Regulatory Index News w/c 18 November 2019

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


Lilly to invest $400M in Indianapolis manufacturing facilities

Eli Lilly will invest $400 million in manufacturing facilities in its hometown of Indianapolis, creating 100 new jobs, the pharma said Wednesday.
The plans call for enhancements to existing facilities that produce insulin, more capacity for the company’s other diabetes treatments ....

To read more follow this BioPharmaDive link


BMS completes $74bn Celgene acquisition

Bristol-Myers Squibb has announced the completion of its acquisition of Celgene, for the grand sum of $74 billion. The final announcement follows the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced on April 12, 2019, approval by Bristol-Myers Squibb and Celgene stockholders.

To read more follow this PharmaTimes link


EU approval for Keytruda in head and neck cancer

The European Commission has approved MSD’s Keytruda (pembrolizumab) as monotherapy or as part of a combination, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

To read more follow this PharmaTimes link


Novartis sickle cell drug wins FDA approval

The Food and Drug Administration on Friday approved Novartis' Adakveo to prevent blood-vessel blockages in patients with sickle cell anemia that can be painful and sometimes fatal.
Adakveo's OK comes on the heels of the 2017 approval of Emmaus Medical's Endari, the first new sickle cell drug in 20 years. 

To read more follow this BioPharmaDive link


Myovant to submit lead drug for prostate cancer approval after Phase 3 results

Myovant Sciences said Tuesday a late-stage trial studying its lead drug in advanced prostate cancer met its primary and secondary goals, clearing the path for the company to next year submit the experimental therapy for Food and Drug Administration approval.

To read more follow this BioPharmaDive link


Adakveo bags FDA approval for sickle cell pain

Novartis has announced the US Food and Drug Administration (FDA) approval of Adakveo (crizanlizumab), indicated to reduce frequency of pain crises in individuals living with sickle cell disease. The drug, previously known as SEG101, has been approved to reduce the frequency of vaso-occlusive crises .....

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

21st November 2019

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