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Headlines > April 2013

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LIVE FROM INTERPHEX

Customers to Save up to 65% as ASI and Chromatan Pen Single-Use Deal

30-Apr-2013 - ASI has teamed up with Chromatan in order to deliver single-use and column-free capture purification services which could save clients 65% in chromatography costs in clinical manufacturing.

Lonza Closes Ireland Site as US Manufacturing Issues Cause Increlex Shortage

30-Apr-2013 - Manufacturing disruptions at Lonza's Hopkinton, Massachusetts site are causing shortages of Ipsen Biopharmaceuticals’ growth failure treatment for children in both the US and EU, just as the company announces that...

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

30-Apr-2013 - Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax vaccine using its solid-dose injector – welcome to our needle-free drug delivery round-up.

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.

News from Novartis, Teva and the EMA – People on the move

29-Apr-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Novartis, Teva and the EMA.

US Congress Needs to Establish Firm T&T Timeline, Standards, Stakeholders Say

29-Apr-2013 - A clear timeline and stepwise approach to a US solution for tracking and tracing pharmaceuticals through the supply chain to root out counterfeits is necessary, stakeholders agreed.

AstraZeneca Cooperating with Manufacturing Questions from US DOJ District Attorney

29-Apr-2013 - The US Department of Justice’s Attorney’s Office in Boston has sent subpoenaed documents related to AstraZeneca's UK manufacturing practices, which the company said it is complying with. 

LIVE FROM INTERPHEX

Tech and Regulatory Issues? Biotech/Manufacturing Firms Discuss

29-Apr-2013 - Purification bottlenecks, integrating single-use technologies and low cost companies are just some of the issues affecting the biotech industry today, according to experts at this year’s Interphex.

Live from Interphex

Experts: Real-Time Release Testing Desirable But Not Primary Goal of QbD

24-Apr-2013 - The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts...

Live from Interphex

Regulatory and Financial Burdens Slow IR/MR Approvals, Says Expert

24-Apr-2013 - Efforts to update SUPAC guidance on immediate and modified release dosage forms will end in faster approvals, if regulatory and financial hurdles can be overcome, says expert.

Live from Interphex

IHolland Talks Tabletting Solutions for Sticky Formulations

24-Apr-2013 - IHolland says tableting-focused research project will save customers time and money.

Live from Interphex

Almac Talks Facility Expansions on Both Sides of the Atlantic

24-Apr-2013 - Almac says $10m investment at its recently expanded facility in Northern Ireland compliments the sites existing formulation development capabilities.

Fujifilm's Cell Banking Facilitates "Larger Slice" of Biologics Pie

23-Apr-2013 - Third-party manufacturers of biologics are seeing increased demand but more short term contracts, according to Fujifilm.

US Senate Bill Seeks to Establish Lot-Level Track-and-Trace System

23-Apr-2013 - A new bipartisan draft bill released by four US senators late last week seeks to establish a lot-level electronic system to track pharmaceutical products and further secure the US supply...

US FDA Seeks Help in Selecting High-Risk Manufacturing Facilities for Inspections

23-Apr-2013 - The cash-strapped FDA is looking to cut corners any way it can, especially if it can hone in on which pharma manufacturing facilities and sites need to be prioritized for...

Drug Industry gathers for Interphex 2013 - Check for live updates

23-Apr-2013 - Pharmaceutical conferences are like buses - to paraphrase an old British joke - you wait for one and then three come along at once.

Avoiding Cross-Contamination in Antibiotic Manfacturing, the FDA Way

23-Apr-2013 - The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.

Hikma Opts to Keep its Lucrative Injectable Business

22-Apr-2013 - Despite offers from Amgen and Novartis reportedly worth up to $2bn, Hikma announced last week it will keep its profitable and growing injectable business.

News from Israel, Bangladesh and Australia – People on the move

22-Apr-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, in a rather global edition including news from Israel, Bangladesh and Australia.

Prof Says Knowing How to Handle Dangerous Reagents is Key

22-Apr-2013 - The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.

EMA Updates Database with GMP Data to Strengthen Supply Chain Safety

22-Apr-2013 - The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance....

ATMI Adds New Single-Use Fill/Finish Tech in Deal with CMO D-Lab

18-Apr-2013 - ATMI has started selling a new cGMP-compliant fill finish platform in a continuation of its focus on what it says is the growing single-use tech market.

GSK’s Contract Manufacturing Delays Cause Shortage of Restless Leg Treatment

18-Apr-2013 - GlaxoSmithKline’s contract manufacturer has experienced unspecified manufacturing issues that are expected to set back supplies of its restless leg treatment Horizant until June. 

Metrics Latest Company to Offer Extrusion and Speronization Tech

18-Apr-2013 - Following its acquisition by Mayne Pharma, Metrics says it is to offer proprietary pellet form technology for advanced drug release and to increase bioavailability.

update

Sanofi Starts Semisynthetic Malaria Drug Production

17-Apr-2013 - Sanofi has started making artemisinin using a novel semisynthetic method it says will strengthen the global supplies of malaria drugs.

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