DUBLIN – Zambon SpA is acquiring Breath Therapeutics BV for €140 million (US$155.8 million) up front plus up to €360 million more in regulatory and commercial milestones linked to the progress of Breath's drug-device combo, which is currently in phase III development for bronchiolitis obliterans syndrome (BOS), a fatal form of airway inflammation that can arise in lung transplant recipients. Read More
Eli Lilly and Co.'s FDA win with Baqsimi (glucagon) nasal powder, the first non-injected therapy to gain clearance for emergency treatment of hypoglycemia, makes the rescue of severely hypoglycemic patients quicker and easier, and coming down the pike are more treatments that could simplify therapy. Read More
The role of the government in restraining U.S. prices was the underlying subplot of the Senate Finance Committee's markup Thursday of the Prescription Drug Pricing Reduction Act (PDPRA). Read More
With Incyte Corp. expecting data from a trio of phase III trials across chronic and acute graft-vs.-host disease (GVHD) and the indication's treatment paradigm continuing to evolve, investors have begun paying more heed to clinical efforts underway by firms trying varied approaches. Read More
Device makers have reporting responsibilities for devices used in combination products per an FDA final rule published in 2016, but the FDA said in the 2018 draft guidance that the applicant of a drug- or biologic-led combo product must evaluate whether a malfunction of the device component would suggest a hazard for similar combinations using that device. That provision appears in the final rule, and thus puts the onus on makers of drugs and biologics to do a job device makers say is theirs to handle. Read More
TAIPEI, Taiwan – Western pharma players might not be addressing diseases that are specific to or predominant in Asia, speakers said on the second day of the BIO Asia-Taiwan conference, making regional collaboration important for developing therapeutics targeting unmet needs at home. Read More
Liquid biopsy startup Freenome Inc., of South San Francisco, reeled in $160 million in a series B financing that was led by RA Capital Management and Polaris Partners. The funds are earmarked to advance Freenome's multiomics blood testing platform for early cancer detection and to grow its laboratory and software capabilities. Read More
Curza Global LLC, of Salt Lake City, received a $5.25 million investment from Novo Holdings Repair Impact Fund to support the advancement of its CZ-02 program that targets multidrug-resistant gram-negative infections. Read More
In what it called one of the largest pharmaceutical settlements on behalf of end payers in an antitrust case in the last decade, law firm Hausfeld reported this week that it reached a $55 million settlement with Celgene Corp. in a long-running class action, In re Thalomid and Revlimid Antitrust Litigation. Read More
Snap Bio Inc., of San Diego, and Torrey Pines Investment (TPI) reported that their joint early drug discovery program within the framework of the i2020 Accelerator has resulted in achieving the projected milestone in developing several small-molecule lead candidates for treatment of hepatocellular carcinoma and hepatoblastoma. Read More
