The 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 »

When only a handful of manufacturers supply a given drug, production problems at any of those companies can lead to a shortage. Earlier this year, problems at Ben Venue’s Bedford, Ohio, site contributed to shortages of the cancer drug Doxil. The shortages are likely to continue now that Ben Venue has suspended manufacturing at the plant. Read more »

The 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 »

Consortiums are nothing new, but they do seem to be popping up more than usual throughout the pharmaceutical sector lately. Rx-360 and its supply-chain efforts come to mind, as does the IQ consortium on advancing innovation in the quality of pharmaceutical development. There’s also an international pharmaceutical privacy consortium, a consultants consortium, and more.

The fact is, industry seems to be tired of waiting for standard-setting bodies and regulators to take action on solving key challenges such as counterfeiting, economically motivated adulteration, the implementation of quality by design, and so forth. It’s not that the agencies and organizations aren’t working on these issues, but they have to do deal with more legal and governmental bureaucracy than do representatives from various companies sitting around a table over coffee or drinks. Read more »

With 2011 sales of approximately $54.1 billion, Pfizer currently holds the crown as the world’s largest drugmaker, but next year may see the pharma giant usurped from its throne by Sanofi and Novartis, who will claim pole and second position respectively in the global pharmaceutical rankings. Pfizer, meanwhile, will drop to third place, and is likely to remain there for the foreseeable future, according to analysis firm EvaluatePharma. Read more »

It’s getting harder for the pharmaceutical industry to ignore neglected diseases. The globalization of national economies and the rise in air travel are increasing the potential for exposure to these diseases, which previously had been limited to the developing world. “Now is the time to have this discussion,” Kishor M. Wasan, chair-elect of the American Association of Pharmaceutical Scientists’s Pharmaceuticals in Global Health Focus Group, told Pharmaceutical Technology earlier this month. Industry now seems to be getting the message. Read more »

In attending CPhI this week in Frankfurt, one theme that repeatedly emerged was the increasing importance of CROs, CDMOs, and CMOs to build more strategic, deeper, and collaborative relationships with pharmaceutical companies as a way to meet the evolving needs of the industry and as a a mutual tool in value creation. Read more »

Written by A. Nair, a PharmTech correspondent based in Mumbai

After months of deliberation, the Indian government has decided not to cap foreign direct investment (FDI) in the pharmaceutical sector and to continue with the 100% FDI regime. A decision in this regard was taken by an inter ministerial group presided over by India’s Prime Minister Manmohan Singh, which sought to allay fears about clearing investments automatically. Read more »

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 »

Worried 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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