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Pharmaceutical

U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

May 26, 2022 By Sean Whooley

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health. HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy […]

Filed Under: Pharmaceutical Tagged With: Dept. of Health & Human Services (HHS), National Institutes of Health (NIH), Personnel Moves

Entegris opens Life Sciences Technology Center in Massachusetts

May 24, 2022 By Sean Whooley

Entegris (Nasdaq:ENTG) announced today that it opened a new Life Sciences Technology Center in Billerica, Massachusetts. The new Life Sciences Technology Center was built to offer life sciences customers the opportunity to leverage Entegris’ cold-chain supply expertise to optimize processes, reduce costs and increase speed to market. Get the full story at our sister site, […]

Filed Under: Business/Financial News, Contract Manufacturing, Pharmaceutical Tagged With: Entegris

Alcon to pay $60M to acquire Kala Pharmaceuticals’ dry eye treatment

May 23, 2022 By Sean Whooley

Alcon (NYSE:ACL) announced today that it agreed to acquire Eysuvis pharmaceutical eye drops from Kala Pharmaceuticals. Geneva, Switzerland-based Alcon will pay $60 million upfront to Kala for the dry eye treatment. As part of the agreement, the company will also acquire Kala’s Inveltys corticosteroid for twice-per-day treatment of post-operative inflammation and pain following ocular surgery. Get the […]

Filed Under: Business/Financial News, Drug-Device Combinations, Mergers & Acquisitions, Optical/Ophthalmic, Pharmaceutical Tagged With: Alcon, Kala Pharmaceuticals

MedTrace Pharma moves forward on 15 O-water imaging tech

May 23, 2022 By Chris Newmarker

MedTrace Pharma announced the first person scanned in its Rapid-Water-Flow Phase 3 clinical trial, further testing its tech to bring 15 O-water to imaging. The first subject scan took place at Aarhus University Hospital in Denmark, using 15 O-water produced, dosed and injected through MedTrace’s P3 automated delivery system. The clinical trial aims to evaluate […]

Filed Under: Clinical Trials, Imaging, News Well, Pharmaceutical, Research & Development Tagged With: MedTrace Pharma

Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

May 23, 2022 By Sean Whooley

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, Pfizer

Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise

May 19, 2022 By Brian Buntz

Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study. The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron. Get the full story from our sister site, Drug Discovery […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: COVID-19 vaccine candidate, Moderna, mRNA-1273, mRNA-1273.211, vaccine

ApiJect picks up $111M investment from Royalty Pharma, Jefferies

May 18, 2022 By Sean Whooley

Injection delivery system developer ApiJect announced today that it completed a private investment round worth $111 million. Royalty Pharma and Jefferies Financial Group led the investment round. Jefferies also acquired a revenue interest in addition to equity through the financing. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Business/Financial News, Drug-Device Combinations, Funding Roundup, Pharmaceutical Tagged With: ApiJect

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

May 17, 2022 By Brian Buntz

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said […]

Filed Under: Blog, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, COVID-19 boosters, COVID-19 vaccine, Pfizer

Massachusetts is competing for ARPA-H biomedical research center

May 17, 2022 By Brian Buntz

The U.S. government is planning to establish the Advanced Research Projects Agency for Health (ARPA-H) to accelerate biomedical research. The new federal research agency will not be based alongside its NIH parent in Bethesda, Maryland. After winning authorization to create the agency, Sen. Edward J. Markey (D-Mass.) and several colleagues in Massachusetts are asking the […]

Filed Under: Featured, Pharmaceutical Tagged With: Advanced Research Projects Agency for Health, ARPA-H

Here’s what’s next for Insulet after the launch of Omnipod 5, CEO change

May 12, 2022 By Sean Whooley

The future for Insulet (Nasdaq:PODD) has a different look than it did about a week ago. A massive shake-up at the executive level came on May 5 when Shacey Petrovic announced she would step down as president and CEO for personal reasons. Petrovic will stay on as a board member at the Acton, Massachusetts-based automated insulin […]

Filed Under: Business/Financial News, Diabetes, Drug Pumps, Drug-Device Combinations, Featured, Patient Monitoring, Pharmaceutical Tagged With: DeviceTalks Boston, Insulet, Personnel Moves

Moderna’s new CFO leaves after former employer discloses investigation

May 11, 2022 By Brian Buntz

Moderna (Nasdaq:MRNA) CFO Jorge Gomez is gone from his new job effective immediately, the COVID-19 vaccine maker said today. Cambridge, Massachusetts–based Moderna said the departure comes after Gomez’s former employer, Dentsply Sirona (Nasdaq: XRAY), announced an “ongoing internal investigation into certain matters, including financial reporting,” Moderna said in a news release. Get the full story […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: Dentsply Sirona, Jorge Gomez, Moderna

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