Contributor: Allison Thrower

In October, I reviewed some of Broadway’s most buzz-worthy musical comedies and paired them with their gastronomical counterparts for the consummate New York Dinner-and-a-Show experience. With DRG’s NYC Market Access Seminar fast approaching, now would be a good time to book your tickets and put in your reservations for some more unforgettable meals and timeless theater:
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Contributor: Lulu Pickering and Michaela Miller

On March 20, 2012, the U.S. Supreme Court announced a highly anticipated ruling and rejected the patents associated with Prometheus Laboratories’ GI in-vitro diagnostic test. The patents concern the monitoring of thiopurine therapy for autoimmune diseases; the court declared that the “Prometheus’ process is not patent eligible.” On March 26th the Supreme Court next ordered the U.S. Court of Appeals for the Federal Circuit to revisit whether human genes are patent eligible and to reconsider its earlier decision to hold valid patents for Myriad’s BRCA1 and BRCA2, which are two-specific gene mutations linked to breast cancer. Read more.

Contributors: LaTese Briggs, Ph.D. and Allison Thrower

The FDA is reviewing the possibility of marketing certain HIV drugs as a preventative measure for individuals who are healthy but at-risk for infection. However, research that was viewed optimistically over a year ago is coming under fire by the AIDS Healthcare Foundation (AHF) when the group petitioned against FDA approval due to questions of efficacy, high costs, side effects and patients’ lack of commitment to the regimen. Whether or not the petition sticks, the real-world, widespread use of this treatment ultimately comes down to the payers. Read more.

Contributor: Natalie Taylor, Ph.D.

Mylan announced yesterday that the company has launched the first generic version of escitalopram (Forest Laboratories’ Lexapro, Lundbeck’s Cipralex/Seroplex). Under an agreement with Forest, Mylan will exclusively be able to market its product until the pediatric exclusivity of Lexapro’s patent expires in mid-March 2012. The launch of generic escitalopram marks the end of an era for branded selective serotonin reuptake inhibitor (SSRI) antidepressants. Read more.

Contributor: Allison Thrower

Napa promises a leisurely detour for a weekend following, for example, the Competitive Landscape Seminar Series: Oncology in nearby San Francisco. Despite the time of year, the area still features spectacular scenery, quaint shopping and dining locales, mild weather and arguably some of the best wine in America, with the off-season perk of avoiding throngs of summer tourists. While you’ll never be able to explore all of the county’s 300-plus wineries, it is possible to get more than a taste of the culture (and viticulture) of this small but welcoming bit of Northern California in only the span of a day.
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Contributor: Gideon Heap

After a second FDA Advisory Committee meeting, Qnexa received a landslide 20-2 vote in favor of approval. Opinion seems to have turned in Qnexa’s favor following reassurance that the proposed REMS will prevent the use of Qnexa in pregnant women and will serve to monitor the emergence of adverse effects. This vote does not guarantee approval; the final decision will come from the FDA in April 17, but the agency will be under pressure to approve Qnexa following such a positive result. Read more.

Contributor: Andrew Merron

On 9th February 2012, the FDA finally published draft guidance addressing the over-arching requirements for biosimilar medicines to gain approval in the United States. The publication has been met with considerable relief throughout the biosimilar industry after much anticipation and speculation, although provides only general guidance and little detailed information. Read more.

Contributor: Christine Helliwell

Well, it has been a busy start to the year for the type 2 diabetes market, with both good and bad news from the FDA for some of the major players in this market. First came the news on the 19th of January that the FDA had issued a Complete Response Letter (CRL) for Bristol-Myers Squibb/AstraZeneca’s dapagliflozin, the first-in-class sodium glucose cotransporter-2 (SGLT-2) inhibitor. Read more.

Contributor: Rachel Webster

Medivation/Astellas Pharma’s MDV3100 took center-stage at the annual ASCO Genitourinary Cancers Symposium, and was heralded as practice-changing treatment for metastatic castration-resistant prostate cancer (mCRPC). MDV3100 becomes the fifth novel agent to significantly improve median overall survival (MOS) in mCRPC in less than three years. Read more.

Contributor: Matthew Killeen, Ph.D.

After a testing last year for Multaq (Sanofi’s dronedarone) – in 2011, its major PALLAS study was terminated and safety alerts were issued by the FDA and European Medicines Agency – 2012 offers a ray of hope for the antiarrhythmic drug.
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