Breaking News on Contract Research, Manufacturing & Clinical Trials

Headlines > November 2007

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30-Nov-2007

OctoPlus feels the market pressure

Dutch drug delivery and development company OctoPlus is withdrawing its follow-on financing on its five-strong product portfolio in response to the US mortgage crisis and the struggling stock market.

Jubilant Organosys eyeing up European acquisitions

Indian pharma services provider Jubilant Organosys is looking to buy up European contract research organisations (CRO) and contract research and manufacturing services (CRAMS) and it has got $100m to spend, according to a report in The Economic Times.

27-Nov-2007

Akorn and Cipla team up again

Specialty pharmaceutical company Akorn has signed up with India-based Cipla in an exclusive manufacturing and supply agreement for an undisclosed inhaled drug.

Contract manufacturing news in brief

Dr Reddy's, China Aoxing Pharmaceutical, Cook Pharmica and Alpha Biologics have all recently announced contract manufacturing news.

Xenome and Amylin team up to poison metabolic diseases

Xenome, which specialises in extracting therapeutic peptides from the venom of poisonous animals has penned a deal with Amylin Pharmaceuticals to find drugs that tackle metabolic diseases such as diabetes and obesity.

PolyTherics gets funding for antibody fragments

PolyTherics has been boosted with £350,000 ($723,135) in funding to explore the development and production of long-lasting therapeutic antibody fragments.

Private equity firm puts crores into Indian CRO

GVK Bio has reinforced its claim to be India's top contract research organisation with a 100-crore ($25m) push from a private investment company. The funds will be used to expand its drug discovery services and push further into preclinical and clinical development.

Astellas snaps up cancer antibody specialists Agensys

Japanese drugmaker Astellas has agreed to acquire US biotech firm Agensys as part of its plan to ramp up antibody research, especially in the field of cancer.

26-Nov-2007

Sanofi expands flu vaccines in China

Sanofi-Aventis is to build a new influenza vaccine manufacturing facility in China.

Singapore's pharma output continues to slow

Singapore's biomedical manufacturing output was down again over October, stunting growth for the region's entire manufacturing sector.

Preclinical services news in brief

In this week's review of activity within the preclinical research services arena, news has emerged involving ChemDiv, SRI International, ShangPharma, Ranbaxy and Xceleron.

Targeted Genetics restarts trial after death

The US Food and Drug Administration has allowed Targeted Genetics to restart testing its arthritis gene therapy after deciding the drug wasn't at fault when one person died in the original clinical trial.

23-Nov-2007

Pharma should keep outsourcing in mind

The pharmaceutical industry is backward when it comes to outsourcing, industry experts said at the American Association of Pharmaceutical Scientists (AAPS) conference in San Diego last week.

22-Nov-2007

Merck, Vertex halt aurora kinase cancer trial

Merck & Co. and its partner Vertex Pharmaceuticals have stopped enrolling cancer patients to the clinical trial of its aurora kinase trial after one patient suffered heart problems.

Boehringer Ingelheim takes on prefilled syringes

Boehringer Ingelheim has added to its contract services with the manufacture, fill and finish capacity for drugs in prefilled syringes.

Recipharm rescues Ashton Pharma

Recipharm has come to rescue of UK-based Ashton Pharma, which has been nervously awaiting to discover its fate, having spent five months in administration after its former owners Inyx Inc. suffered major financial woes.

FMC improves on existing excipients

FMC BioPolymer has introduced two new excipient products to the pharma market - the first in two years.

Take off immune system brake to improve cancer vaccines

The discovery of a new molecule that can act as a brake for the immune system could lead to new therapies for cancer and autoimmune diseases such as diabetes.

Drugs moving into the clinic: 36

The latest in a series of periodic roundups of drugs that have moved from preclinical research into clinical testing via the announcement of a Phase I trial or an application for a trial to industry regulators.

New research offers CRO market snapshot

New research from Frost & Sullivan provides a snapshot of biopharma spending trends on contract research organisations (CROs), along with forecasts for industry growth.

21-Nov-2007

Weekly Comment

No embryo required: human stem cells from the skin

A startling breakthrough has allowed scientists to create human stem cells from just reprogrammed skin cells, with no embryo and thus, perhaps no ethical dilemma.

Covance rescues Eli Lilly's forgotten facility

Covance has acquired a partially constructed facility from Eli Lilly and plans to invest $175m (€118m) to convert it into a drug development laboratory to meet demand from its biopharmaceutical customers.

Puerto Rico's problems piling up

Pfizer's revelation this week that it plans to slice jobs in Puerto Rico is the latest in a string of blows for this popular offshore manufacturing location.

Evolution study finds 300 new genes

A supercomputer designed to root out genes that have been conserved over millions of years of evolution has discovered 300 new human genes.

20-Nov-2007

Weekly Comment

South Africa 'underutilised' for clinical trials

While India, the Asia-Pacific, Eastern Europe and Latin America are all gaining recognition as potential new hot spots, South Africa remains 'underutilised as a clinical trial destination,' according to a prominent industry figure.

Simultaneous measurement of multiple cytokines

Researchers at Randox, UK, have developed a biochip that enables the simultaneous measurement of 12 human cytokines from human serum samples enabling cytokine studies to be conducted faster.

Merck turns to India for latest R&D partnership

Merck & Co. has turned to India's Nicholas Piramal (NPIL) for its latest research collaboration, as the preclinical offshoring trend persists.

Blast at Aesica London plant

Contract manufacturer Aesica has confirmed reports of a blast at its Ponders End facility in North London last night, hospitalising three workers.

United Drug goes shopping again

United Drug has continued this year's shopping spree, snapping up a UK pharmaceutical conference services firm.

CML snaps up API services firm

Cambridge Major Laboratories (CML) has bought up a Dutch supplier of active pharmaceutical ingredient (API) development services, creating one of the largest pharma chemistry development organisations in the western hemisphere.

Cystatin C can wash away Alzheimer's plaques

Scientists have discovered that a protein called cystatin C can prevent damaging Alzheimer's plaques from forming by keeping their constituent protein water soluble.

Pharmaceutical outsourcing: people on the move

AstraZeneca, Encorium, Icon and Eden Biodesign have all had people on the move in the world of pharmaceutical outsourcing.

Cancer antibody marches on quoths Raven Biotechnologies

Raven Biotechnologies have announced positive initial clinical trial results for their anticancer antibody that causes tumour cells to swell up and die.

19-Nov-2007

APIcross goes solo in drug delivery

Contract pharmaceutical development company Azopharma has carved out its drug delivery segment into a new company, APIcross Drug Delivery Technologies.

Russia's clinical biz showing signs of recovery after biologics ban

Russia's clinical trials industry appears to be making a gradual recovery from a setback earlier this year when the government imposed an unexpected ban on biologic exports.

NeoMPS gets acquired

PolyPeptide Laboratories Group is to acquire the peptide manufacturing group NeoMPS.

J&J Belgium suffers strike over job cuts

Workers at Johnson & Johnson's (J&J's) Belgium subsidiary went on strike today in protest at the compensation being offered to those at the firm falling foul of the dreaded pharma axe.

Pipeline match following Celgene's $2.9bn acquisition of Pharmion

Celgene has agreed to pay $2.9bn for Pharmion in the hope of becoming a 'global leader in the haematology and oncology field', but do the company's pipelines match up well together?

Caliper launches combo drug testing services

Caliper Life Sciences has launched new testing services that will help researchers weed out unsuitable combination drug therapies in the preclinic.

15-Nov-2007

Celesio sees profits drag

Celesio fingerpointed two 'extraordinary items' in its dominant Wholesale division for the drag on company profits during the third quarter.

Targeted lupus treatment on the horizon

Researchers have uncovered some of the underlying causes of lupus, and have even suggested certain targeted therapies to tackle the autoimmune disease.

Drugs moving into the clinic: 35

The latest in a series of periodic roundups of drugs that have moved from preclinical research into clinical testing via the announcement of a Phase I trial or an application for a trial to industry regulators.

PRA's profits will soon be private

PRA International continues to see its profits ebb away but will soon face less financial scrutiny as it nears a handover of ownership into private hands.

Extra breathing space for epinephrine MDI ban

The US Food and Drug Administration (FDA) has given stakeholders an extra month to get their views in on scrapping epinephrine inhalers containing CFCs.

Preclinical services news in brief

In this week's review of activity within the preclinical research services arena, news has emerged involving GATC Biotech, NextGen Sciences and Genedata.

Icahn invests in Genzyme, prompts takeover rumours

The man often credited with causing Biogen Idec to be put up for sale, billionaire corporate raider Carl Icahn, has invested in Genzyme and promptly started industry tongues wagging about a takeover.

AMRI continues growth

Albany Molecular Research Inc (AMRI) recently turned in Q3 results, posting figures buoyed by continued demand for its pharmaceutical development services.

14-Nov-2007

Evotec's metamorphosis erodes profit

Evotec's bid to distance itself from being a services business and eventually morph into a fully fledged pharma company has been felt on the company's balance sheet during the third quarter.

Pfizer, Nektar agreement not so sweet after all?

Pfizer yesterday announced a multi-million dollar pay-off to ex-partner Nektar Therapeutics, but the details of the deal reveal not only Nektar's concerns for its future, but also that Pfizer is still keeping its fingers in the Exubera pie.

Accelrys offers academics its scientific operating system for free

Accelrys is offering its SciTegic scientific operating system to academics for free to enable them to create software applications and share them with both academic and commercial communities.

Ventana reluctantly opens up to Roche in a bid to boost offer

In the latest twist in Roche's fight to acquire diagnostics expert Ventana, the companies have signed a confidentiality agreement that will enable the pharma giant access to Ventana's books.

eClinical news in Brief

Outsourcing-Pharma tracks the latest eClinical movements, featuring Phase Forward, Nextrials, Octagon and Omnicare.

BioCryst clinical trials debacle highlights protocol perils

BioCryst's recent clinical trials debacle highlights the importance of the robust and realistic design of, and careful adherence to, a drug trial protocol.

13-Nov-2007

PharmEng opens new Canada plant

Canadian contract manufacturer PharmEng recently announced that its new specialised manufacturing facility in Nova Scotia is open for business.

China gets serious on drug GMP; safety pact with FDA imminent

As of next year Chinese pharmaceutical manufacturers will face a tougher time gaining good manufacturing practice (GMP) certification after the country's regulator signalled new and stricter standards were on the way.

NPIL to trim ex-Pfizer site

NPIL Pharma last week told workers at its former Pfizer plant in Morpeth, UK that the company is considering hiving off jobs in a bid to maintain the site's viability.

AstraZeneca in 'serious trouble', say analysts

An analyst report released yesterday identified AstraZeneca as being in 'serious trouble' and branded it as potentially the 'worst [large cap] performer in [the] entire sector' over the next eight years.

Giving lung cancer a Smac

A small molecule version of a protein called Smac can turn the survival signal for a variety of tumour cells into a death signal and could be effective as a new class of drug, especially for lung cancer patients.

12-Nov-2007

New drug safety model unveiled as Merck shells out for Vioxx

A new 3D model of the human liver that even has its own blood supply could pump new life into drug safety tests by predicting problems earlier and cut down on animal experiments.

WHO talks on research strategy for developing world diseases stall

Talks between World Health Organization (WHO) member states and the drug industry over how to narrow the health gap between rich and poor countries have stalled.

China CRO attracts $30m US investment

China's second largest contract research organisation (CRO) ShangPharma has attracted $30m (€21m) from US private investment firm TPG as the Asian pharma market continues to simmer.

Tripos lands Schering-Plough deal

Tripos Discovery Research (TDR) has risen from the ashes surrounding the liquidation of its previous owners Tripos, Inc. to land a 'library enrichment' deal with Schering-Plough.

AstraZeneca axes packaging plant

AstraZeneca's axe has made its latest appearance in South Africa, with the sale of a packaging plant and the formation of an outsourcing deal with its new owners.

Synexus agrees to private sale

Management of publicly-traded Synexus have agreed to the £18.1m (€25.7m) sale of the company to a private equity firm that has promised to fund its global expansion ventures.

Hefty price hike for BASF excipients

German chemicals firm BASF has announced a major price hike across its range of pharmaceutical excipients, upping price tags by as much as 9 per cent.

09-Nov-2007

Wacker expands further into biologics

Biopharmaceutical contract manufacturer Wacker will be expanding its German facility in Jena for €15m ($22m) as it meets demand for biologics.

08-Nov-2007

Good news follows bad news for InVentiv

After losing a key Novartis contract and getting caught up in the Inyx collapse, Inventiv Health had good news this week when it reported its third quarter results.

Drugs moving into the clinic: 34

The latest in a series of periodic roundups of drugs that have moved from preclinical research into clinical testing via the announcement of a Phase I trial or an application for a trial to industry regulators.

Pharmaceutical outsourcing: people on the move

INC Research, Quintiles, Bridge Pharmaceuticals, Charles River Laboratories and PharmaNet have all had people on the move in the world of pharmaceutical outsourcing.

'World's first' NanoImaging service centre opens

NanoImaging Services has opened what it claims is a first of its kind fee-for-service imaging business to enable structural characterisation and validation of biological drugs throughout the development pipeline.

Merck HIV vaccine failure puts cold virus on trial

Merck & Co's failed HIV vaccine may actually increase the risk of infection and the latest data raises questions over whether the cold virus used as a delivery technique was at fault.

West unscathed by Exubera shot - for now

West Pharmaceutical Services, one of the two firms responsible for manufacturing Pfizer's failed Exubera device, recently turned in its third quarter financials, so far avoiding any major dent from the company's decision to drop the inhalable insulin product.

CROs link arms to spread reach

This week two sets of contract research organisations (CROs) have announced plans to link arms in order to spread their reach further into this increasingly globalised marketplace.

Aveo strategy ups chances of cancer drug success

US-based Aveo Biopharmaceuticals is hoping to prove its R&D strategy can buck high industry failure rates when trying to design new cancer drugs and it seems to be working after its lead drug has passed a first-in-man trial with flying colours.

07-Nov-2007

DSM third quarter results

DSM's third quarter financial results are paving the way for the company's transition to a life sciences and material sciences company.

New firm to tackle poor solubility head on

A new Belgian company has joined the throng of pharmas tapping into the booming drug delivery business, but claims that its unique technologies will carve it a place as one of the industry's key players.

Merck flexes muscle with GTx deal

Merck & Co has inked a deal potentially worth over $507m (€346m) with GTx over a new class of drugs to treat muscle loss conditions, especially those caused by cancer.

New counterfeit report highlights worrying trends

A new report highlights a number of worrying trends emerging in regard to the increasing number of fake pharmaceuticals infiltrating supply chains around the globe.

Preclinical services news in brief

In this week's review of activity within the preclinical research services arena, new deals have emerged involving MDS Pharma Services, Bruker Biospin and Expression Analysis.

PharmaNet makes a Q3 comeback

PharmaNet has made a strong comeback during its third quarter after previously slipping into the red and recorded its highest revenue to date - $99.8m (€70.0m).

AstraZeneca CEO hacks at pipeline to up profits

AstraZeneca's CEO has said the company will stop research in a number of diseases as it continues to cut costs and restructure in the face of falling sales.

06-Nov-2007

Contract manufacturing news in brief

Bioserv Corporation, Mikart, Laureate Pharma, Cenexi and Lonza have all recently announced new contract manufacturing news.

Icon improves its position, Kendle slips again

Icon has improved its financial position significantly during its third quarter, while its smaller US rival Kendle saw its profit slip again, weighed down by charges from a 2006 acquisition.

Why Pfizer's torcetrapib failure might not thwart other CETP inhibitors

It was supposed to keep Pfizer at the top of the cardiovascular drug tree, but when torcetrapib failed, other pharma firms developing similar drugs looked on nervously to see if their drugs were also doomed. A new study suggests they might have nothing to worry about.

Apitope vaccine stops MS in its tracks

UK biopharmaceutical firm Apitope has developed a vaccine that could halt multiple sclerosis in its relentless march to destroy nerve cells.

Charles River sails through Q3

Charles River Laboratories sailed through its third quarter, with comfortable gains in both revenue and profits.

05-Nov-2007

Weekly Comment

FDA failure on foreign inspections frightening

A US government audit has confirmed the Food and Drug Administration's (FDA's) continual lack of inspection of foreign drug manufacturing plants.

Japan's Tamiflu supply halved

Japan will only be receiving 50 per cent of its usual supply of the blockbuster flu drug Tamiflu (oseltamivir) this year, thanks to significantly reduced demand following reports of suicidal behaviour in adolescents taking the medication.

Pretender to Avastin throne poised to enter clinical trails

BioInvent and ThromboGenics' new anticancer antibody is poised to enter clinical trials and could prove a serious rival to VEGF-blocking drugs, due to fewer side-effects and less drug resistance.

Quintiles makes Panama purchase

Quintiles has bought a contract research organisation (CRO) in Central America to extend its reach in this emerging clinical trials region.

Sigma-Aldrich halves miRNA preparation times

Sigma-Aldrich has continued its push into the RNAi field with the launch of its new mirPremier miRNA (microRNA) isolation kit that promises to speed up miRNA preparation while removing all large, unwanted RNA.

EU considers Afghan poppy pilot

A proposed pilot programme to divert Afghanistan's infamous and illegal opium supply for legal use in analgesics has been backed by the European Parliament but is facing fierce criticism elsewhere.

Mixed results dampen expectations for Eli Lilly's prasugrel

When it comes to choosing between anti-blood clot medicines, clinicians could be stuck between a rock and a hard place following mixed trial results for Eli Lilly's prasugrel.

01-Nov-2007

Treating cancer as infectious disease yields results

For the first time, scientists have found a way to target viral antigens deep inside a cancer tumour, and the result is a new therapy that could treat or even prevent the disease.

GSK blocks new patent rules

Just a day before they were due to come into force, GlaxoSmithKline has won a court case to block controversial changes to patent rules.

Parexel profits perky in Q1

Parexel has seen its profits remain perky during its first financial quarter of 2008.

Clinical contract news in brief

Outsourcing-Pharma.com compiles the news that featured in the clinical contract community of late, involving PPD, Novotech and Generex.

UK updates clinical trial negotiation system to include CROs

An update to the contract negotiation system for hospital-based clinical trials has come into play in the UK - in a further effort to take some of the pain out of the process and speed up trial start-up times.

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