Thursday, February 10, 2022
Lilly to Supply Covid-19 Treatment Candidate to U.S. Government for $720 M
Eli Lilly & Co. said it has agreed to supply 600,000 doses of an investigational drug to the U.S. government in an effort to expand the country's Covid-19 treatment options.
The government will pay $720 million in the agreement to acquire the units of bebtelovimab, an investigational neutralizing monoclonal antibody. It will accept the doses if it is granted an emergency use authorization by the Food and Drug Administration. Eli Lilly has submitted a request for an emergency use authorization for the drug for the treatment of mild to moderate Covid-19 in certain high-risk patients.
The agreement calls for a delivery of the 600,000 doses by March 31, with an option to acquire an additional 500,000 doses by July 31.
AstraZeneca Says Its ADRs Will Join NASDAQ-100 Index Feb. 22
AstraZeneca PLC on Thursday said its American depositary receipts will join the NASDAQ-100 Index and the NASDAQ-100 Equal Weighted Index before the opening of the market of Feb. 22.
AstraZeneca said it will replace Xilinx, Inc. on the indexes.
Earlier Thursday, Advanced Micro Devices said it received all necessary approvals for its proposed acquisition of Xilinx, and expects the deal to close on or about Feb. 14.
US FDA advisers call for new trial of Lilly, Innovent lung cancer drug
Innovent Biologics Inc and Eli Lilly and Co should be required to conduct a trial of their lung cancer drug that is applicable to the US population, a panel of advisers to the US Food and Drug Administration recommended yesterday.
The outside advisers voted 14-1 that the agency require more data from the companies, which has only conducted a trial in China.The FDA in briefing documents released on Tuesday had raised concerns over the lack of a diverse population tested in the study submitted for US approval consideration.
“Single country submission is a step backward in achieving the racial diversity that we need in the United States,” Richard Pazdur, director of the FDA's Oncology Center of Excellence, told the panel.The panel's vote could be a harbinger for other large drugmakers such as AstraZeneca Plc and Roche Holding AG who have made big investments in the hope of benefiting from cheaper trial costs in China.
Lilly said it was “disappointed” with the outcome of the advisory panel meeting, but that it would continue to work with the FDA as the agency completes its review of sintilimab.“We have long-standing initiatives in place to advance diversity and inclusion in Lilly-conducted clinical trials,” it said in a statement.
Sintilimab, in the Chinese trial of patients with the most common form of advanced or recurrent lung cancer, met the main goal of progression free survival (PFS), or the time a patient lived without the disease worsening.In addition to the lack of population diversity, experts raised concerns over the use of PFS as the study's main goal rather than overall survival, the gold standard for cancer drugs.
They also noted a lack of urgency for this medicine given the availability of other effective drugs from the same class of immunotherapies, known as PD-1 inhibitors, such as Merck & Co's Keytruda and Bristol Myers Squibb's Opdivo.Jorge Nieva, a panel member from the University of Southern California and the lone dissenter, said another drug on the market sooner could help lower the cost of such treatments.
“Having more drugs competing for those patients will have greater impact on health equity than the need for diversity in clinical enrolment,” he said. Brad Loncar, who created a China biotech-focused ETF, said the need for trials outside China would make it unlikely a cheap China-made PD-1 inhibitor could enter the United States, because the preference for multicentre trials and overall survival as main outcomes meant longer, costlier trials that would deter most developers. headtopics.com
“Going forward, and this is already happening, Chinese companies will be developing newer drugs based on FDA's expected standard and that will be expensive just like for companies from any other region,” Loncar said.Chinese biopharmas are looking to overseas markets because of domestic pricing pressures, said Helen Chen, greater China managing partner at L.E.K. Consulting.
In the innovative oncology area, 15 per cent of Chinese firms are already running international multicentre trials, Chen said
US Urges Canada to Use Federal Powers to End Bridge Blockade
The Biden administration urged Prime Minister Justin Trudeau’s government Thursday to use its federal powers to end a truck blockade by Canadians protesting the country’s COVID-19 restrictions that is tightening the screws on the auto industry, forcing Ford, General Motors and other car companies to shut down plants or otherwise scale back production on both sides of the U.S. border.
Novavax says COVID-19 shot 80% effective in adolescent study
Novavax Inc said on Thursday its two-dose vaccine was 80% effective against COVID-19 in a late-stage trial testing the shot in teens aged 12 to 17 years.
The trial involved 2,247 adolescents and took place between May and September last year when the Delta variant was the dominant strain in the United States. The vaccine was 82% effective against the variant.
The U.S. biotech said it expects to submit applications to global regulators for the shot's use in adolescents during the first quarter.
Novavax late last month filed for authorization of the shot in U.S. adults, a much-awaited step following months of struggles with development and manufacturing problems.
The vaccine has received authorizations from the European Union and the World Health Organization and has been cleared for use in adults in countries including the United Kingdom and New Zealand.
In the company's trial in adults, which enrolled about 30,000 participants in the United States and Mexico, the vaccine had an efficacy of 90.4%.
Novavax said it did not see any incidents of myocarditis in the adolescent data but said it was keeping a close eye on the inflammatory heart condition and any other adverse events as it deploys its vaccine in the broader population.
"So as we deploy the vaccine in the broader population, we're keeping a very close eye on this and the other adverse events associated with vaccination. We can make sure we inform the public and regulators about how our maximum performance from safety perspective," said Filip Dubovsky, chief medical officer.
https://news.yahoo.com/novavax-says-covid-19-shot-215045378.html
Norwegian Cruise Line dropping mask requirement
Norwegian Cruise Line is preparing to loosen its COVID-19 protocols, including a mask mandate for passengers.
"All guests age five and over, as well as crew are required to be 100% fully vaccinated, so you can cruise with confidence," Norwegian said in a statement about its safety guidance.
Starting on March 1, guests must also show a negative test upon checking in. For those cruises, guests will not be required to mask, the guidelines said.
The cruise line added that the company recognized "the added protections provided when wearing a mask covering and recommend that all guests do so onboard when indoors."
"The decision to wear a mask covering when onboard is at the discretion of each guest," the statement added.
Before that change is implemented, the cruise line said that anyone aboard ships departing now through Feb. 28 will be required to take a COVID-19 antigen test provided by the cruise line and receive a negative test result. During that time period, masks will still be required inside for all guests and crew members.
In December, the Centers for Disease Control and Prevention advised Americans to avoid traveling by cruise ships regardless of their vaccination status as a result of the uptick in COVID-19 infections fueled by the omicron variant.
That same month, a Norwegian ship arrived in New Orleans with at least 10 people who had tested positive for the virus, all of whom were asymptomatic.