US FDA warns against PharmaTech LLC-made meds over B.cepacia risk
The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.
Archives for August 9, 2017
Pfizer pulls lorazepam pills in Japan due to faulty engraving
Pfizer has recalled a batch of the antidepressant Wypax (lorazepam) in Japan after discovering faults with the engraving on some of the pills.
BioreclamationIVT expands biospecimen product portfolio
BioreclamationIVT has acquired the biospecimen and research services provider, Asterand Bioscience, following the purchase of TransCell Science earlier this year.
Germany refuses to renew GMP cert for Dr Reddy's Bachupally FTO 2 plant
German regulators have not renewed the GMP certificate for Dr Reddy’s manufacturing plant in Bachupally, Hyderabad.
Externalization tech facilitates sponsor, CRO collaboration
Certara has added externalization technology to its D360 scientific informatics platform to expedite collaboration between sponsors and their research partners.
Avara agrees to buy ex-Hospira plant in Italy from Pfizer
Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.
Vernalis stopped cold: US FDA rejects cough medicine NDA
The US FDA has rejected Vernalis’ new drug application for its investigative cough and cold treatment CCP-08, which is the second time the firm has failed to win approval for a product this year.
PRA acquires Symphony Health Solutions for $530m
PRA Health Sciences has signed a definitive agreement to acquire Symphony Health Solutions Corporation for $530m as the industry increasingly looks to garner insight from real world data.