JOBS Act Passage—A Boost for Biopharma?

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart. Read more »

Taking Drugs off the Short List

Erik Greb PharmTech editorDrug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

Drugmakers Seek to Outwit Generic-Drug Competitors

Erik Greb PharmTech editorThe day of reckoning is here. As patent protection expires for top-selling drugs, some firms are scrambling to stay one step ahead of generic-drug competitors. As Amy Ritter wrote last week, Pfizer is drawing scrutiny by asking pharmacy benefit managers to block pharmacies from filling prescriptions with generic alternatives to Lipitor, in exchange for a discount on the product. Rep. John Sarbanes (D-MD) asked the Federal Trade Commission to take action against this arrangement, but another tactic is also causing concern. 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 »

Better Quality Could Mean Fewer Drug Shortages

Erik Greb PharmTech editor

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. 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 »

BIO’s Prescriptions for FDA

Erik Greb PharmTech editorIt’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations. Read more »

Knowing When to Stay the Blade

Erik Greb PharmTech editorConcern about the federal government’s budget deficit is reaching a crescendo. Assorted Cassandras warn that failing to address this problem could have dire consequences, and members of both parties seem to agree that spending must be cut. But before Congress tightens its purse strings too zealously, I’d like to remind it of the valuable and necessary work that the national budget funds. Two drug-related stories that emerged last week provide particularly good examples. Read more »

Confusing Language and a Dubious Victory for Patients

Erik Greb PharmTech editorThis week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »

Women’s Victory at Novartis—and Setback in the Senate

Erik Greb PharmTech editorAt the end of a week that saw several major companies announce job cuts, the pharmaceutical workforce finally got some good news on Friday. Manhattan US District Judge Colleen McMahon said that she expected to approve an agreement between Novartis Pharmaceuticals (Basel) and a class of 6200 women, thus settling a gender-discrimination lawsuit. “It is the rare settlement where economic damages are compensated in full,” the judge said, according to an article in the Wall Street Journal. Read more »

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