Tuesday, January 28, 2020

Tuesday, January 28, 2020

Latest News

JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON: Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV.

VIIV HEALTHCARE: Receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

U.S. FDA: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections.

U.S. FDA: California-based food manufacturer agrees to stop production after repeated food safety violations

The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

U.S. FDA: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

U.S. FDA: Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use.

IRRAS: Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®

IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.

ANABIOS: FDA Awards AnaBios Contract to Obtain Critical Translational Data from Ex Vivo Human Cardiac Platform

The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.

Proposed FDA vaping regulations are 'extensive, outdated,' AVA president says

Former U.S. Food and Drug Administration (FDA) commissioner David Kessler drew attention last week when he said he thought Juul and other popular vaping manufacturers would be forced to leave the market under proposed FDA rules.

CORREVIO: Announces FDA Advisory Committee Meeting to Review Brinavess™ for Recent Onset Atrial Fibrillation

Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).

FDA vaping regulations will hurt consumers, independents, CASAA says

As FDA deadlines approach for regulations on electronic tobacco products, observers say the industry is in for a period of change and consolidation.

FDA issued 13 warning letters in October

The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.

Sterilization facility closures may threaten availability of medical devices, FDA cautions

Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.

BLUEPRINT MEDICINES: Announces FDA Intent to Split Avapritinib New Drug Application into Separate Submissions for PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA requested VOYAGER top-line data to inform its review of fourth-line GIST indicatio

FDA Reporter