News and Comments

VERTEX: Orkambi Approved In Europe. What Vertex is Doing to Further improve CF Treatments

  Friday, November 20, 2015

Europe Approves Orkambi®  More...


  Wednesday, September 05, 2012



  Tuesday, May 15, 2012

The time has come for redefining the meaning of “creating shareholders value” in the biotech sector. Pinpointing the real value has become imperative. It is the road to a fair assessment of innovative biotech firms. It helps investors reap the fruits of the real value of excellent firms at the right time, rather than rush to sell extremely promising stocks while still undervalued. It makes investors think twice before throwing their shares of firms that are installing one by one the building blocks of their vision. Creating shareholders value is investing in the future. The cost of this investment shouldn’t be cause for downgrading the stocks because of overspending, which has become a normal pattern. We still see all development-stage biotech stock prices slashed following the announcement of their quarterly results. There is a big difference between spending on the future and spending because the money has been made available. Investors can know the difference. The first thing to look for is whether the firm has any program in development that is worth spending on, including buying firms having a technology that is badly required for the successful outcome of the firm’s program. This kind of investment should not be punished or treated as unnecessary spending. 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...

VERTEX: First Drugs ever to target the root-cause of cystic fibrosis are promising.

  Monday, June 13, 2011

Like many other chronic progressive intractable diseases, Cystic Fibrosis (CF) pathology is about misfolding of the transmembrane conductance regulator (CFTR) protein as a result of CFTR gene mutations. The malfunctioning CFTR protein loses its trafficking capability and fails to reach the cell membrane, resulting in the accumulation of thick, sticky mucus that plugs the airways and chokes the pancreas. The symptoms are chronic coughing, difficulty breathing, malabsorption of food and nutrients from the intestine, inability to gain weight, diarrhea, or bulky, foul-smelling, greasy stools, or constipation. The disease is debilitating and affects about 100,000 babies, children and adults worldwide. The presence of salty skin confirms the diagnosis of the disease. More...

VERTEX: What About Now?

  Wednesday, May 25, 2011

Yesterday, the FDA approved Incivek (telaprevir), Vertex’ (VRTX) HCV protease inhibitor, which demonstrated in clinical trials it cures more treatment naïve patients and more patients who did not benefit from conventional treatments in much less time than Merck’s Victrelis (boceprevir). Less than a month ago, the FDA Antiviral Drugs Advisory Committee voted 18-0 to recommend approval Incivek for HCV patients with genotype 1 chronic hepatitis. The recommendation was based on clinical trial data demonstrating that combining Incivek with pegylated interferon/ribavirin produced a higher cure rate in less time than standard therapy alone. This improvement is most notable for hard-to-treat patients including those with HCV genotype 1, people with liver cirrhosis, and those who did not respond to a prior course of conventional. Merck's drug Victrelis (boceprevir) also an HCV protease inhibitor, was given a positive recommendation and was eventually approved. More...


  Thursday, May 05, 2011

First, we congratulate our subscribers who did not follow the skeptics and believed in the rationality of science and kept their Vertex’ (VRTX) and Regeneron’s (REGN) shares despite years of negative campaigns against the two firms. Following the rally in VRTX, another rally started in REGN for rational reasons. Both firms are among our TOP TEN selection. More...

VERTEX: Time For Celebration

  Wednesday, April 13, 2011

From no treatment at all, to treatments that do not work well, new therapies are reaching the market, probably this month or next, moving hepatitis C virus (HCV) victims from the dark zone of desperation into the light of amazing anticipation – probably of a cure. We don’t know if the opening statement is one of those run-on sentences, from which you might have lost your breath trying to read it to your spouse, but we know with certainty that the news coming from Vertex’ (VRTX) drug is breathtaking. The road has been long, very long, yet, this is always the case when new molecules are designed to become drugs for life-threatening diseases that have yet to find treatments. The fact is that it is a real miracle just finding a road towards conquering a disabling virus that disrupts the functioning of one of the major vital organs. HCV could cause fibrosis (cirrhosis) of the liver, which could, sometimes, necessitate liver transplant or cause cancer. More...

No Role For Serendipity In Vertex' achievements

  Saturday, February 26, 2011

Bad firms do not design and develop chains of breakthrough drugs. Serendipity exists, no doubt about it, but it has no role in Vertex’ (VRTX) accomplishments. Vertex’ products are backed by plenty of science and technologies that are highly appreciated by academia and by well regarded scientists. The time has come for the market analysts to let Vertex’ shareholders share the benefits this firm has offered AIDS patients, patients infected with hepatitis C virus (HCV), and now, as we have just learned from the news, cystic fibrosis patients.  More...

VERTEX (VRTX): At the Finish Line

  Monday, August 09, 2010

When an investigational drug proves it can eradicate a virus we call it a breakthrough. The nearest to approval of the expected breakthroughs is Vertex’ (VRTX) drug telaprevir, a specific hepatitis C virus protease inhibitor. The drug was a blessing for the infected victims who had it in clinical trials. It brought a miracle happy ending to what seemed to be an endless nightmare of acute liver inflammation, chronic liver inflammation, liver cirrhosis, liver transplant and possible liver cancer. We expected telaprevir to be greeted by the government and insurance companies, which spend ton of money on the HCV liver problems where treatments that do not work are, nevertheless, paid for.  More...

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