New analysis from IMS Health has painted a gloomy picture for branded medicines for the next five years as patent expiries and national policy changes take their toll. Spending for branded products in developed markets will remain at the same level in 2015 as in 2010; however, the market share for branded medicines, which fell from 70% in 2005 to 64% in 2010, is expected to decline to 53% by 2015. Read more »

Big Pharma’s sales forecast is not likely to improve anytime soon. Consulting firm Bain and Company predicts that the top 25 drug companies’ annual sales growth will be no more than 1% through 2016. To compensate for reduced revenue, investors are urging manufacturers to cut expenses that do not add value. One such expense, in many investors’ eyes, is research and development (R&D). Read more »

Concern 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 »

To make up for weak pipelines, and to take arms against a sea of generic-drug competitors, many large pharmaceutical companies have pursued mergers and acquisitions. This strategy began to gain popularity about 10 years ago, and the industry’s new motto seems to be “When the going gets tough, the big get bigger.” Has this strategy improved drugmakers’ pipelines or bottom lines? Read more »

Barely a month after its ruling in Bruesewitz v. Wyeth, the US Supreme Court has begun to hear arguments in another case with big ramifications for drugmakers. The current case raises questions about generic-drug companies’ responsibilities and whether federal law pre-empts state regulations, among other issues. Read more »

A sizeable chunk of Big Pharma’s sales will fall off the dreaded patent cliff before the year is out. Patent expirations will allow competitors to market, and patients to buy, generic versions of branded drugs. A renewed focus on discovering and developing new therapies would seem to be the obvious solution for Big Pharma. Yet at least one observer predicts cuts in research and development (R&D) spending throughout the industry. Read more »

Pharmaceutical companies can no longer take strong growth for granted, and CEOs and shareholders are lowering their expectations about future performance. The industry’s global sales growth likely will be limited to 1.3% until 2015, according to Joe Dixon, a spokesperson for Datamonitor. Compare this anemic figure to the 7.1% growth rate that manufacturers enjoyed from 2003 to 2009, and you’ll see little reason for joy in drugville. Read more »

The Federal Trade Commission opposes them. Lawmakers have tried and failed to abolish them. Soon, the US Supreme Court may rule on their legality. The future of pay-for-delay agreements, which pharmaceutical companies use to postpone the introduction of generic drugs to the market, could hang in the balance. Read more »

Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »

The World Health Organization (WHO) has released two new quality guidelines for generic pharmaceuticals concerning the preparation of dossiers in Common Technical Document (CTD) format and the data that should be provided.

It is hoped that both guidelines will support the objectives of the Prequalification Programme, a United Nations program managed by the WHO that aims to make priority medicines available to those who need them. The medicines should meet WHO-recommended norms and standards of acceptable quality. Read more »