| Biovest Meets Skeptic's Requirements for 'The Next Dendreon' - Part 4 James Hill, MD submits: We’re looking at why Biovest (BVTI.PK) may qualify as “the next Dendreon” under standards biotech analyst David Miller describes in his May 12 Minyanville article. Dendreon’s (DNDN) prostate cancer vaccine, Provenge (sipuleucel-T), received FDA approval in April 2010, creating a paradigm shift in cancer treatment. In this series, Part 1 discussed vaccine manufacturing; Part 2 and Part 3, cancer vaccine technology.Complete Story » seekingalpha.com |
AstraZeneca Hopeful for Positive FDA Call on Blood-Thinner but Doubts Linger EP Vantage submits:An FDA advisory committee’s strong vote in favor of AstraZeneca’s (AZN) blood-thinner Brilinta was tempered by long-held concerns over the failure of the drug’s pivotal trial to show a survival benefit in the US population when compared to Plavix (Event - Brilinta has questions to answer, July 21, 2010). With adcom members raising concerns over this unexplained inconsistency in acute coronary syndrome (ACS) patients, there remains the possibility that the FDA will order another trial to sort out the discrepancy.The 7-1 vote in favor of Brilinta was emphatic, and while the FDA does not always follow the advice of its adcoms, many observers believe there is a good chance the agency will grant approval. Yet the 18,624-patient Plato study found an unexplained trend toward increased cardiovascular events and death in its 1,413-subject US subgroup, and that concern has hung over the candidate ever since (Brilinta data soothes some patent cliff woes for Astra, September 1, 2009). This divergence prompted one panel member to vote no because of lack of assurances of a follow-up study, and others to raise questions about how patterns of care in acute coronary syndrome, including the use of aspirin, might have affected the outcome.Complete Story » seekingalpha.com |
FDA Raises Concerns About Fibromyalgia Drug The FDA raised safety concerns about a proposed Jazz Pharmaceuticals drug to treat the pain disorder fibromyalgia, including the potential for misuse and abuse of the product. online.wsj.com |
Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value R.J Steffens submits:Generex Biotechnology's (GNBT) shareholders have read a lot of corporate news as of late, from a management change to the signing of sales and distribution agreements. Last week, Ms. Gluskin was replaced as CEO by VP and General Counsel Mark Fletcher. Generex has a loyal base of shareholders, due to the leadership provided by Ms. Gluskin and Ms. Perri, who have brought the company very close to achieving the success they dreamed of, and Monday another step appears to have been taken to strengthen the foundation of the corporation. Undoubtedly, this could not have come together without the work of the former CEO, since the management change only occurred last week. She should be recognized for her effort, and I begin by doing so. Generex announced Monday morning that they have reached an agreement to acquire a 51% ownership stake in Global Medical Direct LLC. This news comes after a weekend full of wild speculation, due to an after hours press release by Generex alerting investors that they would be making a key material announcement before yesterday morning's market opening. Many shareholders were guessing partnership news could be brewing between Generex's oncology subsidiary and Pfizer (PFE) for the small biotechnology's immunotherapeutic peptide vaccine that has drawn attention due to the very promising interim Phase II results for early stage breast cancer patients that were last updated at ASCO in June. While news of a partnership nature for Generex waits for a later date, I feel Monday's news, once digested, is a surprisingly smart strategic development that brings synergistic strength most often seen in much larger companies completing channel distribution deals to support product growth.Complete Story » seekingalpha.com |
Health-Plan Rules Are Eased Amid pressure from employers, the Obama administration loosened rules for bare-bones health-insurance policies. It marks one of the administration's biggest steps to peel back regulations that big business found onerous under the health-care overhaul. online.wsj.com |