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Home » Newsletters » BioWorld

BioWorld

April 24, 2023

View Archived Issues
Baqsimi

Amphastar to pay Lilly about $1B in Baqsimi blood sugar rescue deal

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. Read More

In8bio soars on ‘curative potential’ of gamma-delta T-cell therapy in phase I trial

The data are early and from only seven evaluable patients, but results from In8bio Inc.’s phase I study of gamma-delta T-cell therapy INB-100 in leukemia patients who have undergone haploidentical hematopoietic stem cell transplant, presented at the European Society for Blood and Marrow Transplantation meeting, were compelling enough to drive the company’s shares (NASDAQ:INAB) up 183% April 24. Read More
Cyclopharm’s Technegas

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. Read More

Land mine? Peninsula vaccine study yields gold for Vir in flu; mRNA data so-so

Moderna Inc.’s mixed results in mid-February from a trial with its mRNA influenza vaccine served to emphasize the need for a more comprehensive preventer of the still problematic-for-many seasonal bug – a space where Vir Biotechnology Inc. has been busy and is slated to report closely watched phase II data from the study called Peninsula in late spring or early summer of this year. Read More
us-supreme-court.png

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. Read More

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 Shanghai-based Junshi Biosciences. Read More

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. Read More

ICYMI: Week in review, April 17-21, 2023

A quick look back at top stories.

Read More

Biggest gainers and losers for April 17-21, 2023

The top 10 biopharma stock gainers and losers for the week. Read More

Appointments and advancements for April 24, 2023

New hires and promotions in the biopharma industry, including: Brainstorm Cell, GRI, Harmony, Immunogen, Ipsen, Tarsus. Read More

Financings for April 24, 2023

Biopharmas raising money in public or private financings, including: AB Science, Albert, Applied, Vaxcyte. Read More

In the clinic for April 24, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Cantargia, Edison Oncology, Elucida Oncology, Janux, Junshi, Oblato. Read More

Other news to note for April 24, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4D, Aevitas, Blue Water, Cidera, Danco, Fortress, Genbiopro, Genentech, Genmab, Janssen, J&J, Melinta, Navamedic, PDS, Roche, Sensidose, Veru. Read More

Regulatory actions for April 24, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bristol Myers Squibb, Daiichi Sankyo, Incyte, Xortx. Read More

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