Eli Lilly and Co. is selling worldwide rights to its hypoglycemia nasal treatment Baqsimi to Amphastar Pharmaceuticals Inc. in a deal potentially worth over $1 billion. Under the agreement, Amphastar, of Rancho Cucamonga, Calif., will foot a $500 million cash payment on closing, and will pay Indianapolis-based Lilly an additional $125 million on the one year anniversary of closing. Lilly is also eligible to receive milestone payments of up to $450 million, based on annual sales of $175 million and $200 million, and on total net sales over five years of $950 million. “We think it’s unlikely that we will hit those milestones,” Amphastar’s Chief Financial Officer Bill Peters said in a conference call.

In8bio rockets on early phase I data for gamma-delta T-cell therapy

Shares of In8bio Inc. (NASDAQ:INAB) shot up more than 170% April 24 on early data from a phase I trial testing INB-100, an expanded and activated allogeneic gamma delta T-cell immunotherapy, in leukemia patients undergoing hematopoietic stem cell transplant. Results, presented at the European Society for Blood and Marrow Transplantation, showed seven of seven evaluable patients (100%) treated with INB-100 remained alive, progression-free and in durable complete remission as of the cutoff date.

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29. Technegas is a nuclear medicine functional lung ventilation imaging agent that produces a gas-like substance that is inhaled, allowing clinicians to see functional ventilation through the lungs. It uses radio-labeled carbon produced by using dried technetium-99 in a carbon crucible. The original user fee date for the NDA was June 26, 2021.

Developers’ quest for better flu vaccine helped by Moderna, Vir efforts

The hunt for a wider-net blocker of influenza was highlighted by Moderna Inc.’s mixed results in mid-February from a trial with its mRNA products. Among those active in the space is Vir Biotechnology Inc., which has a phase II study called Peninsula due to report data this year. Vir is testing VIR-2482, a humanized, Fc-engineered monoclonal antibody with about 60 days of circulating half-life, engineered to neutralize flu A by binding to the conserved stem epitope of the HA glycoprotein – a design similar to that of London-based Glaxosmithkline plc’s sotrovimab against SARS-COV-2.

Axon prevails at US Supreme Court in a decision that opens challenges to FTC

The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically. Axon Enterprise Inc., a manufacturer of body cameras, had petitioned the Supreme Court in 2021 to review FTC’s effort to thwart Axon’s acquisition of another company that had experienced a business failure.

Junshi’s anti-PD-1 drug meets primary endpoints in phase III study for NSCLC

Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to the company.

The BioWorld Insider Podcast: Better times ahead for the biopharma sector? Could be, the new numbers say

It used to be a lot easier to find partners. After two years of strong dealmaking, the volume and value of partnerships slid in the first quarter of 2023. M&As also are down compared to prior years. But there are some reasons to be cheerful. Looking at first quarter numbers and surveying the big picture on this BioWorld Insider podcast are Karen Carey, BioWorld’s managing editor and senior data analyst, along with Tim Shannon, a general partner at Canaan. Carey just wrote about biopharma deals and completed M&As in the first quarter. Shannon, who’s been with Canaan since 2009, has a new fund sporting $850 million in new capital, including an oversubscribed $650 million fund for seed and series A financings. They both offer their insights into the first quarter’s numbers and what may lie ahead.

Also in the news

4D Molecular, AB Science, Abbvie, Aevitas, Albert Labs, Apellis, Applied, Blue Water Vaccines, Brainstorm Cell, Bristol Myers Squibb, Cantargia, Cidara, Daiichi Sankyo, Edison Oncology, Elucida Oncology, Genentech, Genmab, GRI, Harmony, Immunogen, Incyte, Ipsen, Janssen, Janux, Junshi, Leyden Labs, Lianbio, Navamedic, Oblato, PDS, Tarsus, Therapeutic Solutions, Vallon, Vaxcyte, Xortx