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Home » Newsletters » BioWorld

BioWorld

Aug. 31, 2021

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alzheimers-tau-neuro.png

AC Immune stock rises as Tau-targeting antibody slows cognitive decline in Alzheimer’s study

DUBLIN – AC Immune SA and partner Genentech reported Aug. 31 that their Tau-targeting antibody, semorinemab, brought about a dramatic 43.6% reduction in cognitive decline vs. baseline in a phase II trial in patients with mild to moderate Alzheimer’s disease. The effect was statistically significant (p<0.0025) and is clinically meaningful. Indeed, it represents the biggest single treatment effect ever reported in a clinical trial in this population of Alzheimer’s patients and sets the stage for an extensive phase III program that could set the agenda for Alzheimer’s research for the foreseeable future. Read More

J&J winds down HIV vaccine trial over insufficient protection

A closely watched phase IIb test of JNJ-9220, an investigational HIV vaccine regimen developed by Johnson & Johnson's Janssen Vaccines & Prevention BV, has been stopped because the regimen provided insufficient protection against HIV infection. Though safe, the candidate's efficacy was just 25.2%, according to statisticians who analyzed data from the study, called Imbokodo. Further analysis of the study will continue, and the study was deemed to have provided sufficient data for further immunological correlates research, according to J&J. Read More
Moderna COVID-19 vaccine

Titer title: Moderna tops Pfizer-Biontech and other COVID-19 news

Higher antibody titer levels were found in participants receiving two doses of Moderna Inc.’s COVID-19 vaccine compared to those receiving the Pfizer Inc.-Biontech SE vaccine, according to a research letter published in JAMA. Read More

Poseida’s adventure continues, CAR T cruising to positive phase I data in mCRPC

Questions regarding rates of cytokine release syndrome (CRS) cropped up during Poseida Therapeutics Inc.’s conference call on preliminary data from nine patients in the company’s phase I trial of P-PSMA-101, an autologous CAR T product candidate to treat patients with metastatic castrate-resistant prostate cancer (mCRPC). Read More
FDA icons

Class effect is all JAKed up as applications remain pending at FDA

Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent. Read More

Jingxin in-licensing epilepsy drug from Bio-Pharm Solutions in $40M deal

Zhejiang Jingxin Pharmaceutical Co. Ltd. has in-licensed JBPOS-0101, a class I new drug for epilepsy, from Bio-Pharm Solutions Co. Ltd. for mainland China, Hong Kong, and Macau. The partnership could bring South Korea’s Bio-Pharm more than $40 million, including an up-front payment of $5 million, milestone payments of up to $35 million, and potential royalties on future sales. Read More
Central nervous system

NRG gearing up for series A to advance brain-penetrant PTP inhibitors

LONDON – A significant body of research indicates inhibition of the mitochondrial permeability transition pore (PTP) would reduce neuroinflammation and protect neurons, but the difficulty of finding inhibitors that cross the blood-brain barrier to regulate the pore has left the therapeutic potential largely untapped. Read More
Judge's gavel with US flag

AG Garland rescinds twin policies regarding legally binding federal agency guidance

U.S. Attorney General (AG) Merrick Garland has rescinded two important policy documents, including the Brand memo, which limited the ability of federal prosecutors to use non-compliance with federal agency guidance as proof of violations of the law. The rescission of these memos increases the risk that drug and device companies will be prosecuted more vigorously due to deviation from FDA guidance documents, which at times conflict with other guidances and thus may create a series of nearly unavoidable compliance failures. Read More

FDA guidance update looks beyond pandemic

Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency. Read More

Appointments and advancements for Aug. 31, 2021

New hires and promotions in the biopharma industry, including: Lung, Neuvogen, Orion, Pepgen, Pyxis, Rayzebio, Telix, Xortx. Read More

Financings for Aug. 31, 2021

Biopharmas raising money in public or private financings, including: Ars, Versanis.. Read More

In the clinic for Aug. 31, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bayer, Bone, Daiichi, Janssen, Kinnov, Lysogene, Nrx, Pfizer, Regeneron, Sanofi, Uniqure. Read More

Other news to note for Aug. 31, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acurex, Adaptive Phage, Anavex, Bioaegis, Biocure, Cantargia, Curevac, Cytocom, Endevica, Enzen, Futura Medical, Genentech, M8, Oragenics, Osmotica, Revelation, Samyang, Sorrento, Springworks, Thirona. Read More

Regulatory actions for Aug. 31, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaccine, Anixa, Diffusion, Epygenix, Inovio, Junshi, Lantern, Octapharma, Polaryx, Poseida, Therapeutic Solutions, UCB. Read More

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