21-Apr-2017 - Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
20-Apr-2017 - Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.
20-Apr-2017 - The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
19-Apr-2017 - The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.
19-Apr-2017 - Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.
19-Apr-2017 - Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
18-Apr-2017 - Teva Pharmaceutical Industries says the US FDA has raised concerns about its API plant in Hangzhou, China.
18-Apr-2017 - UK life science companies must become global to help offset staffing and funding problems potentially caused by Brexit, says Arecor CEO Sarah Howell.
12-Apr-2017 - Domestic pharmaceutical production increased in Japan in 2015 according to data released by the MHLW.
12-Apr-2017 - The US FDA has criticized quality systems at Mylan’s HIV drug plant in Nashik in Maharashtra, India.
11-Apr-2017 - The EMA has set up an email inbox for drug company employees who report improper manufacturing and trial activities.
10-Apr-2017 - The US FDA has found fault at Neuland Laboratories Limited manufacturing facility in Bonthapally, India.
10-Apr-2017 - Cadila Healthcare Limited says its topical drug manufacturing plant has passed an inspection by the US Food and Drug Administration (FDA).
10-Apr-2017 - API, excipient and drug industry groups have reiterated concerns about the latest iteration of the US FDA’s “quality metrics” reporting requirements.
06-Apr-2017 - India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.
06-Apr-2017 - A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.
05-Apr-2017 - The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.
05-Apr-2017 - Leakage problems for of an ophthalmic drug has landed contract manufacturer Indoco Remedies with a US FDA warning letter at its plant in Goa.
04-Apr-2017 - Alkem Laboratories Ltd says the US FDA has accepted its plan to bring its API plant in Ankaleshwar, India up to code.
04-Apr-2017 - The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.