Breaking News on Pharmaceutical Technology

Lilly & Amylin team up to create diabetes pen

Eli Lilly and Amylin Pharmaceuticals are jointly developing an exenatide once weekly pen device, which should provide a more convenient way for diabetics to treat themselves.

Pfizer eyes FOBs and small to midsized deals

Pfizer is monitoring opportunities in follow-on biologics and continuing to look for small to mid-sized deals as it plans for life without Lipitor, global revenues of which fell by 13 per cent in Q1.

Optimising business key for pharma in downturn, says CourtSquareGroup

US strategic consultants CourtSquareGroup say that while optimisation of operations is key for the drug industry, companies risk losing the business knowledge required to undertake such action in the scramble to cut costs in the global downturn.

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WHO says pandemic “imminent” and will distribute samples soon

The WHO has upgraded the pandemic warning to “imminent” and is expected to begin distributing reference samples of the H1N1 swine flu viral strain that has spread around the world to vaccine manufacturers.

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AAFI expands Benecel hypromellose capacity

Ashland Aqualon Functional Ingredients (AAFI) has expanded capacity at its Doel, Belgium facility that produces Benecel hypromellose, a compound used in tablet coating and granulation.

GEA probe helps companies follow PAT initiatives

GEA Pharma Systems’ process equipment is now available with its Lighthouse Probe technology, which uses fibre optics and mirrors to give a clear view of the product when it is in the machine.

Nanoparticles used to create topical Viagra rival

Erectile dysfunction could be treated by a nanoparticle formulation applied directly to the penis, according to research, reducing the side effects that can occur when taking drugs like Viagra.

Sanofi pulls plug on four Ph III drugs

Sanofi-Aventis has halted development of four Phase III drugs in a “rigorous” pre-patent loss pipeline review that has also seen it drop four Phase II candidates and six Phase I projects.

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Novavax shares soar 80% as swine flu spreads

The spread of swine flu has caused significant rises in the share prices of some vaccine makers, including Novavax, which rose 80 per cent, and BioCryst, which spiked by 76 per cent.

Xspray grows with demand for manufacturing tech

Xspray has doubled its personnel and laboratory space in response to demand for its manufacturing service, which is designed to overcome the drawbacks associated with micronisation.

Novozymes begins work on Chinese bHA plant

Novozymes Biopharma is building a new Bacillus-based hyaluronic acid (bHA) production facility in China to meet “increasing demand” for the substance that has drug delivery applications.

SAFC and Vivalis launch high yield EB66 media

SAFC and Vivalis have launched a new media designed to allow the latter’s commonly used virus producing EB66 cell line to grow at higher cell densities and produce higher yields.

Pfizer’s stem cell unit and UCL focus on eye disorders

Pfizer’s development deal with stem-cell researchers at University College of London’s (UCL) Institute of Opthalmology, aimed at reversing vision loss in AMD, has drawn a great deal of interest from investors and the drug industry alike.

Millipore’s deal to improve influenza vaccine purification

Millipore is collaborating with Microbix Biosystems to improve influenza vaccine manufacturing by developing a purification process using novel chromatographic technology.

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Three more mega-mergers could happen in 2009

More mega-mergers are a possibility in 2009, according to a new report that speculates that three more deals could happen this year, with Bristol-Myers Squibb and Bayer the most likely targets.

Siemens’ process control tech sought by pack firm Aylward

US drug packaging firm Aylward Enterprises has called in Siemens’ energy and automation division to help design the latest generation of its ACT 9000 series bottle filling machine.

Swine flu kills 103 in Mexico; global vacc majors poised to react

Novartis, Roche, GSK and Sanofi Pasteur are poised to start the months of work required to make a vaccine for the swine flu virus that, according to an AFP interview with Health Minister Jose Angel Cordova, is linked to 103 deaths in Mexico.

Hovione shows off Irish API plant

API maker Hovione’s manufacturing facility in Cork, Ireland was unveiled at an opening ceremony yesterday just two weeks after the previous owner, global drug giant Pfizer, formally handed over the keys.

Winpak’s Q1 profits soar despite falling sales

Winpak appears to have benefited from the current economic turmoil, with lower raw material costs and favourable currency rates helping it post net earnings of $9.7m (€7.4m), up by 62 per cent on 2008.

Trial of nanoparticle delivered anti-cancer gene progresses

Research has been presented on the first Phase I trials of a systemic, non-viral, targeted nanoparticle that delivers a p53 tumour suppressor gene to combat cancer.

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EQDM suspends 4 APIs made in China

Last week the EDQM suspended the certificates of suitability of four APIs manufactured in China, adding to the one in March that sparked the recall of 14 products in Spain.

China ramps up stem cell efforts just weeks after US research U-turn

Construction of a new stem cell research and processing plant began yesterday in China’s Eastern Jiangsu province as part of a joint project between the Chinese government and Shenzen Beike Biotechnology.

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War of words escalates over possible Amylin-Lilly deal

An ill-tempered and public argument between Amylin and Carl Ichan has developed over the possible sale of the company to Eli Lilly.

Pharma: people on the move

in-PharmaTechnologist presents its latest round up of appointments in the pharmaceutical industry, including movement at Pfizer, Solvay and Biovail.

IntelGenx furthers novel antihypertensive formulation

IntelGenx’ clinical pilot study indicates the bioequivalence of a leading antihypertensive and its product, which has been developed using its multilayer Versatab delivery technology.

Sinobipharma claims manufacturing first with capsule perindopril

Sinobiopharma is seeking a Chinese patent covering the manufacture of capsule forms of the heart drug perindopril, claiming it is the first company in the world to produce the medication in this easy to swallow format.

Aoxing’s pain drug plant gets GMP OK

China Aoxing Pharmaceutical, a specialist developer of pain management drugs, has received GMP accreditation for the new tablet production and packaging plant it has set up in Shijiazhuang.

Sanofi investment targets China’s diabetes market

Sanofi-Aventis is investing a further $90m in its Chinese manufacturing facility and performing “the world’s largest diabetes genotyping project” in partnership with the Chinese Diabetes Society.

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GSK to buy Stiefel for $2.93bn

GlaxoSmithKline’s (GSK) $2.9bn (€1.8bn) cash acquisition of US skin drug specialist Stiefel Laboratories “re-energises” the UK firm’s dermatology range, according to CEO Andrew Witty.

India assesses if patent laws would violate TRIPS

A committee appointed by the Indian government has submitted a report into whether patent issues around microorganisms and NCEs are in compliance with TRIPS.

FDA approves high titre manufacture of Tysabri

The FDA has approved Biogen Idec to manufacture Tysabri using a high titre process but the product’s sales have been “negatively impacted” by the cases of patients developing PML.

Domino increases Portuguese footprint with €7m buy

Domino Printing is expanding its presence in Portugal through the €7m ($9m) acquisition of Labeljet SA and its subsidiary Marque TDI, which is currently a distributor for the traceability specialist.

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Actavis reintroduces products after FDA inspection

Actavis has reintroduced Oxycodone 15 mg and 30 mg tablets to the US market having resolved the manufacturing difficulties discovered by the US Food and Drug Administration (FDA).

Polestar launches sensor for disposable reactors

Polestar Technologies has launched its iDOT single-use pH and dissolved oxygen sensor, which can be welded into the walls of disposable reactors to provide in situ process monitoring.

bioMerieux launches “groundbreaking” MFT medias

French diagnostics and microbiology firm bioMerieux claims its new range of indicator medias will help drugmakers cut testing times and reduce errors during GMP mandated sterility analysis.

GSK & Pfizer merge HIV portfolios into shared company

In a radical departure from Big Pharma’s traditional business model Pfizer and GSK have formed a jointly controlled company to develop and distribute their combined HIV portfolios and pipelines.

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Supply Chain integrity and anti-counterfeiting focus at ISPE 2009

US drug excipient body IPEC Americas will cosponsor a supply chain and anti-counterfeiting focused seminar at the annual meeting of International Society for Pharmaceutical Engineering (ISPE) in Washington in June.

China still important for Big Pharma despite M&A slowdown

Although the downturn has slowed Big Pharma’s investment in China, the country’s wide ranging healthcare reforms and changing economic landscape still provide considerable opportunities says PricewaterhouseCoopers (PwC).

MassBIO reflects on difficulties attracting biomanufacturing

Massachusetts Biotechnology Council’s (MBC) 2015 strategic plan has outlined the difficulties the state faces in attracting biomanufacturing and called for increased focus on R&D.

Zealand licenses Vyteris’ transdermal patch

The drive to license needle-free delivery methods continues with Zealand Pharma signing a deal to use its peptide optimisation technology with Vyteris’ controlled transdermal patch.

MWV expands blister pack range with Shellpak-170

US contractor MeadWestvaco (MWV) claims the latest addition to its Shellpack range, the Shellpak-170, offers drugmakers more options for adherence promotion blister packaging.

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Sanofi to spend $500m on BiPar

Sanofi Aventis has snapped up US cancer drug specialist BiPar Sciences for around $500m (€379m), continuing the recent spate of deals that has seen it move for South American generics firms Medley and Laboratorios Kendrick.

ASEAN GMP audit sharing a step to EU-like single market

The Association of Southeast Asia Nations’ (ASEAN) member states will recognise each others GMP certificates as part of a programme intended to raise standards and eliminate trade barriers.

Levinson replaced as Genentech CEO by Roche employee

Art Levinson is to step down from his role as Genentech’s CEO but will play “an active role” at the company as part of Roche’s attempts to integrate and retain the biotech’s key staff.

Sanofi beats Teva in Medley melee

Sanofi Aventis has confirmed it is buying Brazil’s Medley for $664m (€500m), to position it as the largest player in South America’s generics market.

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Asahi launches high-compactable MCC excipient

Asahi Kasei has added to its range of excipients through the launch of Ceolus UF-711, which it claims is the first high-compactable microcrystalline cellulose (MCC) that makes tablets smaller.

Pfizer moves for Indian unit, following Novartis’ lead

Pfizer is the latest company to seek greater control of its Indian subsidiary, falling into step with Swiss drug major Novartis which made a similar move late last month.

Phylogica targets intranasal peptide delivery

Phylogica is developing formulations of its Phylomer peptides using Aegis Therapeutics’ Intravail absorption enhancers, which enable transmucosal drug delivery.

Ampac expands in child resistant packaging

Ampac Flexibles has expanded its range of Flexi-Free overwrap packaging with the launch of its child resistant product, which can be customised by the client to meet their needs.

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Pfizer opens St Louis R&D centre

Pfizer’s new $200m (€152m) research centre is up and running, bringing to an end the firm’s four year project to amalgamate its existing research facilities in St Louis, Missouri, US.

Stimulus packages won’t drag pharma out of slump; report

The annual sales growth of the top 20 pharma companies will fall below two per cent over the next five years, according to Datamonitor, and the stimulus packages are predicted to offer little direct aid.

South Korea pulls 1,000 asbestos tainted drugs from shelves

South Korean drug regulators have ordered the recall of 1,222 medical products and pharmaceuticals that may contain asbestos-tainted talcum powder.

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Raptiva finally pulled in US over PML link

Genentech has withdrawn its psoriasis drug Raptiva (efalizumab) from US shelves on continuing concerns about its link to the brain disease progressive multifocal leukoencephalopathy (PML).

POM formulation offers pH-responsive targeted colon delivery

Researchers have developed a pH-responsive formulation that could be used to deliver a polyoxometalate (POM), which have broad spectrum anticancer and antiviral properties, to the colon.

Pfizer unveils post-Wyeth takeover R&D structure

Pfizer has outlined its post-Wyeth takeover operating structure, which it believes will ensure the mega-merger boosts R&D and create the “world's premier biopharmaceutical” company.

New PhRMA chief says healthcare system is ‘broken’

The new chairman of US trade body the Pharmaceutical Research and Manufacturers of America (PhRMA) – AstraZeneca CEO David Brennan – has laid out his vision for reforming the “broken” healthcare system.

Compliance initiatives increase despite economy; survey

Companies are maintaining their spending on quality control measures despite the challenging operating environment, according to Matthew Kopecky, product manager at Sparta Systems.

USP effort to raise global standards reaches Russia

The USP and Roszdravnadzor, a Russian public health body, are collaborating in an attempt to improve the standards of ingredients and finished products and reduce the availability of counterfeits.

FDA issues final guidance on ICH Q10

The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle.

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Aspen software a “step-change” in modelling

Aspen Technology has launched an updated version of its aspenONE software, which it claims can accelerate batch process development and cut manufacturing costs.

Shire to close Owings Mills Adderall XR plant

Biopharmaceuticals firm Shire will cease manufacture at its plant in Owings Mills, Maryland, US with the loss of 260 jobs in the latest stage of its plan to wind up the in-house production of small molecule drugs.

Time of rapid change in fine chemicals supply, says SAFC

Tom Beil, SAFC’s VP of Quality and Regulatory affairs, whose talk on fine chemicals supply was a highlight of last month's DCAT week, spoke with in-PharmaTechnologist about the benefits and risks of working with global suppliers.

PTI unveils Toyo's "stick pack" system at Interphex

PTI Packaging Systems chose this year's Interphex show to introduce its new unit dose, or "stick pack," production machine to the North American packaging sector.

Researchers shed light on MRSA treatment

MRSA could be treated through a combination of an antimicrobial drug, a peptide and light, according to researchers who have hailed the treatment as a “magic bullet”.

Asia-Pacific manufacturing growth attracts Werum

Werum Software & Systems has set up offices in Japan and Singapore, which will strengthen its position in Asia-Pacific and help it meet the region’s growing demand for tools to improve manufacturing quality.

Cash strapped MDRNA sells CMO unit to Par

MDRNA is selling its manufacturing business to US generics firm Par Pharmaceuticals in a bid to boost its coffers and complete its transformation into a purely RNAi focused organisation.

Intelligent sorbents can save “6-12 months of development”

The use of intelligent sorbents to improve product stability can save companies six to 12 months of development and boost revenues, according to Adrian Possumato, global director at Multisorb.

Interactive map of global counterfeiting events in Q1

The counterfeiting threat is explored in our interactive map, which details the legislation, seizures, technological advances and much more that occurred in Q1 2009 to give a unique oversight of the global problem.

Alliance launches animal-free culture supplement

Novozymes and Millipore have launched an animal-free culture supplement, which has been designed to reduce risk and regulatory pressures in upstream biopharmaceutical processes.

Pfizer settles Nigerian Trovan trial case out of court

Pfizer will pay an out of court settlement to resolve a long-running case alleging that it carried out an illegal trial of its meningitis drug Trovan (trovafloxacin) in Nigeria that resulted in the death of 11 children.

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Is Novartis eyeing Cubist?

Biopharmaceutical firm Cubist received a boost last week, as speculation that Swiss drug giant Novartis is considering a $1.6bn acquisition drove a 14 per cent jump in its share price.

Sanofi leads pack in €5bn+ pursuit of Solvay; reports

Sanofi-Aventis had a €5bn ($6.6bn) bid for Solvay’s pharma business rejected, according to media reports, but several other companies are believed to be interested in the Belgian firm.

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Google’s VC could be boost for biotech

Google has set up a venture capital fund that will be used to invest in a range of industries, including biotech and healthcare, and is willing to plough tens of millions of dollars into individual companies.

Pharming economical for HIV microbicide production; study

Researchers have used plants from the tobacco family as a large-scale, cost-effective method of producing a HIV inhibitor, which could lead to the creation of a female controlled intervention to stop viral transmission.

Altea inks deal to use Byetta with PassPort patch

The search for more convenient diabetes treatments continues, with Altea Therapeutics reaching a $46m agreement with Eli Lilly and Amylin to develop a transdermal patch administering Byetta.

Cardinal cutting 1,300 jobs ahead of CareFusion spin-off

Falling sales to hospitals are forcing Cardinal Health to cut 1,300 jobs from the clinical and medical products units that it plans to float under the CareFusion banner later this year.

PTI leak tester can “save money” over dye ingress

PTI’s non-destructive micro leak tester can cut costs for companies using dye ingress, according to general manager Heinz Wolf, who demonstrated the technology to in-PharmaTechnologist at Interphex.

Bayer’s engineering affiliate opens up in India

Bayer Technology Services GmbH, an affiliate of Germany's Bayer, has opened its first regional office in India, enlarging its presence in the fast-growing Asian markets.

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Caraco recalls digoxin pills

US generic drugmaker Caraco Pharmaceutical Laboratories has recalled batches of its heart drug digoxin after tests revealed the tablets may vary in size and dosage.

ProMetic sees improvement despite economic climate

Protein technology and therapeutic specialist ProMetic managed to increase revenues in 2008, despite the challenging economic climate, but still posted a net loss of CN$20.2m (€12.1m).

ESS’ Taskmate adds robotics to tube filling and closing

ESS Technologies’ says its unique robotic loading system improves the speed, efficiency and accuracy of pharmaceutical manufacturers’ tube filling and closing operations.

Nanoparticles created to boost probucol solubility

Researchers have created nanoparticles to increase the solubility of probucol, a nearly insoluble drug used to reduce cholesterol, with a technique that could be used for other drugs.