Weekly Roundup 12.1.17

Today marks the 30th World AIDS Day. It is at the same time breathtaking and heart breaking to note the progress made during the course of this epidemic. In that first year, there were no treatments for HIV/AIDS, transmission was rampant as were stigma and discrimination. Hope was in very short supply, despair was abundant. Today, millions of people take a combination of any number of therapies that not only keep them from getting sick, but can keep them from infecting others. Treatment is also prevention. Three decades seems at once both short and long for such progress – so many lives being saved today, so many lost yesterday. It is something to consider when thinking of the progress of medicine. 

And here is a bit of what happened in our world not only this week but last week as well (given the Thanksgiving holiday):

  • Spotlight on Nicotine Replacement Therapies – In a joint post to the FDA blog FDA Voice, Commissioner Gottlieb, CDER Head Janet Woodcock and Mitchell Zeller, head of FDA’s Office of Tobacco Products announced the formation of a new steering committee aimed at advancing the science behind FDA’s approach to evaluating the safety and efficacy of new nicotine replacement therapies for smokers who want to quit. The approach appears to be comprehensive in that it could address existing products as well as new ones, with one potential outcome of redefining the endpoints necessary in clinical trials to achieve approval. You can see the entire blog post here .
  • FDA Approves New Opioid Treament – Following the recommendation of an  advisory committee held last month, the agency announced approval yesterday of the first monthly injectable treatment option for opioid use disorder, buprenorphine. The treatment is indicated for patients who have already started a 7 day course of therapy. A once-monthly injectable could increase adherence for some who might be challenged by continuing daily therapy. The label contains a boxed warning for the product. The company press release can be found here.  And pursuant to the posting on Wednesday – Manner of Speaking – in addition to the FDA press release about the approval, the Commissioner issued a separate statement that can be found here where he outlines the agency’s commitment to expanding options for medical treatment for opioid use disorder.
  • An Eye on the Eye – And during Thanksgiving week, FDA approved a new lens indicated for implantation to treat cataracts which can be adjusted post-surgery to improve vision reducing the possible use of glasses in some patients. In the past a patient can experience a need for adjustment after surgery to optimize the outcome of the surgical implant of a lens to address cataracts using either contacts or glasses. The approval of this new product means that such adjustment may occur on the implanted lens after its insertion, potentially foregoing the need for glasses or contact lenses to make the adjustment for some patients. That said, FDA noted that there are a few exclusion factors for patients where it should not be used.  The company press release can be found here.

Upcoming Events to Keep an Eye On

  • Senate HELP Committee HearingImplementation of the 21st Century Cures Act – Progress and Path Forward for Medical Innovation – On December 7 – both Francis Collins from NIH and FDA Commissioner Scott Gottlieb will appear. You can see a copy of testimony from this past week on the same topic before House Energy and Commerce here
  • Bone, Reproductive and Urologic Drugs Advisory Committee MeetingOn December 7, to discuss patient selection criteria and clinical design features for drugs to treat interstitial cystitis and bladder pain syndrome as well as a discussion of the two conditions. 

Regulatory Developments in Pharma/Biotech/Devices

That’s it for me this week folks. Have a wonderful weekend!  

Photograph by Lynne Bertram


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