Top Regulatory News Stories – Week Ending March 23, 2018

This week saw the approval for Sun Pharma’s first biologic program along with a supplemental approval for Seattle Genetics. Here is my recap of the top regulatory news stories for this week:

The FDA on Monday officially launched its pilot project to publicly release portions of clinical trial-related summaries from pivotal trials, with initial data coming from Janssen’s recently approved Erleada (apalutamide), which is for patients with prostate cancer that has not spread.

Sun Pharma announced that the U.S. FDA has approved the biologic ILUMYA™ (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This is a major breakthrough for Sun Pharma which is betting big on specialty drugs to stay ahead of generic rivals:

Seattle Genetics announced that the FDA has approved ADCETRIS (brentuximab vedotin) in combination with chemotherapy in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma.  This is the fifth FDA-approved indication for ADCETRIS.

Pfizer Inc. and partner Astellas reported that the FDA has accepted their sNDA  for the combination of Xtandi and androgen deprivation therapy in in non-metastatic Castration-Resistant Prostate Cancer (CRPC). The FDA also granted a Priority Review designation and is expected to make a decision on the expanded indication in July. Xtandi has already been approved for the treatment of patients with metastatic CRPC.

Regeneron say they hit the primary endpoint in their Phase III study for severe non-proliferative diabetic retinopathy, setting up a supplemental application at the FDA.

Heron Therapeutics announced good news from its Phase III trial for a long-acting local anesthetic made up of bupivacaine and meloxicam, which Heron calls HTX-011. This data will support their bid for FDA approval of the drug later this year.

Based on positive results from a Phase 3 study of siponimod in later-onset multiple sclerosis, Novartis plans to submit an application for FDA approval:

AbbVie is abandoning plans to seek an expedited approval from the FDA for its troubled oncology drug Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC).  This follows disappointing midstage data for the experimental drug:

The FDA released two new guidance documents to help companies address a final rule from 2016 on postmarketing safety reporting (PSMR) requirements for combination products.

In other news…

Alzheon has filed for an $80M IPO to take a once-failed Alzheimer’s drug into Phase III

Celgene will bolster its neuroscience pipeline through a $150 million preclinical-stage deal with Prothena potentially picking up three compounds.

Regeneron Pharmaceuticals unveiled a new research collaboration with RNA specialist Alnylam Pharmaceuticals aimed at developing new drugs for a form of liver disease called non-alcoholic steatohepatitis (NASH).

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