In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The drug, which expects to be branded Oclaiz in the U.S. upon approval, is called Oczyesa in the EU and the U.K., where it received marketing authorization in 2025.
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.
Laekna Inc. is handing ex-China rights to internally discovered PI3Kα pan-mutant selective inhibitor LAE-118 to U.S.-based Vasque Bio Inc. in a deal worth up to $527 million, marking another asset-monetization move by the Shanghai company as it looks to fund and accelerate development across its oncology and metabolic disease pipeline.
Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions.
Tolerability is a key factor in the appeal of Enliven Therapeutics Inc.’s ELVN-001 for previously treated chronic myeloid leukemia (CML), which yielded positive updated phase I data from the Enable trial. Dennis Kim, hematologist from Princess Margaret Cancer Center in Toronto, said he would use the drug for a patient “who doesn’t have any other options.”
Former principal officers of the American Diabetes Association (ADA) have hit back at the association’s board and CEO after it prohibited the distribution of an editorial published in its flagship journal Diabetes Care at the ADA’s meeting in New Orleans last Friday.
Former principal officers of the American Diabetes Association (ADA) have hit back at the association’s board and CEO after it prohibited the distribution of an editorial published in its flagship journal Diabetes Care at the ADA’s meeting in New Orleans last Friday.
Two companies with European ties signed billion-dollar deals with large pharma firms in the last two days to discover and develop molecular glue drugs, as well as to advance a preclinical Alzheimer’s disease prospect. For both companies, the up-front payments are relatively small, only $10 million for Alzecure Pharma AB, and just $40 million for Orionis Biosciences Inc. But it’s the back-end milestone amounts that are headline-grabbing.
Investors in Dianthus Therapeutics Inc. apparently chose to ignore subtleties in the difference between efforts with that firm’s claseprubart vs. those by competitor Sanofi SA, which said that the phase III Mobilize study testing riliprubart in chronic inflammatory demyelinating polyneuropathy (CIDP) will be stopped for futility.
Less than two months after Kailera Therapeutics Inc. made headlines with biopharma’s largest IPO to date, Parabilis Medicines Inc. has come along and surpassed it. The oncology-focused firm priced its upsized IPO of 3.5 million shares at $20 apiece for gross proceeds of $670 million, an amount that could rise to $770 million should underwriters exercise their full 5-million-share overallotment option.