Industry news

• Pharma Supply Chain Still Highly Vulnerable to COVID-19 Pandemic

  23 November 2020 GMP News

  New industry research reveals 75 percent of pharma supply chain leaders believe the COVID-19 will greatly increase problems with drug diversion, including theft and counterfeiting of critical products (such as test kits, vaccines and anti-viral medicines). The report found that COVID-19 has also caused significant challenges with drug shortages and increased production costs.

• NIH scientists collect clues to improving cancer care from 'exceptional responders'

  20 November 2020 Angus Liu / FiercePharma

  A small number of cancer patients respond particularly well to drugs. These so-called “exceptional responders” not only see their tumors shrink with treatment, they also enjoy responses that are unusually long. Understanding of the molecular features of this rare group of patients could guide the development of new strategies for fighting cancer.

• The First 120,000 Doses of CoronaVac COVID-19 Vaccine Arrive in Brazil

  20 November 2020 GMP News

  The first 120,000 doses of CoronaVac, a COVID-19 vaccine developed by China’s Sinovac Biotech that is being tested in Brazil, arrived at São Paulo’s international airport on Thursday (19 November) morning, the state government said.

• Primary Efficacy Analysis Demonstrates BNT162b2 to Be 95% Effective against COVID-19

  19 November 2020 GMP News

  Pfizer Inc. and BioNTech SE announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. 

• Europe is a Key Manufacturing Location for Microbial Biologics

  19 November 2020 GMP News

  The Roots analysis stated that despite mammalian cell cultures being the preferred biomanufacturing approach for biologics, advances in the microbial manufacturing space – especially in microbial fermentation – has enabled the development of versatile, robust and cost-effective biomanufacturing systems. It adds that the number of service providers offering end-to-end solutions for microbial biologics and “obvious advantages of outsourcing” means drug developers are likely to continue relying on contract service providers, driving growth in the microbial contract biomanufacturing market.

• The President of Kazakhstan says an agreement with Vladimir Putin on the production of COVID-19 vaccine

  18 November 2020 GMP News

  Kazakhstan’s President Kassym-Jomart Tokayev said on Monday (16 November) that he had reached an agreement with Russian leader Vladimir Putin on the construction of a plant for the production of a Russian coronavirus vaccine.

• The Human Clinical Trials of “Sputnik V” Vaccine will Start from Next Week in India

  18 November 2020 GMP News

  The first batch of Russia’s Sputnik V vaccine for COVID-19 is likely to reach Kanpur’s Ganesh Shankar Vidyarthi Medical College by next week wherein the vaccine’s Phase 2 and Phase 3 human clinical trials will be conducted. The decision to conduct the human clinical trials of the vaccine was taken after Dr Reddy’s Laboratories got approval from the Drugs Controller General of India (DCGI) in this regard, an official said.

• After WHO trial failure, influential medical group advises against Gilead's remdesivir in COVID critical care: Reuters

  17 November 2020 Eric Sagonowsky / FirecePharma

  Gilead’s remdesivir, now known as Veklury, is perhaps the most successful COVID-19 drug so far. It scored a full FDA nod in October after months of emergency use and brought in $873 million last quarter as the standard of care in hospitalized patients.

• Pharma brand TV spending continues upswing in October, led by AbbVie and BMS

  17 November 2020 Beth Snyder Bulik / FiercePharma

  Pharma kept up the spending pace on TV in October. The top 10 brands nudged to $187 million total spending for the month, just ahead of September's already robust $182 million.

• EMA Aligns Recommendations for Sartans with Those for other Medicines

  16 November 2020 GMP News

  EMA’s human medicines committee (CHMP) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines.