Small molecule drug, Niraparib combined with abiraterone acetate (AA) and prednisone (P) significantly reduces the risk of disease progression, or death, in patients with a type of prostate cancer, a consultant in Spain has said.
The Dutch company Pharming Group N.V. has switched its rare disease drug leniolisib from an accelerated assessment to a regular review with the European Medicines Agency (EMA).
The regulatory agencies of six European countries are now actively prompting clinical trials sponsors to publicly report their clinical trial results—and have the power to issue fines of up to €250,000 ($243,000) for noncompliance.
The value generated by the manufacture of medicines has doubled since 2000, with one of the smallest countries in Europe responsible for a significant proportion of the total figure.
France, Germany, and the UK recently formed INSTEX to be able to secure trade despite US sanctions on Iran, a move that has been welcomed by Novo Nordisk.
Novartis joined industry associations in expressing concerns over the impact that a ‘hard’ or ‘disorderly’ Brexit could have on the life sciences sector.
Vertex was granted marketing authorization for its cystic fibrosis therapy in a combination regimen, marking the company’s third treatment for the condition to reach the market.
With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
One-third of clinical-trials results in the US go unreported, according to new figures published in the British Medical Journal underlining how far the drugs industry remains from full transparency.
Bacterial resistance to ciproflaxin is spreading according to the European CDC which wants the drug industry to invest in development of alternatives to the "last resort" antibiotic.
Pharmaceutical and chemical manufacturers may have to wait until 2017 to see the benefits of the Transatlantic Trade and Investment Partnership, VP of SOCMA (Society of Chemical Manufacturers and Affiliates) told attendees at InformEx in New Orleans.
China and India have more work to do to confirm their API manufacturing sites comply with EU GMP requirements, according to the European Commission’s Pharmaceutical Committee.
Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.
The European Medicines Agency (EMEA) has called for “in-depth, prospective analysis of potential ethnic factors” when considering whether clinical trials conducted outside the EU will be acceptable in marketing authorisation applications.
The European Union’s coordinated clamp down on counterfeit drugs has resulted in hauls far exceeding expectations, with 34m pills seized in two months.
The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.
J&J has expressed its concern over patient safety as Novartis'
subsidiary Sandoz has received the green light from the European
Commission to launch the first epoetin alfa biosimilar on the EU
market.
Ranbaxy has been granted an EU manufacturing and import license for
its Romania-based Terapia Ranbaxy subsidiary, and says it will make
the company a strategic regional hub for its operations in Europe.
A new international agreement will eliminate customs duties on
pharmaceuticals and chemical intermediates traded between the major
nations dealing in the industry. The move is set to save EU
pharmaceutical companies around €230m in...
Galvanised by the US, thirteen of the EU's major trading partners
have called for a reconsideration of the EU's draft chemicals
legislation, calling it "potentially disruptive" to world
trade.
EU ministers yesterday agreed on a compromise version of the
controversial new chemicals law, REACH, however environment groups
have condemned the latest changes as a further watering down of the
law in favour of industry.
Doctors and cancer researchers have pleaded with EU politicians to
support a strong REACH chemicals regulation in order to halt an
increase in cancer rates, congenital malformations and asthma.
The pharmaceutical and biotechnology industries in the 'new' EU
countries are rapidly expanding, presenting considerable potential,
although parallel imports remain a challenge.
A study into the price of orphan drugs in the EU revealed that
access to treatments for patients with rare disorders can vary by
as much as 70 per cent within individual EU member states.
The US Biotechnology Industry Organisation has come out in support
of European legislation that it says will require extensive tests
to be conducted on so-called 'biosimilar' versions of biological
drugs.
The European Court of Justice has ruled that Internet sales of
prescription drugs should not be permitted in European Union member
states but that over-the-counter drugs may be sold on-line and
through mail-order.
The innovation gap between the EU and the US will not be closed
before 2010 if the present rate of progress continues, according to
new figures contained in the Commission's European innovation
scoreboard for 2003.
While the procedure for designating drugs for orphan diseases has
improved dramatically in the EU, further progress must be made,
says EU biotech group
The Eurobarometer 2002 survey on 'Europeans and biotechnology'
reveals that despite the impression that Europeans are sceptical
about this technology, the majority are optimistic that
biotechnololgy will improve our way...
In its first progress report since adopting the EU strategy on life
sciences and biotechnology in 2002, the European Commission
yesterday indicated that the risk of diverging policies in Member
States could seriously hamper the effectiveness...
