Industry news

Is your bioanalytical and clinical trial testing strategy optimized?

FiercePharma

As sponsors require higher throughput, managers are forced to do more with the same or fewer resources, which causes a strain in scientific depth. This pressure increases as the complexities of therapeutic targets and technologies increase. Beyond that, sponsors are also seeking faster turnaround times from planning and study start to reporting and data transfer. However, many sponsors don’t realize the benefits of bundling services, which can lead to cost savings and operational efficiencies.

First labeled drugs go on sale in retail pharmacies in Russia

GMP News

“The first labeled pack of medicinal product was sold at retail. The activities conducted by the participants in the experiment on labeling the drugs together with Roszdravnadzor, Russian Ministry of Health, and the Federal Tax Service of Russia allowed to close the entire technological chain of drug circulation from manufacturing to retail sales. Now, the manufacturers label each drug package by applying a two-dimensional bar code (DataMatrix) with individual identification number. Then, the information on the transfer of that medicinal product for sales is submitted to the labeling system,” said Olga Chepurina, the Head of the Directorate for Control of Goods Circulation at the Federal Tax Service of Russia.

EC, EMA and FDA signed a new milestone commitment

GMP News

The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators.

Manufacturing of medicines in Russia is up 11.2% in H1 2017

GMP News

In H1 2017, the output of medicinal products in Russia increased by 11.2% compared to the same period of 2016 (in the prices of corresponding years). This year, the Russian Ministry of Industry and Trade estimated their production at 140.37 billion rubles. The growth is also observed in physical terms.

EMA and FDA will now share trade secrets, allowing both regulators to act on each other’s inspection reports

John Carroll / Endpoints News

As part of a landmark agreement forged in March, the FDA and European Medicines Agency said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information.

Bacteriophage medications may become the substitutes for antibiotics

GMP News

The Institute of Chemical Biology and Fundamental Medicine of SB of RAS (ICBFM SB RAS) is developing a new generation of therapeutic bacteriophage medications that represent a soft and safe alternative to antibiotics. In particular, they allow saving the patients with diabetic foot syndrome from amputation.

Big names, big companies back a cell therapy startup run by a high-profile regenerative med expert

John Carroll / Endpoints News

One of the best known names in regenerative medicine is launching a new biotech with assets and cash coming from a range of marquee companies that includes Celgene.

Russian experts forecast an increase in prices for imported drugs by 5-20%

GMP News

In the first five months of 2017, the costs of importers on purchasing drugs abroad increased by 11% compared to the same period of last year. However, in terms of physical volumes, the imports of foreign-made medicinal products grew by only 4%. This is demonstrated by the data from the Federal Customs Service. The representatives of pharmaceutical industry forecast that the retail will feel the changes as early as this fall, as the prices in pharmacies may increase by 5-20%.

National Cancer Center of Japan sets up a new drug development system

GMP News

Japan’s National Cancer Center will establish a system for cooperating on the development of cancer drugs with four medical institutions in South Korea, Taiwan, Singapore and Hong Kong. The scheme aims to expedite the approval of new drugs.

After two years of negotiations, FDA gets its user fee programs authorized through 2022

Arsalan Arif / Endpoints News

President Donald Trump signed the FDA Reauthorization Act of 2017 into law late Friday, quietly ending a two-year long process that until several weeks ago threatened to disrupt agency operations.