Merck

Merck, CDRD partner on Canadian life sciences ecosystem

Monday, November 6, 2017

The Canadian scientific community gathered in Ottawa this week to engage in a national dialogue on science, technology and innovation policy at the annual Canadian Science Policy Conference. Just prior to the Keynote Address at this event by the Honorable Kirsty Duncan, Minister of Science, Merck Canada and CDRD (The Centre for Drug Research and Development) announced the establishment of a new $1.5M Merck-CDRD Innovation Fund. This fund will go directly towards the advancement of projects of high therapeutic potential carried out at CDRD in collaboration with academic researchers.

[Read More]

FDA grants Priority Review for Lynparza in metastatic breast cancer

Wednesday, October 18, 2017

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.

[Read More]

Cybersecurity: Lessons learned in a hacker’s era

Monday, October 2, 2017

Cybersecurity is back in the public eye, with multiple incidents of malware attacks across the globe. Merck recently suffered an attack that disrupted the company’s manufacturing capabilities. Citing concerns about the drug supply, the U.S. House Committee on Energy and Commerce has asked Merck for an update by this week. The potential for cybersecurity intrusions also touches the medical device industry. Most recently, the U.S. Department of Homeland Security and ICS-CERT issued an advisory identifying eight cyber security vulnerabilities in an infusion pump from Smiths Medical. Previously, the FDA issued safety communications regarding vulnerabilities found in certain St. Jude Medical/Abbott cardiac pacemakers and Hospira infusion pumps.

[Read More]

Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

[Read More]

AstraZeneca, Merck to partner

Friday, July 28, 2017

AstraZeneca and Merck & Co., Inc. have announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.

[Read More]

Vaxil BioTherapeutics appoints Dr. Terry Plasse chief medical officer

Tuesday, July 25, 2017

Vaxil Bio, an Israeli-Canadian biotech developing innovative immunotherapy treatments for cancer, announced the appointment of Dr. Terry Plasse as its chief medical officer, responsible for the company’s clinical program surrounding its drug candidate, ImMucin. Dr. Plasse brings 30 years of clinical development experience, including advancing products from IND through to commercially marketed treatments for several big-pharma companies.

[Read More]

Adimab announces platform transfer with Lilly

Friday, July 21, 2017

Adimab, a global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, has entered into an agreement with Eli Lilly to transfer the Adimab Platform to Lilly for the discovery and optimization of antibody-based drugs in all therapeutic areas. This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2010, which has yielded several undisclosed therapeutic candidates for Lilly.

[Read More]