Industry news

Balancing the R&D equation: Measuring the return from pharmaceutical innovation

Pharmalife

Following Deloitte's anaylsis of th return on R&D spend by biopgramaceutical companies, this report, written Colin Terry and Matthew Thaxter, reveals the key difficulties faced, as well as how approches during drug development can boost the success of an asset. 

Labeling will become a compulsory process in Russia from 2018

GMP News

The labeling system for medicinal products will become compulsory from 2018, said Mikhail Murashko, the Head of Federal Service for Surveillance in Healthcare (Roszdravnadzor), during a working meeting on the organization of internal quality control and safety of medical activities.

11 September 2017

Marinus Announces Successful Clinical Trial Results and Declares CDKL5 Disorder Its Lead Pediatric Orphan Epilepsy Program for Ganaxolone

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), today announced that top-line data from the Phase 2 open-label study in patients with CDKL5 disorder support advancing ganaxolone into a definitive late-stage clinical trial. Oral ganaxolone, in addition to baseline treatment, showed a sizable and durable seizure-frequency reduction in the majority of patients, with some achieving an increase in the number of seizure-free days and reporting behavioral benefits. 

Biotech leaders denounce Trump ruling on young migrant status

Phil Taylor / FierceBiotech

In an open letter signed by Decibel Therapeutics CEO Steven Holtzman and his counterpart at Ovid Therapeutics, Jeremy Levin, D.Phil.—and endorsed by a lengthening list of senior biotech figures including Biogen head Michel Vounatsos and Seattle Genetics' Clay Siegall, Ph.D.—the group tells the president that the young people now threatened with deportation from the U.S. "are part of why we will continue to have a global competitive advantage."

U.S. drugmakers chop fewer jobs this year despite headwinds

Eric Sagonowsky / FiercePharma

Even as the drug industry faces a host of growth-stunting challenges, a new report highlights some positive news from an employment point of view. U.S. pharma firms terminated fewer employees this year than at the same point in 2016, according to the analysis.

FDA Commissioner Issues Statement on New Stem-Cell Therapy and Regenerative Meds Policy

BioPharm International

FDA Commissioner Scott Gottlieb, MD, issued a statement on FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicines. The statement comes after two incidents of unauthorized stem-cell treatments investigated by the agency.

A new drug assessment method developed in Russia

GMP News

In health care system, the clinical trials are conducted in order to collect data on safety and efficacy of new medicinal products or medical devices. All drugs, even the so-called “generics,” the copies of original drugs, must pass the testing. There is a two-stage system to study the generics. First, they are tested in vitro; and next, if the results of the first tests are good, the studies are conducted in healthy volunteers (in vivo). The results of such tests allow to assess how the drug dissolves and is absorbed by the human body.

Russia developed a strategy to prevent the spread of antimicrobial resistance

GMP News

The Russian Ministry of Health has developed and submitted to the Government of the Russian Federation a Strategy for the Prevention of the Spread of Antimicrobial Resistance in the Russian Federation for the Period until 2030.

06 September 2017

Liquid Biopsy Tumor Heterogeneity Test Predicts Resistance to Targeted Therapy in Metastatic Prostate Cancer Patients

Researchers at Epic Sciences and Memorial Sloan Kettering developed and applied a ground-breaking new test for measuring the cellular diversity within tumors, or tumor heterogeneity, through the analysis of single circulating tumor cells (CTCs). To measure tumor heterogeneity, researchers analyzed protein and morphology based biomarkers in single CTCs and quantified degrees of variance among CTCs in blood samples from patients prior to receiving targeted androgen receptor signaling inhibitor (ARSi) therapies, including the blockbuster drugs Zytiga® and Xtandi®, compared to blood samples from patients prior to receiving chemotherapy.

EMA started a survey to understand the awareness about side effects of medicines

GMP News

EMA has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reaction, including for medicines under ‘additional monitoring’. Medicines under additional monitoring are monitored particularly closely by regulatory authorities. They are easily identified by a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals, called the ‘summary of product characteristics’ (SmPC). Healthcare professionals and patients are encouraged to report any suspected adverse reactions.