The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
Under the President’s FY 17 proposed budget request, the FDA would receive $2.743bn in budget authority appropriations – and many are frustrated with the lack of funding.
Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.
With the expectation of new regulatory guidelines, and the need for increased productivity, companies will need to become “comfortable with data,” says Quintiles executive.
Genomics England has selected CRO Icon to manage data for what it says is the largest genome sequencing project of its kind for cancer and rare diseases.
AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
On the heels of a new study, which found that Allergan's Waco operations generated an economic impact of $263m on the area’s income, the city is hoping for new expansion.
The Mafia is responsible for most pharmaceutical cargo thefts in Europe according to a researcher who says €30m ($33.5m) worth of drugs are stolen while in transit across the continent each year.
As threats to the pharmaceutical supply chain prevail, the industry is seeing increased regulatory scrutiny as well as more inspection requirements, says industry panel.
Sanofi Pasteur has launched a Zika vaccine project, levering its experience in developing vaccines for similar viruses, as the US government pushes for “intensified research.”
Envirotainer has partnered with Air China Cargo in deal that will see local and international drug and API makers use its range of cold chain shipping containers.
The Royal Statistical Society has questioned the design of the trial of Bial's candidate painkiller BIA-102474-101 in which one person died and others were hospitalised last month.
The pharma industry has traditionally been slow to adopt mobile technology, but as new innovations emerge the process for conducting clinical trials could transform.
The US NIAID is supporting development of several experimental Zika vaccines but none will be ready before Brazil, the country at the centre of the current outbreak, hosts the Olympic Games this summer.
The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.
Yan Mei, a defendant charged with stealing GlaxoSmithKline (GSK) trade secrets including biopharmaceutical manufacturing processes, remains at large, a spokesperson for the US Attourney's office told us yesterday.
ICON has announced Flex Advantage, its next-generation Interactive Response Technology (IRT) platform, as sponsors and investigators continue to embrace adaptive trial designs.
Government purchasing commitments would discourage industry antibiotic marketing and help developers overcome reluctance to invest in new antimicrobials say drugmakers in Davos.
Currently, more than 85% of trial sites are paid using manual or in-house process, but as the need for CROs increases, so does the need for automated payments, says Clinverse's CEO.
Mylan has stopped production at a sterile injectables plant after Polish regulators observed 29 major violations of GMP, an EU statement of non-compliance reveals.
FAAH inhibitors will be looked at closely after a volunteer died in a trial of BIA 10-2474 last week, but it is too early to say drugs of this class are unsafe according to a leading expert.
Drug manufacturers, regulators, and consumers are increasing pressure on pharma companies to make the Rx-to-OTC switch, as non-prescription medications are cheaper and easier to access.
A study halted in France after one volunteer died and others were injured differs markedly from the disastrous “elephant man” trial that hospitalized six in the UK in 2006 according to the MHRA.
As the industry faces new challenges in 2016, the pharmaceutical industry is expected to be the second busiest sector for consolidation with large cash reserves driving deals, according to experts.
Medidata expects to become a strategic partner to even more pharma firms as Boehringer Ingelheim becomes the latest to transition to its cloud technology platform.
Many generic drugs are not truly bioequivalent to the original medicines they copy and switching to them can lead to worse patient outcomes, according to US researchers.
Software firm LZ Lifescience says small drugmakers could increase their productivity by over 25% by accessing Manufacturing Execution Systems (MESs) traditionally restricted to Big Pharma firms
The end of the year is always a time for reflection, and as Andrew Schafer, ISR President told us, “2015 was a very interesting year for pharmaceutical service providers.”
The US FDA has warned Sun Pharmaceutical Industries about its facility in Halol, India just months after it withdrew approval for an epilepsy drug made at the site.
Under new legislation, the FDA and NIH will receive discretionary funding to combat antibiotic resistant bacteria and advance prevision medicine initiatives.
If even the apparently non-joke, potential US presidential candidate Donald Trump criticizes your behaviour, you must know what you are doing is unpopular.
Early and efficient communication is the key to cutting approval times says the US FDA, which published a draft best practices guide for drug firms this week.
