EU lawmakers have approved a new chemical law aimed at making
producers and importers of chemicals, used in goods such as
personal care products, prove that the substances they put on the
market are safe for consumers.
Dr Reddy's Laboratories has boosted its ability to serve Western
pharmaceutical markets with an increase in its manufacturing
capacity for drug formulations.
Schwarz Pharma has awarded an engineering and procurement contract
to a Jacobs Engineering Group subsidiary for the development of a
new active pharmaceutical ingredient (API) manufacturing facility
in Ireland.
India is the first choice for foreign companies looking to offshore
their knowledge process outsourcing (KPO) activities and future
growth will be fuelled by the pharma market, according to a new
report.
Pharmaceutical giant AstraZeneca has invested in a tablet
manufacturing plant in Egypt, which could form a launching pad for
an expansion into emerging markets.
Fine chemicals maker Siegfried Holdings has agreed to sign over
part of the production capacity of its Zofingen production plant to
US biotech Celgene Corp in a collaboration worth €34.9m.
The US Senate has confirmed Andrew von Eschenbach as the official
Commissioner of the Food and Drug Administration (FDA) after months
of delay due to complaints about the regulator's oversight.
A hefty investment by Pfizer in an Irish manufacturing facility
could prove to be a waste after the potential blockbuster it was
designed to make has been canned.
Dutch biotech company Crucell said last week that it had completed
its acquisition of SBL Vaccin in an agreement worth €39.4m, but
remained tight-lipped about its plans for the Swedish firm's
contract manufacturing business.
Actavis has announced its majority purchase of Russian
pharmaceutical manufacturer, ZiO Zdorovje, in a move set to
establish the company's presence in the growing Russian generics
market.
Novo Nordisk is planning to sue the head of the US Patent and
Trademark Office after its inhaled insulin product has had its
patent application knocked back for the second time.
Singapore has successfully completed the first phase of its
biomedical science (BMS) initiative and is now pushing the second
phase forward in order to drive growth in its pharma industry
further.
The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.
Dragon International has announced its plans to acquire Jinguang
Pharmaceuticals, a manufacturer of Chinese herb medicines, in a bid
to get a first step into the burgeoning traditional Chinese herbal
medicine market.
The US Food and Drug Administration (FDA) and the pharmaceutical
industry are in strong negotiations to decide how much drug
companies will pay the agency to review new drugs from the end of
next year, when the current law expires.
The US government to pass new measures that make prosecuting
animal-rights activists who target enterprises much easier. The
move has lead critics to warn that peaceful demonstrators would be
labelled as terrorists.
Cardinal Health has announced the results of its radiofrequency
identification (RFID) tag pilot, the first to test the viability of
the technology across the whole supply chain, from item through to
case and pallet level.
One of the most influential medical journals, The Lancet,
has weighed into the European REACH chemicals debate, which is at
near boiling point as the draft legislation approaches its final
approval date in December.
Drug manufacturers having troubles complying with the FDA?s current
Good Manufacturing Practice (cGMP) regulations, may now have the
help they need thanks to a new white paper available on the
subject.
Massachusetts-based Millipore has reported a fall in net profit in
its third quarter results, mainly due to increased costs and recent
acquisition charges.
The contract sales and marketing business will reach $5.2bn (€4bn)
by 2011, as it represents an ideal outsourcing opportunity for
pharma companies competing in this fast growing sector, according
to new market research.
A start-up company has given new hope for patients with brain
tumour by developing a new medical device that it claims is the
first ultrasound-based system to allow drug delivery to the brain.
Pharmaceutical companies are beginning to catch up with other
industry sectors that take an increasingly realistic view of what
they consider a core competency and outsourcing what is left -
Outsourcing-Pharma takes a snapshot of...
Although manufacturing is the most established of the pharma
outsourcing segments, many service areas are still rapidly
evolving. OutsourcingPharma.com gives a brief run down of the
current state of play.
The Food and Drug Administration (FDA) is expected to issue a
revised version of its regulation on electronic signatures and
records by the end of the year, which will force drug and device
companies to reconsider their current information...
Developing new drugs represents an enormous expense for pharma
companies with top firms spending up to £4bn (€6bn) a year on
R&D, according to new industry report.
China is a big market with a lot of potential but many pharma
industry firms still avoid doing business in the country because of
fears that their intellectual property (IP) cannot be protected.
Fewer first cycle new drug approvals by the US Food and Drug
Administration (FDA) could be the first evidence of a toughening
regulatory environment, according to new research.
The current big pharma business model is not sustainable for the
future and will need to change, delegates heard at the recent
Financial Times (FT) global Pharmaceuticals and Biotechnology
Conference.
Biopharma and lifesciences firms should make use of e-learning
software solutions to relieve the burden on keeping staff updated
on regulatory and compliance training.
GlaxoSmithKline (GSK) has told contract sales organisation (CSO)
PDI that it will not renew its sales contract with the firm at the
end of the year, signalling a devastating $65m-$70m loss in annual
revenue for the struggling firm.
The Food and Drug Administration are set to introduce a series of
measures that will accelerate the review process for generic drugs,
placing a priority on therapies that would address a public health
emergency or nationwide shortage.
Firms engaging in both in-house and contract pharma manufacturing
generally display inferior performance compared to manufacturers
conducting only in-house production, according to new research.
Environmental representatives have emerged triumphant in the latest
round of negotiations over the finer bones of contention of the
European REACH chemicals legislation, due to come in force in April
next year.
By 2010 nearly half of all mid pharma firm revenues will be derived
from products that have been discovered outside of in-house
development pipelines, says a new report from independent market
analyst Datamonitor.
The US pharmaceutical industry could be wasting more than $50bn
(€39bn) per year in manufacturing costs due to inefficient
processes, a new research has warned.
There is a growing realisation in pharma that, to remain
competitive, paper-based trials are not the way forward. Instead,
electronic data capture (EDC) and management technology solutions
are now readily available and becoming more...
A new report is available detailing the top 100 Indian
pharmaceutical companies for those in the industry who have a
business interest in this burgeoning region.