Breaking News on Pharmaceutical Technology

Pall’s Lego-like Stax system attracts biotechs

Pall’s Stax single-use depth filter attracted interest from a “number of biotechnology companies” at Interphex, according to director of marketing Ian Sellick who explained how the system can save space, time and money.

SDTech and Malvern team up on process optimisation

Custom micronisation and milling firm SDTech has bolted on particle size analysis to its suite of drug industry offerings through a new collaboration with UK analysis specialist Malvern Instruments.

Deal bags Flugen a vaccine delivery micro-device

Flugen has secured the exclusive rights to Ratio’s novel vaccine delivery technology, which is a disposable micro-device that it claims can improve efficacy and compliance.

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Winpak wins Reynolds’ Packaging license race

Canada’s Winpak has gained an exclusive license to use Reynolds Packaging’s manufacturing know-how in the production of packaging for the drug and healthcare industries.

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Lundbeck rumours boost Elan’s share price

Speculation that drugmaker Elan is a takeover target for Denmark’s Lundbeck boosted the Irish drugmakers share price 11 per cent on Friday last week.

Target’s packaging failed to increase compliance; study

A US pharmacy’s attempt to implement simpler packaging that clearly communicates information to patients has failed to improve compliance, according to a study.

SAFC’s Kansas culture site goes animal component-free

Operations at SAFC Biosciences’ facility in Kansas, US have been made animal component-free (ACF) under a division-wide strategy to keep pace with customer demands and changing regulations.

Indian plants offer new source for Tamiflu precursor

Researchers believe they have found “more promising” sources of shikimic acid, a precursor in the production of Tamiflu, shortages of which have previously caused bottlenecks in producing the bird flu vaccine.

Flexibility is key for processing sector says Millipore

Flexibility is going to be a key driver for the pharmaceutical market in the next few years, according to Millipore's VP of downstream processing Paul Chapman.

Grassley and Torti face-off over whistleblowers

Senator Grassley has raised concerns that an email by acting Commissioner Torti to FDA employees could be viewed as an attempt to suppress whistleblowers following recent releases of internal agency documents.

Global Federation will “speak as one”, says IPEC Europe chair

The International Pharmaceutical Excipient Council (IPEC) has unveiled plans to set up a worldwide Federation later this year to address the increasingly global excipient supply chain.

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Novartis bids for greater share of Indian subsidiary

Novartis is looking to buy an additional 39 per cent of its majority-owned subsidiary Novartis India for around 4.4bn rupees ($87m), or 351 rupees per share.

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Merck ramps up biologics spending in Ireland

Merck & Co is investing an additional €20m ($27m) in its biologics plant in Carlow, Ireland just weeks after it unveiled plans to create a “powerful biologics presence” through its $41bn move for fellow US drug giant Schering-Plough.

Pharma mega mergers a boon for Patheon's restructuring service, says CEO

The global economic downturn, impending blockbuster patent expiries and the wave of consolidation sweeping the pharmaceutical industry will drive demand for Patheon’s restructuring service according to CEO Wesley Wheeler.

GSK may move for Botox maker Allergan

The pharmaceutical rumour mill is still spinning with the latest speculation that UK drug major GSK is interested in Botox manufacturer Allergan causing the US firm’s share price to leap 13 per cent on the New York Stock Exchange.

Hospira’s “Project Fuel” will cut 1,400 jobs

US drug delivery specialist Hospira will reduce its workforce by around 10 per cent, or 1,400 employees, over the next 24 months as part of its $140m (€104m) a year “Project Fuel” cost cutting and efficiency drive.

Snapshot of technologies at Interphex 2009

St Patrick’s Day celebrations weren’t the only thing bringing people together in New York last week as the pharmaceutical manufacturing and outsourcing industries gathered at the Jacob K Javits convention centre for Interphex 2009.

Vetter launches VPI subsidiary

Vetter Pharma-Fertigung (VPF), a specialist provider of pre-filled injection systems, has formed a new subsidiary, Vetter Pharma International (VPI) to take charge of sales, marketing and customer services.

MDRNA signs deal with second Swiss major

US RNA interference (RNAi) specialist MDRNA has signed a non-exclusive licensing deal granting Swiss drug giant Novartis access to its liposomal siRNA delivery technology platform.

Watson recalls batch oversized arrhythmia drug

Watson Pharmaceuticals has voluntarily withdrawn one lot of its arrhythmia drug propafenone HCl in the US after the tablets were found to contain slightly higher levels of the drug’s API.

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UK and Australia clear Ranbaxy’s Paonta Sahib plant

Regulators in the UK and Australia have issued GMP certificates for Ranbaxy Laboratories' Paonta Sahib plant after a joint inspection deemed manufacturing practices were up to code.

HP claims it can cut costs for 80% flexo printing

Hewlett-Packard has made its high-volume digital press commercially available, which it claims can cut waste, warehousing and environmental impact compared to analogue printing.

Inhaled insulin from conception to...success?

With MannKind approaching US regulatory filing for Afresa in-PharmaTechnologist presents its exclusive interactive timeline spanning the rise, fall and possible resurrection of inhaled insulin treatments, covering Pfizer’s Exubera and all the other potential blockbusters that failed.

Packaging feeling effects of downturn, says Alcan pharmaceutical packaging president

Michael Schmitt, president of Alcan Global Pharmaceutical Packaging, believes a recovery in the global economy, the increasing demand for quality and the emergence of markets like India and Brazil will be key drivers for the packaging sector over the next few years.

Schering pays $165m to settle GMP allegations

Schering-Plough has agreed to pay $165m to settle a class action lawsuit that claims the company’s failure to disclose manufacturing deficiencies defrauded investors.

Catalent closing site in re-jigging of US ops

Catalent is adjusting its packaging operations by closing one facility and simultaneously expanding another, which it believes will improve the service offered to its folding carton customers.

Skin care firm Stiefel considers $4bn sale

Dermatology drug specialist Stiefel Laboratories may be looking for a Big Pharma buyer according to various media reports.

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PLF International appoints new sales director

PLF International has appointed a new sales director to drive organic growth and take the packaging machinery firm into new market sectors.

pH sensor could be boon for bio

Sensorin has used Interphex 2009 to preview its self-calibrating pH measurement system, which it claims is the first of its kind and will help maximise yield in downstream purification processes.

Real-time analysis of tablet surfaces

UK company Paraytec has introduced a new instrument designed to allow formulation scientists to visualise – in real time – what is happening at a tablet surface when it dissolves.

Braille standard drawn up for US pharma packaging

A US trade organisation has drawn up its own set of standards for Braille on pharmaceutical packaging in the absence of any legislative decision by the US.

SCS welcomes StemCells deal in light of US rule change

Alastair Riddell, CEO of UK firm Stem Cell Sciences (SCS), says the US governments’ reversal of the ban on federally funded stem cell research “opens up a market that was inhibited, restrained and impeded under the Bush administration.”

Pharmacopoeias diverging on heavy metals testing?

The three main international pharmacopoeias in the US, Europe and Japan are experiencing a difference of opinion on the tricky topic of testing pharmaceutical ingredients for heavy metals.

FDA raises standards for import testing labs

The safety of drugs imported into the US remains high on the FDA’s agenda, with the agency publishing new draft guidance that raises standards for labs inspecting products made overseas.

Actavis moves towards Japanese generics market

Actavis’ JV with Japan’s Aska Pharmaceuticals opens up the non-branded sector of the world’s second largest drug market

Meet our team at Interphex 2009

Planning to visit Interphex 2009 at the Jacob Javits Convention Center in New York City? Then why not visit our Booth 731 in Exhibition Hall D?

IPECs may emerge in Latin America, India

The International Pharmaceutical Excipients Council (IPEC) – currently represented by divisions in Europe, the Americas, Japan and China – could see sister organisations open up in Latin America and India in the coming months.

Falling biopharma sales hurt Pall’s Q2; but Asia shows promise

Pall CEO Eric Krasnoff says delayed drug industry capital expenditure and moves to conserve inventory in the current global gloom caused life science sales to fall 8 per cent for the second quarter.

Cel-Sci’s contract cold filling process could improve biologics

US Biotechnology firm Cel-Sci has unveiled a new manufacturing process, cold 4°C Aseptic Filling, that it claims can improve the shelf-life and potency of biologic drugs produced using stem cells.

Second lyophilizer goes online at Formatech in Andover

US CMO Formatech has brought a new Virtis Benchmark 3000 luophilizer into service at its manufacturing facility in Andover, Massachusetts, boosting capacity by 13,000 vials per production run.

Roche closes manufacturing site and heads out west

Roche is closing its manufacturing facility in Nutley, New Jersey and relocating its centre of commercial operations in the US to California following its $46.8bn (€36.3bn) takeover of Genentech.

Pfizer and GSK may feel impact of Wyeth vs. Levine ruling

Drug giants Pfizer and GSK may be among the first affected by last week’s US Supreme Court ruling upholding a product liability lawsuit against Wyeth despite FDA approved labelling.

Bill could cripple FDA and harm patients; PhRMA

The backlash against the re-importation bill has begun, with PhRMA warning that the legislation could cripple the FDA’s ability to protect patients and open the door to counterfeits.

Driam launches cycled continuous tablet coating system

German coating technology specialist Driam hopes its new Driaconti-T continuous tablet coating platform will win over manufacturers wishing to improve process efficiency in times of economic gloom.

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Roche and Genentech reach agreement on $47bn deal

After eight months of negotiations Roche and Genentech have reached an agreement, with the Swiss pharma buying out the US biotech for $46.8bn (€36.6bn).

Genzyme accused of cGMP deficiencies by FDA

The FDA has found “significant objectionable conditions” at the Genzyme manufacturing facility that makes Lumizyme, creating another issue in the product’s approval process.

Re-importation bill would punish big pharma’s actions; Dorgan

Following the proposal of his bill re-importation bill Senator Byron Dorgan has accused some of big pharma of taking actions that would be illegal under the Act and outlined the punishments they could face.

Obama overturns stem cell research funding ban

The US green light for federally funded embryonic stem cell research is being hailed as a victory by the US drug industry, which predicts it will open the flood gates for novel medications and help revitalise the sector.

MannKind picks up the pieces of Pfizer’s failure

MannKind is trying to buy a Pfizer insulin facility for $33m (€26m) as it continues to push Afresa towards commercialisation but, like many things in the saga, the deal might not be straightforward.

Merck moves for Schering in $41bn mega-merger

The year of the mega-merger continues with Merck & Co’s move to buy Schering-Plough for $41.1bn, with the intention of boosting its pipeline, entering new markets and creating a “powerful biologics presence”.

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AMPAC site boosts continuous process capacity

AMPAC Fine Chemicals has inaugurated its kilogram scale current good manufacturing practice (cGMP) compliant facility, which can handle batch or continuous processing.

Tabletting delay caused lethal allopurinol contamination, say HK chiefs

Macao Health Bureau director Lam Ping-yan says tabletting delays at Euopharm Laboratories' plant in Hong Kong, China may have led to contamination of the hyperuricemia drug Purinol (allopurinol) linked to several deaths.

Roche raises Genentech bid to $45.7bn

Roche has upped its offer for Genentech to $93 a share, believing that this will be sufficient to bring the drawn out takeover to a close.

US approvals provide some respite for Ranbaxy

Two approvals in a week for drugs made at Ranbaxy’s New Jersey OHM Laboratories subsidiary have eased the generics firm’s North American regulatory woes and strengthened its position in the expanding US market.

SkyePharma mulls 30% cuts at Lyon Geomatrix plant

UK drugmaker SkyePharma may reduce the workforce at its production plant in Lyon, France by a third after “long-running” underutilisation of its manufacturing capacity.

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Merck & Co to pay $41bn for Schering Plough

Merck & Co is to buy fellow US drug major Schering Plough for $41bn (€32.6bn) to boost its pipeline in the face of impending patent expiry for key products.

Acusphere slashes staff as funding flounders

Acusphere has laid off two thirds off its staff, with manufacturing employees among the affected, and closed its headquarters, citing financing difficulties as the cause of the cutbacks.

C&QP partners to launch Evolution of GMP services

Evolution is collaborating with C&QP to offer a more comprehensive range of GMP services to clients, covering plant and equipment qualification, calibration and maintenance.

Wyeth’s appeal failure could impact US drug labelling

Yesterday’s US Supreme Court decision upholding a $7m damages award to a Vermont woman who sued Wyeth means that drugmakers are still vulnerable to State consumer liability lawsuits despite FDA approval for a drug and its labelling.

Piramal won’t “dilute ownership,” or comment on Sanofi rumours

Indian generics firm Piramal Healthcare says it "has no intention to dilute current ownership levels," but has not commented on rumours that it is in talks with French firm Sanofi Aventis.

FDA pushes graphics on product labels

Use of graphs and tables depicting pharmacokinetic attributes is among the recommendations made in the FDA’s latest guidance on clinical pharmacology labelling of prescription drugs.

Genentech to Roche: We’re equipped for hard times

Genentech believes a far-sighted approach to patent expiration, unique and life saving drugs and an unrivalled scientific culture will protect it from recession and ensure greater growth than Roche envisions.

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FDA inflicts another setback on Genzyme’s Lumizyme

The version of Genzyme’s treatment for Pompe disease manufactured in 2000L bioreactors, Lumizyme, has suffered a further delay, with the FDA calling for more information.

"Anywhere, anytime" – Genentech challenges Roche

Genentech used its investor meeting to retaliate against criticisms made by Roche, saying it will debate its financial model “anywhere, anytime with anyone”.

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Dr Reddy’s targets US in downturn

Indian generics firm Dr Reddy’s plans to focus on the US, the world’s biggest drug market, and cut back in other regions to help it weather the global economic storm.

ESS' Monoblock sets big record for small bottles

ESS Technologies has extended the range of its Monoblock platform with a new bottle feeder capable of accurately filling and capping up to 120 small pharmaceutical liquid bottles a minute.

Sinovac’s fill and pack plant gets SFDA GMP nod

Sinovac’s recently opened vaccine filling and packaging facility in Beijing, China has received SFDA GMP certification, which the firm says will increase production capacity to around 40m doses a year.

Symetix launches compact eagle-eyed tablet QC system

Symetix has launched a compact high-volume optical inspection system that is capable of verifying the colour, size and shape of capsules and tablets and removing defective products.

“Untrue data” from Ranbaxy plant news to Daiichi

Daiichi Sankyo, the Japanese drug firm that bought a controlling stake in India’s Ranbaxy last year, says it had no knowledge of FDA concerns that led to a block on ANDA reviews for drugs made at the latter’s Paonta Sahib facility.

Elan cuts jobs, shelves biofacility

Faced with a tougher operating environment, Irish drugmaker Elan has decided to slash staff numbers by 230 – or around 14 per cent of its total workforce – shelve the construction of a new biologics manufacturing facility and shutter fill-and-finish capacity in Ireland.

ISO 15378:2006 award is competitive advantage for French plants, says Alcan

Three plants owned by contract packaging maker Alcan have been cleared to produce containers for pharmaceutical products under the International Organization for Standardization’s ISO 15378:2006 guidelines.

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Obama names Kathleen Sebelius as choice for HHS

President Barrack Obama has named Kansas Govoner Kathleen Sebelius as his choice for US Department of Health and Human Services (HHS) secretary.