Breaking News on Contract Research, Manufacturing & Clinical Trials

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.

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.

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.

Contract manufacturing news in brief

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

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.

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.

Sanofi expands flu vaccines in China

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

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.

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.

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.

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.

FMC improves on existing excipients

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

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.

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.

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.

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.

United Drug goes shopping again

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

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.

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.

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.

NeoMPS gets acquired

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

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.

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.

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.

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.

Celesio sees profits drag

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

AMRI continues growth

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

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.

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.

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.

eClinical news in Brief

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

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.

PharmEng opens new Canada plant

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

'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.

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.

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.

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.

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).

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.

Charles River sails through Q3

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

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.

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.

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.

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.

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.

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.

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.

Parexel profits perky in Q1

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