Biologics

Ultragenyx Sells Priority Review Voucher for $210 million

Ultragenyx Pharmaceutical has agreed to sell its Rare Pediatric Disease Priority Review Voucher to an undisclosed buyer for $210 million. FDA awarded the voucher in August upon approval of Genglycos (pariglasgene brecaparvovec-opnr), also known as DTX401, for use in adult and pediatric patients eight years and older with glycogen storage disease Type Ia.

Under the terms of a 2018 patent license agreement, 20% of the gross proceeds from the voucher’s sale will be payable to NIH.

FDA OKs Tecentriq with Chemotherapy for Stage III Colon Cancer

FDA has approved Genentech’s Tecentriq (atezolizumab) for combination use with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The agency also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) in

HHS Looking Into Vaccine Injuries

HHS says it is taking a series of actions to “strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.” A department statement says HHS: * opened a National

Require More Infigratinib Info: Ascendis

Ascendis Pharma is petitioning FDA to require additional information sufficient to evaluate unresolved safety questions before approving infigratinib to treat children with achondroplasia. The company’s 10/6 petition asks specifically that FDA: * include internal neurodevelopmental experts on the review team to consider the risks infigratinib’s mechanism of action

Bipartisan Biosimilar Access, Affordability Bill Introduced

Rep. Nick Langworthy (R-NY) has introduced the Biosimilars Access and Affordability Act, bipartisan legislation that he says would expand access to lower-cost biosimilar prescription drugs and help bring them to market. In a statement, Langworthy says the bill would update Medicare policy to provide a clearer pathway for

Read more

FDA OKs Tecentriq with Chemotherapy for Stage III Colon Cancer

HHS Looking Into Vaccine Injuries

Require More Infigratinib Info: Ascendis

Bipartisan Biosimilar Access, Affordability Bill Introduced