Eli Lilly's once-daily version of its erectile dysfunction
treatment Cialis (tadalafil) has been granted approval by the
European Commission, giving it a head-start over other ED
treatments that are taken on an as-required basis.
Bioxel Pharma is the latest company to submit a Drug Master File
(DMF) to the US Food and Drug Administration (FDA) for docetaxel in
the lead up to the patent expiring on Sanofi-Aventis' version of
the cytotoxic chemical at the...
US biotech company Alexion has been given the green light by
European regulators to market its new orphan drug Soliris
(eculizumab) - the first therapy to be approved under the EU's new
fast-track review process.
A European regulatory committee has recommended the approval of
three generic versions of Johnson & Johnson's (J&J) anaemia
blockbuster Eprex in what could lead to the market launch of new
"biosimilars" by the...
Research into new tools that will remove the need to use animals in
medical research has received a £240,000 (€356,000) boost at the
University of Nottingham.
Roche has committed hundreds of millions of dollars to an
early-phase rheumatoid arthritis drug, a move that is indicative of
big pharma's increasing tendency to license earlier phase
compounds.
Microtest Laboratories and Texcel Medical have teamed up to offer
biopharma firms services to help them overcome the hurdles of
developing "combination products" - a fast-growing market.
An unusual drug that contains a crucial boron atom can effectively
treat fungal infections, and could also prove invaluable in the
effort to counter antibacterial drug resistance.
China's resolve to clean up corruption in its pharma industry has
intensified as the former assistant to the
already-condemned-to-death former drug chief has now been charged.
Genzyme has put pen to paper on a licensing deal for Ceregene's
Parkinson's drug, as a rival gene therapy for the same disease
shows promise in initial clinical trials.
In the latest episode of the Viracept contamination case, the drug
is now at risk of losing its marketing authorisation across Europe
while the dangers posed by the chemical contaminant are established
and manufacturer Roche rectifies...
Parexel talks to Outsourcing-Pharma about Phase I trials, touching
on trends and growth opportunities, future plans for India and
lessons learned from Tegenero.
US-microfluidics expert Fluidigm has launched a new dynamic array
for its BioMark instrument that increases the efficiency of PCR
(polymerase chain reaction) genotyping while reducing the amount of
costly equipment and reagents needed.
Thermo Fisher Scientific has opened a new RNAi Discovery and
Therapeutics Services Laboratory to help pharmaceutical companies
in their quest for new drugs.
Shire Pharmaceuticals has acquired exclusive development rights to
a new transdermal patch product for Attention-Deficit/Hyperactivity
Disorder (ADHD), adding a further novel product to its ADHD
portfolio.
The International Society for Pharmaceutical Engineering (ISPE) has
published its latest industry guide, a revised edition of its
manual providing industry guidance on facilities and production of
active pharmaceutical ingredients...
Finnish CRO Technical Research Center (VTT) has spun-off Zora
Biosciences, which becomes the only company in the Nordic region to
provide metabolomics services to pharma companies - a market with
high potential.
Novartis' has received US approval for its single-tablet
combination of the world's two most popular hypertension drugs,
taking advantage of rival patent expiries and shoring up its
portfolio.
At a time when single-use manufacturing equipment is riding on a
surge of popularity, in-PharmaTechnologist.com talks to Vijay Singh
of GE Healthcare's newly acquired Wave Biotech unit about the
impact disposables will have on...
The contract manufacturing business that Cardinal Health sold
earlier this year has just been launched as an independent
operating company rebranded as Catalent Pharma Solutions.
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.
A novel super adjuvant is to be put to the test as a new seasonal
flu vaccine enters Phase I trials, and is expected to offer
enhanced immunity and broader protection than other vaccines on the
market.
Patheon is teaming up with formulation development services firm
Senopsys to offer pharma companies combined services to test and
improve drug flavour.
With the world's largest medical study rolling out across the UK,
LabTechnologist.com explores the problems of biobanking with Dutch
biosample storage experts, Micronic.
Roche Diagnostics has strengthened its position in the genomics
field with the acquisition of DNA microarray expert NimbleGen in a
deal worth $272.5m (€203m).
In a bid to maintain its position in the human growth hormone (hGH)
market and offer new solutions to patients, Merck-Serono has teamed
up with a US firm to develop a novel growth hormone product that
could offer significant dosing...
Cosmo Pharmaceuticals is cementing its place in the inflammatory
bowel disease (IBD) drug market with eight new drugs in various
stages of reformulation using the company's cutting-edge MMX
technology, the company announced recently.
Dutch ingredients firm DSM has announced plans to carve out its
anti-infectives business and boost its presence in Asian markets
following a review of the active ingredient unit.
Researchers have developed a new way to deliver drugs into the
brains of mice, which could herald a new dawn for the sufferers of
brain diseases such as Alzheimer's.
US firm Aptuit has announced it will invest $100m (€75m) in
India-based Laurus Labs to form a new joint venture - just a few
months after splurging a similar amount to expand its capabilities.
In the inevitable reshuffle that comes after a major acquisition,
Bayer's healthcare division has today announced plans to cut 30 per
cent of its drug pipeline.
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.
LabTechnologist.com brings you a round up of some of the latest
product releases with new offerings from Agilent, Applied
Biosystems, ESA Biosciences, Illumina, Mettler-Toledo and Syrris.
US pulmonary drug delivery specialist Respirics has decided to sell
its assets relating to its MD Turbo product to focus on its
Acu-Breathe powder inhaler platform.
Following last year's contaminated glycerin poisonings in Panama
and last month's FDA guidance, US-PharmaTechnologist.com takes a
look at the implications of testing for the excipient glycerin in
the pharmaceutical supply...
GlaxoSmithKline's (GSK) new drug to treat a rare form of bleeding
disorder has shown good results in trials so far, but while experts
remain mystified as to why it works, a true cure will remain
elusive.
In a round-up of motley pharmaceutical services contracts,
Outsourcing-Pharma takes a look at recent news involving Movianto,
PDI, inVentiv Health and Exel.
Just over a week after Roche was forced to initiate a Europe-wide
recall of HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com
considers the contamination case and the pharmaceutical processes
blamed for the incident.
LabTechnologist.com brings you an exclusive interview with Chris
van Ingen - the president of Agilent's Life Science and Chemical
Analysis (LSCA) division.
Several major manufacturers have pledged millions of doses of H5N1
vaccine to go towards a global stockpiling scheme initiated by the
World Health Organization to protect against the threat of an avian
flu pandemic.