Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s. Read More
In search of new therapies for amyotrophic lateral sclerosis (ALS), Eli Lilly and Co. has agreed to pay Verge Genomics $25 million in up-front, equity and potential near-term payments, plus as much as $694 million in milestones, to discover and validate up to four new targets for treating the disease over the course of a three-year collaboration. Verge retained rights to its internal lead ALS program, poised to enter the clinic next year. Read More
In infectious disease research, most of the research into genetic determinants of susceptibility to infection and disease severity are focused on the host. For COVID-19, for example, the delta variant’s infectivity, and how likely infection is to lead to severe disease, is the focus of an intense research agenda. But host genetics, too, contribute to the consequences of infections. An ongoing study into the host genetics of SARS-CoV-2 infection has identified 13 such factors that affected either the likelihood of contracting SARS-CoV-2, or the severity of disease, gleaned from the data of 50,000 infected persons and 2 million controls. Read More
DUBLIN – Shares in Oncopeptides AB dropped 26% July 8 on news that the FDA had placed a partial clinical hold on a raft of trials involving its newly approved multiple myeloma drug Pepaxto (melphalan flufenamide; melflufen), following a bizarre incident involving the incomplete handover to an independent review committee of data from a phase III head-to-head trial in myeloma, which had pitted melflufen against Pomalyst (pomalidomide). Read More
Recent findings with the sodium glucose transporter-2 inhibitor Jardiance (empagliflozin) from Boehringer Ingelheim International GmbH and Eli Lilly and Co. drew more attention to the cardiovascular space. Read More
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition. Read More
Aicuris Anti-Infective Cures AG is beginning the pivotal phase III part of its trial of pritelivir for herpes simplex virus infection after an encouraging midstage readout. Read More
With 15 more U.S. states signing on, a bankruptcy settlement appears to be in sight for privately owned Purdue Pharma LP. It also has U.S. lawmakers calling for reforms to the country’s bankruptcy laws. Read More
Keymed Biosciences Inc. debuted on the Hong Kong Stock Exchange (HKSE) on July 8, raising HK$2.94 billion (US$378.48 million) in the process. The company will use the funds raised for the R&D and commercialization of key pipeline candidates. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Alx, Eloxx, Epimab, Moderna, Nextcure, NGM, Nrx, Opiant, Stratatech, Tetherex, Trevena, Xenon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altesa, Beigene, Bioeq, Mindset, Pathios, Puretech, Regeneron, Reset, Silverback, Tetherex, Teva, Tryp, Usher, Vaxart. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus. Bold, Eucure, Jazz, Replicel, Scisparc, Sorrento. Read More
