30-Aug-2016 - Impax Laboratories has issued a voluntary recall for one lot of its Lamotrigine Orally Disintegrating Tablet due to incorrect labeling of its blister packs.
30-Aug-2016 - Congress has asked the US FDA for information on EpiPen generic submissions and processes in light of a series of price hikes by drugmaker Mylan.
29-Aug-2016 - The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.
25-Aug-2016 - Stem cells and biosimilars are driving the Korean pharma market, according to the country’s Biomedicine Industry Association KoBIA.
24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.
23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.
22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
22-Aug-2016 - Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.
22-Aug-2016 - Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.
19-Aug-2016 - Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.
18-Aug-2016 - Roche is updating instructions for its Accu-Chek insulin pump after patients who failed to load the device correctly experienced hyperglycemic symptoms as a result of under dosing.
17-Aug-2016 - Biomanufacturing demand will drive revenues for Patheon according to an Evercore ISI analyst, who has predicted the newly-listed CDMO will strengthen its capabilities through M&A.
15-Aug-2016 - Purdue Pharma has joined the National Pharmaceutical Council (NPC), a health policy research organization working to advance good evidence and science.
15-Aug-2016 - Laboratorios Alcor SL's plan to fix problems at a manufacturing facility in Guadalajara, Spain is insufficient according to Spanish regulators.
10-Aug-2016 - Pfizer unit Hospira has recalled one lot of the anaesthetic made at its facility in Rocky Mount, North Carolina after particulate matter was found in a vial of the drug.
10-Aug-2016 - PharmaTech LLC has recalled more drugs made at the Florida plant that was linked an outbreak of B. cepacia last month.
10-Aug-2016 - The US FDA has criticised Chinese manufacturer Concept Products for not fixing cGMP violations observed by inspectors who visited its manufacturing site in Tianjin.
09-Aug-2016 - Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.
09-Aug-2016 - Bayer has recalled its injectable haemophilia drug Kogenate in Spain according to the country’s regulators.
09-Aug-2016 - The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
09-Aug-2016 - Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.
08-Aug-2016 - The High Court in Bangladesh has ordered 34 firms to stop making drugs and recall products after discovering they had ignored a ban imposed in June.
05-Aug-2016 - The US FDA has ordered Adaptimmune to halt a trial of its candidate liposarcoma therapy and asked for more information about how the treatment is made.
04-Aug-2016 - The US National Institutes of Health (NIH) has permanently halted trial drug production at a site where cGMP violations were identified last year.
03-Aug-2016 - The US Department of Agriculture (USDA) has fined Covance Research Products for violating animal care rules at its preclinical testing facility in Alice, Texas.