Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the topics discussed at the FDA 2/24 Rare Disease Day public meeting were “valuable in generating a shared understanding of the issues facing manufacturers in rare disease drug development, especially regarding the use of natural history studies and registry data.” The
Drugs
FDA will not penalize Novartis for submitting manipulated test results tied to its Zolgensma gene therapy last year. BioPharma Dive reports online that the violations were documents in an 8/2019 inspection of the company’s AveXis unit that led to the dismissal of two AveXis senior executives. FDA had
Drugs
Nevada’s federal court has ruled that six Amarin patents on its Vascepa (icosapent ethyl) heart drug are “obvious” and thus invalid, clearing the way for two generic companies to continue to pursue their ANDAs. Reuters reports that Amarin said it will try to prevent the launch of a generic
Drugs
FDA says it has created a special emergency program for possible Covid-19 therapies. An online agency statement says the Coronavirus Treatment Acceleration Program (CTAP) “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful
Drugs
FDA has accepted a Bristol Myers Squibb and Bluebird Bio BLA for idecabtagene vicleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for treating adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor
Drugs
Coalition for a Prosperous America chief economist Jeff Ferry says it’s time for the United States to restore its capability to manufacture medical items here, rather than relying on a global supply chain. Writing in an opinion column, Ferry says that equipment needed to fight the Covid-19 virus
Drugs
With the president’s signing of the $2 trillion stimulus bill 2/27, FDA says it is pleased with an additional $80 million to fund its Covid-19 response efforts. The funding will go to developing medical countermeasures and vaccines, promoting advanced manufacturing for medical products and monitoring the medical
Drugs
FDA has released a guidance on “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” During the Covid-19 pandemic, FDA has been closely monitoring the medical product supply chain to see how it may be impacted by the outbreak.
Drugs
FDA has issued an updated guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” The document has an appendix on common questions and answers. It was issued earlier in the month because the agency recognizes that the Covid-19 pandemic may impact medical product clinical trials.
Drugs
FDA has approved an Eli Lilly supplemental BLA for Taltz (ixekizumab) injection, 80 mg/mL, for treating pediatric patients (ages six to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The pediatric use’s approval was based on safety, tolerability and efficacy
Drugs
[Report by James G. Dickinson and David McFarland] In what some close observers saw as a hidden political directive from President Trump, FDA 3/30 issued an emergency use authorization (EUA) to permit the distribution and use of 30 million doses of hydroxychloroquine sulfate donated by Sandoz and one million
Drugs
Dr. Reddy’s Laboratories has recalled four lots of phytonadione injectable emulsion, 10 mg/mL single-dose ampules due to the potential for ampules to break and shatter upon opening. According to a recall notice, the company has received reports of cuts and lacerations from breakages. “There may be a
Drugs
FDA has released a guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document is intend to help FDA with monitoring the medical product supply chain, which may be impacted by the Covid-19 outbreak and potentially
Drugs
FDA 3/26 sent a Warning Letter to Carahealth (Galway, Ireland) objecting to herbal products being offered online for treating Covid-19 patients. For example, one claim the company was making said: “Coronavirus (COVID-19, SARS-CoV-2) pandemic has no medical treatment. Natural antiviral herbs boost immunity & decrease
Drugs
Despite the repeated recommendations from president Trump to use chloroquine to treat coronavirus patients, principal deputy commissioner Amy Abernethy this week reiterated that a randomized controlled trial is the “most appropriate way” to determine whether the malaria drug is safe and effective for such use. Speaking remotely at the Wall
FDA Policy/General
FDA has just released the FDA-483 issued following a 10/2-12/18/17 inspection at Innovative Intrathecal Solutions, doing business as Innovative Compounding Pharmacy, a Marietta, CA, producer of human and veterinary drug products. Specific observations on the form were: * procedures designed to prevent microbiological contamination of drug
Drugs
Teva is suing FDA in DC federal court over the agency’s refusal to transition the company’s Copaxone (glatiramer acetate) from an NDA to a BLA on 3/20 as required under the Biologics Price Competition and Innovation Act (BPCIA). The suit says that Copaxone is a leading drug
Drugs
FDA has accepted an Innocoll Holdings NDA resubmission for Xaracoll (bupivacaine hydrochloride collagen-matrix implants), an investigational agent for managing postsurgical pain after open inguinal hernia surgery. The agency set a user fee goal date of 8/26. Xaracoll is a surgically implantable and bioresorbable bupivacaine-collagen matrix that uses
Drugs
FDA has approved Xellia Pharmaceuticals’ Cleveland, OH manufacturing site to make anti-infective drug products for the U.S. market. The specialty pharmaceutical company says it acquired the site in 2015 and subsequently upgraded the facility. In January, FDA conducted a comprehensive GMP inspection at the facility, and this month
Drugs
FDA has approved Bristol-Myers Squibbs’ Zeposia (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The company says Zeposia is the only approved sphingosine-1-phosphate receptor modulator that offers relapsing multiple sclerosis patients an
Drugs
CDER director Janet Woodcock says FDA has decided to end the Clinical Data Summary Pilot Program that evaluated whether disclosing certain information included in clinical study reports following approval of an NDA improves public access to drug approval information. In an online statement, Woodcock says the pilot tested a new
Drugs
The coronavirus-related economic stimulus legislation that is quickly moving to become law includes language to allow FDA to create a new user fee program for over-the-counter (OTC) drugs. The Coronavirus Aid, Relief, and Economic Security (CARES) Act would authorize such fees for OTC monograph drug reviews effective