covid-19 Archives - Page 42 of 113 - Medical Design Sourcing

Abbott stock down on reduced 2021 earnings outlook

Abbott (NYSE:ABT) announced today that it is cutting its earnings outlook for the year amid reduced demand for COVID-19 diagnostics.

The news sent ABT shares down more than 6% to $109.25 apiece in morning trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

Abbott had previously projected adjusted EPS of at least $5 this year. Now, it’s predicting EPS in the $4.30 to $4.50 range. EPS under GAAP will be $2.75 to $2.95, according to the company.

It appears that progress against the pandemic in the U.S. and many other developed countries was bad news for Abbott’s earnings. The company says positive trends have suddenly and fundamentally impacted market demand for COVID-19 tests.

The accelerated rollout of COVID-19 vaccines has significantly reduced cased numbers in the U.S. and other wealthy countries. In addition, the CDC has updated its recommendat…

CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready.

The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.

Sinopharm publishes COVID-19 vaccine trial data

An article recently published in JAMA concluded that two inactivated COVID-19 vaccines from Sinopharm (OTCMKTS: SHTDY) were 72.8% and 78.1% effective, respectively, based on interim Phase 3 study results.

The lower figure refers to the protection from a COVID-19 vaccine based on two 5-µg doses based on the SARS-CoV-2 isolate WIV04 complete genome. The second vaccine in the study was based on two 4-µg vaccine doses developed with the HB02 strain of SARS-CoV-2. Some 13,459 received the WIV04-based vaccine, while 13,465 received the HBO2 version.

A placebo group including 13,465 participants received aluminum hydroxide, a common adjuvant.

In all, the study involved 40,380 participants. Most participants in the study were relatively young men.

Sinopharm recruited study participants in the United Arab Emirates, Egypt, Jordan and Bahrain. The study population consisted of adults at least 18 years of age who believed they had not contracted COVID-19 o…

COVID-19 vaccine booster questions remain

Image from Nataliya Vaitkevich via Pexels

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter.

Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent the spread of COVID-19 infections, which was a significant driver of overall mortality from the novel coronavirus at the beginning of the pandemic. “Hence, if and when the residents’ immunity wanes, we must be on high alert, lest we relive the horrors of the past year,” said Dr. Mike Wasserman, a member of California’s Vaccine Advisory Committee in an interview with ABC News.

Complicating matters is the fact that many older adults have a diminished ability to produce antibodies, increas…

U.K. authorizes J&J COVID-19 vaccine

The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business.

The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a news release.

Get the full story at our sister site, Pharmaceutical Processing World.

U.K. authorizes J&J COVID-19 vaccine

The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business.

The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a news release.

Read: 9 things to know as AstraZeneca and J&J COVID-19 vaccines face safety scrutiny

Approval gives authorization to the use of the vaccine in people aged 18 years old and above in the UK, the MHRA said, while the decision on use of the vaccine in pregnant or breastfeeding women should be made in consultation with a healthcare professional after considering the benefits and risks, the regulatory body said.

“We have undertaken a thorough review of the conditional marketing authorization applica…

FDA shifts gears as mask shortages ease

KN95 mask (Image from the Oklahoma State Department of Health)

The FDA wants healthcare providers to move away from using certain imported disposable masks, such as KN95s.

The recommendation to ease off using non-NIOSH-approved masks comes less than two months after the agency said providers could transition away from reusing decontaminated masks.

Get the full story on our sister site, Medical Design & Outsourcing.

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.

Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulatin…

HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington.

The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351 (South African) variants. Those variants comprise more than 10% of COVID-19 infections in the eight states mentioned above.

HHS still recommends Regeneron’s (NSDQ:REGN) REGEN-COV antibody cocktail in areas with significant spread of the P.1 and B.1.351 v…

DoJ subpoenas Eli Lilly over bamlanivimab plant

In an SEC filing, Eli Lilly (NYSE:LLY.N) revealed that it had received a subpoena from the U.S. Department of Justice connected to a manufacturing site in New Jersey that produces bamlanivimab, one of two COVID-19 monoclonal antibodies it produces. The plant also produces the blockbuster Trulicity and cancer drugs.

Lilly did not state which types of documents the federal government had requested but noted that it is cooperating with the criminal probe. The U.S. government has not made any specific accusations against Lilly.

According to a Reuters report, Lilly employees had accused an executive of modifying federal documents to cover up quality control problems at the facility in Branchburg, New Jersey.

FDA officials inspected the plant in November 2019 and reported discovering missing data related to various manufacturing processes. The agency concluded that the facility had two counts of inadequate “control of computer systems.”

The FDA used its…

Exelead makes first precursor batch of Pfizer-BioNTech COVID-19 vaccine

Pharma industry contract manufacturer Exelead recently announced that it has delivered its first precursor batch of Prizer-BioNTech’s COVID-19 vaccine, produced at its recently expanded facility in Indianapolis.

Exelead plans to add 50 jobs to help it meet COVID-19 vaccine demand.

“We are extremely proud to be part of the manufacture of the Pfizer-BioNTech COVID-19 vaccine, knowing our work has the potential to help millions of people,” said Exelead CEO John Rigg said in a news release. “As a leader in complex drug manufacturing, Exelead is committed to leveraging our manufacturing capabilities and years of experience to help support the supply of the Pfizer-BioNTech COVID-19 vaccine and increase the number of doses available.”

Kevin Nepveux, VP of Pfizer Global Supply, added that contract manufacturer support is one way the pharmaceutical giant has ramped up manufacturing capabilities to produce more COVID-19 vaccine doses.