FDA tries to strike balance on opioids policy | Janssen's Zytiga approved for castration-sensitive prostate cancer | Novo Nordisk introduces hemophilia B therapy
February 9, 2018
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
FDA tries to strike balance on opioids policy
FDA Commissioner Scott Gottlieb says agency staff is working with health care providers and the patient community to craft an opioid-drug policy that does not restrict access by patients with a legitimate need for the drugs while discouraging inappropriate prescribing and use. He also said the FDA will soon release a "comprehensive plan to promote competition and availability of biosimilars," and he noted that a staffing shortage might slow progress on other initiatives.
MedPage Today (free registration) (2/7) 
Janssen's Zytiga approved for castration-sensitive prostate cancer
Johnson & Johnson unit Janssen Pharmaceuticals' Zytiga, or abiraterone acetate, in combination with prednisone was approved by the FDA as a treatment for patients with metastatic high-risk castration-sensitive prostate cancer. The drug, which was previously approved for patients with late-stage prostate cancer, reduced the risk of death by 38% versus placebo use in a late-stage study for CSPC patients.
Seeking Alpha (free registration) (2/8) 
Novo Nordisk introduces hemophilia B therapy
Novo Nordisk's Rebinyn was introduced as a treatment for adult and pediatric patients with hemophilia B. Rebinyn can be used to control bleeding in cases where cuts or injuries occur, or for bleeding management during surgery, but is not recommended for regular use as a routine prophylaxis.
Rare Disease Report (2/8) 
GlycoMimetics, Dutch foundation to initiate trial for blood cancer candidate
GlycoMimetics and the Haemato Oncology Foundation for Adults in the Netherlands will initiate a trial later this year to evaluate the efficacy of its experimental drug GMI-1271 in combination with the chemo agent decitabine as a treatment for newly diagnosed adult patients with acute myeloid leukemia and myelodysplastic syndrome who are intolerant to intensive chemotherapy. The primary goals of the 140-subject study consist of remission rate, disease-free survival and overall survival.
Seeking Alpha (free registration) (2/8) 
Sanofi ends development of leukemia candidate, 5 other drugs
Sanofi said it will halt development of a half-dozen drug programs that include a Phase II study for isatuximab to treat acute lymphoblastic leukemia and GLD52 to treat relapsing multiple sclerosis. The company didn't say why the programs were being discontinued.
Endpoints News (2/7) 
Attend BioData World West 2018
BioData West brings together speakers from the pharma, biotech and healthcare industries. Register now to focus on three streams that will inject new technologies into your industry: Artificial Intelligence, Genomics and Health, and Precision Medicine.
Global Focus
Teva faces possible regulatory approval, launch delay of migraine drug
Teva Pharmaceutical Industries warned that the approval and launch of its migraine drug fremanezumab could be delayed because Celltrion, which is the supplier of the drug to Teva, received a warning letter from the FDA. The company said it is working with the agency to keep the drug's priority approval date.
Reuters (2/8) 
Food & Dietary Supplements
Salmonella risk prompts recall of 2 pet food products
Smokehouse Pet Products recalled its Beefy Munchies pet food product, which was sold in Colorado, Michigan, North Carolina and Washington, over possible salmonella contamination. Pet food company Raws for Paws also recalled about 4,000 pounds of Ground Turkey Pet Food, distributed directly to consumers in Iowa, Minnesota and Wisconsin and through online mail order, for the same reason, with two illnesses connected to the pet food.
Food Poisoning Bulletin (2/9) 
Medical Devices
Study shows positive results for Glaukos' trabecular microbypass stent
A study in the Journal of Glaucoma showed the use of Glaukos' iStent trabecular microbypass stent in cataract surgery demonstrated significant reductions in postoperative intraocular pressure and glaucoma medication use without intraoperative complications among patients with severe open-angle glaucoma. The heparin-coated nonferromagnetic titanium stent, implanted into multiple trabecular meshwork via one corneal entry point, is intended for the reduction of intraocular pressure.
MassDevice (Boston) (2/8) 
Smith & Nephew announces European launch of wound therapy system
The PICO 7 single-use negative-pressure wound therapy system was released in Europe by Smith & Nephew for patients who have a risk of poor healing in community and hospital settings. The system, which comes with an advanced vacuum and leak management, is intended for improved application on areas where a seal is difficult to be achieved and maintained.
Medical Devices Business Review (U.K.) (2/8) 
Canada OKs Siemens Healthineers' SPECT/CT system
Canadian regulators gave Siemens Healthineers approval to market its Symbia Intevo Bold SPECT/CT system, which is intended for various clinical applications in a dual-use setting. The system comes with the company's iterative metal artifact reduction algorithm to reduce metallic material-caused artifacts and the sinogram-affirmed iterative reconstruction algorithm for improved CT image quality and image reconstruction, among other features.
AuntMinnie (free registration) (2/8) 
Food and Drug Law Institute Highlights
Introduction to US Medical Device Law and Regulation
Introduction to US Medical Device Law and Regulation
April 12-13 | Washington, D.C.
Explore medical device law and regulation essentials such as the premarket approval application, quality system regulation and how to prepare a successful 510(k) submission. View the agenda.
Introduction to US Drug Law and Regulation
Introduction to US Drug Law and Regulation
April 12-13 | Washington, D.C.
Expand your knowledge of drug law and regulation essentials like Rx to OTC switches, the new drug application process and Good Manufacturing Practices. View the agenda.
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