Author Archive

More Cost Pressures for Pricey Drugs

Amy RitterIn an op-ed in the New York Times, a trio of physicians from the Memorial Sloan Kettering Cancer Center in New York announced their decision to remove an expensive new cancer treatment from the hospital formulary, citing cost-benefit as their reason. The physicians said that because Zaltrap (ziv-aflibercept) made by Sanofi/Regeneron was no better at extending median survival in advanced metastatic bowel cancer patients than Avastin (bevacizumab) from Roche/Genentech but costs more than twice as much, it would no longer be given to patients at the hospital. Read more »

Nobel Prizes Honor Stem Cell and Cell Signaling Pioneers

Amy RitterThe Nobel Prize for Physiology and Medicine was shared by two researchers: Sir John B. Gurdon of the Gurdon Institute, Cambridge, United Kingdom; and Shinya Yamanaka of Kyoto University, Kyoto, Japan and the Gladstone Institutes, San Francisco, CA, “for the discovery that mature cells can be reprogrammed to become pluripotent.Read more »

Stem-Cell Company Takes Steps Towards Compliance

Amy RitterLaboratories that offer stem-cell treatments have come under close scrutiny by FDA. Read more »

Stepping Away From the Patent Cliff

Amy RitterIn a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable. The Moody’s rating reflects expectations for fundamental business conditions in the industry over the next 12 to 18 months, and until now, the industry had been limping along under a negative outlook assigned back in October 2007. According to a statement from Moody’s, the change in status reflects the fact that worst of the revenue drops caused by blockbuster drugs falling off patent are over, and so earnings are expected to stabilize. Read more »

Members of Big Pharma Collaborate to Define Best Practices

Amy RitterTen biopharmaceutical companies announced the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges. The ten founding companies include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi. Read more »

Be Prepared

Amy RitterAs the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart, according to an announcement from HHS’s Office of the Assistant Secretary of Preparedness and Response. According to the announcement, HHS has awarded three-year contracts to all five US-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. HHS will choose the vaccine strains to be stockpiled, and expects that with vaccine seed stock already in hand, the government will be able to respond to a flu pandemic more quickly. Read more »

Funding for Embryonic Stem Cell Research Gets Green Light

Amy RitterA federal appeals court has ruled that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed. Read more »

Silicon Meets Biology

Amy RitterChips for drug discovery are not new—gene chips, which are microchips containing snippets of DNA, have been in use for a number of years as diagnostic tools or tools to study gene expression. But a few recent initiatives suggest that the combination of silicon and biology can be expanded even further.

A publication in the Aug. 19, 2012 online issue of Nature Medicine highlights a collaboration between researchers at the Stanford University School of Medicine and Intel Corp. to create a peptide chip. In an interesting marriage of wafer fabrication and biochemistry, the researchers were able to synthesize short polypeptide chains directly on the chip, rather than synthesizing the peptides separately and then affixing them to the chip.

In this instance, the chip was designed to detect antibodies recognizing amino acid sequences from a DNA-packaging protein called histone 2B. The chip included every possible overlapping sequence of every length from the last 21 amino acids of the histone 2B protein, and was used successfully to identify lupus patients with high levels of antibodies against histone 2B. In an accompanying press release, the researchers indicate potential uses for the technology in addition to that as a diagnostic tool for lupus. The chip technology could be used to better understand protein-protein interactions or to help design influenza vaccines that elicit a strong immune response.

On a larger scale, the National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency (DARPA) are investing heavily in tissue chips to more accurately detect drug safety signals. Tissue chips are microchips ranging from the size of a quarter to the size of a house key lined with living tissue. The goal is to accurately model the three-dimensional structure and function of human organs, reproducing the complex interactions, both chemical and biomechanical, that occur among different cell types within an organ system. The chips could then be used to predict drug toxicity and efficacy more accurately and at lower cost than current methods.

NIH is providing more than $70 million in funding over 5 years to develop this technology, with part of the funding coming from the recently established National Center for Advancing Translational Science. DARPA is conducting a separate but parallel program. It has awarded two grants, one to the Wyss Institute at Harvard University and the other to MIT, both of which also are NIH tissue chip grant recipients, to develop engineering platforms capable of integrating 10 or more organ systems.

Different Ways of Structuring Pay-to-Delay Deals

Amy RitterOn the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.  Read more »

Generics Help Hold the Line on Healthcare Costs

Amy RitterImproving lives for less—that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines. The study, Generic Drug Savings in the US, found an impressive $1 trillion in savings over a ten-year period (2002 through 2011). Read more »

« Previous PageNext Page »