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China modifies bioequivalence testing rules and sets new deadlines

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.

HIV vaccine developer Theravectys says GMP suspension at Paris plant won't delay trial

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.

update

Fake Harvoni seized in Israel came from India says Swissmedic

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.  

Eurofins cites pharma demand as 2015 driver and predicts more of the same in 2016

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.

ANSM bans production at Theravectys' Paris facility until September

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.

Criminals can manipulate drug production if IT systems not protected says expert

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.

France raises concerns about heparin made by Dongying Tiandong

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.

correction

Zydus Cadila given nod to export antibiotic from US FDA warned plant

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.

Sanofi abandoning Auvi-Q after dosage problems led to total recall

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.

Powder study will help safeguard $12bn Danish drug industry, say scientists

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.

MHRA concerned about pharma's preparedness for excipient risk assessments

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.

Pharmakon recalls “super potent” morphine linked to adverse events

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.

European Pharmacopoeia looks to international experts to help harmonization

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.

As Excipacted? Ashland plant certified GMP compliant under European industry-led scheme

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.

Catalent Q2: Softgel growth blighted by Beinheim plant suspension

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.

Needle in a haystack? Anti-vaxx pins may have adverse consequences

08-Feb-2016 - Persuasive anti-vaxx posts on social media may stop parents vaccinating their kids say researchers.

Increased scrutiny requires digging deeper into the supply chain

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.

Reneuron gets US patent for non-toxic cell cryopreservation system

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.

Ipca not surprised by US FDA warning at three Indian API plants

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.

Thawing market heats up: Biocision expands cell therapy tech offering

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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