Regulatory Index News w/c 8 April 2019

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


Zogenix flummoxes investors as FDA refuses to review epilepsy drug

An unexpected regulatory misunderstanding could push back the approval timeline for Zogenix's only drug candidate by up to 15 months, sending shares in the California biotech down 27% at market open Tuesday. 

To read more follow this BioPharmaDive link


MSD’s Keytruda granted FDA extension

MSD has announced that the US Food and Drug Administration (FDA) has approved an expanded label for the company's anti-PD-1 immunotherapy Keytruda.

To read more follow this PharmaTimes link


Lynparza gains EU approval for type of metastatic breast cancer

AstraZeneca and MSD‘s Lynparza (olaparib) has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer.

To read more follow this PharmaTimes link


Amgen wins FDA approval for osteoporosis drug Evenity

Amgen on Tuesday won Food and Drug Administration approval for its osteoporosis treatment Evenity in postmenopausal women at high risk for fracture, two years after the regulator had turned back the biotech and partner UCB's first attempt to secure an OK. 

To read more follow this BioPharmaDive link


Indivior draws criminal indictment for opioid marketing practices

A federal grand jury indicted Indivior for the marketing practices surrounding Suboxone Film, an opioid addiction treatment that the company claimed was safer and harder to abuse. The government wants a $3 billion settlement and forfeiture of all assets to repay health insurance programs for misuse of the product.

To read more follow this BioPharmaDive link


Concerto inks second AI collaboration in a week, teams up with Pfizer

Concerto HealthAI and Pfizer have entered a precision oncology collaboration.

Pfizer will benefit from the deal through gaining Concerto HealthAI’s eurekaHealth AI platform and Real-World Data, which can be used to help identify new and more precise treatment options as well as accelerate completion times for various outcomes studies.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

12th April 2019

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