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“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.”
A look at what’s going on with pharma and biotech regulatory intelligence this week!
FDA has lifted a clinical hold on two AstraZeneca head and neck cancer phase 3 trials. The hold was placed after several cases of bleeding were reported, but enrollment has already reopened. (Reuters)
FDA approves Janssen’s Darzalex as a second line treatment of multiple myeloma 3 months before its PDUFA goal date. (FDA)
Oragenics has received a fast track designation for its oral mucositis treatment. Oral mucositis is a common, debilitating complication of radiation and chemotherapy cancer treatments. (BusinessWire)
After FDA implemented its August guidance requiring all blood donations be screened for Zika virus, under an emergency use authorization for Roche and Hologic’s screening assays, only a handful of Zika-positive cases have been identified. Over 1 million donor samples have been screened, with only a few dozen screening positive for Zika, with many of those cases not confirmed after follow-up testing, at a cost of at least $100 million to industry. (MedPage Today)
Agilis Biotherapeutics has received an FDA rare pediatric disease designation for their aromatic L-amino acid decarboxylase (AADC) deficiency treatment. With this designation, Agilis has the potential to receive a priority review voucher if the drug is approved. (BusinessWire)
How important is the role of nurse navigator in the cancer patient’s journey?
It’s critical and only gaining significance. In fact, nurse navigators are so important that pharma companies, hospitals, organizations and others are increasingly putting more resources towards this role.
The White House, as part of it’s Cancer Moonshot initiative, in conjunction with Sarah Cannon, the global cancer institute of Hospital Corporation of America (HCA), and the Academy of Oncology Nurse and Patient Navigators (AONN+) just announced plans to study and standardize the scope of the nurse navigator role.
Explore our roundup of regulatory intelligence with pharma and biotech this week!
FDA has granted ARMO BioSciences orphan-drug and fast-track designations for its immunotherapy drug, AM0010, to treat pancreatic cancer. (PRNewswire)
Novartis’ marketing application for its leukemia product has received a priority review. The investigational drug had also received a breakthrough-therapy designation earlier this year. (Reuters)
A Chinese university group has become the first to treat a patient with CRISPR-Cas9-edited genes. The patient is 1 of 10 with lung cancer, in a trial primarily focused on safety. (Nature)
In collaboration, Amgen and Allergan have submitted a BLA for a biosimilar to Roche’s Avastin. This potential biosimilar is one of four that Amgen and Allergan have collaborated on in development. (BiosimilarNews)
Bristol-Myers Squibb’s Opdivo has received approval for the treatment of head and neck cancer, its seventh indication. (BusinessWire) Shortly after, AstraZeneca dropped its plans for accelerated approval of its head and neck cancer drug, as Opdivo and Merck’s Keytruda are already approved for the indication. (Reuters)
Explore what’s happening this week with pharma and biotech regulatory intelligence
Senior FDA official John Jenkins gave his two cents on the lack of new drug approvals in 2016 to a public conference in DC. He attributes the slow down of approvals to a lack of applications, and not a lack of FDA manpower. (RAPS)
FDA has issued the final guidance regarding the use of neurological medical devices for the treatment of diseases like Alzheimer’s and Parkinson’s. (Federal Register)
FDA has released 300 pages of internal email correspondence that detail the disagreements within the FDA regarding the recent approval of Sarepta’s Duchenne muscular dystrophy (DMD) drug. The drug was approved in September, despite votes against it at an FDA advisory committee meeting. (Roll Call)
Juno Therapeutics has announced their list of poster and oral presentations to be presented at this year’s American Society of Hematology (ASH) meeting that pertain to their investigational immunotherapy drug. These results come several months after the FDA placed a temporary clinical hold on a trial do to patient deaths. (BusinessWire)