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Johnson & Johnson rises on mixed bag Q1, increased 2022 guidance

Johnson & Johnson (NYSE:JNJ) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast.

The New Brunswick, New Jersey-based company posted profits of $5.1 billion, or $1.93 per share, on sales of $23.4 billion in the first quarter for a 16.9% bottom-line slide on sales growth of nearly 5%.

Adjusted to exclude one-time items, earnings per share were $2.67, 6¢ ahead of Wall Street, where analysts were looking for sales of $23.7 billion.

Johnson & Johnson’s only segment to see sales decline was its consumer health arm, while pharmaceuticals produced the highest revenue growth, rising 6.3%, with the company’s COVID-19 vaccine contributing to that year-over-year increase.

“Our first-quarter results demonstrate strong performance across the enterprise, despite macro-economic headwinds,” Johnson & Johnson CEO Joaquin Duato said in a news release. “I am incredibly proud of Johnso…

FDA grants EUA for breathalyzer that detects COVID-19

A person provides a breath sample to the InspectIR COVID-19 Breathalyzer through a disposable, sanitary straw placed in the side of the machine. [Image courtesy of InspectIR]The FDA has authorized the first COVID-19 diagnostic test that detects chemicals associated with an infection in a person’s breath.

The company’s maker InspectIR (Frisco, Texas) expects to manufacture roughly 100 instruments per week, the FDA said in an announcement posted yesterday. The devices can each evaluate roughly 160 samples per day. Someone taking the test — under supervision at a doctor’s office, hospital or testing site — can receive a result in less than three minutes.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancin…

How medtech is tackling supply chain challenges

A host of medical device companies with manufacturing in Puerto Rico found their supply chains impacted by Hurricane Maria in 2017. It was a harbinger of what was to come. [Image is public domain]Join us at DeviceTalks Boston on May 10-11 to hear how medical device companies are propping open supply lines and ensuring a steady flow of products to customers in a constantly changing world.

Sharing best practices is more important than ever because supply chain challenges aren’t expected to diminish post-pandemic. That’s because superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

(Go to DeviceTalks Boston’s site to register!)

Over the two-day meeting we’ll hear how companies large and small are adapting to new demands, including:

How Viant and Vapotherm combined forces to meet unforeseen demands brought on by the COVID-19 pandemi…

How medtech is tackling supply chain challenges

A host of medical device companies with manufacturing in Puerto Rico found their supply chains impacted by Hurricane Maria in 2017. It was a harbinger of what was to come. [Image is public domain]

Join us at DeviceTalks Boston on May 10-11 to hear how medical device companies are propping open supply lines and ensuring a steady flow of products to customers in a constantly changing world.

Sharing best practices is more important than ever because supply chain challenges aren’t expected to diminish post-pandemic. That’s because superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

(Go to DeviceTalks Boston’s site to register!)

Over the two-day meeting we’ll hear how companies large and small are adapting to new demands, including:

How Viant and Vapotherm combined forces to meet unforesee…

NIH starts evaluating second COVID-19 booster shots in adults

[Photo by Fusion Medical Animation on Unsplash]

The NIH recently announced that it has started enrolling adults for a Phase 2 clinical trial evaluating various additional COVID-19 booster shots.

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the COVID-19 Variant Immunologic Landscape (COVAIL) trial.

“We are looking beyond the Omicron variant to determine the best strategy to protect against future variants,” NIAID Director Dr. Anthony S. Fauci said in a March 31 news release. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

The COVAIL trial will study immune responses induced by prototype vaccines and variant vaccine candidates — including bivalent vaccines, which target two SARS-CoV-2 variants. The goal is to inform future booste…

Cue Health, Major League Baseball partner on COVID-19 testing

Cue Health (Nasdaq:HLTH) and Major League Baseball (MLB) announced today that will expand on league-wide COVID-19 testing.

Under a national partnership, Cue Health — MLB’s trusted at-home testing solution — will provide MLB clubs as well as the league office with its integrated care platform that includes the portable and reusable Cue Health monitoring system (reader) and the COVID-19 self-test.

Cue Health’s molecular COVID-19 test uses nucleic acid amplification technology (NAAT) to provide lab-quality results directly to connected mobile devices in 20 minutes, according to a news release. The company said its platform can detect all known COVID-19 variants of concern on users age 2 years old and up with or without symptoms.

“Major League Baseball, like other world-class organizations, continues to turn to Cue for testing when the stakes are high and when accuracy, speed, and reliability cannot be compromised,” Cue Health co-foun…

BioNTech 2021 revenue surges 39x year over year

The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021.

Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth.

In 2020, BioNTech’s revenues were €482.3 million.

“Looking back, 2021 was an exceptional year during which BioNTech had a momentous impact on human health and the global economy with our first approved vaccine based on our mRNA technology,” said Dr. Ugur Sahin, BioNTech CEO, in a news release.

The company plans on using the recent cash infusion to boost R&D spending by roughly 50%. In all, the company plans on spending between €1.4 billion to €1.5 billion in R&D in 2022.

It seeks to advance various programs, including the development of mRNA-based immunotherapies, cell therapies and bi-specific antibodies. The company will also invest in regenerative medicine and autoimmune diseases.

BioNTech also plans t…

CureVac launches Phase 1 study for next-gen mRNA COVID-19 vaccine

CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have launched a Phase 1 dose-escalation study to test the performance of CV2CoV, a COVID-19 vaccine candidate based on CureVac’s second-generation mRNA backbone.

In late morning trading, CureVac’s stock ticked up 0.10% to $19.22.

CVAC shares were trading above $100 before announcing in mid-June 2021 that the interim vaccine efficacy of its first mRNA COVID-19 vaccine candidate was 47% in a Phase 2b/3 study.

Tübingen, Germany–based CureVac believes that its second-generation mRNA could prove to be broadly efficacious against SARS-CoV-2 variants and other pathogens.

Nature published a preclinical study involving cynomolgus macaques last year, indicating that the immunogenicity of CV2CoV was superior to its first-generation vaccine candidate, CVnCoV. The paper concluded that CV2CoV was “comparably immunogenic to the BNT162b2 (Pfizer) vaccine in macaques.”

The dose of the CV2CoV vaccine…

FDA amends EUA for SARS-CoV-2 antibody sotrovimab

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S.

FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evushe…

Icosavax stock tanks after announcing disappointing interim SARS-CoV-2 Phase 1/2 results

Icosavax (Nasdaq:ICVX) saw its stock skid 65.5% to $4.26 in mid-day trading after announcing interim results from an ongoing Phase 1/2 trial of IVX-411, a virus-like particle vaccine candidate against SARS-CoV-2.

After going public last July, the company’s stock hit a peak of $39.73 on September 3.

Initial data from IVX-411 was comparable or below human convalescent sera control in previously unvaccinated individuals.

Three weeks after receiving the second vaccine dose, participants’ responses were up to 154 IU/mL across dosage groups in the live virus neutralization assay and up to 592 BAU/mL across groups in the spike IgG assay. The corresponding human convalescent sera control figures were 281 IU/mL and 361 BAU/mL, respectively.

In previously vaccinated participants, an IVX-411 booster drove up neutralizing antibody titers 5x to 599 IU/mL for wild-type virus after 28 days. For the omicron variant, neutralizing antibody titers were a…

Visby Medical triggers $25.5M contract option with BARDA to develop at-home COVID-19/flu test

Visby Medical announced today that it picked up $25.5 million in government funding to develop an at-home flu/COVID-19 diagnostic.

San Jose, California-based Visby executed an option in a contract from the Biomedical Advanced Research and Development Authority (BARDA) to pick up an additional $25.5 in funding for the development and validation of the at-home combination test. The incremental funding follows the initial contract awarded in February 2021.

According to a news release, Visby designed its developmental-stage flu-COVID-19 PCR test as a single-use, handheld, all-in-one device for detecting and distinguishing between influenza A, influenza B and SARS-CoV-2 all in one sample. It delivers results in less than 30 minutes and requires no additional equipment.

“We are honored by BARDA’s confidence in our team’s ability to develop this test and bring it to market, and we’re excited to be a part of the solution to keep kids in s…

Moderna shares R&D updates at third annual vaccines day

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine.

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia.

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…