The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.
“Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.” Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer. read more
Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication
A safety communication has been posted titled, “Lubricious Coating Separation from Intravascular Medical Devices.”
The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes.
This communication contains important information physicians should consider to reduce the potential of adverse events. Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use.
All Novo Nordisk production plants to run on renewable power in 2020
Bagsværd, Denmark, 24 November 2015 – Today, Novo Nordisk announced a new ambition to only use electricity from renewable sources at all its global production sites by 2020. Once implemented, there will be no CO2 emissions from the electricity used at the company’s plants. Already today, the company’s production sites in Denmark, Brazil and Japan use electricity from renewable sources.
“Setting an absolute target of zero CO2 emissions from electricity at all our global production sites in just five years is ambitious, as our production is growing to meet the increasing global demand for our diabetes products,” says Henrik Wulff, executive vice president and head of Novo Nordisk Product Supply.
An important step in achieving the 2020 ambition was taken last month when Novo Nordisk’s production site Tianjin in China signed an agreement on purchasing electricity from a windmill farm in Inner Mongolia. Other production sites in the US, France, Russia, Algeria and Iran will enter similar agreements in the coming years.
“In Denmark, we get our electricity from windmills and this will also be the case in China, but there is not a one-size-fits-all solution and we will identify the most efficient renewable electricity sources for our production facilities in the other countries,” explains Henrik Wulff. “Switching to renewable electricity makes sense from both a climate and a cost perspective. As more companies invest in renewable electricity, the technology is likely to get even more efficient and less costly.”
Novo Nordisk has recently, together with some of world’s most influential companies, joined the RE100, which is a collaborative initiative of global businesses committed to using 100% renewable electricity.
EUROPEAN COMMISSION APPROVES AMGEN’S BLINCYTO® (BLINATUMOMAB) FOR THE TREATMENT OF ADULTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE RELAPSED OR REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA
THOUSAND OAKS, Calif., Nov. 23, 2015 – Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted conditional marketing authorization for BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).read more
Sobi and Biogen’s ELOCTA® (rFVIIIFc) Approved in Europe for the Treatment of Haemophilia A
STOCKHOLM & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) and Biogen (NASDAQ: BIIB) today announced that the European Commission (EC) has approved ELOCTA® (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. ELOCTA, a recombinant factor VIII Fc fusion protein with an extended half-life, will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days. read more
Novartis’ heart failure medicine Entresto(TM) receives EU approval
Basel, November 24, 2015 – Novartis announced today that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart. read more
Debiopharm International SA’s Partner Yakult Honsha Co, Ltd. Announces Elplat® Approbation in Gastric Cancer in Japan
Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, is proud to congratulate its partner Yakult’s commitment in obtaining approval for a supplemental new drug application for Elplat® in postoperative adjuvant chemotherapy in gastric cancer, expanding the indications for this product (50mg, 100mg and 200mg).
This supplemental new drug application was approved mainly based on the results of two clinical studies; a Phase III study which was conducted outside Japan to verify the benefits of the combination therapy with Elplat® and an anticancer drug, capecitabine (CLASSIC study), and a Phase II study which was jointly conducted by Yakult Honsha Co., Ltd. and Chugai Pharmaceutical Co., Ltd. in Japan. For more information, please visit http://www.debiopharm.com