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Headlines > August 2011

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31-Aug-2011

Lactose giant DMV-Fonterra to buy Indian cellulose excipient maker Brahmar

31-Aug-2011 - DMV-Fonterra excipients (DFE) will buy Indian manufacturer Brahmar Cellulose Private Limited (BCPL) to strengthen its position in the pharmaceutical excipient market and reduce costs.

Wacker expands sales presence in ‘high priority’ Indian market

31-Aug-2011 - German chemical maker Wacker Chemie is ramping up its sales operations in India, with the country’s rapidly expanding pharmaceutical sector being one of its key targets.

New spare parts ordering platform is more efficient and user-friendly, Bosch

31-Aug-2011 - A new customised spare parts ordering platform for packaging manufacturers is faster and more user-friendly than its predecessor, said Bosch.

News in brief

Fareva to buy Pfizer plant to build US pharma presence

31-Aug-2011 - US drug giant Pfizer is to sell its plant in Henrico County, Virginia to Luxembourg-headquartered manufacturer Fareva.

Vaccine cell line demand helps Vivalis cut loss in H1

31-Aug-2011 - Vivalis cut its operating loss after demand for its vaccine production cell line drove triple-digit revenue growth.

Unilife sales drop in Q4

31-Aug-2011 - Unilife sales tumbled in the fourth quarter due to closure of its contract manufacturing operations and a drop in milestone payments.

30-Aug-2011

Costs 'a burden' for API and excipient makers, says BASF after raising prices again

30-Aug-2011 - Chemicals giant BASF has increased the price of drug APIs and excipients by 10 per cent for the second time in a year.

update

US Pharma survives hurricane Irene unscathed

30-Aug-2011 - Drug manufacturers on the US’ east coast seem to have survived Hurricane Irene unscathed, with only a few incidents of damage reported so far.

QbD support toned down by FDA in transdermal guidance

30-Aug-2011 - The FDA has toned down its support of QbD in final guidance on cutting residual drug in transdermal delivery systems following industry criticism.

News in brief

Grant to help Stellar ramp up aquaculture vaccine ingredient

30-Aug-2011 - Stellar Biotechnologies is to scale up its aquaculture limpet farms for commercial supply of a vaccine component after receiving a US grant.

Cost-cutting tablet splitting prompts FDA guidance

30-Aug-2011 - The rise of tablet splitting has prompted the FDA to advise manufacturers on what data is needed to support applications for scored doses.

29-Aug-2011

update

Granules to expand API and intermediate capacity

29-Aug-2011 - Chemicals maker Granules India says it will expand manufacturing capacity for oral solid dose (OSD) APIs and drug intermediates in a bid to better meet the needs of clients.

TPI claim new local plant will reduce cost of ARVs in the region

29-Aug-2011 - Tanzanian Pharmaceutical Industries (TPI) is set to open the doors to a new anti-retroviral drugs (ARVs) manufacturing plant.

Batavia gains bioprocessing assets in Xendo collaboration

29-Aug-2011 - Batavia Bioservices has gained access to simulated moving bed (SMB) technology by collaborating with Xendo.

Drug delivery research round up

29-Aug-2011 - in-PharmaTechnologist presents a roundup of the latest drug delivery research, including bone marrow targeting nanoparticles and an imaging-treatment combo.

25-Aug-2011

People on the move: pharma jobs

25-Aug-2011 - in-PharmaTechnologist presents its latest round-up of the movers and shakers within the pharmaceutical industry, including appointments from AAPS, SurModics, Diamedica, and Sirona Biochem.

Ashland completes ISP takeover and predicts customer benefits

25-Aug-2011 - US chemicals maker Ashland says completion of ISP takeover means simplified supply chains for drug and cosmetics industry customers.

Surmodics slashes staff numbers by nine per cent

25-Aug-2011 - Drug delivery and pharmaceutical coating specialists SurModics are set to cut nine per cent of staff in a reshuffle of the business.

New plant moves Irvine into Asia, gives it 2nd media source

25-Aug-2011 - Irvine Scientific has begun shipping from the cell culture media plant it built to expand into Asia and give clients the security of a second source.

News in brief

Emerson adds liquid analyser with high res screen

25-Aug-2011 - Emerson Process Management has released a dual-input liquid analyser with a high resolution colour screen.

24-Aug-2011

PBS Biotech buys Integrity to add manufacturing capacity

24-Aug-2011 - US bioreactor maker PBS Biotech has bought medical device focused CMO Integrity CMI to expand its manufacturing capacity

News in brief

Counterfeiters target countries with weak laws says Antigua Pharma Society

24-Aug-2011 - Drug counterfeiters are using the Caribbean as a transport hub to ship fake pharmaceutical around the world according to the Antigua Pharmaceutical Society.

Unilife creates world's first multi-chamber syringe with in-built safety device

24-Aug-2011 - Unilife has developed the world’s first multi-chamber prefilled syringes that have an in-built safety mechanism.

Foreign investment needed to boost UAE drug production

24-Aug-2011 - The UAE needs overseas investment to kick-start its pharmaceutical manufacturing sector and end reliance on foreign imports, the DCCI says.

23-Aug-2011

Needle-free drug delivery is the wave of the future, says Kalorama

23-Aug-2011 - The worldwide market for needle-free drug delivery will double in value over the next five years, according to new market research by Kalorama.

Takeda gets 24bn yen Govt grant for cell culture vacc plant

23-Aug-2011 - Japanese drugmaker Takeda has been awarded JPY24bn ($313m) to develop and a cell culture influenza vaccine and establish a commercial-scale production facility.

News in brief

TGA to hold workshops on new biologics framework

23-Aug-2011 - Australia’s TGA will begin a series of workshops to help drugmakers navigate its revised guidance of biologics.

Brazil & USP ink deals to up quality, harmonise standards

23-Aug-2011 - The USP is strengthening ties to the Brazilian pharmaceutical sector to improve quality and drive harmonisation of standards.

Strategic deals drive Catalent’s $410m move for Aptuit assets

23-Aug-2011 - Catalent is to buy clinical trial supply assets from Aptuit for $410m (€285m) as it adds scale to handle the shift to preferred provider relationships.

22-Aug-2011

Chemspec to ‘go private’ after Halogen takeover

22-Aug-2011 - Contract speciality chemical maker Chemspec International says it will ‘go private’ after being taken over by Halogen Limited, a holding company co-owned by members of its management board.

News in brief

Valpotherm respiratory delivery system receives US FDA OK

22-Aug-2011 - Vapotherm’s Precision Flow system for the conditioning of breathing gases has received the FDA thumbs up for the administration of nitric oxide via high flow nasal cannula.

Silica-based cartridges boost metal removal at AstraZeneca

22-Aug-2011 - AstraZeneca has adopted and scaled-up silica-based cartridges for removal of metal impurities at its pilot plant.

Ingredients & formulation research round up

22-Aug-2011 - in-PharmaTechnologist presents a roundup of recent ingredient and formulation research, including improved API impurity detection and a simple step to boost stability.

18-Aug-2011

FDA and generic drug sector agree ‘epoch making’ plant inspection fee plan

18-Aug-2011 - The generic drug industry and the US FDA have reached an agreement that would see the former fund the latter’s overseas facility inspection programme to the tune of $299m a...

People on the move: pharma jobs

18-Aug-2011 - in-PharmaTechnologist.com presents its round-up of executive moves within the pharma sector, including appointments from Unilife, Aceto and Cangene.

News in brief

Promega to start work on new medical diagnostics tech facility

18-Aug-2011 - Promega will start work on a US manufacturing facility later this month in a project expected to create 100 jobs over the next five years.

Bioprocessing unit sale could help Repligen, investor says

18-Aug-2011 - Repligen should consider selling its bioprocessing unit, which sells materials used in mAb production, to make best use of its assets, a shareholder suggests.

Biosimilar assessment a goal of FDA modernisation plan

18-Aug-2011 - The FDA is prioritising development of technologies to compare biosimilars to innovator products in its plan to modernise regulatory science.

17-Aug-2011

Novel nasal implant from Intersect is winner for US FDA

17-Aug-2011 - Intersect have received the FDA seal of approval of their targeted drug delivery technology for treatment in chronic sinusitis patients.

News in brief

Pfizer’s former Kent site granted ‘enterprise zone’ status by UK Gov

17-Aug-2011 - Pfizer’s former R&D facility in Sandwich, Kent has been declared an ‘enterprise zone’ by the UK government

Rapid drying tech equivalent to lyophilisation in mAb study

17-Aug-2011 - A study shows mAbs processed with fast acting dehydration show equivalent structural changes to freeze dried compounds after a year, EnWave claims.

Encap offers feasibility package for colonic delivery technology

17-Aug-2011 - Encap Drug Delivery now offers a ‘feasibility package’ to assess the potential of its Phoral coating technology as a vehicle for therapy in colonic diseases.

Drug delivery research round up

17-Aug-2011 - in-PharmaTechnologist presents a roundup of recent drug delivery research, including a pH activated capsule and plant-based administration.

16-Aug-2011

West to expand US packaging and device R&D centre

16-Aug-2011 - West Pharmaceutical Services says new R&D centre will focus on elastomer formulations and process development for its packaging and delivery tech businesses.

Unilife to ramp up Unifill sales and marketing campaign

16-Aug-2011 - Unilife says it will ramp up sales and marketing efforts for its Unifill prefilled syringe range after securing additional funding.

Ampac posts loss as volume shortfall offsets sales gains

16-Aug-2011 - Surging anti-viral sales drove fine chemical growth at Ampac in Q3, but the unit posted a loss after missing efficiency and throughput targets.

11-Aug-2011

Multivac packaging technology allows for broader scale production

11-Aug-2011 - Multivac is developing a new packaging solution for sterile medical products that it says will solve issues in packaging diversity and batch size, as well as speeding up line clearance.

News in brief

Excipient interaction review paper gets nod from IPEC

11-Aug-2011 - A new review paper warning manufacturers about the dangers of under-estimating the effects of excipients has received the thumbs up from IPEC.

US drives contract packaging growth at United Drug

11-Aug-2011 - Contract packaging profit at United Drug rose in its latest results as strong US sales offset weak performance in Europe.

Biopharm turning to 3PL & global suppliers for savings

11-Aug-2011 - Close to two-thirds of biopharm companies plan to increase reliance on 3PL providers and global manufacturers in coming years, a survey found.

10-Aug-2011

News in brief

Tereos Syral to add injectable glucose to range

10-Aug-2011 - Tereos Syral plans to add pyrogen-controlled glucose monohydrate production capacity to expand into pharmaceutical starch derivatives.

Akela plans CMO buys after exiting development project

10-Aug-2011 - Akela Pharma is focusing on its CMO and expanding it through acquisitions after its partner exited their drug development programme.

People on the move: pharma jobs

10-Aug-2011 - In-PharmaTechnologist presents its latest round-up of executive moves in the pharma industry, including appointments at Akrimax, Vernalis, Sanofi and Pregis.

Pfizer “aggressively” pursuing cost saving real-time release

10-Aug-2011 - Pfizer is “aggressively” moving toward real-time release (RTR) and believes return on investment can be realised in a year.

09-Aug-2011

GSK signs packaging deal in Iraq

09-Aug-2011 - GlaxoSmithKline (GSK) has won its four-year battle to start packaging drugs in Iraq by outsourcing production to a local company.

News in brief

Genentech to sell clinical scale biologics plant to Gilead

09-Aug-2011 - Gilead Sciences is to buy a 70,000 sq ft clinical scale biologics production plant in California from Genentech.

Hyaluron buy a “money pit” for AMRI, analyst warns

09-Aug-2011 - FDA scrutiny of the Burlington, MA sterile plant AMRI bought in 2010 has made the takeover a “money pit”, an analyst said.

AstraZeneca looks to printers for personalised medicines

09-Aug-2011 - AstraZeneca has collaborated to research a scalable system based on inkjet printing for formulating personalised medicines.

08-Aug-2011

First-to-file race slowing QbD adoption in generics

08-Aug-2011 - Generic manufacturers can benefit from QbD but fears it will hinder companies in the race to be first-to-file are slowing progress, a VP at Teva said.

ICIG takes Roche Colorado in bid to flex contract peptide manufacturing muscle

08-Aug-2011 - International Chemical Investors Group (ICIG) will take over Roche’s Colorado API plant in a bid to gain footing in the peptide manufacturing industry.

EC revises stability testing

08-Aug-2011 - The EC has updated stability testing guidance to cover procedures for variations, such as change in batch size, to marketing authorisations.

News in brief

API sales & peptide synthesis underpin growth at Neuland

08-Aug-2011 - Neuland Laboratories posted a first quarter profit after API sales and peptide synthesis drove double-digit revenue growth.

04-Aug-2011

final update

Joint API plant inspection programme could be extended globally, says EMA

04-Aug-2011 - The final results of the US FDA, EMA, TGA joint manufacturing facility inspection programme will make for interesting reading for API producers as they strongly hint the approach is here...

News in brief

Cambrex shares soar after generic APIs drive Q2 growth

04-Aug-2011 - Shares in Cambrex soared 30 per cent after custom manufacturing and generic API sales drove revenue growth.

HP launches ‘cloud’ track and trace system to help fight counterfeits

04-Aug-2011 - HP has launched a global authentication service it says will help identify counterfeit and stolen pharmaceuticals.

Limpet-derived intermediate supply deal inked by SAFC

04-Aug-2011 - Stellar Biotechnologies is supplying SAFC with an intermediate derived from limpets to support production of cancer vaccines.

Excipient capacity & portfolio expansion in FMC plans

04-Aug-2011 - FMC plans to add controlled release technologies and expand excipient production to drive growth at its BioPolymer unit.

03-Aug-2011

Tentative US OK for Intelliject’s ‘talking’ delivery device

03-Aug-2011 - Intelliject has received tentative US FDA approval for its e-cue ‘talking’ autoinjector, setting the device maker up for a potentially lucrative partnership with licensee French drug giant Sanofi.

EDQM to work on Chinese medicine quality monographs

03-Aug-2011 - The EDQM will work to improve the quality of traditional Chinese medicines (TCM) sold in Europe under a memorandum of understanding (MoU) with SATCM.

Pharma cargo theft in decline, says new FreightWatch report

03-Aug-2011 - The number of in-transit pharmaceutical robberies in the US has been sliced by almost half since last year, according to FreightWatch’s Biannual Cargo Theft Report.

News in brief

US FDA on track to OK more drugs in 2011 than last year, study

03-Aug-2011 - The US FDA is on track to approve more drugs in 2011 than it did last year but industry and regulators need to do more to sustain the improvement according...

Vial to prefilled syringe shift on in US ahead of flu season

03-Aug-2011 - More-and-more US biopharm companies are moving from vials to prefilled syringes ahead of the upcoming flu season, according to BD.

02-Aug-2011

EDQM advocates Google Earth for plant GPS data on CEP applications

02-Aug-2011 - The EDQM has suggested Google Earth as a potential source of GPS co-ordinate data for manufacturing sites that must be supplied in CEP applications under recently introduced requirements.

News in brief

CHO genome sequenced to boost bioproduction

02-Aug-2011 - Researchers have sequenced a Chinese hamster ovary (CHO) cell line to support improvements to biopharm protein production.

Engineering can cut protein aggregation during storage

02-Aug-2011 - Protein engineering is an untapped method for limiting post-production aggregation that causes immunogenicity, academics say.

Specialty generic players a target for OctoPlus tech

02-Aug-2011 - OctoPlus is targeting specialty generics manufacturers it believes can benefit from its controlled release drug delivery technologies.

Brooks continues to build in biobanking with Nexus Biosystems buy

02-Aug-2011 - The pharma biobanking and compound management services sector welcomed its newest member last week with Brooks Automation’s acquisition of Nexus Biosystems.

01-Aug-2011

News in brief

US workforce focus of Merck & Co cuts

01-Aug-2011 - US drugmaker Merck & Co announced plans to reduce its workforce by 13 percent, or 13,000 employees, in a bid to cut costs and focus its efforts in emerging markets.

West adds pricing surcharge to offset rising commodity costs

01-Aug-2011 - West has applied a pricing surcharge to offset rising raw material costs that dragged on margins in the second quarter.

Bosch sells aseptic filling line to Pharmalucence

01-Aug-2011 - Robert Bosch Packaging Technology has sold a filling line to US firm Pharmalucence Partners, which is expanding its contract pharmaceutical manufacturing business.

People on the move: pharma jobs

01-Aug-2011 - in-PharmaTechnologist.com presents its latest round up of executive moves in the pharma sector, including appointments at Sanofi, GlaxoSmithKline, Croda and Provectus.

Millipore eyes long-term growth beyond Q2 problems

01-Aug-2011 - Biosimilars should help Millipore achieve long-term growth but cancellation of an insulin contract and rising raw material costs hit second quarter results.

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