PharmTech Talk

This guest blog was written by Christie Bloomquist is a partner in health practice at Hogan Lovells, a global legal practice firm based in Washington DC.

The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the U.S. health care system.

Roche’s recent announcement that it will be closing its venerable Nutlley, NJ R&D site is the latest in a string of mergers and reorganizations that have resulted in the loss of thousands of life-sciences jobs from New Jersey,

A coordinated European programme was recently carried out involving routine inspections of pharmaceutical companies’ safety reporting systems.

Development in hot melt extrusion (HME) using twin-screw extruders to make solid-dosage drug forms has increased significantly in the past decade, although it is still in its infancy, said Charlie Martin, president of the US operations of Leistritz at the recent Pharmaceutical Extrusion Seminar organized by the company.

Here in Boston, the crowds are bustling at the BIO 2012 Convention and Exhibition. Today, BIO unveiled survey results that polled about 170 biotech industry leaders and 800 US voters, conducted by Hart Research and Public Opinion Strategies.

Improving bioavailability of poorly water-soluble drugs is an ongoing challenge for formulation scientists and is of crucial importance to advance clinically promising drug candidates.

House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support FDA regulatory programs.

Are pharmaceutical manufacturers really serious about ensuring the quality of their medicines? And do they recognize that cutting corners on controls and quality management can be tremendously costly in the long run?

Germany used to be a golden market for the pharma industry in Europe because the country allowed global pharmaceutical companies to set their own prices for new medicines. However, all good things must come to an end…

Combustible dust is a fire and explosion hazard in many industries that handle dusty materials, including pharmaceuticals.

The House Appropriations Committee released the fiscal year 2013 Agriculture Appropriations bill, which, sets proposed spending levels for FDA as well as for other programs

UK chooses to use off-label drug indication to cut healthcare costs. Will others follow suit?

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure.

The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures ( and ) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).

With pharmaceutical R&D efforts in decline, public-private partnerships are emerging as a way to bolster early stage discovery efforts. In Europe, concern over a dwindling antibiotic pipeline led to the European Commission’s Action Plan Against the Rising Threats from Antimicrobial Resistance, launched in November last year (see here).

Recognizing that traditional market forces – namely incentives related to intellectual property and a steady demand for products – have failed in developing countries, the World Health Organization (WHO) asked a member state-nominated group to come up with ways to fund R&D and pay for the treatment of neglected diseases in the world’s poorest nations. The group’s proposals will be discussed at the sixty-fifth session of the World Health Assembly, beginning today in Geneva.

Efficient energy consumption has taken to the friendly skies with a little help from the sun-and pharma.

A theme shared by several of Wednesday’s sessions at the AAPS National Biotechnology Conference seems to be how the tools and techniques that have evolved for development of small molecules are spilling over into the design of large molecules.

A bill has recently been in discussion in the US that contains measures to strengthen the ways in which drug shortages are dealt with. The US FDA is also taking action by asking companies to alert them as to possible drug shortages so that it can prepare back ups.

AAPS Biotech is holding its annual meeting this year in San Diego, CA, the city with arguably the best weather in the world.

The biopharmaceutical industry is increasingly turning to disposable, single-use systems that offer flexibility and cost benefits.

PDA held a successful workshop earlier this spring in Phoenix for over 100 attendees on key elements of the association’s forthcoming Technical Report on Single-use.

ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus.

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story).

The potential of single-cell genomics took a step forward recently with the announcement by The Broad Institute and Fluidigm Corporation of a new research center focused on developing research methods and discoveries in mammalian single-cell genomics.

More than a year has passed since the FDA issued its guidance, “Process Validation: General Principles and Practices,”.

The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on.

The pricetag of pharmaceuticals are coming under increasing scrutiny in today’s age of cost constraints.

FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total).