Industry news

• Mass spectrometry for gene therapy vector analysis

  11 October 2021 Hannah Balfour / European Pharmaceutical Review

  Researchers show combining mass spectrometry and a gas-phase electrophoretic mobility molecular analyser improves detection of full and empty virus-like particles for gene therapies.

• Enhertu HER2-directed cancer treatment: key trials and results

  08 October 2021 Anna Begley / European Pharmaceutical Review

  Detailed positive results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu demonstrated superior progression-free survival (PFS) versus trastuzumab emtansine (T-DM1), a HER2-directed antibody-drug conjugate (ADC) currently approved to treat patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

• 5 Key Factors to Successfully Leveraging Person-Generated Health Data

  07 October 2021 FiercePharma

  To improve outcomes and care delivery, personalized medicine is the ideal from the point of view of patients and clinicians alike. Digital health tools and wearable devices play a critical role in helping to make personalized health a reality. These instruments capture person-generated health data (PGHD), which is health-related data created, recorded, or gathered by individuals or by their family members and other caregivers. 

• New FDA draft guidance on microbiological quality of NSDs

  07 October 2021 Hannah Balfour / European Pharmaceutical Review

  The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.

• The Role of Quality and Speed in Custom Model Generation

  06 October 2021 FierchBiotech

  The pressure to produce results quickly during the drug discovery and development process continues to increase as does the role of genetically engineered custom mouse models. However, even the fastest custom mouse model generation projects take about 6 months to reach the stage when a few F1 heterozygous mice are available for experiments or breeding. This timeline increases if more than a few heterozygotes or homozygotes are needed. 

• FDA greenlights combination at-home test for COVID and influenza in children as flu season approaches

  06 October 2021 Conor Hale / FierceBiotech

  With the school year now solidly underway and more people making their return to the workplace, the U.S. is once again facing a familiar wrinkle to dealing with the COVID-19 pandemic: the return of flu season.

• Denis Manturov suggests creating a specialized site for the production of vaccines

  05 October 2021 GxPnews

  The Ministry of Industry and Trade of the Russian Federation is considering the possibility of creating a separate site where the production of vaccines will be concentrated. This was stated by Denis Manturov, the Minister of Industry and Trade, at the BiotechMed forum.

• API Synthesis Laboratory opened at Ogarev Moscow State University

  05 October 2021 GxPnews

  With the support of AO “Biokhimik” of the Promomed Group, a research and educational laboratory for the synthesis of active pharmaceutical ingredients was opened in the Institute of Physics and Chemistry of the N.P. Ogarev Mordovian State University on September 30.

• New map of protein interactions offers opportunity to 'do such damage to cancer,' scientists say

  04 October 2021 Arlene Weintraub / FierceBiotech

  There are now myriad drugs that attack cancer by targeting gene mutations in tumors, but they don’t always work, and patients often become resistant to them. To help address those shortcomings, a team of University of California researchers decided to look beyond individual genes for fresh insights into the underlying forces of cancer.

• FMBA plans to file documents for registration of its COVID-19 detection device

  04 October 2021 GxPnews

  The Federal Medical and Biological Agency (FMBA) has completed clinical and technical tests of Izascrin-8, a device for detecting coronavirus, and it is planned to submit documents for its registration soon, as Veronika Skvortsova, the head of the agency, reported.