition of Physio-Control International, Inc. (Physio-Control). Physio-Control develops, manufactures and markets monitors/defibrillators, automated external defibrillators (AEDs) and CPR-assist devices along with data management and support services.
As indicated in the February 16, 2016 press release, the transaction is expected to be slightly accretive to Stryker’s 2016 adjusted net earnings per diluted share and to be accretive thereafter.
FDA Approves Celltrion’s INFLECTRA™ (biosimilar infliximab) For All Indications
INFLECTRA is first biosimilar monoclonal antibody licensed in United States
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved INFLECTRA™ (biosimilar infliximab) for all indications of the reference product, Janssen Biotech Inc.’s Remicade®(infliximab). INFLECTRA is the first biosimilar monoclonal antibody (mAb) medication to receive approval in the U.S., and is indicated for the treatment of patients with a number of serious autoimmune diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis read more
OrtoWay extends usage of its hydraulic OrtoWell®Distractor tool to include spinal tumor or trauma surgery
STOCKHOLM–(BUSINESS WIRE)–OrtoWay AB, a medical technology company based in Stockholm, Sweden, says that its OrtoWell® Distractor instrument for spinal surgery can now be used by surgeons in connection with spinal tumor removal or trauma. Following tests on animals and cadavers, it was shown that the device may offer time-saving possibilities for surgeons, giving them freer access and resulting in more accurate implant positioning. The instrument fixates the vertebra in a unique way which allows safer and less complicated insertion of implants and can be used with any prosthesis. read more
Allergan Reiterates Strong Standalone Growth Profile and Strategy Following Termination of Pfizer Transaction
DUBLIN, April 6, 2016 /PRNewswire/ — Allergan plc (NYSE:AGN) announced that its merger agreement with Pfizer (NYSE: PFE) has been terminated by mutual agreement, effective today. In connection with the termination of the merger agreement, Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction. read more
Medtronic Statement on U.S. Department of Treasury’s Recent Temporary and Proposed Regulations
DUBLIN – April 6, 2016 – Medtronic plc (NYSE: MDT) has conducted a preliminary review of the United States Department of Treasury Temporary and Proposed Regulations issued on April 4, 2016, which are designed to address certain concerns around transactions referred to by Treasury as “tax inversions” and “earnings stripping.” Medtronic has concluded that the Temporary and Proposed Regulations do not have a material financial impact on any transaction undertaken by the company. Medtronic will continue to more fully examine the Regulations and will provide appropriate disclosure concerning any potential material impact on the company, if applicable. read more
Diamyd Medical is engaged in discussions regarding an extension of GABA/Diamyd® trial in Birmingham, Alabama
Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced in its second quarterly report for the fiscal year 2015/2016 that the Company is engaged in discussions regarding an extension of the ongoing GABA/Diamyd®-trial in Birmingham, Alabama. The Company also announced that the associated company Companion Medical, Inc. has submitted a 510(k) Premarket Notification in the US as well as a CE-mark application in Europe. read more