Biovie Inc. shares (NASDAQ:BIVI) fell $3.10, or 62%, to trade midday at $1.89 after the firm disclosed top-line efficacy data from its phase III trial testing NE-3107 in the treatment of mild to moderate Alzheimer’s disease (AD). Patients treated with NE-3107 showed improved performance compared to placebo on all cognitive and functional assessments commonly used in the prior approval of amyloid beta-based AD therapies. But the data missed statistical significance due to site exclusions caused by what the Carson City, Nev.-based firm said were “significant good clinical practice violations and protocol deviations.” NE-3107 is designed to block inflammation and insulin resistance specifically in the brain.

Phenomic signs onto a deal with Boehringer for cancer targets

Phenomic AI is bringing in up-front and near-term payments of about $9 million in its new collaboration with Boehringer Ingelheim GmbH (BI). Phenomic also could receive about $9 million in research funding and milestones payments. The two will use privately held Phenomic’s transcriptomics platform to discover targets for treating stroma-rich cancers. BI will be able to license the targets that Phenomic validates. BI is handling all the nonclinical and clinical development, along with commercializing any of the cancer therapies.

US warns of safety issues from seizure medications; UK restricts valproate

The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. Due to the risk, which can lead to hospitalization and death, the FDA is requiring warnings be added to prescriber information and patient medication guides. Levetiracetam sells under the brand names Keppra, Keppra XR, Elepsia XR and Spritam, while clobazam sells under the names Onfi and Sympazan. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s (MHRA) new regulatory measures to reduce the risks of valproate, including birth defects and neurodevelopmental disorders following use of the drug in pregnancy and the risk of impaired fertility in males. MHRA noted that other effective treatment options are available for the majority of patients with epilepsy or bipolar disorder.

Redhill shares climb eightfold on Talicia exclusivity

Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of H. pylori infection, which affects about 35% of the U.S. adult population. Shares rose 216% on Nov. 27, the day the news was announced, and climbed another 128% on Nov. 28. As of midday Nov. 29, shares were up again, by 16%, trading at $2.65, significantly above the 31-cent close on Nov. 24. The market exclusivity was made under the Generating Antibiotic Incentives Now Act Qualified Infectious Disease Product designation, and is on top of three years of exclusivity granted for approval of Talicia under section 505(b)(2). Talicia is also covered by U.S. patent protection until 2034.

Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology. “CSL has been a vaccine company for nearly 100 years, so we realized it is probably helpful to have a portfolio of vaccines. We see this self-amplifying messenger RNA – the first in the world to be approved by any regulator – has been an advance when it comes to vaccines,” Jonathan Anderson, executive medical director of international regions for CSL Seqirus, told BioWorld.

Also in the news

20med, Abcellera, Adaptimmune, Agomab, Aldeyra, Alpha Tau, Ambrx, Arcturus, Arecor, Argenx, Arrivobio, Arrowhead, Ascendis, Belhaven, Biolexis, Carisma, Cellcentric, Eagle, Effector, Eli Lilly, Engene, Erasca, Escient, Ethris, Exonate, Generation, Geneuro, Gossamer, Harrow, Immunovant, Index, Kazia, Merck, Nanoviricides, Novavax, Orexo, Orlance, Prism, Rallybio, Remegen, Seelos, Sernova, Skye, Springworks, Tectonic, Timber, Tolremo