27-Apr-2017 - Industry group the ABPI has called on the next UK Government to support local drug production, increase National Health Service (NHS) funding and put life sciences at the heart of its post-Brexit plan.
26-Apr-2017 - The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.
25-Apr-2017 - The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
25-Apr-2017 - Drug track and trace rules introduced in Saudi Arabia prompted a €300,000 ($326,078) investment in processing technology and software according to Sweden-based contractor Recipharm.
24-Apr-2017 - The World Health Organisation (WHO) has urged pharma companies to help combat neglected tropical diseases (NTDs) via increased drug donations.
24-Apr-2017 - The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
24-Apr-2017 - Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
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 - 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.
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 - Akorn Inc is in takeover talks with German injectable drug specialist Fresenius SE & Co. KGaA.
10-Apr-2017 - Synergy Pharmaceuticals Inc has launched a set of smartphone emojis – the Poop troop – to help chronic constipation sufferers express the physical and emotional impact of their disease in text messages.
10-Apr-2017 - Cadila Healthcare Limited says its topical drug manufacturing plant has passed an inspection by the US Food and Drug Administration (FDA).
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.
03-Apr-2017 - Chinese regulators have proposed changes to rules covering clinical trials, API importation and drug approval in a bid to improve access to medicines.
30-Mar-2017 - The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.
30-Mar-2017 - The US FDA has criticised Opto-Pharm Pte for selling unlicensed "drugs" and not bringing its Singapore manufacturing plant up to code.
28-Mar-2017 - Wockhardt claims the US has approved its version of the combination antibiotic Zosyn (piperacillin and tazobactam).
28-Mar-2017 - As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.
27-Mar-2017 - Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.