Industry news

• FDA, DHS link arms on medical device cybersecurity, plus new agency guidance

  19 October 2018 Conor Hale / FierceBiotech

  The FDA and the Department of Homeland Security are teaming up on securing medical devices from cyberattacks, formalizing a long-standing relationship in the field. The two federal agencies agreed to share additional information and collaborate more on evolving vulnerabilities, and to assist the healthcare sector to proactively respond when possible exploits are identified, including the use of ransomware or wider attacks on a health system.

• Ferring and Evotec to create a research alliance in reproductive medicine

  18 October 2018 GMP News

  Ferring Pharmaceuticals and Evotec AG announced a strategic research alliance to discover and develop new small molecule therapies to treat patients living with fertility and gynaecological conditions.

• Russia emerges as frontrunner in global fight against tuberculosis

  17 October 2018 Remedium

  Russia has turned out to be the world’s most successful tuberculosis fighter, Russian Health Minister Veronika Skvortsova stated  during the interview with the Rossiya-24 channel. "We are the global leader according to the pace in solving this issue," she noted, adding, "all countries acknowledge Russia’s foremost role here."

• Pharma TV buys so far top last year's $1B spend; AbbVie, Pfizer lead September

  16 October 2018 Beth Snyder Bulik / FiercePharma

  Call it blockbuster TV ad spending. With three quarters down and one to go, national media buys are tracking ahead of last year. The top 10 brands dropped $1.19 billion through Sept. 30, according to data from real-time TV ad tracker iSpot.tv—and that's a 12% increase over the $1.07 million spent so far last year.

• Scientists developed new tool for open exchange of biomaterials

  16 October 2018 GMP News

  A new easy-to-use legal tool that enables open exchange of biological materials was launched. The OpenMTA is a Material Transfer Agreement (MTA) designed to support openness, sharing and innovation in global biotechnology. Material Transfer Agreements (MTAs) provide the legal frameworks within which research organisations define terms and conditions for sharing their materials – everything from DNA molecules to plant seeds to patient samples.

• EMA published update on Brexit preparedness

  15 October 2018 GMP News

  The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced at the beginning of August 2018.

• Over 10,000 Russian pharma market participants joined the labeling system

  15 October 2018 GMP News

  According to Mikhail Murashko, the head of Roszdravnadzor, about 10,000 of pharma market participants across the country have joined the program for monitoring of preparedness for the project on the labeling of drugs. As the head of the department noted, federal law No. 425 established the obligation for labeling drugs as of January 1, 2020.

• Russia now has a development strategy for the cosmetic industry until 2030

  12 October 2018 GMP News

  The Ministry of Industry and Trade of the Russian Federation has developed a draft executive order of the Government of Russia “On the approval of the Strategy for the Development of the Perfumery and Cosmetic Industry of the Russian Federation for the Period up to 2030”.

• Pfizer rewards $3 million in grants for breast cancer researchers

  12 October 2018 GMP News

  Pfizer announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants totaling more than $3 million in funding will be awarded to investigators to support clinical research projects involving Pfizer compounds in breast cancer.

• The First FDA-approved Digital Pill — What It Means for Pharma

  11 October 2018 Harsha Madannavar, Managing Director at L.E.K. Consulting / Fierce Pharma

  Last year, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill that is integrated with an ingestible sensor that captures information about whether the patient has complied with her medication regimen. A patient ingests the pill and it sends the data to a patch worn on her torso, which adds various physiologic measures. From there the information is wirelessly sent to a mobile phone app, allowing both the patient and her physician to track how the patient is using and responding to her medication.