15-Mar-2016 - Generic drugs in China must demonstrate bioequivalence (BE) to branded medicines under new CFDA rules prohibiting the use of locally-made generics as reference products.
09-Mar-2016 - Theravectys has outlined a 1-year plan to fix GMP deficiencies at its Paris facility and said the current manufacturing ban will not delay its clinical programmes.
08-Mar-2016 - Swissmedic has warned hepatitis C sufferers not to buy Harvoni from unknown sources after fake versions of the Gilead drug imported by a Swiss trading company were found in Israel.
08-Mar-2016 - Eurofins says its drug testing business performed above expectations in 2015 thanks to increased demand and relocation of its central labs operations.
07-Mar-2016 - ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.
02-Mar-2016 - Hackers trying to steal drug formulae for counterfeiters can wreak havoc says an IT expert advocating stronger security for networked pharmaceutical manufacturing facilities.
02-Mar-2016 - French regulators have raised concerns about heparin made by Chinese supplier Dongying Tiandong Pharmaceutical and called on the EMA to revoke its GMP certificate.
24-Feb-2016 - The US FDA has given approval to Zydus Cadila to market an antibiotic made from an Indian facility hit with a Warning Letter in December.
23-Feb-2016 - Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product.
22-Feb-2016 - Research examining how API particle characteristics impact drug stability will help safeguard Denmark’s $12bn (DKK80bn) a year drug manufacturing industry say scientists.
22-Feb-2016 - There are concerns that pharma companies are not fully prepared to meet the new requirements on risk-assessment for excipients, even though the deadline is just a few weeks away.
18-Feb-2016 - Pharmakon Pharmaceuticals has recalled a batch of morphine after reports three infants reacted badly to the painkiller while being treated in hospital.
16-Feb-2016 - The European Pharmacopoeia Commission (Ph. Eur.) has decided to recruit international experts to ensure the compendium evolves with the globalisation of the pharma industry.
15-Feb-2016 - An Ashland excipient facility in Kentucky has become the first US plant certified under Excipact, the European industry-led GMP quality scheme.
10-Feb-2016 - Suspension of operations at a French softgel facility reduced Catalent’s second quarter revenues by around $21m, but the firm expects full production to restart in March.
08-Feb-2016 - Persuasive anti-vaxx posts on social media may stop parents vaccinating their kids say researchers.
04-Feb-2016 - As threats to the pharmaceutical supply chain prevail, the industry is seeing increased regulatory scrutiny as well as more inspection requirements, says industry panel.
02-Feb-2016 - Reneuron has been granted a US patent for a cryopreservation technology that does not rely on toxic reagents and says it would consider licensing it to other stem cell therapy developers on a case-by-case basis.
01-Feb-2016 - Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.
29-Jan-2016 - Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.
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