The Challenge of Change - Managing Excipients Control
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MedImmune has recalled unused doses of its intranasal H1N1 vaccine FluMist in the US after checks revealed that some had fallen below the minimum potency threshold in the two months since they were shipped.
Rio Tinto today formally accepted the offer by Amcor to buy Alcan Packaging for US$2.025bn.
Patheon says a slowdown in “outsourcing decision making,” manufacturing problems in Puerto Rico and cost related to JLL’s takeover bid hurt it in fiscal 09.
French drugmaker Sanofi Aventis will pay $1.9bn (€1.3bn) for OTC firm Chattem, according to a statement released yesterday.
Welcome to this seasonal holiday video from Decision News Media. As we prepare to celebrate our tenth anniversary next year and first year as part of William Reed Business Media, we present 10 fun number facts about our company. And, later this week, the holidays begin.
In-Pharmatechnologist presents its latest round up of movements in the pharma sector, including appointments at Merck & Co, MediGene and Medivation, as well as departures at Bristol-Myers Squibb and KV Pharmaceutical.
US drug major Merck & Co will buy into the UK's contract biologics manufacturing sector with the acquisition of Tees Valley-based Avecia Biologics.
Hospira will pay India’s Orchid Chemicals and Pharmaceuticals approximately $400m (€278m) for its generic injectables business.
The Indian pharmaceutical market was worth $10.8bn (€7.5bn) this year and will more than double in value by 2014 according to a new industry report by Cygnus Business Consulting & Research.
Geron says the USPTO appeals board granted a request to declare “interference” between a patent application owned by the firm and one issued to Novocell in March.
Swedish CDMO Recipharm will buy privately-owned group Cobra Biomanufacturing to build its presence in the expanding biologics sector.
Dishman Pharma says its new Saudi Arabian joint venture (JV) will establish the first API production plant in the Middle East.
Artificial red blood cells (RBC) that mimic “biologically optimised” characteristics could better nanotech drug delivery, say US scientists.
GSK says UK plans to apply a reduced tax rate to all drugs patented after 2013 will encourage investment, provided it is applied to products already being developed.
Sanofi Pasteur has recalled four lots of its pediatric H1N1 vaccine in the US that were found to have fallen below potency limits despite being be in spec at the time of manufacture.
US drugmakers developers Isis and Alnylam say the US PTO has allowed 75 new claims relating to the development of RNAi drugs.
Lonza will use its GS (glutamine synthetase) Gene Expression system to produce clinical trial stocks of Femta Pharmaceuticals’ candidate rheumatoid arthritis (RA) treatment, FM101.
GSK halted production in Rajahmundry, India and Eisai postponed the opening of a facility in nearby Vizag on Saturday after days of unrest over plans to create a new state, Telangana, within Andhra Pradesh.
US formulation services provider Bend Research says a new safety file for the bioavailability enhancing drug excipient, HPMCAS, can now be referenced by its clients in FDA filings.
Sanofi Aventis has revamped operations at its sterile injectables plant in Le Trait, France, adding three new production units that double syringe making capacity and diversify its vaccine manufacturing capability.
Taro Pharmaceutical Industries has warned shareholders about “Sun’s conduct at Caraco” in its latest effort to block the Indian firm’s takeover bid.
Amcor’s takeover of Alcan has been cleared by the European Commission after the Australian company agreed to sell off two pharmaceutical and food packaging plants in Spain.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Genzyme, Amarin and Hard To Treat Diseases.
Sanofi Aventis plans to launch 15 new generic products in rural India, under its new Prayas marketing initiative being rolled out through its Hoechst brand.
Intercell’s needle-free patch delivery technology has the potential to change the way vaccines are delivered, according to Jean Stephenne, president of GSK Biologicals.
Amcor unveiled its proposed management shake up in preparation for the $2bn takeover of Alcan last week – with the European Commission set to announce its final decision on the deal later to day.
Officials carried out another set of surprise inspections at pharma companies yesterday, in the latest stage of the European Commission's clampdown on anti-competitive practices.
Unigene Laboratories is laying off one-third of its workforce and temporarily suspending production of some materials in an attempt to cut its operating expenses by up to $10m (€6.8m) in 2010.
Sanofi-Aventis will manufacture and supply recombinant human insulin crystals to Generex Biotechnology for use in Oral-lyn commercial production and clinical trials.
Teva will continue to use Codexis’ biocatalysis technology for key processing steps in the production of four generic drugs under a revised agreement announced last week.
Sanofi-Aventis, Teva Pharmaceutical Industries and Sinopharm lead the pack in the race to acquire German generics firm Ratiopharm.
Hermes Biosciences has been acquired by Merrimack Pharmaceuticals in a deal which aims to combine the companies’ drug discovery and delivery platforms to develop cancer treatments.
The EU industry commissioner has said the scale of pharmaceutical counterfeiting “exceeded our worst fears” and the EPHA has weighed into the debate on the development of the draft directive.
FDA approval for a 24-hour liquid sustained-release formulation could significantly improve tailored dosing, according to US developer Tris Pharma.
Repeated mandatory inspection of overseas API facilities should be performed to prevent falsified products entering the EU, according to a committee which has published proposed amendments to the draft directive.
Dow has joined with Signet Healthcare Partners to form a new independent company which will use the chemical company’s Pfenex protein expression technology to accelerate development.
Ranbaxy Laboratories is selling its 50 per cent stake in its Japanese joint venture (JV) to its partner Nippon Chemiphar (NC), allowing both companies to independently pursue their generic businesses.
Watson Pharmaceuticals gained US rights to market a generic version of Lipitor (atorvastatin) in 2011 with the acquisition of non-branded drugmaker Arrow Group late last week.
Diurnal has received a £600,000 ($982,000) investment to further development of products using its drug delivery technology, which uses delayed and sustained release to mimic the body’s circadian rhythm.
Alexion Pharmaceuticals’ manufacturing facility in Rhode Island, US has received a positive opinion from the CHMP, furthering its efforts to gain in-house capacity to supplement a deal with Lonza.
in-PharmaTechnologist presents its latest round up movements in the pharma sector, including CytRx bolstering its manufacturing expertise and KV preparing its management as it strives to resume distribution.
Pfizer and Protalix have increased the pressure on Genzyme by signing a new accord to commercialise Uplyso (taliglucerase alfa), a potential rival to its Gaucher’s disease treatment Cerezyme, just days after the US biotech resumed production.
Australia’s Sterling Products plans to buy a 4,310 sqm pharmaceutical manufacturing plant from a Canadian drugmaker that has fallen victim to the global economic crisis.
CDMO Haupt Pharma has invested in a combined heat and power unit (CPHU) for its site in Wolfratshausen, Germany, which is now expected to produce 14 per cent less CO2 a year.
Roche has licensed Aegis Therapeutics’ ProTek stabilisation technology, which uses GRAS excipients to prevent aggregation and therefore improve production of peptide and protein drugs.
A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
Indian API maker Avon Organics’ share price rocketed 10 per cent on the Bombay exchange yesterday after the US launch of a generic herpes treatment by Ranbaxy Laboratories.
Cell culture solutions provider Vivalis will be listed on the French stock exchange’s CAC Small 90 and SBF 250 indices from December 21.
Sartorius Stedim Biotech has introduced FlexAct BP, the first product in a range which will be an integrated single-use system for entire biomanufacturing steps in upstream and downstream processing.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Takeda, Aquapharm and Cannabis Science.
India’s Cipla is in talks with a number of global pharma players, including Pfizer, about potential generics supply deals.
Leeds University in the UK has unveiled a new £4m (€4.4m) laboratory designed to make small-scale process development “greener, cheaper and more effective.”
The Pharma sector’s shift away from blockbusters could result in higher taxes according to PricewaterhouseCoopers (PwC).
Terapio has secured $5m (€3.3m) in funding to develop RLIP76, which is being used to counteract radiation and deliver large molecules across cell membranes, such as genetic material across the BBB.
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