Parexel talks to Outsourcing-Pharma about its clinical research
experiences in emerging hot spot Latin America, as the contract
research organisation (CRO) has a presence in every country in this
continent that conducts international...
A novel antifungal treatment developed by French firm BioAlliance
has attracted a US partner, bringing $65m (€48m) to the company
only months after announcing a multi-million deal in Europe.
PharmaNet Development Group has reached a significant turning point
in its attempt to finally close the doors on a long period of
trouble with its Phase I clinical business.
Outsourcing-Pharma.com compiles the news that featured in the
clinical contract community this past week, involving Encorium,
Amarex, Paragon Biomedical, Pacific Biometrics and Parexel.
Sanofi-Aventis' hotly touted anti-obesity blockbuster drug has
become weighted down in safety concerns as the French company
withdraws its New Drug Application (NDA) in the US and awaits a
safety review in the EU.
India's Reliance Life Sciences (RLS) is planning an acquisition in
Europe or in the US joining the slow infiltration of Indian firms
cementing themselves in Western markets.
Six months after a couple of failed Phase III trials, Nuvelo has
reinstated clinical development for its blood clot dissolving drug,
but it will have to go it alone after Bayer decided enough is
enough and pulled out of the collaboration.
Pfizer has had its first day in a Nigerian court in a legal dispute
over its alleged involvement in the death of Nigerian children
during a clinical trial 11 years ago.
Parexel talks to Outsourcing-Pharma about Phase I trials, touching
on trends and growth opportunities, future plans for India and
lessons learned from Tegenero.
Despite a lift of the ban on biological sample transportation out
of Russia, the country's clinical research industry is still in the
dark on the new rules to control export of such materials.
Diamyd Medical will continue with a clinical trial of its gene
therapy designed to protect insulin-producing cells in diabetes
patients, despite major errors invalidating the study.
Critical Therapeutics is developing a new injectable formulation
for the treatment of asthma, and is the latest company to use
Captisol technology to achieve it.
Ipsen has cancelled its Phase III trial of its sustained-release
formulation of triptorelin while it attempts to fine-tune the
manufacturing process of the hormone therapy drug.
Amsterdam Molecular Therapeutics (AMT) lead candidate AMT 011, a
Lipoprotein Lipase (LPL) Deficiency treatment has received Orphan
Drug Designation from the US Food and Drug Administration (FDA).
A joint effort to develop a winning oral formulation for the
treatment of multiple sclerosis (MS) has taken another step towards
the finish line with initiation of Phase III trials for the novel
laquinimod compound.
Just as the clinical trials sector in Russia is
starting to take off, the industry has been dealt a severe
blow with the sudden and indefinite banning of biological sample
exports.
Bionovo, Somaxon Pharmaceuticals, Trius Therapeutics, Exelixis,
AmerisourceBergen Corporation and Kindred Healthcare have all had
people on the move in the world of pharmaceutical manufacturing.
Oxigene's potentially first-in-class cancer drug is showing
promising clinical results and could rival a drug Novartis'
recently spent nearly a billion dollars on.
Amgen will strengthen its drug portfolio aimed at fighting renal
disease after agreeing to acquire Ilypsa, a private biotechnology
company which is developing a novel drug for the treatment of
elevated blood phosphate (hyperphosphataemia)...
Veeda Clinical Research, an Anglo-Indian contract research
organisation (CRO) formed two years ago, said it will soon enter
the US market with a new acquisition - the fourth since the
company's creation.
Pfizer is facing fresh legal action from the Nigerian government
over its alleged involvement in the deaths of children it gave
an experimental drug to, more than a decade after the incident
occurred.
MDS Pharma has decided to continue the 'consolidation' of its
Canadian operations by putting an end to some activities at its
Montreal facility, cutting 160 jobs.
US-based contract research organisation (CRO) Covance is offering
microdosing studies for early clinical development without the
perceived drawbacks of having to radiolabel compounds for detection
through ultra-sensitive accelerator...
The first contract research service alliance (CROSA) in China has
been formed between three leading local firms to provide a more
exhaustive range of drug development services to pharma companies.
Bosch Packaging Technology has launched the FLT1020 vial filling
system, a scaled-down version of full-sized filling units that is
geared specifically to use in the early stages of clinical trials.
US company Alnylam Pharmaceuticals has consolidated its
relationship with researchers from the Massachusetts Institute of
Technology (MIT) by signing an agreement to sponsor a five-year
program at the Institute's Center for Cancer...
Clinsys Clinical Research, BioReliance Corporation, InVentiv
Health, PRA International, Kendle, Parexel, PPD, Wyeth and
PharmaNet have all had people on the move in the world of
pharmaceutical outsourcing.
The race to put the first cancer therapy based on RNA interference
(RNAi) technology into clinical trials has heated up with one
developer claiming it is almost ready to go.
US-base firm Quest Pharmaceutical Services (QPS) has announced that
its Taiwan testing facility can now provide bioanalytical services
managed directly from the US.
Outsourced pharmaceutical R&D spending is set to increase
at twice the expected rate of general R&D expenditure
for the next five years, according to new research published this
week.
The pharma industry sees great opportunities in using Radio
Frequency Identification (RFID) technology during clinical trials,
a new survey has revealed.
Clinical trial sponsors are outsourcing the majority of clinical
work in Phase I and gradually bringing functions back in-house as
compounds move through the development stages.
Contract research organisation (CRO) Chiltern has announced it is
expanding its services with a new solution aimed at helping clients
boost their clinical research staff recruitment process - an
increasingly difficult task due to...
Novartis has licensed a potential first-in-class vascular
disrupting agent from Antisoma in a deal worth up to $890m (€656m),
highlighting the company's increasing focus on the oncology market.