Industry news

Do New Cancer Drugs Increase Overall Clinical Benefit?

Caroline Hroncich / BioPharm International

A new study published in JAMA Oncology on Dec. 29, 2016 assessed overall survival, quality of life, and patient safety for 53 cancer drugs approved from 2003–2013. The researchers used a narrative synthesis approach to review analyses of new cancer drugs written by health technology assessment (HTA) agencies in England, Australia, and France. 

Deficiencies in Manufacturing Derail CDER Approvals in 2016

Randi Hernandez / BioPharm International

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).

Using genomics to improve detection of endometrial cancer

Arlene Weintraub / FiercePharma

Endometrial cancer is becoming both more prevalent and more deadly, yet there are still no good screening methods to catch the disease in its earliest stages, when treatments stand the best chance of being effective. Scientists at the Icahn School of Medicine at Mount Sinai in New York are working on a solution, and it lies in detecting genetic mutations in the lining of the uterus.

After 2015's bumper crop, 2016's new drug approvals don't measure up

Amirah Al Idrus / FierceBiotech

After two of the most bountiful years in nearly two decades, new drug approvals slowed this year, with 2016 notching a disappointing 22 approvals compared to the 45 approved in 2015 and the 41 in 2014.

That pharma-patient gap companies are working to bridge? It's still pretty wide, survey finds

Beth Snyder Bulik / FiercePharmaMarketing

While patient centricity is on every pharma company agenda these days, there's still a lot of work to be done, if results from a new survey are any indication.

M&A inflation just pushed the average biopharma valuation to a scary new peak

John Carroll / Endpoints News

The consultants at Novasecta have been crunching the numbers on biopharma M&A for the past few years and concluded that a lot more of these deals are weighing in so heavily inflated now that many buyers would be better off looking for other ways to grow their businesses and their pipelines.

The winners, and losers, in the ugly 2016 race for new drug approvals

John Carroll / Endpoints News

We've known for a few months now that 2016 was going to be a disappointing year for new drug approvals. So it was no great surprise that the final tally at the FDA rang up at a meager 22.

2017 gets started with a bang as we get a glimpse of the good, the bad and the ugly

John Carroll / Endpoints News

Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry. Pre-JPM biotech news burst underscores a strong start to 2017, for the private side.

06 January 2017

Study from MSK and Epic Sciences Shows Only Nuclear-localized AR-V7 Is Predictive of Therapy Benefit for Patients with Metastatic Prostate Cancer

Investigators from Memorial Sloan Kettering Cancer Center (MSK) and Epic Sciences published findings in European Urology, that only nuclear localization of AR-V7 protein in circulating tumor cells (CTCs) from metastatic castration resistant prostate cancer (mCRPC) patient blood samples is predictive of therapeutic benefit.  

05 January 2017

Marinus Provides Business Outlook for 2017

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business overview to outline the clinical status of its CNS-selective GABA_A modulator, ganaxolone, and an overview of near-term value-creating milestones expected in 2017.