Pharma News - Chemdiv

FDA grants breakthrough status for Accucinch ventricular restoration system

Ancora Heart has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Accucinch ventricular restoration system. ...

FDA Fast Tracks Investigational Drug for the Treatment of Recurrent Brain Cancer

The Food and Drug Administration (FDA) recently granted Alpheus Medical orphan drug and fast track designations for its investigational CV-01 delivery of sonodynamic therapy as a potential treatme...

Alzheimer's Research Moves Ahead with Whole Blood Exchange, Tau Revelations

Many Alzheimer’s clinical trials researchers express optimism that they are entering a new era.

Real-World Data Support the Use of Sobi and Sanofi’s Elocta for Hemophilia A

Sobi and Sanofi’s Elocta (efmoroctocog alfa) has shown efficacy in a real-world study in patients with the rare genetic bleeding disorder hemophilia A.

Bavarian Nordic’s Danish Manufacturing Plant FDA-Inspected for Jynneos Monkeypox Vaccines

The FDA has inspected a Bavarian Nordic manufacturing facility in Denmark which manufactures a monkeypox vaccine that’s now awaiting the agency’s green light to ship to the United States. ...

Twist Bioscience Launches Monkeypox Virus Synthetic DNA Controls

Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today launched two human monkeypo...

FDA Grants Fast Track Designation to Abelacimab

The FDA granted Fast Track status to Anthos Therapeutics’ investigational monoclonal antibody, abelacimab, for treatment of patients with cancer-associated blood clots. ...

Horizon’s Krystexxa Approved for Treating Uncontrolled Gout

The FDA has approved Horizon Therapeutics’ supplemental Biologics License Application (sBLA) for its injectable drug, Krystexxa (pegloticase), coadministered with methotrexate for patients with u...

Genetically engineered pig hearts transplanted into dead people

Researchers successfully transplanted genetically modified pig hearts into two recently deceased people connected to ventilators, the New York University team announced today. ...

AbbVie cuts Alzheimer’s alliance with Alector in half

AbbVie is pulling out of its collaboration with Alector on the development of Alzheimer’s disease candidate AL003, which aims to tackle the neurodegenerative disease by restoring reduced immune s...

Vertex to Acquire ViaCyte for $320 Million

Vertex Pharmaceuticals has entered into a $320 million agreement to acquire ViaCyte, a privately held biotechnology company focused on delivering novel stem cell-derived cell replacement therapies...

Chemical heals wounds twice as fast, could be antibiotic alternative

Israeli scientists say they have used a natural chemical to make pigs’ wounds heal twice as fast as they otherwise would.