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!
Here’s a look at what’s going on this week with pharma and biotech regulatory intelligence!
CDER’s accomplishments for 2016 and priorities for 2017. CDER Director Janet Woodcock’s priorities for 2017 include: developing a plan to automate processes for new drug reviews, implementing provisions of the 21st Century Cures Act, and supporting reauthorization of the user fee acts. (FDA)
New postmarketing safety requirements for combination products. On December 19, FDA finalized new postmarket safety reporting requirements for combination drug/device, biologic/device, biologic/drug, or drug/biologic/device products. (FDA)
FDA grants accelerated approval to Clovis Oncology’s Rubraca (rucabarib) for BRCA+ ovarian cancer. Rubraca was approved for the treatment of women with advanced ovarian cancer who have received two or more prior chemotherapies and whose tumors have a BRCA gene mutation, as identified by the CDxBRCA companion diagnostic test. (FirstWord)
FDA approves removal of boxed warning for neuropsychiatric events for Pfizer’s Chantix (varenicline). Chantix is approved to help adults quit smoking. Removal of the boxed warning was based on the results of a randomized clinical trial designed to determine whether smokers with a history of psychiatric disorders are at a greater risk than other smokers for developing clinically significant adverse neuropsychiatric events. (Pfizer)
European Medicines Agency (EMA) to launch a tailored scientific advice pilot to support the development of biosimilars. The pilot will advise developers on the studies they should conduct, based on a review of their available quality, analytical, and functional data. (RAPS)
Here is one outlook for marketing biosimilars. The main point of launching biosimilars is to subsidize costs of biologic drugs to patients and payers. It costs less to develop them; therefore, it would seem counterintuitive to spend the amount of money it takes for marketing, especially direct-to-consumer (DTC).
This article points out some more cost-effective options for pharma companies marketing biosimilars, which also happen to be specialties of ours at Aegis Creative, such as: educational training and resources for physicians and providers, and more digital approaches to providing information and education.
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)