Sean Whooley

Kala Pharmaceuticals (NSDQ:KALA) shares dipped this morning on fourth-quarter results that came up short of the consensus forecast. The Watertown, Mass.-based company posted losses of -$31.1 million, or -55¢ per share, on sales of $2.2 million for the three months ended Dec. 31, 2020, for a more than $10 million bottom-line slide on sales growth of…

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted…

Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the…

Thermo Fisher Scientific (NYSE:TMO) announced today that it acquired cell sorting technology assets from SIDIS Corp. subsidiary Propel Labs. Waltham, Mass.-based Thermo Fisher’s agreement with Propel Labs stipulates that the recently introduced Bigfoot spectral cell sorter and approximately 40 employees will become part of Thermo Fisher’s biosciences business unit, while Propel Labs will continue to operate…

Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on…

PerkinElmer (NYSE:PKI) announced today that it launched the first cell painting kit as part of its PhenoVue cellular imaging reagent portfolio. Waltham, Mass.-based PerkinElmer’s new range of reagents utilizes the company’s expertise in cellular imaging and high-content screening while working with its microplates, automation offerings and software to allow researchers to better understand diseases and develop…

Dialectic Therapeutics issued an SEC Form D to confirm the sale of nearly $6.4 million in debt, options, warrants and/or other rights to purchase securities. According to the filing, the Dallas-based cancer treatment technology developer made the first sale in its offering of $6.35 million on Dec. 15, 2020. The $6.35 million already sold is…

Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production. The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110…

The FDA announced that it issued emergency use authorization (EUA) for monoclonal antibodies developed by Eli Lilly (NYSE:LLY) for treating COVID-19. Eli Lilly’s bamlanivimab and etesevimab received authorization to be administered together for treating mild to moderate COVID-19 in adults and pediatric patients over 12 years old and weighing at least 40 kilograms (about 88 pounds),…

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…

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 was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of…

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon. The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J subsidiary Janssen Pharmaceutical appears to have a “good profile for a vaccine,” indicating the potential for a third authorized…

AstraZeneca (NYSE:AZN) announced yesterday that it completed the divestment of the commercial rights to Atacand to Cheplapharm. United Kingdom-based AstraZeneca’s Atacand (candesartan cilexetil) is a selective AT 1 subtype angiotensin II receptor antagonist indicated for managing hypertension in adults and children, along with heart failure in adults. In addition to the commercial rights to Atacand, AstraZeneca…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received…

Ahead of a meeting to discuss the potential approval of the COVID-19 vaccine from Moderna (NSDQ:MRNA), FDA data says the candidate is safe and effective. Cambridge, Mass.-based Moderna filed for emergency use authorization in November, having conducted a Phase 3 study, known as the COVE study, that enrolled more than 30,000 U.S. participants, with 196 confirmed cases…

AstraZeneca (NYSE:AZN) announced that it entered into a definitive agreement to acquire Alexion Pharmaceuticals (NSDQ:ALXN), expanding its presence in the rare-disease and immunology drugs space. The acquisition price for Boston-based Alexion is set to total approximately $39 billion, or $175 per share, according to a news release. The boards of both companies unanimously approved the acquisition and,…

The FDA today said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets success criteria. Ahead of an advisory meeting on Thursday, Dec. 10, to review the vaccine candidate, the FDA found that data from Pfizer and BioNTech’s trials was “consistent” with its recommendations for emergency use authorization and that the candidate was…

U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential…

AstraZeneca (NYSE:AZN) announced today that one of its COVID-19 vaccine candidate dosing regimens is up to 90% effective in preventing the virus. Cambridge, United Kingdom-based AstraZeneca, working in collaboration with Oxford University, found the vaccine to be highly effective in preventing COVID-19 for subjects in the UK and Brazil, with no hospitalizations or severe cases of…

The FDA announced that it issued emergency use authorization (EUA) for the first at-home, rapid COVID-19 diagnostic test. A diagnostic designed for self-testing in the home, the Lucira COVID-19 all-in-one test kit is a molecular (real-time loop-mediated amplification reaction) single-use test designed to detect SARS-CoV-2, according to an FDA news release. Get the full story…

Dr. Anthony Fauci is reportedly expecting that early data from Moderna’s (NSDQ:MRNA) COVID-19 vaccine candidate is not far away. Following Monday’s news that the candidate being developed by Pfizer and BioNTech has proven to be 90% effective at preventing infection, the nation’s top infectious disease official expressed optimism over Moderna’s potential, according to a Forbes report. Get the full…

Tandem Diabetes Care (NSDQ:TNDM) shares took a hit after hours today on third-quarter results that were mixed compared to the consensus forecast. The San Diego-based insulin delivery and diabetes technology company posted losses of -$9.4 million, or -15¢ per share, on sales of $123.6 million for the three months ended Sept.30, 2020, for a bottom-line slide […]

The director of the group developing a COVID-19 vaccine candidate at Oxford University says it’s possible that the vaccine could be ready by Christmas. According to a Reuters report, Oxford vaccine trial chief investigator Andrew Pollard said he’s optimistic that the university, which is collaborating with AstraZeneca on the vaccine, will present trial results by…

Johns Hopkins researchers are touting microdevices that can latch onto intestinal mucosa and release drugs into the body. Led by engineering professor David Gracias and gastroenterologist Dr. Florin Selaru, the team of researchers and biomedical engineers designed and tested shape-changing microdevices that they say can mimic the way the parasitic hookworm affixes itself to an…