ProPhase Labs (NSDQ:PRPH) announced today that it is introducing a new saliva-based test for COVID-19, Influenza A, B and more. Garden City, N.Y.-based ProPhase Labs said in a news release that it filed for FDA emergency use authorization for its two new testing methodologies, which integrate the Spectrum Solutions saliva self-collection system with a new […]
coronavirus
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
South Africa pauses rollout of AstraZeneca COVID-19 vaccine
South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there. In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE). Researchers at Oxford University […]
Hillrom beats The Street in Q1, raises 2021 guidance
Hillrom (NYSE:HRC) shares remain up after Street-beating first-quarter results and a raised 2021 guidance. The Chicago-based company posted profits of $58 million, or 88¢ per share, on sales of $741.1 million for the three months ended Dec. 31, 2020, for a 47.7% bottom-line gain on sales growth of 8.2%. Adjusted to exclude one-time items, earnings […]
Feds to order 61M more at-home coronavirus tests, build surgical glove factories
Just days after ordering 8.5 million at-home tests from Ellume, the Biden administration announced today that it’s in talks with six other at-home coronavirus test manufacturers. In an online briefing, Tim Manning, the national supply chain coordinator for COVID response, told reporters that these companies could produce another 61 million at-home tests by the end of […]
Johnson & Johnson applies for vaccine approval from FDA
Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate. New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its […]
Which companies will likely produce the most COVID-19 vaccine in 2021?
Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.” One thing that […]
Cardinal Health posts Street-beating Q2, raises EPS guidance
Cardinal Health (NYSE:CAH) shares dipped slightly on second-quarter results that topped the consensus forecast. The Dublin, Ohio-based company posted profits of $629 million, or $2.13 per share, on sales of $41.5 billion for the three months ended Dec. 31, 2020, for a more-than doubled bottom-line on sales growth of 4.5%. Adjusted to exclude one-time items, earnings […]
Align Technology rises on Street-beating, record-breaking Q4 revenues
Align Technology (NSDQ:ALGN) shares skyrocketed today on fourth-quarter results that topped the consensus forecast. ALGN shares were up 13.44% at $619.60 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 2.1%. The Tempe, Ariz.-based dental aligner maker posted profits of $133.8 […]
Pandemic Emergency Manufacturing Act would supplement DPA
A rewritten pandemic manufacturing bill was introduced to both houses of Congress yesterday to enable the federal government to manufacture or contract with existing manufacturers to make products to fight COVID-19. The bill, introduced by Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.), builds off the COVID-19 Emergency Manufacturing Act, introduced in 2020 to […]
Quidel opens new COVID-19 antigen test factory in Calif.
Quidel Corp. (NSDW:QDEL) yesterday said it has opened a manufacturing facility in Carlsbad, Calif. to produce its QuickVue line of COVID-19 rapid antigen tests. The new 128,000 sq. ft facility will become the San Diego-based company’s highest-volume production plant. It will begin operations during the second half of 2021 with a goal of producing 600 million […]
Becton Dickinson beats The Street, raises 2021 guidance
Becton Dickinson (NYSE:BDX) shares dipped slightly despite first-quarter results that came in well above the consensus forecast. The Franklin Lakes, N.J.-based company posted profits of $981 million, or $3.35 per share, on sales of $5.3 billion for the three months ended Dec. 31, 2020, tripling its bottom-line on sales growth of 25.8%. Adjusted to exclude one-time […]