WHAT’S TRENDING ON PHARMPRO.COM
Watchdog Group Files Amendment to FDA
Citizen Petition After 20 Deaths in Clinical
With at least 20 treatment-related deaths in clinical
drug trials between May
2016 and April 2017,
Center for Responsible
Science (CRS) has
updated its July 2015
citizen petition, also adding
a declaration from the
father of a 24-year-old
patient who died two days
after receiving an experimental cancer therapy developed by
The amendment, filed before the latest death was reported,
urges the Food and Drug Administration to amend 29
regulations to allow the preclinical test method most predictive
of human response to be used during drug testing.
Current regulations mandate the use of animal
models, even if there are human-relevant tests that
could predict toxicity that animal tests may miss.
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The U.S. Food and Drug
the companies’ new
(sBLA) for a once-monthly 300 mg dose
of Praluent (alirocumab)
Injection for the
treatment of adults with high LDL cholesterol.
Praluent is indicated as an adjunct to diet and maximally
tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease who require additional
lowering of LDL cholesterol.
The 300 mg dose is administered via two 150 mg injections at
two different injection sites. Each 1 mL pre-filled pen
delivers 150 mg of Praluent in 20 seconds or less.
The European Commission also approved the monthly
300 mg dose of Praluent in November 2016.
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Thermo Fisher Scientific Inc. and Patheon N.V., a global provider
of high-quality drug development and delivery solutions to the
pharmaceutical and biopharma sectors, announced in May that
their boards approved Thermo Fisher’s acquisition of Patheon.
The transaction represents a purchase price of
approximately $7.2 billion, which includes the assumption of
approximately $2 billion of net debt. Patheon generated 2016
revenue of approximately $1.9 billion and will become part of
Thermo Fisher’s Laboratory Products and Services segment.
Patheon, a leader in the high-growth $40 billion CDMO
market, has an extensive network of state-of-the-art facilities primarily in North
America and Europe, and approximately 9,000
Read more at: http://bit.do/dvJpn
Sanofi and Regeneron Receive
FDA Approval of New Praluent
Thermo Fisher Scientific
Acquires CDMO Patheon
in $7.2B Deal
Natural Treatment Has an
Antibiotic-Like Effect on HPV
the dis wer
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