SAB Biotherapeutics Inc., of Sioux Falls, S.D., said it received a $10 million investment from T. Denny Sanford as part of its series A-2 raise. The businessman and philanthropist previously invested in the company in 2014. Read More
While the U.K.'s National Institute for Health and Care Excellence (NICE) recognizes the promise of CAR T therapies, it's balking at the price. In a draft guidance released Tuesday, NICE recommended against using Foster City, Calif.-based Gilead Sciences Inc.'s Yescarta (axicabtagene ciloleucel) to treat aggressive diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma because of its cost. Read More
Hemispherx Biopharma Inc., of Orlando, Fla., said the new Ampligen (rintatolimod) batch manufactured earlier this year is now released for patients' use in the pancreatic cancer early access program (EAP) in the Netherlands pursuant to the terms of the agreement with the company's EAP provider. This is the initial shipment (500 vials) of a previously disclosed 2,100 vial standing stock order, Hemispherx said. Read More
CSL Ltd.'s vaccine business Seqirus expects to roll out real-world findings "in the next few months" that will help show whether and to what degree the cell-based approach to making influenza vaccines is better than the egg-based, said Gordon Naylor, Seqirus' president. Read More
Unlike some of its peers, Anavex Life Sciences Corp. has toiled along the tortoise path to drug development with its lead candidate, the oral sigma-1 receptor (S1R) agonist ANAVEX-2-73, in early Alzheimer's disease (AD). For more than a decade, the New York-based company has bet that compounds for AD based on its discovery platform will have competitive advantages over candidates based on the amyloid beta approach, which hypothesizes that plaques in the brain cause the disease. (See BioWorld Today, May 6, 2008.) Read More
Word that the U.S. and Mexico are finalizing a renewable 16-year agreement to update the North America Free Trade Agreement (NAFTA) had Canadian officials heading back to the negotiating table Tuesday with hopes that all three countries could reach an agreement by week's end. Read More
DUBLIN – Shares in Affimed NV (NASDAQ:AFMD) surged 150 percent during premarket trading Tuesday on news of an alliance with Genentech to develop bispecific drugs that will direct a natural killer (NK) cell response against multiple solid and hematological tumors. Heidelberg, Germany-based Affimed is getting $96 million in up-front and guaranteed near-term funding and could earn as much as $5 billion from development, regulatory and commercial milestones. Read More
An FDA complete response letter (CRL) for the experimental familial chylomicronemia syndrome (FCS) drug Waylivra (volanesorsen) left the team at Ionis Pharmaceuticals Inc. subsidiary Akcea Therapeutics Inc. disappointed and possibly surprised following a qualified endorsement of the candidate by an agency advisory committee last spring. Akcea relayed nothing about the agency's reasons for the response, but concerns over the drug's safety, clinical benefit and trial population arose in the adcom meeting last May. Read More
