Two Early Cancer Studies Show Promise

Erik Greb PharmTech editorThe coming patent cliff and the nation’s continuing economic problems have tightened many drugmakers’ R&D budgets. Cancer research has remained a priority, however, as GE Healthcare’s recent $1-billion investment in oncology demonstrates. Two recent studies show the importance of this research by offering glimmers of hope. Read more »

Prosperity through Biology

Erik Greb PharmTech editor

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »

Tax Breaks for Big Pharma: A Remedy for Unemployment?

Erik Greb PharmTech editorWorried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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Meet the New Drugs: Same as the Old Drugs

Erik Greb PharmTech editorStock prices have fluctuated wildly in response to factors such as persistently high unemployment, impending cuts in federal spending, and the downgrade of America’s credit rating. The already conservative pharmaceutical industry is hunkering down and socking away cash to be safe. Since January, Merck has saved $1 billion in cash, and Johnson & Johnson has saved $3 billion. The savings have come at the expense of R&D budgets, making observers wonder where the new drugs will come from.

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QbD in Theory and Practice

Erik Greb PharmTech editorThe pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

Is Pharma’s Innovation Slump over?

Stephanie Sutton Pharm Tech EuropeIt’s a well-known fact that new product approvals in the pharma industry have been in decline in recent years. In 2010, for instance, the FDA only approved 21 new drugs compared with 26 and 24 in 2009 and 2008, respectively. July 2011, however, saw the FDA approve its twenty-first product for 2011 with AstraZeneca’s blood-thinner Brilinta, so it seems as if the agency is set to outpace 2010’s dreary approval numbers. Read more »

The Super Antibody And The Holy Grail

Stephanie Sutton Pharm Tech EuropeLast week, I complained about the British weather (which is still awful by the way) and outlined how the pharma industry is already preparing for this year’s winter flu season. Following on from that, I’ve just read a really interesting story about the holy grail of flu vaccine manufacturers — the possibility of a super, universal vaccine that could protect against all common strains of influenza. Read more »

Woodcock Cites a “Turning Point” in Drug Development

Erik Greb PharmTech editor

Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all. Read more »

Weak Pipelines? Don’t Blame FDA.

Erik Greb PharmTech editorFacility rationalizations, outsourcing, and staff reductions can provide only so much of a cushion to pharmaceutical and biopharmaceutical manufacturers about to drop off the patent cliff. The ideal way to remain profitable is to discover and develop innovative new drugs, but this task has proven increasingly difficult for drugmakers over the past few years. Jonathan Leff, a managing director at venture-capital firm Warburg Pincus, says that FDA is partly to blame. Read more »

Is Biotech Following in Big Pharma’s Footsteps?

Erik Greb PharmTech editorBiologics are still the hot commodity in the drug industry. Observers call large-molecule drugs the therapies of the future, and these medicines’ complexity makes them difficult for would-be follow-on manufacturers to create. Big Pharma companies that have not yet acquired biopharmaceuticals firms are considering doing so to bolster their pipelines and profits. But not all biologics companies are living large, as data from Ernst & Young remind us. Read more »

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