Monday January 5, 2009 Navivest

Shares of Apple (AAPL) are up over 3% today, after the company’s CEO Steve Jobs issued a letter explaining his recent dramatic weight loss and that, at least for today, is reassuring investors.

According to the letter, the reason for the weight loss throughout 2008 has been diagnosed as being the effects of a hormonal imbalance that has been “robbing me of the proteins my body needs to be healthy. Sophisticated blood tests have confirmed this diagnosis.” He has already started treatment for it and “will continue as Apple’s CEO during my recovery.”

Apple’s stock tumbled late last month, after the company announced that Steve Jobs would not be delivering the keynote address at the 2009 Macworld this month as he has done for the past 11 years.

This prompted concerns that Steve Jobs was suffering a reoccurrence of the pancreatic cancer that he was diagnosed

...

GenVec, Inc. reported today that the U.S. Food and Drug Administration (FDA) has approved GenVec’s TNFerade™ for Fast Track development in the treatment of locally advanced pancreatic cancer. TNFerade™ is designed to stimulate the production of immune system proteins with anti-cancer properties that are injected into tumors. GenVec is developing TNFerade™ for use in combination with other tools such as radiation and chemotherapy for the treatment of various cancers.

TNFerade™ qualifies for Fast Track status because GenVec provided the FDA with evidence that TNFerade™ may have potential to improve the survival rate of patients suffering from pancreatic cancer. The FDA grants Fast Track designation to drugs that are designed to treat life-threatening conditions and that have a proven potential to address an unmet medical need.

Fast Track designation only applies to situations where a developmental stage drug is used to treat one specific

...

Eli Lilly and Company (LLY) is a global healthcare company with core products in a number of primary-care pharmaceutical markets. The leading product is Zyprexa, a treatment for schizophrenia and bipolar disorder. The company's other leading drugs include Gemzar (pancreatic cancer), Evista (osteoporosis), Cymbalta (depression), Byetta (type-II diabetes), Cialis (erectile dysfunction), Strattera (ADHD), and Alimta (chemotherapy).The company is entering a challenging period, brought about by recent pipeline disappointments, most notably uncertainty surrounding antiplatelet drug Prasugrel. Although we believe the underlying fundamentals of the company remain solid, the recent pipeline setbacks and lack of clarity surrounding prasugrel will likely limit the upside to the stock. We also believe that sales of Zyprexa will begin to decline in 2008 as generic Risperdal eats into market share. We see little movement in the stock until the above issues are addressed. We rate the shares a Hold with ...

GenVec, Inc. (NASDAQ: GNVC) announced Thursday that it received a third year option of funding, as part of a five-year contract with the National Institute of Allergy and Infectious Disease. The company will receive up to $3.8 million to continue the development of new HIV vaccine candidates. GenVec’s research is based on its proprietary adenovirus vector and production cell line technologies.

“We appreciate NIAID’s decision to execute its renewal option under our contract,” said Dr. Rick King, GenVec’s senior vice president of research and development. “GenVec’s adenovector technology platform now includes six distinct serotypes that can be used singly or in combination.”

GenVec and the NIAID Vaccine Research Center have partnered on HIV vaccine development under a Collaborative Research and Development Agreement for several years. Under a separate contract, GenVec has produced adenovector-based HIV vaccines that have been tested in about 1,400 subjects in 16 NIAID-sponsored Phase I and Phase II clinical

...

Cell Genesys (Nasdaq:CEGE) focuses on the development and commercialization of novel biological therapies for patients with cancer. The company’s lead product platform, GVAX immunotherapy for cancer, holds the potential to treat multiple types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer.

The company today announced the U.S. Food and Drug Administration has placed an expected partial clinical hold on phase 3 program for GVAX. The halt follows the company’s August 27, 2008 announcement in which it said it will end the VITAL-2 phase 3 trial for GVAX.

Cell Genesys terminated the trial after its Independent Data Monitoring Committee (IDMC) observed an imbalance in deaths between two treatment arms of the VITAL-2 study, which compared GVAX immunotherapy in combination with Taxotere to Taxotere plus prednisone in patients with advanced prostate cancer.

In today’s announcement, Cell Genesys said the FDA confirmed that patients in the VITAL-1 phase 3 trial

...

Steve Jobs took the stage at about 1 PM today at Apple’s (AAPL) “Let’s Rock” event where it is expected that he will introduce a new line up to the Ipod. Behind him on a screen, was the line “The reports of my death are greatly exaggerated.”

The joke is a reference to concerns about his health that recently became an issue after Steve Jobs appeared at an Apple (AAPL) conference looking very thin and gaunt. It even got to the point where on August 27th of this year, Bloomberg actually ran a Steve Jobs obituary across its screen after updating his biography/obituary and accidentally ran it. Steve jobs was diagnosed with pancreatic cancer back in October 2003 and successfully underwent surgery in the summer of 2004.

Unfortunately, Wall Street is apparently not expecting anything exciting from the conference as the stock keeps getting battered, currently down about $5.15

Tag:

...

Cell Genesys, Inc. (Nasdaq: CEGE) focuses on the development and commercialization of biological therapies to treat multiple types of cancer. The company’s lead product platform, GVAX immunotherapy, holds the potential to treat various types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys today announced it has terminated VITAL-2, the second of two phase III clinical trials of GVAX.

The trial was set to compare GVAX immunotherapy in combination with Taxotere to Taxotere combined with prednisone in patients with advanced-stage prostate cancer. However, after reviewing an imbalance in deaths between the two treatment arms of study, the company’s Independent Data Monitoring Committee (IDMC) recommended the trial end to ensure patient safety.

“Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients

...

Bionovo (BNVI) is leveraging its proprietary drug discovery and development platform to elucidate promising drug candidates from naturally occurring compounds.