Possible API Contamination at Chinese CMO Leads to Canadian Recalls

22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

Impax Hires Specialists to Help Sort Manufacturing Issues

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.

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.

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 pharmaceutical industry group, 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.

Ranbaxy Pleads Guilty to Manufacturing Adulterated Drugs

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 .

Canada Solidifies GMP Requirements for APIs to Secure Supply Chain

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 .

People on the Move: Pharma Jobs

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.

Local Indian Committees to Conduct Annual Inspections of Trial Sites

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.

FDA: Foreign Manufacturers to Help Alleviate US Infant Drug Shortages Next Week

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.

EMA Seeks to Revise Some Phthalate Limits in Excipients

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 .

Pfizer Sells On-Line to Dampen Fake Viagra's Rise

07-May-2013 - Pfizer has begun selling Viagra online in order to counter the trade in fake versions of its erectile dysfunction drug.

FDA Releases Alexion Response to Form 483 on Microbial Contaminations

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.

DISPATCHES FROM INTERPHEX

AlpVision's iPhone Tech Offers Authentication in War on Counterfeits

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.

US FDA, USP Look to Ghana for Pilot Testing of Antimalarial Counterfeit Detector

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.

Hospira says Troubled Plant on 'Rocky' Road to Recovery

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.

People on the Move: Jobs in Pharma

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.

Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

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.

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

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.