With an overwhelming majority, the House on Friday morning passed a new bipartisan bill that would increase NIH funding by about $8.75bn and the FDA by $550m over the next five years.
The fanfare that accompanies Big Pharma strategic partnerships with CROs is rarely followed by progress reports according to an industry consultant, who warns the lack of feedback means mistakes are repeated.
With the bipartisan 21st Century Cures Act coming up for a vote Friday in the US House, the White House and others are raising a number of concerns over how the bill would be paid for and what it will actually do to speed new cures to market.
Proposed amendments to TTIP backed by MEPs will either encourage foreign investment or allow US drug firms to sue EU states whose laws restrict profits, depending who you ask.
US and China-based CRO FMD K&L has expanded into Armenia with a new office to support clients’ needs in the region and grow the company’s business further in Europe.
A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption...
ReNeuron will automate processing of its stem cell-based stroke therapy ahead of planned Phase III trials using a system acquired from Sartorius Stedim Biotech (SSB) subsidiary, TAP Biosystems.
Specialty trials services and tech provider BioClinica has acquired the patient recruitment and retention firm, MediciGroup. Financial terms of the deal were not disclosed.
The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU.
Even if claims about Kumdang-2 are real, access to the drug and other pharmaceuticals in North Korea is limited to those who can pay black market prices according to a UK-based defector.
Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
The world’s second-largest central lab services company is now operational, with Quintiles and Quest Diagnostics calling their new creation Q2 Solutions.
More evidence linking fake pharmaceuticals and organised crime emerged today with Dutch police seizing suspicious Viagra pills along with cocaine, MDMA and burglary tools.
Europeans who want to fund organised crime can now do so more easily by buying medicines from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.
As the outbreak of Middle East Respiratory System (MERS) slows in South Korea, logistics supplier Marken has been granted government permission to deliver the first direct to patient (DTP) shipments of clinical drugs and supplies in the country.
US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer.
In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices)...
The Broad Institute of MIT and Harvard is teaming up with Google Genomics to break down technical barriers hindering biomedical research by creating tools to analyze reams of new genomic data.
Contract analytical and bioanalytical service provider SGS Life Science Services has completed construction of its Shanghai, China, cGMP chemistry and biotechnology testing laboratories and will further increase space at its microbiology lab at the site.
Demand for CNS assets will help break records for pharma M&As in 2015, Neel Patel, VP of inVentiv Health consultancy Campbell Alliance, tells in-Pharmatechnologist.com.
Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).
Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.
Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.
Health Action International (HAI) has set up an office in Brussels, Belgium in a bid to further influence European pharmaceutical policy and improve access to medicines and public health.
Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.
As the death toll from MERS in South Korea edged to two dozen scientists there say the outbreak is different from in Saudi Arabia and also from its the related virus SARS.
Eurofins Scientific has announced plans to buy French testing services firm Biomnis in what would be its third investment in the diagnostics space this month.
Mayr-Melnhof Packaging has bid €80m ($91m) for the carton folding operations of Ileos SA, a private equity owned pharmaceutical and cosmetics packaging sector services firm.
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
Ex-Allergan CEO David Pyott has spoken of his “total war” battling Valeant’s failed hostile takeover, and given advice to other pharmaceutical companies on how to deal with activist shareholders.
Aragen Bioscience and Transposagen Biopharmaceuticals have launched a knockout CHO cell line and development services they clam allows for the development of more effective therapeutic mAbs.
Rumoured Big Pharma takeover target GSK has invested $95m to set up an cell genetics research institute to help developers better identify drug candidates.
The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes, according to US Homeland Security’s former head of cybercrimes...
Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.
A new trial model is needed to encourage cardiovascular disease drug development say researchers who claim the large, lengthly studies used to prove safety and efficacy of such drugs are a disincentive.
