Regulatory Index News w/c 03 June 2019

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


FDA ‘yes’ for Emgality in cluster headache

The US Food and Drug Administration (FDA) has announced the approval of the first treatment for episodic cluster headache that reduces the frequency of attacks, Eli Lilly’s Emgality (galcanezumab-gnlm).

To read more follow this PharmaTimes link



Biotechs dive deeper into targeted cancer research, despite costs

CHICAGO — An AstraZeneca cancer drug works best in people with an uncommon mutation. For a recent study evaluating whether the drug offered benefits to pancreatic cancer who have the mutation, researchers screened more than 3,300 patients. Only 247 of them tested positive, and even fewer participated in the study.

To read more follow this BioPharmaDive link


Judge, CVS witness clash on merger settlement, July hearing set

Federal Judge Richard Leon voiced doubts about whether CVS' $69 million acquisition of Aetna gives the merged company too much leverage and what that would mean for consumers on the final day of an unprecedented hearing on the mega-deal.

To read more follow this BioPharmaDive link


Merck, Rigaku to form molecular structure analysis technology collab

Rigaku and Merck have announced plans to form a partnership to develop novel molecular structure analysis technology. The two companies are collaborating to develop commercially available lab solutions employing highly innovative crystalline sponge technology, under a new joint agreement.

To read more follow this PharmaTimes link


Coeliac UK, Innovate UK announce £180K research funding available

Coeliac UK and Innovate UK have announced that the companies have £180k available for research and are inviting applications from UK businesses and researchers. The collaboration is launching a second research call to industry and researchers to make improvements for people living with the autoimmune condition, coeliac disease.

To read more follow this PharmaTimes link


MacroGenics dives as breast cancer drug shows small improvement

Shares of Maryland-based MacroGenics fell by nearly 20% Tuesday after its experimental drug for advanced breast cancer showed only a "modest" impact on delaying tumor growth, and questionable efficacy in helping patients live longer.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

09th June 2019

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