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FDA Says No To BHVN, Detraxi Eyeing Solution For Blood Shortage, MRKR On Watch

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Today's Daily Dose brings you news about the FDA decisions related to Biohaven's NURTEC and Celgene's OTEZLA; interim data from Marker's MultiTAA T cell therapy trial and Takeda's phase III trial results of subcutaneous formulation of Vedolizumab in Crohn's disease, among others.

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The FDA has refused to approve Biohaven Pharmaceutical Holding Company Ltd.'s (BHVN) drug candidate NURTEC, proposed for the treatment of amyotrophic lateral sclerosis.

Nurtec is a sublingually administered tablet formulation of Riluzole, which is FDA-approved for amyotrophic lateral sclerosis.

Riluzole is the first FDA-approved medication for amyotrophic lateral sclerosis, which has been available since 1995. The existing formulations of Riluzole consist only of an oral tablet taken with water or an oral suspension.

Biohaven's Nurtec is designed to be placed under the tongue where it dissolves in seconds and is absorbed by the vasculature, thereby eliminating the need for swallowing.

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. Voluntary muscles produce movements like chewing, walking, and talking. (Source: NIH)

The last time the FDA approved a drug for ALS was in 2017 - when the regulatory agency greenlighted Radicava (edaravone), a new treatment in more than two decades.

BHVN closed Friday's trading at $44.10, down 1.43%.

Celgene Corp.'s (CELG) OTEZLA has secured FDA approval for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

Behçet's Disease is a rare, chronic, multisystem inflammatory disease that is difficult to treat. This is the third indication for which OTEZLA has been approved. The drug received the FDA nod for the treatment of psoriatic arthritis in May 2014 and for plaque psoriasis in September of that year.

The annual global sales of OTEZLA in 2018 were $1.61 billion compared to $1.28 billion in 2017. For full-year 2019, Celgene expects OTEZLA to bring in sales of about $1.9 billion.

Celgene anticipates a regulatory decision for OTEZLA in oral ulcers associated with Behçet's Disease from the Pharmaceuticals and Medical Devices Agency in Japan in the second half of 2019. The Company also submitted a Type II Variation to the Marketing Authorization Application earlier this year seeking approval in the European Union.

CELG closed Friday's trading at $90.20, down 0.78%.

The acquisition of insurer Aetna by pharmacy giant CVS Health in a $69 billion deal closed last November. However, there are a number of parties who are opposed to the deal - say, AIDS Healthcare Foundation (AHF), the American Medical Association (AMA), Consumer Action and U.S. PIRG.

The critics of the CVS-Aetna merger fear that the deal has anticompetitive effects on Medicare Part D, pharmacy benefit management services, health insurance, retail pharmacy, and specialty pharmacy.

Judge Richard J. Leon of the U.S. District Court for the District of Columbia who heard the closing arguments from attorneys for the parties and also from several friends of the court (amicus curiae) opposed to the acquisition of Aetna by CVS Health is expected to issue a decision in the not-so-distant future, noting that the merger potentially has "grave consequences to millions of people."

CVS closed Friday's trading at $55.94, down 0.99%.

In a bid to end global blood shortages which could help prevent millions of avoidable deaths, Detraxi, a privately held biotechnology company, is working on a regenerative solution.

The Detraxi technology is backed by global technology billionaire Tej Kohli and is currently undergoing pre-clinical trials.

The Company expects the innovative biotechnology solution, which has the potential to end global blood shortage, to be available within the next ten years.

Marker Therapeutics Inc. (MRKR) is slated to host a conference call and webcast on Monday, July 22, following interim results of its MultiTAA T cell therapy in patients with pancreatic adenocarcinoma, which were presented at the American Association for Cancer Research on Friday.

The interim data were from three arms of the trial - Arm A, which had 9 evaluable patients; Arm B, which had 6 evaluable patients and Arm C, which had 3 patients.

According to the Company, the interim data suggest that MultiTAA therapy may contribute to more durable responses without added toxicity when used in combination with standard-of-care chemotherapy, or as a second-line therapy for patients who are chemo-refractory.

Despite the encouraging results, MRKR fell 27.24% on Friday to close the day's trading at $6.33.

Takeda Pharmaceutical Company Ltd.'s (TAK) subcutaneous formulation of Vedolizumab has met the primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active Crohn's Disease in a phase III trial, dubbed VISIBLE 2.

Vedolizumab subcutaneous is currently under review for approval for ulcerative colitis with the European Medicines Agency and U.S. FDA.

Vedolizumab in intravenous formulation is marketed by Takeda under brand name Entyvio, which is approved for the treatment of Crohn's disease and ulcerative colitis. The drug is marketed in over 60 countries, including the United States and European Union.

TAK closed Friday's trading at $17.38, down 0.11%.

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