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 important for the safety use of several new Factor Xa inhibitors anticoagulants aimed at replacing Coumadin (warfarin). The Factor Xa inhibitors anticoagulants have many advantages over …

Observing the biotech sector’s stock prices post losses yesterday, Wednesday, Dec. 21 convinced us that investors and traders in the biotech sector might have wrongly interpreted a bipartisan Senate report regarding the high price of drugs. The report is the outcome of a study that forms the basis of a recommendation that would enable the Congress take the right action against unjustified increases in the …

Ionis Pharmaceuticals (IONS) has further good news with a new revelation from Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals that the Phase 3 COMPASS study met its primary endpoint. COMPASS is a randomized, double-blind, placebo-controlled, 26-week Phase 3 study evaluating the firm’s drug volanesorsen in 113 patients with severe hypertriglyceridemia.   The average incoming triglyceride level of patients in the study was 1,261 mg/dl. …

Prohost Letter #403 Part 2 Continued From Wednesday Instead of continuing yesterday article about Agenus, we decided to post it all so that the reader can find it in one place. Important changes and additions have been made especially under the headline “Near-­Term Priorities, Possibilities and Catalysts”, which are important to read. Learning More About AGENUS Since its inception, Agenus (AGEN), previously known as Antigenics, …

ProhostLetter #403 Part 1 On December 8, 2016 under News & Comments Prohost commented on President Elect Trump’s statement that he is going to bring down the exorbitant drug prices. The Skyrocketing Prices of Drugs Like everybody else we happen to talk to, we agree that the prices of drugs have skyrocketed to a level that made them unaffordable. It is a serious problem that …

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …

President Elect Trump was quoted in a Time person of the year as saying “I am going to bring down drug prices.” The President Elect did not say he is going to bring down the drug producing and developing firms. Mr. Trump did not say he will bring down medical research, which is mostly conducted by the biotech and pharmaceutical firms. He did not say …

Bellicum Pharmaceuticals (BLCM) announced results from the BP-004 multicenter clinical trial for children with Primary Immune Deficiencies (PIDs) and hemoglobinopathies. The candidates received an add-back of Bellicum’s BPX-501 modified T cells following a haploidentical, T cell-depleted hematopoietic stem cell transplant (haplo-HSCT). The data were presented in oral and poster sessions today during the 58th Annual Meeting of the American Society of Hematology (ASH). Results: All …