22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
22-May-2013 - Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.
22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
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.
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.
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.
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.
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 pharmaceutical industry group, the ABPI.
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.
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.
15-May-2013 - In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500m after pleading guilty to manufacturing and distributing adulterated drugs, according to the US Justice Department settlement agreement .
14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette .
13-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Mylan, Sigma-Tau and Immunocore.
13-May-2013 - Clinical trial sites in India will be inspected at least once a year under a new regulatory plan issued by the CDSCO.
10-May-2013 - Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical drugs for infants, the agency told us.
08-May-2013 - The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline .
07-May-2013 - Pfizer has begun selling Viagra online in order to counter the trade in fake versions of its erectile dysfunction drug.
07-May-2013 - In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.
07-May-2013 - In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.
06-May-2013 - A push to root out antimalarial counterfeit drugs in Ghana will begin later this year or early 2014 as part of a pilot project to test an FDA-developed counterfeit detector.
06-May-2013 - Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.
06-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Sanofi, Bausch + Lomb and BASF.
02-May-2013 - As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
30-Apr-2013 - International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...
Dispatches from Excipient Fest in Baltimore
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have...
Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...