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News headlines

Merck KGaA’s varied track & trace approach: 'We cannot rely on a singular security feature'

26-Sep-2017 - Merck KGaA says using a variety of tracking and authentication technologies and engaging with patients are vital to creating secure supply chains. 

EMA says it’s busy with Brexit and needs specifics of EU pre-submission probe

25-Sep-2017 - The EMA has asked the European Ombudsman for concrete details of its probe of pre-submission activities, warning that Brexit preparations have limited its capacity to respond.

Low budgets drive consolidation trend, say serialisation experts

25-Sep-2017 - According to industry delegates, smaller contract services firms struggling to meet track & trace implementation costs will look to consolidate with competitors in light of impending serialisation deadlines.    

US FDA slams 13 firms for selling unapproved drugs online

21-Sep-2017 - Thirteen companies have received US FDA warning letters citing the unlawful sale of unapproved and misbranded drug products over the internet.

US FDA warns Korean & Chinese firms for cGMP violations

20-Sep-2017 - The US Food and Drug Administration (FDA) has issued warning letters to Korean company Firson Co. and Chinese firm Wuxi Medical Instrument Factory, citing sterilisation violations.

News from Laurus, ZCL Chemicals and Johnson Matthey: API briefs

18-Sep-2017 - A round-up of developments in the API sector with news from Laurus, ZCL Chemicals and Johnson Matthey.

US FDA approves Amgen and Allergan's Avastin biosimilar

15-Sep-2017 - US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab). 

update

Synthon says EPO appeal board has revoked Copaxone API patent

13-Sep-2017 - Synthon BV says a Teva patent covering the active ingredient in Copaxone has been revoked by the European Patent Office’s technical board of appeal.

update

Biocon says Malaysia insulin plant passed HPRA inspection

12-Sep-2017 - Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).

No fraud, no conspiracy, no error: France and Merck say reformulated Euthyrox is safe

12-Sep-2017 - A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.

German inspectors find problems at Dr Reddy's' Duvvada plant

11-Sep-2017 - German regulators have found problems as Dr Reddy’s’ drug formulations plant in Duvvada, Vishakapatnam.

When is a commercially available chemical not "commercially available"? ICH issues new Q11 Q&A

07-Sep-2017 - The ICH has sought to clarify how API and drug firms should source and justify their starting materials under Q11 guidelines.

Ageing facilities & drug shortages: industry concern drives guidance for manufacturers

07-Sep-2017 - The Parental Drug Association (PDA) is offering guidance to drug makers with ageing, sometimes non-compliant facilities, which it hopes will help combat drug shortages.

Celltrion confident in quality of biosimilar supply despite US FDA 483

07-Sep-2017 - Celltrion Inc has received a FDA Form 483 with 12 observations but remains confident no exported biosimilar products have any quality issues.

Cadila says Moraiya drug plant has passed US FDA inspection

07-Sep-2017 - Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.

US FDA tells Cellectis to halt cell therapy trials after patient death

05-Sep-2017 - The US FDA has ordered Cellectis SA to halt studies of its cell therapy UCART123 after the death of a patient.

Centurion Labs pulls products over Burkholderia cepacia concerns

04-Sep-2017 - Centurion Labs has recalled two lots of cold and allergy meds after the US FDA warned they may have been made at a Pharmatech LLC plant linked to a Burkholderia cepacia outbreak.

News in brief

US FDA adds Mahendra Chemicals to import alert "Red List"

30-Aug-2017 - Mahendra Chemicals has been banned from shipping drug ingredients made at its plant in Ahmedabad, India to the US.

Dissolution testing and dirty gaskets: US FDA warns Hetero Labs

30-Aug-2017 - The US FDA has sent a warning letter to Hetero Labs Limited citing GMP violations at its finished dose formulations facility in Telangana, India.

News in brief

US FDA gives CordenPharma Latina's Italian plant the all clear

30-Aug-2017 - CordenPharma Latina has resolved the problems that earned its API and injectable drug facility in Sermoneta, Italy a warning letter from the US FDA last year.

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