Breaking News on Pharmaceutical Technology

ATMI launches single-use powder transfer bag

ATMI has launched a powder transfer bag, for substances such as APIs and excipients, which it claims has three times the shelf life of alternatives, increases process efficiency and improves safety.

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Caraco enters into consent decree with FDA

Caraco Pharmaceutical Laboratories has entered into a consent decree with the FDA which details a series of measures that must be fulfilled to allow the company to resume manufacturing.

Hovione's Loures plant gets latest FDA pre-approval nod

Portuguese API maker Hovione says its contract manufacturing plant in Loures has passed a pre-approval inspection by the US Food and Drug Administration (FDA).

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J&J buys 18% of Crucell

US health care major J&J has paid €302m for an 18 per cent stake in Dutch biotechnology Crucell and announced plans for a collaborative drug development programme.

Unlikely CEE CROs & CMOs can maintain sustainable growth; report

Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.

FDA proposes cGMP rule for combination products

The FDA is to establish current good manufacturing practice (cGMP) requirements for combination products to eliminate inconsistencies that could affect product safety and public health.

Waste reduction boosts demand for deblistering, says Sepha

Northern Irish Packaging specialist Sepha says increasing pressure to reduce waste is driving drug industry demand for its range of Press-Out deblistering technologies.

People on the move: pharma jobs

in-PharmaTechnologist presents its latest round up of appointments in the pharma sector, including a new president of Eli Lilly USA and a resignation over disagreements at Caraco.

West opens its first manufacturing site in China

West has opened its first manufacturing facility in China to meet rising demand but the process has taken since 2006 and been “very tedious”, its president of West Asia Pacific told Outsourcing-Pharma.

Nycomed plans €75m Russian plant; may up €4.5bn bid for Solvay

Late last week Swiss drugmaker Solvay confirmed its plan to invest up to $75m (€51m) to build a new manufacturing plant in Yaroslavl, Russia.

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Camlin Fine Chemicals mulls API unit sale

The pharmaceutical division of Indian API maker Camlin Fine chemicals may be put up for sale by its parent company, stationary giant Camlin, after failing to expand.

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Abbott beats Nycomed and UCB in battle for Solvay’s drug unit

Abbott Laboratories will buy Solvay’s pharmaceutical unit for €4.8bn ($7bn) according to reports released earlier today.

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EC OKs Novartis’ move for Ebewe SP's injectables biz

The European Commission has approved Novartis’ €925m ($1.2bn) acquisition of Ebewe Spezial-Pharma’s generic injectables business.

Philips collaborates to tackle cancer

Philips has entered into a joint research programme to evaluate ThermoDox with MR-HIFU, a combination therapy that could provide a precise, non-invasive way to treat difficult cancers.

Ampac bulks up API capacity with 3 LLC units

Ampac Fine Chemicals (AFC) has added three new commercial-scale Hastelloy liquid-liquid centrifuges to its API making business in a move that, it says, will increase batch size and lower manufacturing costs.

Teva further streamlines ops with Czech plant closure

Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plants in the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.

Bio-Path licenses siRNA targeted delivery tech

Bio-Path Holdings has signed an exclusive licence to develop a liposomal tumour targeting technology that delivers antisense and FAK siRNA and cuts toxicity.

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FDA enlarges and extends QbD pilot programme

The FDA has enlarged and extended its quality-by-design (QbD) pilot programme, moving back the submission deadline and increasing the number of applications.

Synthetic PEG could cut interferon dosing requirements

Coupling interferon to a synthetic PEG molecule could increase the therapeutic’s dosing schedule from every other day to every one to two weeks, according to researchers who believe the technology has blockbuster potential.

Gerresheimer invests in plastics with two new plants

Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the US and a production facility in Spain.

Apotex recalls some drugs; supply cuts staff

Apotex’s manufacturing difficulties have begun to impact on its operations, with the company recalling some products, New Zealand authorities issuing a temporary import ban and lay offs at a supplier.

People on the move: pharma jobs

in-PharmaTechnologist presents its latest round up of movements in the pharma space, including appointments at Sanofi-Aventis, MorphoSys and Ironwood Pharmaceuticals.

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Praxair installs NCOOL at facility in China

Shanghai The First Biochemical & Pharmaceutical Company has installed Praxair China’s NCOOL cryogenic heat exchanger, becoming the first company to sign this sort of liquid nitrogen supply contract.

Flexible packing boost following mLLDPE resin launch

The North American launch of a new range of mLLDPE resins will result in greater lightweighting, cost savings and sustainability for flexible packaging in the region, said manufacturers LyondellBasell.

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Corden fined over explosions at Irish plant

Corden Pharma has been fined and ordered to pay legal costs after it was prosecuted for health and safety offences following explosions at its facility in Little Island, Ireland, according to media reports.

Genzyme starts work on new Mass facility

US biotechnology major Genzyme has begun $68m of refurbishment work on a new 211,000 sgft manufacturing and shipping complex in Northborough, Massachusetts.

MWV hopes Med-Easy packs will be a hit among EU patients

US packaging group MeadWestVaco (MWV) has launched its Med-Easy pharmaceutical packaging solution in Europe in an effort to appeal to patients who need to take their treatments on the move.

Vaccine growth and single-use systems boost Pall in ‘09

Revenues from Pall’s biopharmaceuticals division grew in fiscal 2009, excluding foreign currency changes, with the company benefiting from the “thriving market” for vaccines and expanding adoption of single-use systems.

FDA approves four H1N1 swine flu vaccines

The FDA has approved four H1N1 vaccines, made by CSL, AstraZeneca, Novartis and Sanofi-Aventis, that will be distributed in the next four weeks as part of the US’ swine flu preparation.

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B-MS sells facilities and product rights

Bristol-Myers Squibb (B-MS) is continuing to sell divisions, with the latest deal offloading its Indonesian unit and product rights to Japan-based Taisho Pharmaceutical for $310m (€211m).

Welcome, here’s a warning letter; Dekkers named as Bayer CEO

News of Bayer’s selection of ex-Thermo Fisher Scientific boss Marijn Dekkers as its CEO was somewhat overshadowed by a new FDA warning letter about quality testing at its manufacturing facility in Bergkamen, Germany.

LyondellBasell announces LDPE plant closure on demand slump

LyondellBasell is to close a low density polyethylene (LDPE) plant in the UK by the end of the year on continued weak demand and as it seeks to phase out uneconomic facilities from its global operations.

Space-age tech to tackle pharma counterfeiting

Researchers have combined crime research and space-age technology to create an anti-counterfeiting system that they claim is cheap, quick and non destructible.

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GSK must hand over Paxil emails

GlaxoSmithKline (GSK) must hand over emails from researchers studying birth defects allegedly caused by Paxil (paroxetine) after a district judge refused to block a family’s request to see the documents.

Lilly to cut workforce 10% in bid to save $1bn by 2011

US drugmaker Eli Lilly plans to cut 5,500 jobs by 2011 as it prepares to enter what CEO John Lechleiter said will be “the most challenging period in [the] company’s history.”

People on the move: pharma jobs

in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Roche appointing Genentech’s CEO to lead its pharma division and Mylan’s CFO leaving after three months in the job.

Biologics boost for $2.7bn needle-free delivery market

Demand for new delivery options for biologic drugs will drive an expansion of the $2.7bn needle-free technology market over the medium-term, according to a new report by industry analysts Kalorama Information.

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AstraZeneca cuts 113 jobs at Mass Pulmicort plant

UK pharmaceutical major AstraZeneca will eliminate 133 US drug manufacturing jobs in response to increasing market competition for its asthma treatment Pulmicort Respulses.

Pfizer $2.3bn payout; how much does your State get?

Last week, US pharmaceuticals giant Pfizer agreed to pay $2.3bn to resolve criminal and civil liability relating to the off-label promotion of several of its drugs in what the Department of Justice called the largest fraud settlement in its history.

Patheon overview - a look at what Lonza would gain

With Lonza and JLL competing over Patheon Outsourcing-Pharma looks at what the CMO offers to a prospective buyer, analysing its global manufacturing capacity and backlog using interactive maps and graphs.

Supply chain lapses slow pandemic responses; survey

More than 50 per cent of executives believe their company fails to respond quickly enough to pandemics because of lapses in the supply chain, according to an IBM survey.

Targeted Genetics out of crisis after selling AAV kit to Genzyme

Struggling biotech Targeted Genetics (TG) has sold certain patents and AAV manufacturing technology to fellow US group Genzyme in a $7m deal that “shifts the firm out of crisis mode,” according to CEO Susan Robinson.

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Pharmworx, MSO and Sun collaborate on anti-counterfeiting solution

Pharmworx and MSO Packaging have teamed up to form a multi-layered brand protection solution, designed to help fight counterfeiting in the pharmaceutical, cosmetic and food sectors.

FDA places import alert on two Apotex facilities

The FDA has issued an import alert against products manufactured at two Apotex facilities after the agency issued a warning letter, which raised several issues that the company is now working to resolve.

Solvay cell-based vaccine facility validated

Dutch authorities have completed validation of Solvay Biologicals cell-based production facility which the company will use to meet growing worldwide demand for influenza vaccines.

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Sanofi deal to supply H1N1 vacc to Brazil

Sanofi Aventis says it has been contracted to supply the Brazilian government with up to 33 million doses of H1N1 “swine” flu.

Speed and flexibility claimed for new top load case packer

The new, fully automatic top load case packer from end-of-line packaging specialist Brenton significantly improves packing speeds compared with manual operations while boosting flexibility, claims the company.

Novavax’ VLP delivery tech could accelerate H1N1 vacc production

Novavax’ VLP delivery system has been the subject of industry excitement this week after the US firm released Ph II data showing that a combination seasonal influenza vaccine based on the technology is effective and well tolerated.

Encap targets growth opportunities in colonic delivery

CMO Encap has expanded its colonic delivery offering and is combining the technology with liquid dosage forms to provide clients with a way to administer a wide range of therapeutics to the region.

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Galencia extends global reach with OM Pharma deal

Pharmaceutical manufacturer Galencia says its acquisition of Switzerland-based biotech group OM Pharma will bolster its international presence.

People on the move: pharma jobs

in-PharmaTechnologist presents its latest round up of movements in the pharma space, including Merck’s post-merger management structure and a difference of opinion at LifeCycle Pharma.

Cloud Packaging meets shorter run trend with Toll takeover

Cloud Packaging Solutions has said the acquisition of Toll Packaging will boost its ability to meet the increased demand for shorter packing runs triggered by the current global economic crisis.

Slump bad for North American APIs, but biotech to lead recovery

The global economic crisis has drastically reduced the growth of the North America API market, but brighter days are ahead according to new research by Global Markets Direct (GMD).

Controlled-release can deliver for generics firms, says Espicom

Wyeth’s battles to protect the controlled-release (CR) version of its anti-depressant Effexor are a sign of things to come according to a new Espicom report identifying 30 CR drugs likely to face competition.

KV rehiring after FDA accepts work plan

KV Pharmaceutical has begun rehiring employees to produce verification batches of certain products prior to resuming commercial manufacture, which appears to be on schedule after the FDA accepted the work plan.

Biosimilars market to be worth $19.4bn by 2014

The biosimilars sector is predicted to be worth $19.4bn (€13.6bn) by 2014, by which time the US will have overtaken Asia as the dominant market, according to a report.

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Dainippon to buy Sepracor for $2.6bn

Japanese drugmaker Dainippon Sumitomo Pharma (DSP) has entered into a definitive agreement to acquire US pharmaceutical group Sepracor for $2.6bn (€1.8bn).

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Novartis buys HySolv technology from BTG

Swiss drug major Novartis will UK specialty pharma firm BTG up to $10m (€7m) for its HySolv drug delivery technology.

Genzyme receives EMEA letter about Allston plant

The EMEA has issued US biotech firm Genzyme with a letter detailing “one major observation and several other observations” following an inspection of its Allston, Massachusetts manufacturing plant last month.

SFDA set to approve two H1N1 vaccines

In the next week the Chinese SFDA is expected to approve licences for two locally produced H1N1 vaccines, which unlike some alternatives only require one dose to confer immunity.

Nanostructure catalysts could save pharma time & money

Researchers believe they are a step closer to creating superefficient industrial catalysts after a team made platinum-on-gold bimetallic nanorods that are soluble in organic solvents.

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Sanofi to close Kansas plant impacting 370 employees

Sanofi-aventis is initiating the phased closing its manufacturing facility in Kansas, US, with complete shutdown expected to occur in 2012 and impact on 370 employees.