covid-19 Archives - Page 73 of 113 - Medical Design Sourcing

BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants

Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants.

The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies, which was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination, proved less effective in South Africa, where a new variant of the virus has appeared, offering just 57% protection from moderate-to-severe infection there (where 95% of cases were due to infection from the variant). The level of protection in the U.S. was 72% and it was 66% in Latin America.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” Janssen R&D global head Dr. Mathai Mamment said in a news release. “Changing the trajector…

Eli Lilly rises on Street-beating Q4

Eli Lilly (NYSE:LLY) shares ticked up this morning on fourth-quarter results that beat the consensus forecast.

The Indianapolis-based company posted profits of $2.1 billion or $2.32 per share, on sales of $7.4 billion for the three months ended Dec. 31, 2020, for a 41.5% bottom-line gain on sales growth of 21.7%.

Adjusted to exclude one-time items, earnings per share were $2.75, 40¢ ahead of Wall Street, where analysts were looking for sales of $7.3 billion.

The company’s quarter included receiving FDA emergency use authorization (EUA) for both bamlanivimab and baricitinib (the latter for use in combination with remdesivir) in COVID-19 patients. Bamlanivimab, a COVID-19 antibody treatment, is for mild-to-moderate cases at risk of progresing to severe COVID-19, while baricitinib’s indication is for hospitalized patients who require supplemental oxygen, ventilation or extracorporeal membrane oxygenation.

“Lilly closed a complex yea…

Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants

A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants.

The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in South Carolina.

The Pfizer and University of Texas Medical Branch scientists conducting the research concluded that modifying the BNT162b2 was unnecessary.

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

Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants

A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants.

The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in South Carolina.

The Pfizer and University of Texas Medical Branch scientists conducting the research concluded that modifying the BNT162b2 was unnecessary.

The researchers, however, acknowledged that the study involving engineered viruses did “not include the full set of spike mutations found in the UK or SA variants” and that clinical data are required to better understand the impact of viral mutations on the vaccine.

The Pfizer findings are broadly similar to those from Moderna, whose experiments indicated that its mRNA-1273 vaccine is effective against emerging variants from the U.K.…

NeuroMetrix slides on Q4 losses

NeuroMetrix (NSDQ:NURO) shares dipped today on fourth-quarter results that showcased losses despite an improved bottom line.

The Woburn, Mass.-based company posted losses of -$325,767 on sales of $1.8 million for the three months ended Dec. 31, 2020, for a 69.2% bottom-line gain on sales growth of 6%.

NeuroMetrix experienced headwinds from the COVID-19 pandemic and felt the effects of positioning its Quell Watch App for transcutaneous electrical nerve stimulation (TENS) for profitability, according to a news release.

“We are pleased that our prioritization of operating profitability has been effective in reducing our quarterly loss and cash consumption,” NeuroMetrix president & CEO Shai N. Gozani said in the release. “We are now positioned to resume a focus on growth, while continuing to improve the bottom line. “To this end, we have a number of impactful product development efforts for both DPNCheck and Quell which we expect to…

Danaher rises on Street-beating Q4

Danaher (NYSE:DHR) shares ticked up this morning on fourth-quarter results that topped the consensus forecast.

The Washington, D.C.-based company posted profits of $1.2 billion, or $1.66 per share, on sales of $6.8 billion for the three months ended Dec. 31, 2020, for a -4.8% bottom-line slide on sales growth of 38.9%.

Adjusted to exclude one-time items, earnings per share were $2.08, 21¢ ahead of Wall Street, where analysts were looking for sales of $6.5 billion.

Danaher’s life sciences segment posted revenue totaling $3.4 billion (75.4% growth from Q4 2019), while its diagnostics arm registered sales of $2.2 billion (23.4% growth year-over-year).

The company’s growth also included contributions from Cytiva, which is the biopharma business (formerly GE Healthcare Life Sciences) acquired by Danaher in April.

“For the full year 2020, we achieved nearly 10% core revenue growth including Cytiva, strong margin expansion, and more than …

Abiomed skyrockets on Street-beating Q3

Abiomed (NSDQ:ABMD) shares shot up this morning on third-quarter results that topped the consensus forecast.

Shares of ABMD were up 12.4% at $369.45 per share in early-morning trading today.

The Danvers, Mass.-based oxygenation device maker posted profits of $61.9 million, or $1.35 per share, on sales of $231.7 million for the three months ended Dec. 31, 2020, for a -10.6% bottom-line slide on sales growth of 4.5%.

Adjusted to exclude one-time items, earnings per share were also $1.35, 23¢ ahead of Wall Street, where analysts were looking for sales of $225.6 million.

“Abiomed delivered a record revenue quarter as we continue to remain both focused and committed to our mission of recovering hearts and saving lives despite the challenging COVID environment” Abiomed chairman, president & CEO Michael R. Minogue said in a news release. “We are excited to close Q4 as Abiomed 2.0 and enter Fiscal Year 2022 with our best ever clinical outcomes from ex…

House committee investigates $70M federal contract for AutoMedx ventilators

The AutoMedx SAVe II+ ventilator (Image from AutoMedx)

A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19.

The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee on Oversight and Reform. Soon after this contract was signed, officials at the Department of Health and Human Services (HHS) reportedly concluded that the SAVe II ventilator model was inadequate to treat coronavirus patients, a news release from the committee says.

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

Using technology to improve efficiency and safety in pharma manufacturing

Image courtesy of Nymi

The pandemic has amplified the pressure pharmaceutical companies face to improve operational performance while also forcing them to accelerate innovation, clinical trials and production. All of this requires employees to work as efficiently as possible.

Technology is available to meet these needs while also helping pharma companies respond to new worker safety challenges. Within pharma facilities, workers want to touch fewer surfaces and minimize their interactions. Accomplishing these goals requires deploying hands-free systems, conducting self-health attestations before shifts, and enforcing social distancing and contact tracing procedures.

Efficiency and safety are not mutually exclusive goals. Businesses that fall short in these areas risk their brand reputation, bottom line and employees’ lives. While many companies previously addressed individual challenges using point sol…

COVID-19 assays sales power Hologic to Street-beating Q1

Hologic (NSDQ:HOLX) shares ticked up after hours today on first-quarter results that topped the consensus forecast.

The Marlborough, Mass.-based company posted profits of $653.4 million, or $2.50 per share, on sales of $1.6 billion for the three months ended Dec. 26, 2020, for a 69.4% bottom-line gain on sales growth of 89.3%.

Adjusted to exclude one-time items, earnings per share were $2.86, 69¢ ahead of Wall Street, where analysts were looking for sales of $1.4 billion.

Hologic continues to benefit from demand for its two COVID-19 assays that run on its Panther and Panther Fusion systems as its worldwide molecular diagnostics business brought in $995.3 million for an increase of 457.6% year-over-year.

“Hologic had a strong start to fiscal 2021 across all our businesses and major geographies,” Hologic chairman, president & CEO Steve MacMillan said in a news release. “Our Diagnostics division continued to deliver incredible performance by maki…

Johnson & Johnson gearing up for COVID-19 vaccine data announcement

Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week.

In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details.

“We think it’s very important to follow the data — to follow the science,” said JNJ CEO Alex Gorsky after declining to answer a question related to COVID-19 variants and vaccine efficacy until the official data announcement.

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

Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer

Sanofi (NYSE:SNY) announced today that it entered into an agreement to support the manufacturing and supply of the Pfizer/BioNTech COVID-19 vaccine.

Pfizer and BioNTech’s vaccine is one of two to receive FDA emergency use authorization in the U.S. and it also has clearance in Europe, having received both nods in December 2020.

The deal between Sanofi provides BioNTech access to its infrastructure and expertise to produce over 125 million doses of the COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt starting in the summer of 2021, according to a news release.

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