What happens when creativity and intelligence walk into a bar? The Conversation. This is where the scientific and creative meet to discuss topics in the life science industry intelligently with scientists and medical writers as well as creatively with marketers and business leaders. You will also hear insights from people who care most about improving health outcomes: patients, health care providers, research fellows, and industry leaders. We invite you to join in!
Take a look at what’s happening this week with pharma and biotech regulatory intelligence!
President Obama has signed into law the 21st Century Cures Act, a $6.3 billion bill to fund and promote the accelerated development of new drug cures. Despite the fact that a previous version of the bill stalled in the Senate for over a year, the Cures Act signed by Obama has become a symbol of bipartisan effort. (Washington Post)
FDA grants priority review to AstraZeneca’s durvalumab for urothelial carcinoma. Durvalumab was also awarded breakthrough therapy status earlier this year. The agency is expected to make a final decision on the urothelial carcinoma indication in the second quarter of 2017. (FirstWord)
FDA grants Biohaven orphan drug designation for BHV-0223, a sublingually administered, orally dissolving tablet for the treatment of amyotrophic lateral sclerosis (ALS). There have been no other clinical improvements or advances in ALS therapeutics since 1995. (PR Newswire)
U.K. fines Pfizer $108 million for a licensing deal that triggered a 2,600% price increase in an epilepsy drug. The company refutes the findings and plans to appeal. (FiercePharma)
Foundation for the National Institutes of Health (FNIH) releases “Framework for Defining Evidentiary Criteria for Biomarker Qualification.” Developed in partnership with government and industry stakeholders, the framework suggests biomarker developers focus on five specific steps: describing a statement of need, defining a specific context of use, performing a benefit analysis, performing a risk analysis, and concisely describing available evidence. (FNIH)
“The [Medical Science Liaison] MSL role is different today, so what should MSLs do differently to succeed? To provide meaningful answers to this critical question, the Medical Science Liaison Society launched a major, first-of-its-kind, global, quantitative survey in 2015.”
Our team recently read this survey and report by the MSL Society (MSLS) and we found it insightful for the following reason. Everyone knows MSLs are proficient in science and technical information, but one of the things we also found is that MSLs who are really great in their role are not just Scientific & Technical Experts—they’re also Great Communicators.
Explore what’s going on with pharma and biotech in regulatory intelligence this week!
Senate expected to pass 21st Century Cures Act. The U.S. Senate voted on December 5 to end debate and is expected to clear the 21st Century Cures Act this week, sending it to President Obama’s desk for signature. Among other commitments, the Act contains $4.8 billion in funding for the National Institutes of Health for programs like President Obama’s precision medicine initiative and Vice President Biden’s cancer research “moonshot” program. (Modern Healthcare)
UPDATE – Senate overwhelmingly passes the 21st Century Cures Act despite patient safety concerns. (RAPS)
FDA expands approval of Boehringer Ingelheim’s Jardiance (empagliflozin), to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. The agency based its decision on the results of a required postmarketing study. (PharmacyTimes)
FDA issues final guidance on completing the Clinical Pharmacology section for drug, generic drug, and biologic labels. FDA first released the draft guidance in 2009. The Clinical Pharmacology section of the labeling must contain subsections on Mechanism of Action, Pharmacodynamics, and Pharmacokinetics and may contain sections on Microbiology and Pharmacogenomics. (RAPS)
FDA approves Genentech’s Avastin (bevacizumab) plus chemotherapy for women with platinum-sensitive advanced ovarian cancer. The approval was based in part on a Gynecologic Oncology Group cooperative clinical trial, reinforcing the importance of partnerships with study groups to identify new treatment options for people in need. (BusinessWire)
Viking Therapeutics receives orphan drug designation for VK0214 for treatment of X-linked adrenoleukodystrophy, a rare and often fatal metabolic disorder for which there is no approved treatment. VK0214 is currently demonstrating promising activity in preclinical models. (FirstWord)
“A patient navigator is the person (or persons) who guides you through the healthcare continuum.”
An article from the AONN+ publication, Conquer, defines the different terms for “patient navigator” and “nurse navigator.” Both patient navigators and nurse navigators help patients access support services. Nurse navigators, also called clinical patient navigators, have specific clinical duties and responsibilities that patient navigators may not. These clinical duties may include: explaining test results, addressing medication side effects, and serving as a direct communication link with the care team.
AONN+ continues to make strides in recognizing and standardizing the role of navigators in patient cancer care. At Aegis Creative, we understand the importance of differentiating groups within a diverse audience and how to communicate with them effectively.
Join us in January for our nurse navigator series—sign up using the form below!
Take a look at what’s going on in regulatory intelligence with pharma and biotech this week!
FDA has issued a draft guidance titled Submission of Quality Metrics Data, regarding FDA’s proposal for collecting quality metrics data from drug manufacturer’s. The guidance’s outline proposal is currently voluntary, but it will become mandatory in 2018. (RAPS)
Merck’s supplemental biologics license application for Keytruda for the treatment of advanced microsatellite instability-high cancer has received a priority review from the FDA. If approved, this will be the fifth cancer indication for Mercks’s anti-PD-1 therapy. (Merck)
PhaseRx has received an orphan drug designation for their ornithine transcarbamylase deficiency treatment. (PRNewswire)
FDA has issued a final guidance regarding the submission of postmarket safety reports in ICH format. (RAPS)
Momenta Pharmaceuticals’ biosimilar to AbbVie’s psoriasis drug, Humira, has met the primary endpoint of its pivotal trial. The percentage of patients achieving a reduction in the severity of their psoriasis was equivalent between Momenta’s product and Humira. (Reuters)
“Even though health care workers don’t really know what it’s like to be you (well, us), it’s ok. Nobody does. I just hope that I was still able to give you a little guidance and strength to help you get through your cancer treatment. Even if I didn’t get it.”