News

OncoCyte provided additional details about the history of the Razor test, its timeline for making it commercially available, and plans for a follow-on study.

OncoCyte’s newly appointed CEO Ronald Andrews is making good on a promise for more transparency in the company. Investors and analysts witnessed this new level of transparency first hand during a detailed conference call the Alameda, CA-based company held concerning its plan for acquiring Razor Genomics.

Orchestra BioMed said yesterday that it received the CE Mark for its Moderato implantable pulse generator system for BackBeat cardiac neuromodulation therapy (CNT), just nine days after naming a new chief medical officer. BackBeat therapy is a bioelectronic treatment designed to lower blood pressure while modulating the autonomic nervous system. The Moderato implantable device [...]

Orchestra BioMed, a company out of New Hope, Pennsylvania, won the European CE Mark of approval for the Moderato implantable pulse generator which delivers Orchestra’s unique BackBeat Cardiac Neuromodulation Therapy (CNT) to treat hypertension. High blood pressure is typically treated using drugs, but BackBeat allows even existing cardiac implants to deliver therapy in a [...]

Sometimes things don’t go your way in the biotech industry. The CEO of Valneva, Thomas Lingelbach, shared his experience of migrating from big pharma to biotech, and how his first biotech company weathered phase III failures to develop vaccines for neglected diseases.

A year into his cancer treatment, Stephen heard about the benefits of medical marijuana and CBD oil, but it has proven difficult to get.

You’ve invested millions of dollars, spent over a decade conducting trials and it’s only when you reach the final phase that you realize your product doesn’t even work. That can be the unfortunate reality for vaccine development. Few understand this better than Thomas Lingelbach, CEO of Valneva, a company focused on the development of [...]

For Anima Biotech, it’s all in the translation—that is, mRNA translation. Drug development and small molecule discovery have long targeted small binding pockets or catalytic sites on proteins’ surfaces. This approach has yielded many therapeutic molecules as well as substantial returns on investment, but it is not without its pitfalls.

Chairman and CEO Krish Krishnan is an experienced biotech executive. But even he didn’t expect to go from self-funding Krystal Biotech to IPO in 18 months. The Pittsburgh-based company, which Krishnan co-founded with his wife and COO Suma Krishnan, is working to develop to develop treatments for rare, orphan skin diseases caused by the absence [...]

Social media has become increasingly important in the biopharma space as it not only allows emerging clinical-stage companies to efficiently increase their visibility online by posting interesting content, but it also provides a unique platform to engage with members of specific disease communities. By listening to these members’ voices online, valuable insight can be [...]

Wouldn’t it be amazing to be able to see a protein being made in a cell in real time? And wouldn’t it be even better if you could use that capability to discover new drugs to previously “undruggable” targets, creating new medicines? Well that’s exactly what Anima Biotech is aiming to do. “We are going [...]

As the threat of Lyme disease grows and fears surrounding it spread faster than the ticks that carry the infection, researchers are developing two vaccine or vaccine-like approaches to prevent this increasingly problematic disease. But don’t expect to get one soon. They are at least three to five years away from clinical use, according [...]

A novel topical gene therapy, developed by Krystal Biotech, shows promise for treating wounds of patients with dystrophic epidermolysis bullosa (DEB). The therapy KB103 targets the type VII collagen gene (COL7A1), missing in patients with DEB, to improve wound closure and skin cohesion.

Chief Commercial and Strategy Officer Elizabeth Jeffords told BioWorld that the endpoints in Alkahest Inc.'s just-begun phase II trial with human plasma fraction GRF-6021 will not only test how well patients bounce back from hip or knee arthroplasty but "could absolutely support the work in cognitive and neurodegenerative indications as well," where data rolled out earlier [...]

Founded in 2008, Samumed has spent most of its lifetime working under the radar. It came out of the shadows in 2016 with a war chest of $220 million drawn from investors including Ikea’s private venture arm and some very wealthy individuals along with a pipeline of drugs it says can reverse aging. [...]

Last month at the 2019 Congress of the International Society on Thrombosis and Haemostasis (ISTH), Catalyst Biosciences Inc. presented Phase 2 data regarding its subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis in patients with hemophilia A or B with inhibitors. The study met its primary endpoint of significantly reducing the annualized [...]

The FDA has cleared an investigational new drug application for QR-1123, an investigational oligonucleotide treatment candidate for vision loss with autosomal dominant retinitis pigmentosa due to the P23H mutation in the rhodopsin gene, according to a press release from ProQR Therapeutics.

OSE Immunotherapeutics S.A. and Boehringer Ingelheim GmbH are testing the SIRPA inhibitor BI 765063 in solid tumors as a monotherapy and in combination with Boehringer's anti-PD1 mAb BI 754091. OSE Immunotherapeutics CSO Nicolas Poirier told BioCentury BI 765063 overcomes resistance to checkpoint inhibition in preclinical models by modulating macrophage activity and allowing more T [...]

Officials are optimistic about the initial results of a phase 2 clinical trial for a new plasma-based treatment for mild-to-moderate Alzheimer disease (AD). California-based Alkahest announced that GRF6019, a proprietary plasma fraction comprised of about 400 proteins, was both safe and well-tolerated with no cognitive decline as a treatment for AD.

Alzheimer’s patients who received an experimental protein cocktail derived from young blood plasma maintained their performance on measures of cognition and function after six months, the biotech company behind the therapy, Alkahest, said on Monday.

Newcomer NeuBase Therapeutics is re-engineering antisense oligos to access a broader range of targets, while simultaneously solving the modality’s dosing and delivery issues. With three approvals since the start of 2016, antisense oligonucleotides (ASOs) have started to hit their stride, yet first-generation technologies are limited on multiple fronts.

Alkahest announced that its phase 2a trial of AKST4290, an orally-administered small molecule CCR3 inhibitor, met the primary endpoint of achieving an increase in best corrected visual acuity (BCVA) in patients with refractory wet or neovascular age-related macular degeneration (nAMD). AKST4290 was also found to be safe and well-tolerated, meeting the secondary endpoint of [...]

The Gaitherburg biotech’s CEO, not yet a year into his tenure, sees the prospect of more acquisitions or licensing deals going forward.

Check-Cap announced positive final results from its completed post-CE approval study evaluating the efficacy and safety of the C-Scan system. “The final results from the post-CE approval study confirm the potential clinical value of the C-Scan system. The results also demonstrate an advancement in the detection of larger polyps, generally considered to have higher potential [...]

Francis R. Amato is Chief Executive Officer of electroCore, Inc. Prior to being the Chief Executive Officer and joining electroCore in 2012, Mr. Amato spent 22 years in the pharmaceutical industry, most recently at Merck, where he served as Vice President of the Specialty Commercial Operations Group within Global Human Health.

Hot on the heels of inking an international distribution deal with Terumo, Orchestra BioMed has secured $34 million in new funding for its devices aimed at high blood pressure and blocked arteries. The series B-1 raise, and its previous series B round, also provide for follow-on investments of up to $57 million in the [...]