A new generation of therapeutic protein products has entered the
biopharma scene and are proving more efficient than antibodies when
using the same drug delivery systems.
Indian pharmaceutical manufacturing company Shasun Chemicals and
Drugs has now got its eye fully on the US market after recent
approval of its new formulation facility in Puducherry.
AstraZeneca is planning to gradually withdraw from making its own
active pharmaceutical ingredients (APIs) and will use China as the
pinnacle of its new outsourcing plans.
Australia is soon to boast the largest monoclonal antibody
production facility in the Southern Hemisphere, which will go some
way in alleviating the increasing demand for the biologic agents.
One of the most significant deals to take place in the vaccine
industry in the last ten years was signed late last night between
vaccine heavyweight Novartis and biotech firm Intercell.
A new and improved extended-release treatment for schizophrenia has
been granted marketing authorisation by the European
Commission. Invega (paliperidone) is a once-daily formulation
that will be marketed by J&J subsidiary, Janssen-Cilag.
Aptuit Laurus, the newly formed joint venture between Aptuit and
Laurus Labs in India, will focus on an expected rise in the demand
for preclinical and Phase I research and development services as
part of its growth plan in India.
Procter & Gamble (P&G) has announced its intention to
outsource the active pharmaceutical ingredient (API) R&D and
manufacturing work undertaken at one of its US factories, with
resultant closure of the site and job losses.
Orphan drug Soliris (eculizumab) has been approved by the European
Commission and marks the first therapy for a rare and
life-threatening blood disease.
SkyePharma's novel controlled-release sleep therapeutic has been
licensed by Somnus Therapeutics in an exclusive worldwide
development and commercialisation deal.
Asterand said it is to slash 10 per cent of its total workforce in
a cost-cutting strategy although it is not a knock-on effect of the
recent ban on export of human samples from Russia.
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...
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...
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.
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.
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.
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...
Solvay today announced plans to increase production of ultra-pure
soda ash at it Dombasle, France, site to meet the growing demand in
the pharmaceutical industry.
Lonza is building a new plant in its home country to become the
only contract manufacturer with large-scale capacity for making
highly potent active pharmaceutical ingredients (APIs).
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.
Roche has initiated a recall of its HIV drug Viracept (nelfinavir)
right down to the patient level after finding evidence of dangerous
contaminants in the tablets.
The first ever non-steroidal anti-inflammatory drug (NSAID) to be
delivered via the nose has been developed, and its makers are
heralding it as "an important breakthrough in treating
pain".
Switzerland-based Roche is helping African nations fight the AIDS
epidemic by sharing its coveted saquinavir drug-producing
technology with two more manufacturers in Ethiopia and Zimbabwe.
A fund to promote biotech collaborations between Australia and New
Zealand has awarded a lump sum to two Antipodean firms which will
result in a new good manufacturing practice (GMP) compliant peptide
manufacturing plant in the under-served...
The fine chemicals division of Japanese contract manufacturer Daiso
has taken out a license to a highly-selective technology used to
synthesise chiral molecules.
Biopharma firm Vivalis has announced several licence agreements for
its proprietary cell line technology, adding to the list of
companies applying the technology to develop and commercialise new
human influenza vaccines.
UK biotech firm Acambis has decided to bring the manufacturing of
its soon to be approved smallpox vaccine in-house while its
agreement with contract manufacturer Baxter comes to an end.
YM BioSciences today announced that the upgraded manufacturing
facility for the firm's humanized monoclonal antibody (MAb) for the
treatment of cancer has successfully passed a series of regulatory
reviews.
Indian firm Alembic has landed a licensing deal with biopharma
heavyweight UCB to apply the company's novel drug delivery system
for a once-a-day version of UCB's market leading epilepsy drug.
A young start-up company is gearing up to challenge the likes of
Pfizer by developing a new insulin product, based on its novel
nano-based intranasal delivery technology.
India-based Dr Reddy's Laboratories has boosted its revenue by 168
per cent for the 2006 year, fuelled by a strengthening position in
the international market.
An approvable letter for Shire's long-lasting formulation of its
best-selling attention deficit and hyperactivity disorder (ADHD)
drug Adderall is not the stumbling block it may appear says the
company.
Molecular Insight Pharmaceuticals is buying a commercial-scale
radiopharmaceutical manufacturing facility in Texas for $3m as it
moves towards increasing its manufacturing in the increasingly
profitable pharmaceutical area.
A white knight in the form of Indian-based Sun Pharmaceuticals, has
rescued an Israeli company from a looming financial crisis by
investing more than $400m in the company.
Solvay's Epicerol process for manufacturing the chemical
intermediate epichlorohydrin from glycerine won the Belgian company
the 2007 Glycerine Innovation Award at the Annual Meeting and Expo
of the American Oil Chemists'...
US contract manufacturer Albemarle has announced it will move
operations of its pilot plant in Ohio to its recently acquired
manufacturing facility in Michigan.
India's Lupin Ltd is ramping up its active pharmaceutical
ingredient (API) capability by teaming up with compatriot and
corticosteroid specialist Symbiotec Pharmalab Ltd.
Lower than expected yields of varicella zoster virus (VZV) have
forced Merck & Co to run down US supplies of ProQuad, its
all-in-one children's vaccine for measles, mumps, rubella (German
measles) and varicella (chickenpox).
BASF is boosting by 30,000 tons its annual production capacity for
the chemical intermediate tetrahydrofuran (THF) at the group's site
in Ludwigshafen, Germany.