Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulatory & Safety: Top Headlines

EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats

21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.

Related news

Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing

21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.

US House Bill Aims to Expand Release of Clinical Trials Data

21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.

Russia Working to Align Biologics Regs with International Standards

20-May-2013 - Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.

People on the Move: Pharma Jobs

20-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.

UK Animal Research Labelling Plan Must Not Put Patients Off Treatment, Says ABPI

16-May-2013 - New UK proposals to label all drugs as “produced as a result of research on animals” have met with muted response from the ABPI.

US House Committee Advances Track-and-Trace Legislation

16-May-2013 - The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.

Regulatory & Safety: Featured news

Spotlight

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients
Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...

China Looks to Tighten Excipient Regulations with Limited Resources
Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have...

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...