Novartis AG is expanding its position in the optogenetics space with the acquisition of Vedere Bio Inc., bringing with it a program aimed at vision loss prevention and treatment. Shareholders of Vedere, created in June 2019 through the Atlas Venture incubator, received $150 million up front and are eligible for up to $130 million in milestone payments, bringing the total to $280 million. Read More
With avacopan’s PDUFA date in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis) set for next summer, Chemocentryx Inc. rolled out long-awaited, COVID-19-delayed top-line findings from the company’s phase II, 390-patient Aurora study testing the compound for hidradenitis suppurativa (HS). Read More
Shares of Tricida Inc. (NASDAQ:TCDA) fell 47.2% to $4.37 on Oct. 29 after the company said the FDA would require data on how veverimer, its investigational therapy for metabolic acidosis in patients with chronic kidney disease (CKD), impacts CKD progression to support an accelerated approval. The news followed a complete response letter that met the NDA in August. Read More
DUBLIN – The global product development pipeline for COVID-19 is now twice as big as for any particular cancer indication, a major disease like Alzheimer’s or any other infectious disease indication. Read More
CYBERSPACE – “We are not very good at predicting drug response in the clinic,” Ayesha Muhammad told the audience at the 2020 annual meeting of the American Society of Human Genetics (ASHG), “though it is not for lack of trying.” Nevertheless, adverse drug reactions are among the top 10 causes of in-hospital mortality. Read More
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: NIH lays out final policy on data sharing; NICE to review Spinraza data; Olinvyk a Schedule II; FDA issues REMS MAPP. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apstem, Asieris, Avrobio, Genprex, Insignis, Mesoblast, Oncosec, Pepromene, Rafael, Regeneron, Tricida. Read More
