Coronavirus tracker: GSK, Sanofi burned by Warp Speed picks; EU members launch COVID vax alliance

Fiercepharma | June 04, 2020

The Trump administration unveiled its finalists for Operation Warp Speed on Wednesday afternoon, with a notable Big Pharma bent. Meanwhile, Novavax—whose shot did not make the cut—recruited Japanese manufacturer AGC Biologics to churn out adjuvant for its coronavirus vaccine candidate. And on the heels of a controversial report by the Lancet, the New England Journal of Medicine published data showing hydroxychloroquine didn't do much to prevent infection in people exposed to the virus. But that didn't stop the World Health Organization from resuming trials on the antimalarial, which were halted last week over safety concerns. Plus, four European countries forged a new vaccine alliance to bring COVID shots to the continent, taking cues from a U.S. agency, the Biomedical Advanced Research and Development Authority, as more countries aim to secure supplies to fight the pandemic.

Spotlight

Dr. Elisabeth Kogan, Sr. VP Teva Global Generic R&D and NTEs The word generic is so… generic. However, there is nothing generic about the way Teva has become the No. 1 generics company in the world.

Spotlight

Dr. Elisabeth Kogan, Sr. VP Teva Global Generic R&D and NTEs The word generic is so… generic. However, there is nothing generic about the way Teva has become the No. 1 generics company in the world.

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GenScript Receives FDA Emergency Use Authorization for World's First SARS-CoV-2 Neutralizing Antibody Detection Kit

GenScript | November 09, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2.

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PHARMA TECH

AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland. The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday. An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer. In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm. Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu. Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

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CSA Medical Announces First Procedure in the SPRAY-CB Pivotal Trial for the Treatment of Chronic Bronchitis

CSA Medical Inc | October 22, 2020

CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced the first patient treated in the SPRAY-CB, U.S. pivotal trial utilizing the RejuvenAir® System for COPD with Chronic Bronchitis at Temple University. Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and principal investigator completed the procedure on October 14th. "We are pleased to have performed the first procedure in this landmark pivotal trial, building on the European data in which patients achieved meaningful improvements in their cough and overall quality of life," said Dr. Criner. "RejuvenAir Metered Cryospray is a promising new interventional tool that has the potential to reduce emergency hospital visits due to chronic bronchitis symptoms. This definitive intervention may provide a long-term benefit to millions of adults suffering with Chronic Bronchitis."

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