Regulatory Index News w/c 05 August 2019

Here is a selection of this week's news from around the world


FDA decision on Amarin heart drug delayed as agency to hold expert review

Amarin surprised investors Thursday with an announcement the Food and Drug Administration plans to hold an advisory panel review of the biotech's heart drug Vascepa, a decision that just a week ago the company had called "unlikely." 

To read more follow this BioPharmaDive link


New blood test ‘highly accurate’ at early Alzheimer’s identification

Researchers from Washington University School of Medicine have developed a test that when combined with age and genetic risk factor, could help detect the brain changes of early Alzheimer’s disease.

To read more follow this PharmaTimes link


Tecentriq, chemo combo shows bladder cancer promise

Roche has announced that Tecentriq (atezolizumab) in combination with platinum-based therapy showed a statistically significant reduction in the risk of disease worsening or death (PFS) in people with previously untreated locally advanced or metastatic urothelial carcinoma, also known as bladder cancer.

To read more follow this PharmaTimes link


Hospitalized gene therapy patient triggers Sarepta sell off

Shares in Sarepta Therapeutics fell sharply Thursday on news a patient in a key Duchenne muscular dystrophy gene therapy trial was hospitalized, spurring Nasdaq to suspend trading for more than three hours.

To read more follow this BioPharmaDive link


Medicare boosts CAR-T cancer therapies with expanded coverage

Medicare and Medicaid will cover CAR-T cell therapies nationally, a decision that helps address, but doesn't fully solve, the reimbursement challenges that have hampered uptake of the pricey cancer drugs. 

To read more follow this BioPharmaDive link



Cancer Research UK, Hummingbird join forces on anti-HER3 antibody drug

Cancer Research UK and Hummingbird Bioscience have teamed up to develop the latter’s anti-HER3 antibody drug, HMBD-001, for the treatment of people with HER3 driven cancer.

To read more follow this PharmaTimes link



Lorna Osborn

Date Published

09th August 2019

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