Breaking News on Global Pharmaceutical Technology & Manufacturing

Gov’t delay could postpone usability, patient recruitment

23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to – and ultimately, study start up.


Raging bull' - Vaccines don’t cause autism and saying otherwise costs lives

22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.

Cancer drug plant likely source of radio isotope detected across Europe say experts

21-Feb-2017 - A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.

News in brief

Takeda pulls Danish paracetamol batch after two packs found to contain ibuprofen

20-Feb-2017 - Takada Pharma A/S has recalled a batch of its Pamol paracetamol tablets in Denmark after two packs were found to contain ibuprofen.

Tilray begins shipping medical marijuana to more countries

20-Feb-2017 - Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.

Pfizer hit with US FDA warning at Kansas generic Copaxone site

20-Feb-2017 - The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.

Dr. Reddy's Laboratories continues European hospital market expansion

16-Feb-2017 - Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.

US FDA says Japanese OTC firm Sato must do more to fix plant problems

15-Feb-2017 - The US FDA says Sato Pharmaceutical Co., Ltd. has not addressed environmental monitoring shortcomings at its Tokyo plant.

India asks drug firms to help discourage off-prescription antibiotic sales

13-Feb-2017 - Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.

Sanofi awaits FDA inspection of fill/finish plant before Q1 Kevzara resubmission

09-Feb-2017 - Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.


Denmark bids to host EMA and says DKMA can provide MHRA-like scientific support

08-Feb-2017 - Denmark has bid to be the new home of the European Medicines Agency (EMA) after the UK leaves the European Union.

Trump's travel restrictions will hurt cell therapy sector says ISCT

06-Feb-2017 - If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).

Banned wholesaler Europharma DK hires repackager Abacus Medicine and replaces CEO

06-Feb-2017 - Banned wholesaler Europharma DK has appointed a new CEO and hired Abacus Medicine to repackage and distribute drugs on its behalf.

News in brief

AEMPS slams QC systems at Euro Far Alergi plant

01-Feb-2017 - Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.

Shredded records and unofficial spreadsheets land Italian plant with FDA warning

31-Jan-2017 - Data integrity issues have landed Italian drugmaker FACTA Farmaceutici with a US FDA warning letter.

Novartis oncology drug bolsters revenue with another EU approval

31-Jan-2017 - The European Commission has approved oral formulation of Novartis' seizure treatment Everolimus under the trade name Votubia.

GMP-status 'a major step' for medical marijuana recognition, Bedrocan

26-Jan-2017 - The GMP certification of a Dutch cannabis production facility is a “major step” in bringing medicinal marijuana to the level of evidence based medicines, says Bedrocan.

FDA hits UK state-owned CDMO with warning over leukemia drug production

25-Jan-2017 - Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.

Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

23-Jan-2017 - Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

GCP 'Renovation' paper outlines revisions to ICH E8 and E6

23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

SUKL finds GDP problems at B.Braun warehouse in Czech Republic

19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.

GAO wants US FDA to show benefits of overseas inspections

18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.

US FDA criticises Sato Yakuhin Kogyo Co efforts to fix data issues

18-Jan-2017 - The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.

Janssen-Cilag switches Haldol supplies to Switzerland after production problems

17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.

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