Industry news

Will some pent-up deal pressure amp up a biotech rally?

John Carroll / ENDPOINTS

Over the last 6 weeks we’ve seen the Nasdaq biotech index surge 21%, an early-stage company just upsized its IPO and stuck to the range, secondary offerings are doing better and a whole slate of big biotechs and pharmas have made it plain that they’re hunting for significant new deals before the end of this yea

China shuts down online drug sales

Pearl Liu / BioWorld

China is shutting down online drug sales for the time being, despite rapid growth. “The supervision system for third-party online pharmaceutical product sales is not mature yet,” said Shi Li Chen, director of Beijing Dingchen Pharmaceutical Management. “Traceability is a big problem. For example, how can we make sure of the sources of drugs selling online and also how could we make sure where do these drugs, prescription medicines in particular, go since people are usually anonymous online?”

15 August 2016

NovaDigm Therapeutics Announces Positive Results from First-ever Antifungal Immunotherapy in a Phase 2a Study in Women with Recurrent Vulvovaginal Candidiasis (RVVC)

NovaDigm Therapeutics, a company developing innovative immunotherapeutics and preventative vaccines for fungal and bacterial infections, today announced positive data from the Company’s Phase 2a clinical trial evaluating its NDV-3A immunotherapeutic vaccine in women with recurrent vulvovaginal candidiasis (RVVC). Initial results were presented at the Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology in Annapolis, Maryland on August 13, 2016 by Paul Nyirjesy, MD, Professor of Obstetrics and Gynecology and of Medicine at Drexel University College of Medicine.

CRISPR patent fight: The legal bills are soaring

Sharon Begley / STAT

The meter is running like mad on the dispute over key patents on CRISPR genome editing. In its latest 10-Q filing with the Securities and Exchange Commission, Editas Medicine — which has licensed one of the patents in question — disclosed that it has spent $10.9 million so far this year on legal fees incurred by the Broad Institute and Harvard, mostly to defend patents awarded for CRISPR inventions by the Broad’s Feng Zhang.

Ethically Speaking: Patients deserve a stronger voice in clinical trial design

Charles Craig / Bio World

Scientific and ethical justifications for randomized clinical trials involving targeted cancer drugs are outdated and overlook the most significant players in those high stakes experiments – patients coping with an incurable illness.

Basket Trials – an Emerging Clinical Trial Design for Targeted Cancer Therapies

Maria A. Berezina / Citeline

Traditionally, clinical trials for oncology have been designed to evaluate treatments in patients with a particular tumor type, e.g. breast cancer, lung cancer, etc. This design can be challenging when evaluating targeted therapies that are tailored to a subpopulation of patients with a specific mutation. 

An Integrated Approach to Ensure the Viral Safety of Biotherapeutics

Mark Plavsic / BioPharm International

Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.

Biopharma looks to big data for the next big breakthrough

Marie Powers / BioWorld

The big data revolution is all around us, from politics to power plants, manufacturing to multimedia content, Wall street to Main Street. Small wonder that big data also is driving radical change in health care and therapeutic development.

New entrants will propel ophthalmological disorders market to $26 billion by 2022, says GBI Research

GBI Research

The ophthalmological disorders market, which is set to almost double from $13.7 billion in 2015 to $26 billion by 2022 at a compound annual growth rate (CAGR) of 9.48%, will see the entry of a range of new companies over the forecast period as the treatment space is transformed by patent expiries and new product entrants, according to business intelligence provider GBI Research.

11 August 2016

Clearside Biomedical, Inc. Reports Second Quarter 2016 Financial Results

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today reported a corporate update and financial results for the quarter ended  June 30, 2016 .