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Breaking News on Global Pharmaceutical Technology & Manufacturing

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

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.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

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.

Actavis pulls Patheon-made diabetes pills after out-of-spec tests

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.

Fast-tracked Factor Xa inhibitor is being made for Portola by CMC Biologics and Lonza

Portola 'surprised' with CMC concerns in FDA rejection of anticoagulant candidate

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.

EMA says biologics developers need to be extra vigilant

19-Aug-2016 - Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.

Roche updating Accu-Chek manual after reports of insulin leaks and under dosing

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.

Public Patheon's $2bn warchest may bolster biologics offering, analyst

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.

Q&A

Purdue Pharma joins health policy research organization

15-Aug-2016 - Purdue Pharma  has joined the National Pharmaceutical Council  (NPC), a health policy research organization working to advance good evidence and science.

AEMPS says Alcor's plan to fix problems at Spain plant is insufficient

15-Aug-2016 - Laboratorios Alcor SL's plan to fix problems at a manufacturing facility in Guadalajara, Spain is insufficient according to Spanish regulators.

Pfizer recalls anaesthetic made at Hospira's Rocky Mount facility

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.

PharmaTech expands recall of drugs made at Florida plant linked to B. cepacia outbreak

10-Aug-2016 - PharmaTech LLC has recalled more drugs made at the Florida plant that was linked an outbreak of B. cepacia last month.

News in brief

US FDA warns Concept Products for failing to fix cGMP violations at Tianjin plant

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.

Amikacin recalled by Teva after US shortage ends

Teva recalls injectable antibiotic in US over contamination concerns

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.

Bayer recalls Kogenate lots in Spain after out of spec stability results

09-Aug-2016 - Bayer has recalled its injectable haemophilia drug Kogenate in Spain according to the country’s regulators.

update

US FDA raises concerns about Alexion's Rhode Island Soliris facility

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.

Pfizer halts production at Hospira India plant slammed by regulators

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.

News in brief

Bangladesh Court orders 34 drug firms to halt production, again

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.

US FDA orders Adaptimmune to halt fat cancer cell therapy trial

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.

US NIH permanently halts drug production at site criticised by US FDA

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.

USDA fines Covance $35,000 after animal deaths at Texas drug testing facility

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.

India relaxes rules on clinical investigators and trial sites

03-Aug-2016 - India has relaxed its study rules to let clinical investigators to take part in multiple drug trials and to allow smaller sites to be used for research.

AstraZeneca: Retaining current regulatory procedures crucial, post-Brexit

01-Aug-2016 - AstraZeneca says it will be critical to avoid duplicated regulatory efforts and costs once the UK leaves the European Union.

Scientists at ex AstraZeneca site join Obama’s $350m antibiotic effort

28-Jul-2016 - Scientists at AstraZeneca’s former R&D site in Alderley Park will play a key role in researching antibiotics and the spread of resistance under an initiative launched by US President Barack Obama.

EMA proposing changes to FIH clinical trials, accepting comments

26-Jul-2016 - The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.

US FDA finds cGMP deviations at ALK-Abello facility in Denmark

26-Jul-2016 - The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).

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