We are finally about to Fall Backward! Don’t forget to set your clock back this weekend to mark the end of Daylight Savings Time as we once again return to dark early evenings and even in December – dark late afternoons. We will maintain sunny dispositions nonetheless, especially those of us with leftover Halloween candy to provide succor.
In the meantime, here is a bit of what happened this week.
- FDA Warns on Marijuana Claims – This week the agency issued warning letters to four companies for marketing products that contained a cannabiodiol component – derived from a marijuana plant – with therapeutic claims. FDA said in its release (which contains links to the letters) that the companies were selling products online that claimed to prevent, diagnose, treat or even cure cancer. The products came in a variety of forms. In a statement in the release, Commissioner Gottlieb noted that there is a growing interest in developing therapies from components of marijuana, but that such products would need the scrutiny of the FDA approval process, while unsubstantiated claims could steer patients away from products with proven effects.
- Accelerated Approval for Lymphoma Treatment – The 2017 list of FDA approvals rolls on. This week the agency granted accelerated approval for Calquence (acalabrutinib) with an indication for treatment of adults with mantle cell lymphoma, a particularly aggressive type of cancer, who have undergone at least one prior therapy. Early trials yielded a high response rate from patients with 80 percent seeing a response and 40 percent achieving a complete response, according to the company press release. The treatment is a kinase inhibitor which blocks an enzyme needed by the cancer to multiply and spread. It represents not only another approval for FDA this year, but another in oncology which has seen a remarkable number of new therapies approved. The compound is also being studied for use in other cancers.
- Orphan Drug Tax Credit Repeal Proposed – This week the GOP unveiled a sweeping proposal for tax reform that among other things included a repeal of the tax credit for companies in the development of orphan drugs – those compounds meant to treat conditions that affect fewer than 200,000 people. The purpose of the current structure is to facilitate drug development in areas where companies are not likely to recoup the costs of development because so few people are affected by the condition and has resulted in a marked increase in the number of applications by companies. The credit has had its critics as well. For a good overview, see articles from the Regulatory Affairs Professional Society (RAPS) here and here.
That’s it for me this week folks – don’t forget to set your clocks back Saturday night/Sunday morning!
Upcoming Events to Keep an Eye on This Week
- Partners in Progress: Cancer Patient Advocates and FDA – On November 13 FDA will hold a meeting to provide basic training on the role of the FDA and cancer patient advocates in product development – deemed as most relevant for those with limited knowledge and experience in cancer product development.
- Antimicrobial Drugs Advisory Committee – On November 16 to discuss NDA for ciprofloxacin inhalation powder for reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) in patients with respiratory bacterial pathogens.
- Device Referencing Drugs – On November 16 FDA is holding a public meeting to get input on potential approach for certain device sponsors to get marketing approval for devices that are labeled for use with a drug already on the market when the sponsor of the drug does not want to pursue the new use.
Regulatory Developments in Pharma/Biotech/Devices
- FDA Announces Approval for non-US entities to perform GMP inspections
- FDA Proposes New Rule to Remove Soy Health Claim Re Heart Disease
- Multiple Myeloma Investigative Compound Granted Breakthrough Therapy Status by FDA
- FDA Advisory Committee Votes to Recommend Approval of Opioid Use Disorder Treatment