News and Comments

Ariad's mTOR and the FDA Committee

  Tuesday, March 20, 2012

Ariad’s (ARIA) drug Taltorvic (ridaforolimus) is a novel small-molecule inhibitor of the protein mTOR interferes with cell growth, division, metabolism and angiogenesis. The FDA independent committee will discuss, debate and decide whether this drug should, or should not be approved for metastatic soft tissue sarcoma or bone sarcoma whose disease has not progressed after at least 4 cycles of chemotherapy.  More...

AGENUS: Stimulon Stimulates The Immune System And Investors

  Friday, March 16, 2012

Agenus (AGEN) has outperformed. Of course some profit-taking was expected, but the firm has definitely done a good job rebuilding a new pipeline backed by updated information and more mature understanding of the immune system and the requirements for a successful immunotherapy. Investors might have been missing the transformation but when they got the chance to look deeper into the firm’s programs, they liked what they saw. AGEN’s  price has more than doubled since January 2012 on large trading volume, insinuating that the rally is for real and that investors are expecting good news to finally emerge from the firm’s labs and finances in the same time. A relevant comforting symptom is that Agenus’ partnership with GlaxoSmithKline (GSK) has proven solid like a rock, which might have helped convince the skeptics that Agenus’ QS-21 Stimulon is genuine adjuvant essential for to the efficacy of vaccines both preventive and therapeutic.  More...

XOMA: In Pursuit Of Novel Diabetes Drugs And New Collaborators

  Friday, March 09, 2012

In chronic debilitating diseases, improved therapeutics are those state-of-the-art drugs that control the devastating symptoms and limit, or prevent disease progression without causing other pathologies through the treatments’ adverse effects. More...

Vertex/Gilead Confusion

  Thursday, March 01, 2012

Hepatitis C virus (HCV) treatments are moving stocks of HCV developers up and down in a chaotic way that makes no sense. While Vertex’ (VRTX) Incivek sales have been breaking the record of drug sales, investors who have been fed immature and unconfirmed knowledge that Pharmasset’s oral HCV therapeutics combination will render Incivek obsolete caused a selloff in VRTX. Investors logic that patients would definitely prefer all oral drugs over a combination that has injectable alfa interferon is undisputable, that’s we too are waiting for a successful all oral HCV treatment, which has yet to emerge.  More...

Pharmacyclics: When the Power of Biotechs' Pipelines Overshadows the Market’s influence on the Firms' Values.

  Thursday, February 23, 2012

Pharmacyclic’s (PCYC) story is one of a few where the power of pipeline drugs has overshadowed the stock market’s technical influence on the biotech companies’ values. In other words, in the case of Pharmacyclics, investors should be looking for something extraordinary in the firm’s pipeline, in its choices of its programs, in its plans and strategies in developing its pipeline products and its capability of executing its plans and reaching its goals. Pharmacyclics’ Bruton’s tyrosine Kinase (BTK) inhibitor PCI-32765 therapeutic is unique. In December 2011, Pharmacyclics was granted U.S. patent that testifies to the drug’s exceptionality. It is, indeed, the first irreversible inhibitor in the BTK zone.     More...

Illumina, Roche and Fairness

  Thursday, February 09, 2012

Illumina (ILMN) is occupying the center stage these days. Roche’s persistent attempts to acquire ILMN, has opened investors’ eyes on the importance of this firm’s technology in moving away from the road of stagnation to that of innovation. Innovation is the insurance that guarantees the survival and growth of the drug companies in the future that has already begun. Illumina’s technologies and marketed state-of-the-art sequencers and gene analyzers have been a major contributor to the flourishing of information about the origins of diseases at the molecular level.  This capability, which lured Roche, was overlooked by Wall Street investors who have recently caused a selloff in the stock for theorized reasons. The real value of Illumina resides in its indispensability as the cornerstone of future advancement in medical diagnosis and treatment. With all the new-targeted drugs on the market and in the firms’ pipelines, the current diagnostic and treatment statuses are still far from perfect. More...

FDA Approves KALYDECO™ (ivacaftor) The First Medicine to Treat the Underlying Cause of Cystic Fibrosis

  Tuesday, January 31, 2012

The U.S. Food and Drug Administration (FDA) has approved KALYDECOTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. KALYDECO  is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. More...

Xoma: New Plans That Can Bring Hope

  Monday, January 23, 2012

Thursday’s news brought to mind our old friend, Xoma (XOMA), which, unlike Raymond, not everybody loves it. Actually, many still love Xoma, but with reservation and resentment. Many time we questioned whether Xoma is addictive. For a couple of months, when we had nothing to write, good or bad, about Xoma, readers accused us of infidelity. It is important to mention that two decades ago, many investors highly treasured Xoma, viewing it as the personification of hope for breakthrough drugs the budding biotechnology industry was promising to get across to medical practice. In London, investors asked us if we know Xoma and the same came about in Paris, Milan, Rome, and Zurich. As a matter of fact, this firm was esteemed everywhere for its technologies, scientists, and pipeline products. More...

Elan: Between Speculation and Reality, Where the Firm is headed now?

  Thursday, January 19, 2012

Elan (ELN) was granted FDA approval of Tysabri for Multiple Sclerosis in November 2004. It was great news for the firm and its shareholders, as it was no secret that the drug was a breakthrough expected to become bestseller in a huge market. The celebration of the great achievement was of short duration. Three patients developed PML (progressive multifocal leukoencephalopathy), two of them died. It was Biogen Idec, Elan’s partner on Tysabri, not the FDA, which decided to withdraw the drug from the market. The FDA was aware that the reward from such a great drug outweighs the risk, which is a rare complication that would occur with any drug that compromises the immune system and there are many on the market. Bottom line, Tysabri was reinstated on the market on condition that the patients take part in a risk-minimization program with mandatory patient registration and regular follow-up. More...

Circumstances That Encourage Picking Specific Biotech Stocks

  Tuesday, January 10, 2012

Picking biotech stocks for short-term and long-term investment could be a good practice if investors know what to pick. In most cases, picking biotech stocks that have no near-term catalysts could be disappointing, leading investors to wait and wait, then get bored, and sell their shares at a great loss. To pick firms in early- or mid-phase development the firms should have very advanced technologies and product pipelines with strong evidence of promise that they are the envy of rich pharmaceutical firms. The large-pocketed drug developers usually desire what they need and buy what they desire. Most are currently in dire need of breakthrough products, as the patent lives of many of their bestsellers are expiring. Investors must be aware of the fact that stocks of development-stage firms’ are destined to fall after each and every quarterly financial results announcement, as they have no revenues or incomes. They also fall after shareholders get disappointed in the negative performances of their stocks, hence, trash them. Compensation can come early, however, in the event of takeovers, alliances that pay huge upfront payments, or the announcement of stunningly positive clinical trial results of products that deal with life-threatening diseases with large markets. Focused investors may be able to catch big fish in situations exemplified by the following three circumstances: More...

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