Archive for the 'Uncategorized' Category

Live from ExcipientFest: Deadly Sins of Quality Management

Angie DrakulichToday in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management. Beatrice heads Quality at Abbott and used to serve as deputy director of CBER at FDA. The seven items to avoid, he notes are: bureacracy, tradition (just because you’ve always done something a certain way doesn’t make it right), excess (too many priorities), isolation (lack of communication among groups and with public), deafness (not listening to employees at all levels), and complacency. Read more »

Illumina Continues to Reject Roche

Stephanie Sutton Pharm Tech EuropeIn February, I wrote that Roche could be in for a lengthy battle if it wants to acquire the gene-sequencing specialist Illumina. And indeed, the battle is still raging on. Here’s an update on some of the latest developments. Read more »

What Does Overturning ACA Mean to Pharma?

Guest blog written by Reid Paul.

In contentious three days of hearing on the Affordable Care Act, the Supreme Court now seems far more likely to overturn the landmark legislation. Given the strong support the bill originally received from the industry, does overturning it benefit or hurt pharma? Read more »

USP Promotes Supply Chain Integrity, Seeks Industry Input

“One of the most daunting challenges facing pharmaceutical companies is securing the long and complex supply chains that are typical in today’s global industry. From the sourcing of raw materials to final delivery to the pharmacy, practitioner or patient, the number of nodes in the global supply chain for a medicine is astounding, with each link presenting an opportunity for the insertion of risk or harm. Although most companies have highly sophisticated, multifaceted approaches to addressing this challenge, approaches vary.

“In addition, there can be huge differences in approach not only between large and small or medium pharmaceutical manufacturers, but also among raw-materials suppliers, logistics providers, and the plethora of other companies involved in the production, distribution, and delivery of medicines to patients….To address this issue, the US Pharmacopeia (USP) recently published a proposed set of recommended best practices on supply-chain integrity, for which it is seeking broad input….”

Read the rest of the article by US Pharmacopeia’s Anthony J. Destefano and Desmond Hunt. You can also listen to USP officials speak about supply chain integrity as part of a video series on Click on the “USP” tab.

Biosimilars—It’s the Differences That Really Matter

Amy RitterThis week, the Drug, Chemicals, and Associated Technologies Association (DCAT) is holding its annual week-long meeting in New York City. The meeting covers topics including the business and regulatory environment, manufacturing practices, and supply chain logistics of the pharmaceutical industry. Wednesday Mar. 14, 2012 featured a session devoted to biologics, in which the first two speakers spoke at length on the topic of biosimilars, and highlighted important differences between follow-on biologics and generic small molecules. Read more »

Roche and Illumina Ready the Trenches

Stephanie Sutton Pharm Tech EuropeAfter its high profile acquisition of Genentech in 2009, Roche is back in the M&A spotlight again. This time, the Swiss pharma giant has its eyes on the DNA sequencing company Illumina, which is based in San Diego in the US. However, both companies are digging their trenches in preparation for a potentially lengthy battle. Read more »

Shrinking Economy Hits California Biotech Sector

Amy RitterA report released on Feb. 8, 2012 from the California Healthcare Institute, BayBio and PwC shows that the shrinking economy, changes in investment strategies, and pressures on the pharmaceutical market have put the brakes on one of the US’s most robust biotechnology centers. California had enjoyed steady growth in its biotech sector for the past two decades, and according to the report, is the source of 28% of the country’s biomedical pipeline. More recently, as with the rest of the world, the slowdown in the global economy has taken its toll on this area. The industry lost approximately 6,300 jobs, or about 2.3% of its life-sciences workforce since 2008, returning employment levels to those seen in 2006. Read more »

FDA Gives Biosimilars Update

Angie Drakulich PharmTech editorRachel Sherman, MD, Associate Director for Medical Policy, within FDA’s Center for Drug Evaluation and Research, gave a press briefing today. Below is a summary. Read more »

Bring Manufacturing Back, Orders Obama

Angie Drakulich PharmTech editorLast night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union address provided a blueprint for rebuilding America’s economy—and a large component is of that plan is to bring manufacturing back to the US. “Tonight, my message to business leaders is simple: Ask yourselves what you can do to bring jobs back to your country, and your country will do everything we can to help you succeed,” he said. Read more »

US Still Strong but Europe Waning in Life-Sciences Investment

Amy RitterA newly released report from Jones Lang LaSalle, a financial and professional services firm specializing in real estate services and investment management, looks at the world in terms of life-sciences investment, and finds some not-so-surprising trends over the past 10 years. The report ranked areas of the world according to how much direct investment they received in life sciences, and compared the rankings made between 2003–2006 with those made between 2007–2010. Those time periods were chosen to represent periods before and after the world-wide economic slowdown. Not surprisingly, on both lists, the US was number one, with Ireland, China, and Singapore also in the top 5 in both analyses. However, there have been some changes over the past few years. Puerto Rico, which ranked number 8 on the 2003–2006 list, failed to make the top 10 ranking in the 2007–2010 list. And Canada and Brazil, two non-European countries, replaced Sweden and France as top 10 recipients of life-sciences investments. India, ranked at number 9 in the 2003–2006 analysis, moved up to number 4 in the more recent ranking. Read more »

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