Industry executives revealed their biggest worries for global supply-chain management in a report by PricewaterhouseCoopers and the analyst firm Axendia that focused on major areas of concern in the pharmaceutical supply chain. The report, titled Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity, surveyed 112 executives from the pharmaceutical, medical device, and biotechnology sectors. Read more »

Wall Street analysts gave Eli Lilly (Indianapolis, IN) executives the third degree last Thursday when the company presented its third-quarter results. Lilly’s revenue had increased only 2%, mostly because it had raised its prices. Although demand for its products had stayed flat, the company boosted its profits by 38% mostly through layoffs and cost-cutting measures. The patents on many of the company’s top drugs (e.g., Zyprexa and Actos) will expire in the next few years, however, and no new drugs seem poised to replace them. Analysts wanted to know how Lilly would weather the storm. Read more »

FDA issued an alert today that it has detected “excessive levels of peroxide in one lot of Crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by China-based Tianjin Boai NKY International Ltd.” Although there have not been any related adverse-event reports to date and although the level of peroxide found does not pose a major health risk, said the agency in an advisory statement yesterday, there is concern that elevated levels of peroxide can cause “subpotent finished products.” Read more »

Driving to work yesterday, I listened to a story on National Public Radio about the effect of Johnson & Johnson’s massive recalls on consumer choices. The news wires and blogosphere have been hyping up a major shift in consumer purchasing in the US from over-the-counter brand-name drugs to generic drugs ever since J&J had to remove from the market millions of bottles of its most popular allergy and fever-reducing medications, including Tylenol, Motrin, and Benadryl. Read more »

Pfizer announced this his week that it had entered into a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon (Bangalore) for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro). The move signals Pfizer’s strategic interest in entering the biosimilars market as well as a continuing focus of building its position in emerging markets. Read more »

Does federal law shield the makers of vaccines from product-liability lawsuits? Last week, the US Supreme Court began considering this question, which is the heart of a lawsuit against Wyeth, now a part of Pfizer (New York). Read more »

The UK government has said it will not progress with plans for automatic generic substitution of medicines in primary care because “it is not clear whether the proposals would have provided substantial benefit to the NHS”, according to the UK Health Minister Lord Howe. Read more »

Dr. Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke about the growing problem of counterfeit drugs at last Friday’s Counterfeit Drug Interchange Conference in Washington, DC, hosted by the Partnership for Safe Medicines (PSM), a collection of more than 60 non-profit organizations focused on the safety of prescription drugs. Read more »

Pharmaceutical manufacturers are always chasing the twin goals of greater efficiency and reduced costs, regardless of whether the economy is doing well or badly. Each of these goals can be elusive, and achieving both at once even more so. That’s why news about a promising method for producing paclitaxel caught my attention. Read more »

Today wrapped up the US-based ICH Implementation Working Group Workshop in Bethesda, Maryland, for the Quality Trio guidelines Q8, Q9, and Q10. Team leaders provided reports from four breakout sessions that occurred during the meeting. Sessions addressed key elements of the development and implementation of a quality-based approach to pharma manufacturing:  design space, control strategy, pharmaceutical quality system (PQS), and quality risk management. Industry and regulatory representatives were equally represented in the breakout groups. Read more »