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BioMarin: The DMD Drug and the FDA Committee Options

Today, the FDA advisory panel will discuss BioMarin (BMRN) product drisapersen for Duchenne muscular dystrophy based on documents released to the committee by the FDA. The FDA said, “The benefit of drisapersen in exon 51 skip amenable patients is ...

November 24, 2015

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

Europe Approves Orkambi ® The European Commission has granted Marketing Authorization for Orkambi ® ( lumacaftor / ivacaftor ), for cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. There are approximately...

November 20, 2015

Ziopharm Wages Its Own War on Brain Cancer

When we hear about a new approach that promises bringing in hopefulness in patients diagnosed with brain glioma, we try to listen and hope for the best, rather than develop and demonstrate skepticism. Are we not walking the road of...

November 19, 2015

Aimmune Therapeutics: Oral Peanut Desensitization Treatment is Promising

Food allergies are bad, significant, dangerous and growing in the U.S. and the rest of the world. More than 30 million people in the United States and Europe have a food allergy, and more than five million people in the...

November 11, 2015

Exelixis Will Begin Reaping the Fruits

Exelixis (EXEL) received the first of the great news we expected to hear. Today, the U.S. Food and Drug Administration (FDA) approved COTELLIC™ (cobimetinib) a cancer drug discovered by Exelixis in combination with Roche’s drug vemurafenib for BRAF V600E...

November 10, 2015

Array Rallies on Successful NEMO Trial Results of Binetinib on NRAS-Mutant Melanoma

When you do your due diligence, you do not lose your faith in what you believed in giving up to the hype that’s sprayed around you. We were happy today to hear Array BioPharma (ARRY) report that results from the...

December 16, 2015

The Two Pianists: Breakthrough in the Diagnosis and Treatment of Diseases. See Also: Illumina

The Evolution of Liquid Biopsy TWO PIANISTS, GUARDANT HEALTH and C4 THERAPEUTICS Biotech firms are bringing future technologies and treatments into the present days, while Stock Market’s evaluators are assessing their values with out-of-date inappropriate methods. The unfair evaluations add...

January 11, 2016

Exelixis Has Good News About CABO

EXELIXIS Good News about CABO The FDA has determined that Exelixis’ (EXEL ) cabozantinib New Drug Application (NDA) for advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed...

January 28, 2016

Who Skipped the Bloody Market? Why Gilead Embarked on Galapagos NV Drug Filgotonib?

The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations,...

January 4, 2016

The FDA Manufacturing Issues. Why Portola Rallied but is Still Way Undervalued

MANUFACTURING ISSUES?! Why PORTOLA Stock Rallied? On Aug. 17, 2016, we learned that the FDA sent a Complete Response Letter (CRL) to Portola Pharmaceuticals (PTLA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa), which is an antidote...

December 26, 2016

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