Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
Apotex Corp. agreed to pay $26 million to the state of Texas to resolve claims that it had reported inflated drug prices to the Texas Medicaid program.
Six weeks ahead of its PDUFA date, Kadmon Holdings Inc.’s NDA for Rezurock (belumosudil) has been approved to treat chronic graft-vs.-host disease. The selective oral inhibitor of Rho-associated coiled-coil kinase 2, a daily treatment for patients 12 and older after failure of at least two prior lines of systemic therapy, is the New York-based company’s first approved therapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Eli Lilly, Fibrogen, Hutchmed, Kintor.
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
The COVID-19 pandemic brought in-person inspections of device manufacturing sites to a near halt, but that has left the agency with a significant backlog in these inspections. The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin said recently that the FDA is intent on prodding Congress to provide the Office of Regulatory Affairs (ORA) with more monies, particularly given the meager increases in funding for oversight of the med-tech industry in the past few years.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Foundation Medicine, NG Biotech.
A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone.
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
Stryker Corp. has won the FDA’s nod for an implantable balloon spacer to aid in the healing of torn rotator cuffs. The de novo clearance of the Inspace subacromial tissue spacer system comes more than a decade after the biodegradable shoulder repair implant first debuted in European markets. The minimally invasive Inspace device is intended for arthroscopy treatment of massive irreparable rotator cuff tears (MIRCTs).