Tech Talk

Guidance offered on how to deal with off-label information requests.

As part of Ranbaxy’s recently announced consent decree, the company is required to set up a program whereby whistleblowers can come forward with information related to potential violations of the Food, Drug, and Cosmetic Act. According to the decree, available through Pharmalot’s post, Ranbaxy must, within 75 days, establish a phone line and a system to receive and maintain submissions from individuals wishing to report suspected violations

Quality-by-design or “enhanced” approaches to drug manufacturing offer several benefits to industry, including better process understanding and better understanding of the interrelationship of material attributes and process parameters.

Targeting a drug for small subgroups of patients is a new way to find effective therapies. This is often called personalized medicine, and it’s one of today’s most promising areas of new drug development.

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry.

Pharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost.

When should there be restrictions on the dissemination of basic research results? This question has arisen in the context of papers from independent laboratories submitted to the journals Science and Nature.

Last night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union address provided a blueprint for rebuilding America’s economy-and a large component is of that plan is to bring manufacturing back to the US.

Earlier this week, Novo Nordisk launched a diabetes initiative in the US that stars the celebrity chef Paula Deen. Usually, it’s the pharma company that gets the sharp end of the stick when it comes to criticism but this time the negative attention has fallen on Deen, with Norvo Nordisk barely getting a mention in many news sources.

FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products.

Ever wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that-to see through video how other scientists carry out particular experiments and processes.

GlaxoSmithKline has faced intense media scrutiny this week after being fined approximately 72 650 Euros by a court in Argentina for allegedly conducting unethical clinical trials on children for the company’s pneumococcal vaccine, Synflorix.

A newly released report from Jones Lang LaSalle, a financial and professional services firm specializing in real estate services and investment management, looks at the world in terms of life-sciences investment, and finds some not-so-surprising trends over the past 10 years. The report ranked

New Jersey is known to many as a pharmaceutical mecca on the international stage with several leading pharmaceutical majors headquartered and/or with operations in the state. So to say that lawmakers need to create an economic climate conducive to foster growth is an understatement.

First of all, I wish all of you a very happy new year! The pharma industry and its workers have been through a lot of hardships in recent times with huge job losses, eroding profits and drying pipelines. A lot of gloomy predictions have been made about 2012 (including ongoing economic woes and the end of the world) but let’s hope that this year finally brings good times for pharma as it seems that the industry is well overdue for a successful year.

2012 will be a transition year for pharma, one of the most important in the industry’s history of product cycles that spin from plenty to penury. On the positive side, the fires of drug discovery are finally being stoked by a growing understanding of how genomics shape the biology of disease.

If a clinical trial is run, but the results are never published, what benefit is there to patients, physicians, or the public?

Copay coupons may help patients and drugmakers, but who ends up holding the bag?

As 2011 comes to a close, a new paradigm of product development is ever more important.

British racing car company and GlaxoSmithKline team up on a winning formula for innovation.

Corporate management must be held accountable for quality at all levels.

New studies reveal the promise and feasibility of transdermal vaccine delivery.

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

Can microdosing make medicines safer and more effective for children?

Can the semiconductor industry help Big Pharma develop therapies?

The need for greater process understanding raises the bar for suppliers.

Social media tools have taken over many aspects of our lives, now including regulatory info.

Government and private sector efforts take on counterfeit drugs online.

World AIDS Day 2010 reminds us that prevention and hope can help fight the disease.

Connecting science and policy might increase support for innovation.