Industry news

New machine learning model could significantly speed up drug discovery

GMP News

Drug discovery could be significantly accelerated thanks to a new high precision machine-learning model, developed by an international collaboration of researchers, including the University of Warwick, UK.

A fundamentally new infertility drug made in Russia will be launched by 2021

GMP News

A fundamentally new infertility medication was developed in Obninsk. It is expected to be launched in 2021. The trade name is yet unknown. Currently, the drug is presented to scientific community under a tentative name of PAM-8. The acronym “PAM” stands for the Park of Active Molecules located in Obninsk and engaged in the development and promotion of promising medicinal products. PAM-8 is at the stage of clinical trials.

EAEU adopts common requirements to water for pharmaceutical use

GMP News

Common Requirements to Water for Pharmaceutical Use in manufacturing the medicinal products were adopted by the Board of the Eurasian Economic Commission (EEC) on December 13. The regulations define three categories of water quality.

A new future for R&D?

Deloitte

The pharmaceutical industry continues to face an extremely challenging research and development (R&D) environment and has yet to turn a corner in terms of its R&D value proposition. Despite this, the Deloitte UK's report presents an optimistic road ahead for R&D and business leaders, exploring the emerging technologies that have the potential to dramatically transform the productivity and efficiency by which drugs are discovered, developed, and brought to patients.

FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

FDA

The U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.

Contract Manufacturing Raises Regulatory Concerns

Jill Wechsler / BioPharm Inertnational

FDA officials continue to be alarmed about violative production practices and inadquate quality control at drug outsourcers, as seen in a rise in warning letters and citations to contractors and their pharma clients. Contract manufacturing has gone “from bad to worse,” in the pharmaceutical compliance area, said Donald Ashley, director of the Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER), at the Enforcement, Litigation and Compliance conference sponsored by the Food & Drug Law Institute (FDLI) in December 2017 in Washington, DC. 

SKOLKOVO Foundation and Janssen signed a collaboration agreement

GMP News

Kirill Kaem, Senior Vice-President at SKOLKOVO Foundation, and Luis Diaz-Rubio, Managing Director, Emerging Markets EMEA at Janssen, signed a collaboration agreement.

Will Pharma Meet the Drug Tracking Deadline?

Jill Wechsler / BioPharm Inertnational

As FDA and industry near the halfway mark in the 10-year process for establishing a national electronic drug tracking system by 2023, there’s considerable concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline. The process for establishing the rules and infrastructure for the track-and-trace system envisioned in the Drug Supply Chain Security Act (DSCSA), part of the Drug Quality and Security Act of 2013 (DQSA), is proving to be complex and challenging for all parties.

Russia’s pharma imports resume growth for the first time since 2014

Remedium

Drug imports by Russia for the period of January-September of 2017 grew for the first time since 2014 and amounted to 108.700 tonnes, which is 6.5% more than in the same period a year ago.

13 December 2017

Marinus Pharmaceuticals Added to NASDAQ Biotechnology Index

Marinus Pharmaceuticals, Inc.(Nasdaq:MRNS) (the “Company”), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that it has been selected for addition to the NASDAQ Biotechnology Index^®, which will become effective prior to the open of U.S. markets Monday, December 18, 2017.