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Biotech

Tela Bio names clinical development VP

January 8, 2021 By Nancy Crotti

Soft-tissue reconstruction company Tela Bio (NSDQ:TELA) announced the appointment of Dr. Bruce Freedman as VP of clinical development. Freedman has practiced 32 years as a general surgeon specializing in hernia repair and abdominal wall reconstruction. He joined Tela Bio after having used its OviTex material in his practice. The Malvern, Penn.-based company’s tech platform is […]

Filed Under: Biotech, Implants, Surgical Tagged With: Tela Bio

Regeneron antibody cocktail wins emergency use authorization

November 24, 2020 By Brian Buntz

Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19. The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency […]

Filed Under: Biotech, Featured, Hospital Care, Pharmaceutical Tagged With: Clinical Trials, coronavirus, COVID-19, Regeneron

5 takeaways from the latest White House Coronavirus Task Force meeting

November 20, 2020 By Brian Buntz

The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics. The […]

Filed Under: Biotech, Clinical Trials Tagged With: coronavirus, COVID-19, Moderna, Pfizer

Why the COVID-19 vaccine market won’t be ‘winner take all’

November 17, 2020 By Brian Buntz

There are a dozen Phase 3 COVID-19 vaccine candidates with more than 50 in either Phase 1 or Phase 2 trials. But the fact that Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have vaccine candidates with efficacy greater than 90% could ultimately narrow the playing field. “Efficacy matters, but I don’t think [Pfizer’s and Moderna’s efficacy rate of] greater […]

Filed Under: Biotech, Clinical Trials, Featured, Research & Development Tagged With: Clinical Trials, coronavirus, COVID-19, Moderna, Pfizer

Moderna and Pfizer COVID-19 vaccines set a high bar for competitors

November 16, 2020 By Brian Buntz

Moderna (NSDQ:MRNA) is now the second company to release positive preliminary results from a Phase 3 trial of a COVID-19 vaccine candidate — and it appears to be more good news. Last week, Pfizer (NYSE:PFE) announced that early data suggested its BNT162 mRNA-based vaccine was more than 90% effective at reducing symptomatic COVID-19 infections. Today, […]

Filed Under: Biotech, Clinical Trials, Pharmaceutical Tagged With: Clinical Trials, coronavirus, COVID-19, Moderna, Pfizer

7 things to know about COVID-19 vaccines

November 10, 2020 By Brian Buntz

Enthusiasm surrounding COVID-19 vaccines is on the upswing after Pfizer announced preliminary data suggesting its vaccine could be 90% effective at preventing COVID-19 infections. The Bay Area Council hosted a webinar yesterday to provide more information about coronavirus vaccines. Here are seven considerations to keep in mind now that the prospect of a widely deployed COVID-19 […]

Filed Under: Biotech, Clinical Trials Tagged With: Clinical Trials, coronavirus, COVID-19, Pfizer, vaccines

Pfizer claims its COVID-19 vaccine could be 90% effective

November 9, 2020 By Brian Buntz

Pfizer (NYSE:PFE) has announced its vaccine candidate promises to be 90% effective in protecting against COVID-19 infections.  The announcement included the interim analysis results of its Phase 3 trial. Pfizer had earlier suggested that it would announce those results in late October. The promising data clears the way for Pfizer to apply for emergency-use authorization from FDA […]

Filed Under: Biotech, Clinical Trials, Featured, Pharmaceutical Tagged With: Clinical Trials, coronavirus, covid, COVID-19, Pfizer

5 ways Election Day could impact pharma

October 30, 2020 By Brian Buntz

The pharmaceutical industry stands at a crossroads as Election Day nears in the U.S. The election could ultimately have sweeping implications for the sector, or it could yield only modest changes. While the presidential election could have a significant influence on the pharma sector, arguably more important is who gains control of Congress. A blue sweep […]

Filed Under: Biotech

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

August 21, 2020 By Tom Salemi

In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer. We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is […]

Filed Under: Bioelectronic Medicine, Biotech, Device Talks Podcasts, Diabetes, Featured, Initial Public Offering (IPO) Tagged With: Avail Medsystems, Bayer, Cala Health, ClearMask, CureVac, Fractyl Laboratories, Thermo Fisher Scientific

Windtree names Hamill as new CFO

July 20, 2020 By Tom Salemi

Drug- and medtech developer Windtree Therapeutics (NSDQ:WINT) today announced it named John Hamill as SVP and chief financial officer, replacing John Tattory, who is leaving to pursue other opportunities. Hamill joins the company, which develops drug product and devices to treat acute cardiovascular and pulmonary disease, with 30 years in the pharma, biopharma and clinical […]

Filed Under: Biotech, Business/Financial News, Cardiovascular, Respiratory, Wall Street Beat Tagged With: Windtree Therapeutics

Philips wins 510(k) for sensor to detect COVID-19 patient deterioration

May 26, 2020 By Nancy Crotti

Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital. The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so […]

Filed Under: 510(k), Biotech, Business/Financial News, Featured, Food & Drug Administration (FDA), Patient Monitoring Tagged With: coronavirus, COVID-19, FDA, Philips

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