6 Volunteers Hospitalized After
Botched Drug Test
Six medical volunteers have been
hospitalized—including one who has
been declared brain dead—after taking
part in a botched drug test at a clinic in
western France, the Health Ministry said.
The prosecutor’s office has opened
an investigation into what the ministry
called a “serious accident during a
clinical test” at the Biotrial laboratory
in Rennes. Biotrial’s CEO, Jean-Marc Gandon, was joining Health
Minister Marisol Touraine at a news conference later
Friday. The minister went to Rennes after ordering the
investigation into how Biotrial conducts its clinical tests.
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Lawsuit is Filed
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Rhythm, a biopharmaceutical company that develops peptide
therapeutics for rare genetic deficiencies treatments, has been given
two thumbs up by the FDA for its treatment.
Setmelanotide, the company’s novel melanocortin- 4 receptor
(MC4R) agonist for the treatment of pro-opiomelanocortin (POMC)
deficiency obesity, was granted Breakthrough Therapy designation
today by the FDA. Setmelanotide is presently in Phase 2
clinical trials for the treatment of rare genetic disorders of
obesity caused by MC4 pathway deficiencies.
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FDA BTD & Orphan
Abbott Recalls All
Unexpired Lots of Sterile
Abbott’s Compounding Pharmacy voluntarily
recalls all unexpired lots of sterile
compounded products due to
concerns of lack of sterility
assurance. All unexpired lots are
subject to the recall. These include
injectable medications, sterile solutions, eye
drops, and eye ointments. All recalled products
were distributed to patients, physician offices
and clinics, and veterinarians within California.
The recall was issued after a series of onsite
inspections by the FDA.