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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

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

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.

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.

Hired while you were on holiday: pharma appointments

05-Sep-2017 - Novartis announces a new CEO, the MHRA re-appoints its chair, Paul Smith to lead BioAscent Discovery, and MedPharm welcomes Simon Redgrove and Jeremy Drummond.In-PharmaTechnologist catches you up on recent pharma hires.

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.

‘A new frontier:’ US FDA approves Novartis’ $475,000 CAR-T cell cancer therapy

31-Aug-2017 - Kymriah (tisagenlecleucel), made at the former-Dendreon site in New Jersey, has become the first gene modified cell therapy to be approved in 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.

US FDA says Acorda can't file Inbrija NDA and asks for production data

29-Aug-2017 - The US FDA has refused to let Acorda Therapeutics Inc. file an NDA for Inbrija, its inhalable version of levodopa.

News in brief

Interpol led operation seized 420 tonnes of fake meds in West Africa

29-Aug-2017 - 420 tonnes of counterfeit pharmaceuticals have been seized in West Africa in an operation co-ordinated by Interpol.

US FDA steps up enforcement against unscrupulous stem cell firms

29-Aug-2017 - The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.

Manufacturers, wholesalers or 3PLs? US FDA guidance looks to define supply chain roles

24-Aug-2017 - The US FDA has released draft guidelines to identify trading partners in the pharma supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).

Coffee for erectile dysfunction? The threat of adulterated herbal supplements

24-Aug-2017 - Active pharmaceutical ingredients found in products marketed as herbal supplements have prompted voluntary recalls in the US.

FDA, EMA agree to share confidential info to further mutual recognition

23-Aug-2017 - The FDA and EMA have reached a new milestone during the process to implement mutual recognition of drug manufacturing facility inspections.

US FDA plans facility inspection efficiency drive

23-Aug-2017 - The US Food and Drug Administration (FDA) has released a document to address the integration of pharmaceutical facility evaluations and inspections.

Rodent faeces and damaged equipment land Chinese OTC maker FDA warning

23-Aug-2017 - The US FDA has published a warning letter slamming the sanitary conditions of a Chinese OTC facility run by Bicooya Cosmetics Limited.

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