Novartis

Information Update - Health Canada advises of a second impurity linked to recalled valsartan drugs

Retrieved on: 
Thursday, September 13, 2018
Chemistry, Organic chemistry, Angiotensin II receptor antagonists, Novartis, Tetrazoles, Valsartan, Drug Safety, Angiotensin II receptor blocker, N-Nitrosodimethylamine, Nitrosamine, National Disaster Management Authority, Health Canada

All drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals have already been recalled in Canada after the first impurity, N-nitrosodimethylamine (NDMA), was identified earlier this summer.

Key Points: 
  • All drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals have already been recalled in Canada after the first impurity, N-nitrosodimethylamine (NDMA), was identified earlier this summer.
  • Health Canada also recently advised Canadians of its health risk assessment related to valsartan products containing NDMA .
  • Health Canada is assessing the issue and will update Canadians as more information becomes available, including whether the presence of NDEA impacts Health Canada's health risk assessment related to valsartan products containing NDMA.
  • Contact their health care provider if they have taken recalled valsartan products and they have concerns about their health.

Claims Filing Deadline in Syngenta Corn Seed Class Action is October 12, 2018

Retrieved on: 
Wednesday, September 12, 2018
AstraZeneca, Intensive farming, Novartis, Syngenta, Ethanol fuel, Economy of Switzerland, Business

RICHMOND, Va., Sept. 12, 2018 /PRNewswire/ -- The Claims Administrator of the settlement reached in In re Syngenta MIR162 Corn Litigation, No.

Key Points: 
  • RICHMOND, Va., Sept. 12, 2018 /PRNewswire/ -- The Claims Administrator of the settlement reached in In re Syngenta MIR162 Corn Litigation, No.
  • 14-md-2591-JWL-JPO (D. Kan.) and other related actions issues the following announcement on behalf of Settlement Class Counsel to remind farmers that the deadline to file a claim in this settlement is October 12, 2018.
  • Settlement Class Counsel, on behalf of all corn producers, reached this settlement with Syngenta of lawsuits over the "Agrisure Viptera" and "Agrisure Duracade" corn seeds and how they were marketed.
  • "This Settlement provides $1.51 billion for corn farmers, landlords, elevators, shippers, and other grain handlers and ethanol plants.

MPM Capital and Versant Ventures Launch CODA Biotherapeutics to Accelerate Development of Chemogenetic Gene Therapy Platform

Retrieved on: 
Wednesday, September 12, 2018
Biology, Health, Nature, Medical research, Drug discovery, Health policy, Medicinal chemistry, Therapy, Novartis, Gene therapy

Lead investors MPM Capital and Versant Ventures were joined by Astellas Venture Management and Novartis.

Key Points: 
  • Lead investors MPM Capital and Versant Ventures were joined by Astellas Venture Management and Novartis.
  • "This financing will enable the company to advance its gene therapy platform toward the clinic."
  • With chemogenetics, the goal is to modify a target cell population using gene therapy to express a tunable "switch" protein.
  • CODA Biotherapeutics, Inc., is a preclinical-stage biopharmaceutical company developing an innovative gene therapy platform for the treatment of many disorders and diseases.

DarioHealth Appoints Olivier Jarry, Former Head of Diabetes Care at Bayer and Executive at Novartis and Bristol-Myers-Squibb, as President and Chief Commercial Officer

Retrieved on: 
Wednesday, September 5, 2018
Biotechnology, Business, Health, Novartis, Bristol-Myers Squibb, Bayer

As Global Business Head at Bayer Diabetes Care, he managed in excess of $1.4 billion in sales.

Key Points: 
  • As Global Business Head at Bayer Diabetes Care, he managed in excess of $1.4 billion in sales.
  • At Novartis he headed four regions: Europe, India, Latin America, and Asia Pacific in consumer health products, generics and vaccines.
  • Mr. Jarry has led corporate strategy and M&A at Novartis and Bayer, globally, as well as at Bristol-Myers-Squibb, regionally.
  • Erez Raphael, Chief Executive Officer of DarioHealth stated, "We are pleased and honored that Olivier has joined DarioHealth.

/R E P E A T -- Information Update - Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution/

Retrieved on: 
Monday, August 20, 2018
Pharmacology, Chemistry, Angiotensin II receptor antagonists, Novartis, Valsartan, Drug Safety, Health, Organic chemistry, National Disaster Management Authority, Angiotensin II receptor blocker, Pharmaceutical industry, Teva Pharmaceutical Industries

Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on patients.

Key Points: 
  • Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on patients.
  • The additional Teva Canada products are being recalled after sample testing of the active ingredient by Zhejiang Huahai Pharmaceuticals identified trace levels of NDMA.
  • Health Canada continues to work with companies selling valsartan medications to determine whether their processes are at risk of producing NDMA.
  • Health Canada is also working with stakeholders to monitor the Canadian supply of valsartan products and alternative medications.

Homology Medicines Reports Second Quarter 2018 Financial Results

Retrieved on: 
Monday, August 13, 2018
Health, Pharmaceutical industry, Novartis, Medication, Homology, Biotechnology

BEDFORD, Mass., Aug. 13, 2018 /PRNewswire/ --Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today financial results for the quarter ended June 30, 2018, and highlighted recent accomplishments.

Key Points: 
  • BEDFORD, Mass., Aug. 13, 2018 /PRNewswire/ --Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today financial results for the quarter ended June 30, 2018, and highlighted recent accomplishments.
  • All other therapeutic approaches that do not replace the mutated gene, including those delivering a non-natural enzyme, require chronic dosing.
  • Collaboration revenue for the quarter ended June 30, 2018 was $0.9 million in connection with a strategic collaboration with Novartis.
  • Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines.

Cryoport Revenue Grows 59% for Second Quarter 2018; 73% in Biopharma

Retrieved on: 
Thursday, August 9, 2018
Novartis, Health, Biotechnology, Pharmaceutical industry

"This was another strong quarter for Cryoport, as revenues from clinical support programs and the ongoing ramp from our commercial agreements with Gilead and Novartis, drove 59% revenue growth year over year," Jerrell Shelton, Chief Executive Officer of Cryoport, commented.

Key Points: 
  • "This was another strong quarter for Cryoport, as revenues from clinical support programs and the ongoing ramp from our commercial agreements with Gilead and Novartis, drove 59% revenue growth year over year," Jerrell Shelton, Chief Executive Officer of Cryoport, commented.
  • Of note, we have moved quickly to open two new, state-of-the-art Cryoport Global Logistics Centres in New Jersey and The Netherlands.
  • Biopharma revenue increased by 73% in the three months ended June 30, 2018 compared to the same period in 2017.
  • 22 new biopharma clinical trials were added, on a net basis, in the three-months ended June 30, 2018.

Eyevensys Appoints New Board Member, Gerald Cagle

Retrieved on: 
Thursday, August 9, 2018
Alcon, Novartis, Cagle, Health

Eyevensys, a clinical stage biotech company developing non-viral gene therapies for ophthalmic diseases, today announced that Gerald (Jerry) Cagle, Ph.D., former Senior Vice President and Chief Scientific Officer at Alcon Laboratories has joined its Board of Directors.

Key Points: 
  • Eyevensys, a clinical stage biotech company developing non-viral gene therapies for ophthalmic diseases, today announced that Gerald (Jerry) Cagle, Ph.D., former Senior Vice President and Chief Scientific Officer at Alcon Laboratories has joined its Board of Directors.
  • Dr. Cagle holds 28 issued patents in both drug and device areas and has published numerous scientific articles.
  • Dr. Patricia Zilliox, CEO of Eyevensys, stated: "I am excited to welcome Dr. Cagle to our Board of Directors.
  • Dr. Gerald Cagle said: "I am delighted to join Eyevensys' Board and look forward to working with a strong team and unlock the potential of its pioneering ocular drug delivery technology.

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

Retrieved on: 
Friday, July 13, 2018
Chemistry, Organic chemistry, Health, Angiotensin II receptor antagonists, Novartis, N-Nitrosodimethylamine, Nitrosamines, Valsartan, Active ingredient, Food and Drug Administration, NDMA, Angiotensin II receptor blocker

This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.

Key Points: 
  • This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.
  • NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
  • Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.
  • The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Novartis launches the Galaxies of Hope app, a digital experience for the Neuroendocrine Tumor (NET) cancer community

Retrieved on: 
Thursday, July 12, 2018
Tablet computers, Novartis, App store, iPad Air 2, IPad 2, Health, Technology, E-commerce

Galaxies of Hope engages users through the art of visual storytelling, using the actual words and voices of patients, caregivers, and physicians who are part of the NET cancer community.

Key Points: 
  • Galaxies of Hope engages users through the art of visual storytelling, using the actual words and voices of patients, caregivers, and physicians who are part of the NET cancer community.
  • Galaxies of Hope is now available to download for free on the App Store for iPhone and iPad in the US only.
  • Novartis believes that raising awareness of NET cancer in creative ways is important in improving understanding and management of this rare disease.
  • Novartis collaborated with Numinous Games, award-winning video game developers, to create Galaxies of Hope.