Agenus on the Move

Analysts have just delivered a major upgrade to the near-term forecasts for Lexington, Massachusetts-based Agenus, Inc., reported Simply Wall Street. Consensus numbers for revenue and earnings per share (EPS) increased, with the analysts’ views much more bullish on the company’s business prospects. Investor sentiment seems to be improving as well.

After the upgrade, the current consensus from Agenus’ three analysts is for revenues of US$263M, reflecting a 284 percent increase on Agenus sales over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 76 percent to US$0.28…


Stepping Down

Marion Gruber and Phil Krause, two of the Food and Drug Administration’s top vaccine reviewers, are leaving the agency just as a decision on COVID-19 boosters is imminent. Both intend to step down from the FDA within the next two months.

Gruber, who has been with the FDA for three decades and is the head of its vaccine review office, will retire on October 31. Krause, who serves as the vaccine team’s deputy director, will leave in November.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said Gruber’s departure is a “huge loss” and…


Resolution to Confusion

The US Food and Drug Administration (FDA) finally finalized a rule that clarifies its position on the types of evidence it will consider when determining the intended use of a medical product. In addition, the new rule repeals and replaces the unimplemented portions of an earlier final rule on intended uses.

The FDA said that the final rule, which comes less than a year after the agency proposed it, is “largely unchanged from the proposed rule.” According to the agency, the only change from the proposed rule is a modification to the codified language of the intended…


Roller Coaster

Zymergen, which researches, develops and manufactures microbes for industrial application, develops molecules for biomedical coatings and adhesives that can be used as surgical glues inside the body or on the skin to close a wound or to protect against infection. In addition, the company integrates artificial intelligence algorithms and robotic genomics to search the microbial genome, discover new materials, commercialize new products and improve existing bio-manufactured products.

Zymergen’s stated goal was to manufacture products like films used in smart devices at a fraction of the cost of similar existing products using a process called biofacturing. …


Solving Sleep Disorders

The US Food and Drug Administration (FDA) approved Dublin-based Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults. Idiopathic hypersomnia is a debilitating neurological sleep disorder characterized by chronic excessive daytime sleepiness, explained Pharma Times.

According to Diane Powell, board chair and chief executive officer of the Hypersomnia Foundation, “Idiopathic hypersomnia can have a significant impact on the social, educational and occupational functioning of people living with the condition. …


Shorter Path to Market

Eli Lilly & Co. announced on August 17 that it will split its Lilly Bio-Medicines division into two business units: Lilly Neuroscience and Lilly Immunology, effective September 5, reported Tonya Garcia in MarketWatch. Splitting Lilly’s division that develops and markets drugs for neurology and inflammatory diseases into two appears to be related to an anticipated shorter path to market for the company’s experimental Alzheimer’s treatment donanemab, according to Jonathan Gardner of Biopharma Dive.

Anne White, currently president of Lilly Oncology, will lead Lilly Neuroscience. She is responsible for launched products and the unit’s phase 3 portfolio…


Is 23 and Me for You?

23andMe, Inc., a publicly held personal genomics and biotechnology company based in Sunnyvale, California, was founded by Linda Avey, Paul Cusenza and Anne Wojcicki in 2006 to provide genetic testing and interpretation to individual consumers. The company is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analyzed, using single nucleotide polymorphism genotyping, to generate reports relating to the customer’s ancestry and genetic predispositions to health-related topics. …


Stock rises and falls as FDA approval is pending

Senseonics of Germantown, Maryland, produces the Eversense CGM (continuous glucose monitoring) product that it claims is the first implantable device to monitor glucose levels. The market for diabetic care is growing fast. The disease is among the top 10 causes of death in the country. Almost a third of U.S. adults have prediabetes.

The Eversense system, a prescription device that has to be implanted and then removed by a medical professional, is currently approved in the U.S. and Europe. However, the implant can only stay in a person for 90 days…


New Model Pharma

In February Centessa Pharmaceuticals launched a new kind of pharmaceutical R&D model with $250 million Series A Financing. The company, which was founded by Medicxi, described itself as a merger of 10 privately-held biotech companies with highly validated programs. Each of the companies within Centessa is led by specialized teams committed to accelerate development and reshape the traditional drug development process.

Financing was led by General Atlantic and co-led by Vida Ventures and Janus Henderson Investors. Additional blue-chip investors participated in the financing, including Boxer Capital, Cormorant Asset Management, T. Rowe Price Associates, Inc., Venrock Healthcare Capital…


Answers for Cancer

Salarius Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focusing on the development of drugs targeting rare, orphan cancers and cancers with a high unmet need, has added Fox Chase Cancer Center Center in Philadelphia to its ongoing trial of seclidemstat as a treatment for Ewing Sarcoma and FET-Rearranged Sarcomas. The Houston-based company, which was founded in 2014, now has nine U.S. clinical trial sites participating in the open label trial intended to assess seclidemstat at the recommended Phase 2 dose (RP2D).

Fox Chase Cancer Center has been added as an active trial site for the dose-expansion stage…

Dan Sfera

Entrepreneur. Clinical Trials. 👋🏻. Arizona Wildcat for life. http://www.TheClinicalTrialsGuru.com

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