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A look at what’s going on this week in regulatory intelligence with pharma and biotech:
Trump’s push for deregulation may put patients at risk. President Trump is currently vetting candidates to run the FDA. Among them is Jim O’Neill, who has suggested that pharmaceutical companies should not have to prove efficacy in clinical trials before selling products to customers. (NYTimes)
Bristol-Myers Squibb and Innate Pharma’s lirilumab failed to meet its primary endpoint in a Phase 2 trial in elderly patients with acute myeloid leukemia (AML). The checkpoint inhibitor failed to improve disease-free survival more than placebo. (FierceBiotech)
Merck receives priority review for Keytruda. Merck & Co has filed for approval of Keytruda for both first-and second-line use in bladder cancer. The FDA has assigned priority review for both applications, with action anticipated by June 14. (PharmaTimes)
The FDA expanded the use of Bristol-Myers Squibb’s Opdivo and approved it to include urothelial carcinoma, the most common type of bladder cancer. The immunotherapy product is already approved to treat other types of cancer, including advanced melanoma, lung cancer, kidney cancer, and Hodgkin lymphoma. (Reuters)
FDA approves MRI-conditional labeling for Abbott’s tiny pacemaker. Abbott’s tiny wireless device, the Assurity MRI pacemaker, is now the smallest and longest-lasting MRI-compatible device of its kind. The pacemaker allows physicians to monitor their patients remotely, offering wireless access to data. (FierceBiotech)
“One of the areas where [nurse navigators] are being used is in the oncology department. Here, [nurse navigators] play a critical role in helping patients gain access to care and assist them in all the stages of cancer, from screening to diagnosis to treatment and even to survivorship.”
There are numerous ways a nurse navigator influences and affects patient care. Explore more about what a nurse navigator does and the areas they assist, and gain insight into some core competencies of the role.
Some interesting things going on with pharma and biotech in regulatory intelligence this week, take a look!
Trump vows to eliminate “unnecessary” regulations. President Donald Trump vowed to accelerate drug approvals and cut costs while eliminating 75%-80% of regulations applicable to drug companies. (Politico)
FDA’s interchangeability guidelines set a “high bar” for biosimilars. The FDA released much-awaited biosimilar interchangeability draft guidelines, setting forth stringent requirements for an interchangeability designation. (FiercePharma)
ICER deems Sanofi’s Lemtrada is the most cost-effective treatment for multiple sclerosis (MS). The Institute for Clinical and Economic Review (ICER) released an evidence report evaluating disease-modifying therapies for MS in which it asserted that Sanofi’s Lemtrada “consistently demonstrated improved health outcomes and good value” at a lower cost than other treatment options. (BioCentury)
The National Institute for Health and Care Excellence (NICE) has approved Gilead’sEpclusa, in Europe, for the treatment of adult patients with genotype 1-6 chronic Hepatitis C virus (HCV). (PharmaTimes)
“Even after years of working in oncology and having seen this shattered look on countless faces, I still felt uncomfortable in the presence of such terrible news.”
~ Jenny Marais, RN, BN, OCN
What drives an oncology nurse navigator? Read how one nurse navigator opens up about how hard it can be when a patient is diagnosed with cancer and what motivates her to continue being there for patients during their hardest moments. This day in the life gives insight into the nurse navigator role and how important a nurse navigator’s relationship—and connection—is with patients.
“A diagnosis of breast cancer is often referred to as the first step on a journey. Your nurse navigator is your travel companion on that journey.”
Cancer is a scary diagnosis. Thankfully there are people to help patients find all the information they need, and support along the way—the nurse navigator. See the many ways nurse navigators are involved in a patient’s treatment plan and survivorship.
With all the interaction nurse navigators have with patients, pharma companies have the opportunity to reach patients and speak with them about access, adoption, and adherence to treatment by communicating with nurse navigators. Continue to know more about who this audience is through our nurse navigator series and gain insights to reach and empower this influential audience.
A look at some things going on in regulatory intelligence with pharma and biotech.
FDA has granted Concert Pharmaceuticals an orphan drug designation for its cystic fibrosis (CF) therapy. CTP-656 is a potential treatment for CF in patients with gating mutations. The drug is being studied in a Phase 2 trial, with results expected by the end of 2017. (eMPR)
FDA launched Oncology Center of Excellence as part of the National Cancer Moonshot initiative, to better address the needs of cancer patients and “expedite development of novel cancer products”. (FirstWordPharma)
FDA has accepted Shire’s Class 2 resubmission of its new drug application (NDA) for SHP465, an exploratory treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The resubmission was in response to the FDA’s Approvable Letter requesting additional clinical studies. The Agency is expected to provide a decision around June 20, 2017. (PRNewswire)
FDA has granted Roche priority review designation of their rheumatoid arthritis therapy, Actemra, which is being investigated for the treatment of giant cell arteritis (GCA). GCA is a potentially life-threatening autoimmune condition. (Reuters)
OssDsign has received FDA clearance to market its personalized 3D-printed cranial implants in the US. The device is designed to give neurosurgeons an alternative to using the patient’s own bone in reconstruction procedures. (FierceBiotech)