Industry news

GMP Inspection practice: a case for global benchmarking, convergence and mutual reliance/recognition

GMP News

In 1969 the global agreement on the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce was proposed by WHO. The aim was to facilitate international trade in pharmaceuticals through mutual recognition of GMP inspection results. Today, almost 50 years later, up to one hundred countries conduct foreign inspections. As a result a manufacturing site well established, might be inspected  many times in one year by local and different foreign authorities. This leads to duplication of work and waste of recourses both by regulators and industry.

Kaluga is expected to complete its program for radiopharmaceuticals in two years

GMP News

Kaluga pharmaceutical cluster recently increased the number of locally manufactured drugs from 65 to 154. The Governor Anatoly Artamonov expects that the region needs 2 more years to complete its import substitution program for radiopharmaceuticals, reported Kaluzhskaya Nedelya, a local newspaper.

Blockchain technology has a special potential to confront counterfeit drugs

GMP News

DHL has released a trend report in cooperation with Accenture, a leading global technology consultant, on blockchain technology’s potential to transform the logistics industry. The report includes initial findings on a working prototype developed by DHL and Accenture, which tracks pharmaceuticals from the point of origin to the consumer, preventing tampering and errors.

Russia establishes its National Quality Infrastructure Council

GMP News

On March 14, Denis Manturov, the Russian Minister of Industry and Trade, chaired a meeting of the State Commission on Counteraction to Illegal Circulation of Industrial Products. The Minister said that, ensuring the “market purity” would require, in addition to providing more preferences for entrepreneurs operating strictly within the legal field, to guarantee to potential consumers that they purchase genuine rather than counterfeit and falsified products.

Researchers in aging tie genes to brain degeneration

Arlene Weintraub / FierceBiotech

As brain cells age, they lose their ability to perform basic functions, often leading to dementia and other neurodegenerative disorders. But what’s behind this decline, and can it be stopped? Two new studies out this week uncover links between genes and brain-cell functioning that could provide new targets for therapies aimed at neurodegenerative diseases.

China established a new drug regulator

GMP News

After about five years as a standalone agency, the China Food and Drug Administration (CFDA) will merge into a gigantic national market supervision administration, with drug regulation as a new, second-tier bureau underneath.

Project of EAEU unified goods traceability system was presented to the public

GMP News

The unified goods traceability system in the Eurasian Economic Union (EAEU) will provide consumers with access to reliable information about products, allow businesses to reduce their transaction costs, let member states to monitor the payment of taxes, minimize smuggling, and protect consumers.

Unbranded pharma ads—what are they good for? Actually quite a bit, marketing panelists say

Beth Snyder Bulik / FiercePharma

While unbranded pharma campaigns can be easier to pull off—or at least easier to get through medical and legal review internally—they still need to follow the same marketing rules as those used for branded drugs. Relevant content, well-targeted distribution and measurable return on investment still have to be the goals, a group of panelists told attendees at the first FiercePharmaMarketing Forum last week.

FDA's promo police put pharma marketing to the test with 6 new research studies

Beth Snyder Bulik / FiercePharma

The FDA is plotting a half-dozen new studies of drug advertising and marketing tactics, and among them is an analysis of TV ads promoting disease awareness and a look at drugs that sped their way to market using the agency's accelerated approval processes.

14 March 2018

Clearside Biomedical Announces Fourth Quarter 2017 Financial Results and Provides Corporate Update

Clearside Biomedical, Inc.  (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today reported financial results for the fourth quarter and full year ended  December 31, 2017 , and provided an update on its development programs.