BioSpace News Archive

FDA

FDA Action Alert: Daré, Reata, Merck and Amgen

The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.

December 3, 2021
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3 min read
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Mark Terry
BioCapital

Emerging Omicron Variant Reinforces the Role of Rapid Antigen Testing

Ellume has conducted an assessment of the new Variant of Concern, Omicron, using the available genome sequencing data, and is highly confident that the Ellume COVID-19 Home Test will detect this new variant.

December 3, 2021
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5 min read
Drug Development

Kolon TissueGene To Expand Indications For TG-C

ACTIVITIES ARE UNDERWAY TO INITIATE US PHASE II IN HIP OSTEOARTHRITIS

December 3, 2021
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3 min read
Job Trends

Merck Canada Announces Supply Agreement of Up to 1 Million Patient Courses of Molnupiravir, an Investigational Oral Antiviral Medicine for the Treatment of COVID-19, with the Government of Canada

Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that it has entered into a Supply Agreement with the Government of Canada for up to 1 million patient courses of molnupiravir, its investigational oral antiviral medicine for the treatment of COVID-19.

December 3, 2021
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6 min read
Job Trends

Government of Canada signs agreements for COVID-19 oral antiviral treatments

Today, the Honourable Filomena Tassi, Minister of Public Services and Procurement, announced that the Government of Canada has signed agreements with Merck and Pfizer for access to their COVID-19 oral antiviral treatments.

December 3, 2021
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2 min read
Statement from the Council of Chief Medical Officers of Health (CCMOH): Update on the Use of COVID-19 Vaccine Boosters and on COVID-19 Vaccines and the Risk of Myocarditis and Pericarditis

Progress continues across Canada with COVID-19 vaccination campaigns now underway in all jurisdictions for children aged 5 to 11.

December 3, 2021
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6 min read
Policy

Information Update - Update: Pharmascience Inc. recalls certain lots of over-the-counter ranitidine

Pharmascience Inc. is recalling 18 lots of over-the-counter ranitidine drugs after tests found NDMA, a nitrosamine impurity, close to and above the acceptable level.

December 3, 2021
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1 min read
Deals

Atara Biotherapeutics Reported Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Atara Biotherapeutics, Inc. today reported the grant of an aggregate of 21,438 restricted stock units of Atara’s common stock to seven newly hired employees and stock options to purchase an aggregate of 24,017 shares.

December 3, 2021
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3 min read
AbCellera-Discovered Bamlanivimab Together with Etesevimab Authorized as the First and Only Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12

AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12.

December 3, 2021
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6 min read
Deals

Pear Therapeutics and Thimble Point Announce Closing of Business Combination to Create Publicly Traded Prescription Digital Therapeutics Company

Pear Therapeutics, Inc. announced today the completion of its business combination with Thimble Point Acquisition Corp.

December 3, 2021
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6 min read