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OncoCyte Adds Lung Cancer Assay Resurrected by Razor After Previous Sale to Life Tech

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.

By | 2019-09-10T14:47:18-04:00 September 9th, 2019|News|Comments Off on OncoCyte Adds Lung Cancer Assay Resurrected by Razor After Previous Sale to Life Tech

OncoCyte Spells Out the Acquisition Plan for Razor Genomics

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.

By | 2019-09-10T14:45:29-04:00 September 5th, 2019|News|Comments Off on OncoCyte Spells Out the Acquisition Plan for Razor Genomics

Orchestra BioMed wins CE Mark for BackBeat hypertension neurostim, names CMO

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 [...]

By | 2019-09-10T14:43:13-04:00 September 5th, 2019|News|Comments Off on Orchestra BioMed wins CE Mark for BackBeat hypertension neurostim, names CMO

Pacemaker-Like Implant Cleared in Europe to Lower Blood Pressure

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 [...]

By | 2019-09-10T14:41:13-04:00 September 4th, 2019|News|Comments Off on Pacemaker-Like Implant Cleared in Europe to Lower Blood Pressure

Overcoming Clinical Setbacks to Fight Tropical Diseases

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.

By | 2019-09-10T14:39:09-04:00 September 4th, 2019|News|Comments Off on Overcoming Clinical Setbacks to Fight Tropical Diseases

With pancreatic cancer, what Stephen needs is legalised cannabis

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

By | 2019-09-04T12:31:55-04:00 September 4th, 2019|News|Comments Off on With pancreatic cancer, what Stephen needs is legalised cannabis

How Valneva are changing the approach to vaccine clinical trials

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 [...]

By | 2019-09-04T11:18:23-04:00 September 4th, 2019|News|Comments Off on How Valneva are changing the approach to vaccine clinical trials

https://www.genengnews.com/get-the-gen-digital-magazine/

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.

By | 2019-09-03T17:05:59-04:00 September 3rd, 2019|News|Comments Off on https://www.genengnews.com/get-the-gen-digital-magazine/

How Krystal Biotech Went From Founding To IPO In 18 Months

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 [...]

By | 2019-09-03T17:03:47-04:00 August 29th, 2019|News|Comments Off on How Krystal Biotech Went From Founding To IPO In 18 Months

Using Social Listening In The Design Of A Diabetes Clinical Trial

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 [...]

By | 2019-08-27T14:44:27-04:00 August 27th, 2019|News|Comments Off on Using Social Listening In The Design Of A Diabetes Clinical Trial

Seeking Small Molecule Drugs to Control mRNA Translation

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 [...]

By | 2019-08-28T13:06:21-04:00 August 27th, 2019|News|Comments Off on Seeking Small Molecule Drugs to Control mRNA Translation

Can a new Lyme disease vaccine overcome a history of distrust and failure?

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 [...]

By | 2019-08-23T09:21:57-04:00 August 22nd, 2019|News|Comments Off on Can a new Lyme disease vaccine overcome a history of distrust and failure?

Topical Gene Therapy Shows Promise for DEB

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.

By | 2019-08-23T09:20:23-04:00 August 20th, 2019|News|Comments Off on Topical Gene Therapy Shows Promise for DEB

Old made new: Alkahest plasma fraction research entering another phase II

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 [...]

By | 2019-08-23T09:20:34-04:00 August 20th, 2019|News|Comments Off on Old made new: Alkahest plasma fraction research entering another phase II

In conversation with Samumed CEO Osman Kibar: Drugging Wnt, restoring youth and unconventional capital

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. [...]

By | 2019-08-15T14:07:52-04:00 August 15th, 2019|News|Comments Off on In conversation with Samumed CEO Osman Kibar: Drugging Wnt, restoring youth and unconventional capital

Straight A’s for MarzAA

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 [...]

By | 2019-08-15T14:09:19-04:00 August 14th, 2019|News|Comments Off on Straight A’s for MarzAA

ProQR’s retinitis pigmentosa candidate gets investigational NDA clearance

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.

By | 2019-08-13T11:01:13-04:00 August 12th, 2019|News|Comments Off on ProQR’s retinitis pigmentosa candidate gets investigational NDA clearance

Eat this, don’t eat that: CD47 companies’ first hurdle

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 [...]

By | 2019-08-12T10:37:11-04:00 August 9th, 2019|News|Comments Off on Eat this, don’t eat that: CD47 companies’ first hurdle

Inside the Arena Makeover | Kevin Lind, CFO, Arena Pharmaceuticals

Up until about three years ago Kevin Lind would likely have been identified as yet another gifted private equity executive – capable of issuing business remedies from the tip of his tongue. At least in the minds of his CFO peers, who are accustomed to listening to PE pundits routinely hand down such remedies [...]

By | 2019-08-08T13:33:36-04:00 August 8th, 2019|listen, News|Comments Off on Inside the Arena Makeover | Kevin Lind, CFO, Arena Pharmaceuticals

Initial Reports Positive for Plasma Treatment of Alzheimer Disease

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.

By | 2019-08-08T12:50:15-04:00 August 7th, 2019|News|Comments Off on Initial Reports Positive for Plasma Treatment of Alzheimer Disease

Alzheimer’s patients didn’t decline after getting a cocktail derived from young blood, but big questions remain

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.

By | 2019-08-07T14:59:36-04:00 August 5th, 2019|News|Comments Off on Alzheimer’s patients didn’t decline after getting a cocktail derived from young blood, but big questions remain

NeuBase takes antisense oligos to more targets in more places

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.

By | 2019-08-02T10:22:28-04:00 August 1st, 2019|News|Comments Off on NeuBase takes antisense oligos to more targets in more places

Oral AMD treatment meets phase 2 endpoints

At the American Society of Retina Specialists meeting, Michael Stewart, MD, chairman and professor of ophthalmology at the Mayo Clinic of Jacksonville, Florida, discusses phase 2 results of AKST4290 (Alkahest), an orally administered small molecule CCR3 inhibitor.

By | 2019-07-30T15:05:17-04:00 July 29th, 2019|News, video|Comments Off on Oral AMD treatment meets phase 2 endpoints

Alkahest Phase 2a Study AKST4290-202 in Refractory Wet AMD Meets Primary and Secondary Endpoints

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 [...]

By | 2019-07-30T14:55:21-04:00 July 29th, 2019|News|Comments Off on Alkahest Phase 2a Study AKST4290-202 in Refractory Wet AMD Meets Primary and Secondary Endpoints

Anthony Fiorino, MD, PhD: Using nVNS in Various Migraine Populations

At the 2019 American Headache Society Annual Meeting, July 11-14, in Philadelphia, Pennsylvania, one of the topics of focus among the newly approved therapies for migraine was the use of devices to treat the condition acutely. As such, a number of companies presented data on neuromodulation and neurostimulation devices—including electroCore, which has undergone the development [...]

By | 2019-07-30T15:02:24-04:00 July 25th, 2019|News, video|Comments Off on Anthony Fiorino, MD, PhD: Using nVNS in Various Migraine Populations

Oncocyte CEO, Ronnie Andrews On Developing New Ways To Test For Lung Cancer

Watch "Ronnie Andrews On Developing New Ways To Test For Lung Cancer", an archived episode of The Watch List originally aired 07/15/2019 on the TD Ameritrade Network.

By | 2019-07-16T11:37:33-04:00 July 15th, 2019|News, video|Comments Off on Oncocyte CEO, Ronnie Andrews On Developing New Ways To Test For Lung Cancer

Not just a vaccine company: How this Gaithersburg biotech CEO plans to grow the business

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

By | 2019-07-15T09:57:52-04:00 July 12th, 2019|News|Comments Off on Not just a vaccine company: How this Gaithersburg biotech CEO plans to grow the business

Positive results of a prep-free colon cancer screening device reported

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 [...]

By | 2019-07-15T09:55:46-04:00 July 12th, 2019|News|Comments Off on Positive results of a prep-free colon cancer screening device reported

Interview with the CEO: electroCore, Inc. (NASDAQ:ECOR)

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.

By | 2019-07-15T09:53:48-04:00 July 12th, 2019|News|Comments Off on Interview with the CEO: electroCore, Inc. (NASDAQ:ECOR)

Encore: Orchestra BioMed quickly nets another $34M for its cardiovascular pipeline

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 [...]

By | 2019-07-15T09:51:15-04:00 July 12th, 2019|News|Comments Off on Encore: Orchestra BioMed quickly nets another $34M for its cardiovascular pipeline