The Cellular, Tissue and Gene Therapies Advisory Committee scrutinized Bluebird Bio Inc.’s gene therapy elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) in patients without a matched sibling donor. Read More
Two years on from establishing the first such fund, Dutch venture capital firm Forbion has announced a second growth opportunities fund, to be devoted to late-stage biotechs in Europe. The new fund has reached a first close of €470 million (US$500.6 million) and is expected to meet its hard cap of €600 million over the summer. Read More
In August 2020, it looked like DBV Technologies SA was in considerable trouble after the U.S. FDA served it with a rejection for its Viaskin Peanut allergy patch, raising concerns efficacy could be compromised because the product wasn’t sticking to the skin well. But could the Montrouge, France-based firm be making a comeback with the epicutaneous technology? Read More
After a sharp drop in April, BioWorld’s Drug Developers Index is beginning to rise, although it is not yet showing what many investors would like to see, and it remains at one of its lowest points in 18 months. Read More
Artificial intelligence is moving further into drug discovery with the launch of Charm Therapeutics Ltd., which arrives on the scene with a $50 million series A round. Read More
Profoundbio Inc. closed a $70 million series A financing round that will see it advance its two lead antibody-drug conjugate (ADC) programs to the clinic. The Suzhou, China, and Woodinville, Wash.-based company has raised a total of more than $138 million in the past two years. Read More
Jiangsu Hengrui Medicine Co. Ltd., its subsidiary Shengdi Investment Management Holding Co. Ltd., and Hengrui Group are to invest ¥2.01 billion (US$301 million) to jointly set up an equity investment company targeting pharmaceutical and health care companies. Read More
More than two years into the COVID-19 pandemic and nearly 18 months since a vaccine was first available for adults, the U.S. is on the cusp of having vaccines available to the youngest Americans. Read More
The U.S. House of Representatives voted June 8 to pass the legislation reauthorizing a number of user fee programs at the FDA, a welcome bit of good news for FDA-regulated industries. Nonetheless, there are several substantive differences between H.R. 7667 and the parallel Senate bill, differences that may take some doing to overcome before a final bill can be forwarded to the Oval Office. Read More
The issue of life science espionage continues to reverberate across the U.S., and a new report by the Office of Inspector General (OIG) suggests that vulnerabilities in the U.S. have not been adequately addressed. The OIG report said that more than two thirds of NIH grantees failed to meet at least one requirement for investigator disclosures about their activities related to foreign entities, including governments, a problem OIG says is in dire need of a fix. Read More
As multidisciplinary care extends survival and improves the quality of life for people with amyotrophic lateral sclerosis (ALS), can a host of new ALS drugs vying to slow its progression make a difference? Join the BioWorld Insider podcast as we discuss what the future of medicine may hold for ALS patients. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Ascentage, CNS, PMV. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Astrazeneca, Bicycle, Crinetics, DBV, Fibrogen, HMNC, Innovent, Marinus, Medicinova, Moderna, Neurelis, Precision, Prometheus, Promontory, Rigel, Sagimet, Sellas, Talaris, Tevogen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alimera, Allogene, Astrazeneca, Biocryst, Epimab, Gannex, Harbour, Immunocore, Immunovant, Karyopharm, Novavax, Oryzon, Passage, Regeneron, Roche, Scynexis, Sonoma, Sumitomo, Vertex. Read More
