Korean regulators have approved a second Samsung Bioepis biosimilar, this time granting the JV rights to sell a version of J&J's Remicade (infliximab).
Pfizer says it will decide in 2018 whether to split its generics and branded businesses but M&A experts are already predicting how the giant will get rid of its established drugs programme.
The number of pharmaceutical cargo thefts has fallen in recent years, but manufacturers still need to be vigilant according to an expert who says the holidays are a risky period.
Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.
Thermofisher Scientific has stopped selling two agars used in pharmaceutical industry control labs, citing a worldwide shortage of the seaweed used to make them.
Tweaks to EU orphan drug rules (OD) may be needed to accommodate Ebola treatment development and block industry attempts to delay generic entry says the European Commission.
A professor who conducted fast-track trials during last year’s Ebola outbreak says next time such trials must be part of humanitarian response… because there will be a next time.
The CEO of Immuno Biotech who said he only employs “beautiful women” and noted a candidate’s lipstick and high heels on her job application has been fined for sex discrimination.
Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.
Horizon Pharma has hit back at allegations it was secretly working with a “captive pharmacy” to preferentially dispense its own drugs, claiming its accuser is trying to reduce competition with its own distribution service.
The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?
In the second setback for Dr Reddy’s within a week, the District Court of Delaware has granted a temporary restraining order preventing the company from selling esomeprazole, the generic version of AstraZeneca’s Nexium.
Legislation allowing compounders to register as outsourcing facilities was a key driver in the acquisition of PharMEDium, AmerisourceBergen says as it completes the $2.6bn deal.
A UK government report on accelerated access to medicines proposes overhauling conditional licensing and reimbursement pathways to drive drug development.
Inconsistent tablet colour and issues with compressing procedures have landed Indiana OTC maker American Family Pharmacy (AFP) with a US FDA warning letter.
Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.
The number of clinical trials given the green light in Russia has increased 13% in the third quarter of the year, which could be thanks in part to a reduction in red tape.
Around 500,000 doses of unlicensed erectile dysfunction (ED) drugs have been seized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
An advisor to the pharma industry on M&A says the current boom in pharma valuations will not last, and R&D cost pressures will reshape firms of the future.
Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.
Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.
