Top Regulatory News Stories – Week Ending March 9, 2018

This week we saw the approval of a new molecular entity by the FDA along with the first marketing authorization approval for a genetic health risk assessment. Here is my recap of the top regulatory news stories for this week:

The FDA approved TaiMed Biologics’ Trogarzo (ibalizumab-ulyk) for the treatment of adults with chronic HIV infection who have not responded adequately to other treatments.

23andMe became the first company with FDA marketing authorization for genetic health risk assessments for three cancer-associated variants.

The FDA has approved a supplemental new drug application for Sunovion’s Latuda (lurasidone) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in children and adolescents aged 10 to 17 years.

Microbiome company Finch Therapeutics announced that the FDA has issued Fast Track designation to CP101, its oral microbiome capsule in development for recurrent Clostridium difficile infection.

Zynerba Pharmaceuticals announced a positive meeting with FDA regarding its planned development strategy for ZYN002 for Fragile X syndrome and the company said it plans to conduct a single pivotal study to support an NDA filing

The FDA has accepted Jazz Pharmaceuticals’ NDA for standard review for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The PDUFA goal date for an FDA decision is December 20, 2018.

ProMetic Life Sciences received the FDA’s Rare Pediatric Disease Designation for its Inter-Alpha-Inhibitor-Proteins (IAIP) treatment for necrotizing enterocolitis.

GlaxoSmithKline and Innoviva announced that the European Commission has approved a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) in patients with asthma.

The advertising and promotional labeling branch (APLB) at the FDA Center for Biologics Evaluation and Research (CBER) released an untitled letter sent last week to CSL Behring for claims and presentations that “misleadingly overpromise the effect that the drug will have on a hemophilic patient’s activities and overall quality-of-life.”

January saw a steep decline in the number of FDA approvals for generic drug applications when compared to the three previous months and all of FY 2017, and that trend is continuing into February, according to the latest activities report.

On Wednesday, FDA Commissioner Scott Gottlieb, M.D., blasted a “rigged” contracting system that’s hurting uptake and development of biosimilars, pledging agency action to amend the situation.

In other news…

Unum Therapeutics, which is developing antibody-coupled T cell immunotherapies for cancers, filed on Friday with the SEC to raise up to $86 million in an initial public offering.

Immuno-oncology biotech Arcus Biosciences sets terms for $99 million IPO on Monday:

A closely watched drug candidate from Dermira Inc. failed to meet any of its objectives in two Phase 3 studies testing the topical therapy as a treatment for acne, dashing hopes raised by an earlier trial success.

Vivek Ramaswamy is launching his seventh biotech company, Metavant, and is building a diabetes pipeline with the acquisition of a Phase II drug from Ligand

Merck will partner with Eisai to develop and market their cancer drug Lenvima, inking a sweeping collaboration deal potentially worth up to $5.76 billion

Martin Shkreli was sentenced to seven years on felony fraud convictions

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