Regulatory Roundup: Top News Stories – Week Ending August 4, 2017

There was a lot of regulatory news this week including an extension of the PDUFA bill, FDA approval of two New Molecular Entities, and an approval of the first treatment for Chronic Graft Versus Host Disease. Here is my summary of the top regulatory stories this week:

The US Senate passed a bipartisan bill to reauthorize the FDA User Fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. President Trump is expected to sign the bill which will allow the FDA to collect industry user fees through 2022 to help pay for timely reviews.

The FDA approved Abbvie’s Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis:

Jumping ahead of its late August PDUFA date, the FDA approved Celgene and Agios’ enasidenib for acute myeloid leukemia. The approval comes with a boxed warning designed to call attention to the risk of differentiation syndrome, an adverse reaction that could be fatal if untreated. Agios and Celgene share rights to enasidenib as part of a partnership that began in 2010.

The FDA approved Jazz Pharmaceuticals’ Vyxeos (daunorubicin and cytarabine) for the treatment of adults with two types of acute myeloid leukemia

The FDA approved AbbVie’s Imbruvica as the first treatment for Chronic Graft Versus Host Disease. The treatment was previously approved for certain indications in treating chronic lymphocytic leukemia.

Seattle Genetics announced that Health Canada has issued a non-conditional marketing authorization for use of ADCETRIS as post-autologous stem cell transplant (ASCT) consolidation treatment of patients with Hodgkin lymphoma (HL) at increased risk of relapse or progression.

 Agile Therapeutics announced that the FDA has accepted for review their NDA re-submission for Twirla® (AG200-15), an investigational low-dose combined hormonal contraceptive patch.

Bristol-Myers Squibb announced that the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA). This approval, which allows for the expanded marketing of ORENCIA as a treatment for PsA in all 28 Member States of the EU, marks the second new indication for ORENCIA in less than a year.

An FDA advisory panel recommended against approving Johnson and Johnson’s experimental arthritis drug sirukumab by a vote of 12-1. FDA reviewers reported that here were more deaths in patients taking the experimental rheumatoid arthritis drug than among those taking a placebo:

AstraZeneca said its Imfinzi (durvalumab) oncology drug, which treats locally-advanced, unresectable non-small cell lung cancer won Breakthrough Therapy Designation from the FDA after a successful phase III trial. This comes just a few days after Imfinzi failed a crucial clinical trial when administered as a combination with tremelimumab.

AstraZeneca also reported that the FDA has accepted and granted priority review for its NDA for its Bruton tyrosine kinase inhibitor, acalabrutinib, for mantle cell lymphoma.

 Ra Pharmaceuticals received Orphan Drug Designation from the FDA for RA101495 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria:

Kite Pharma announced that it has submitted an MAA to the EMA for their axicabtagene ciloleucel CAR-T treatment for patients with various types of lymphoma.

Spark Therapeutics announced that it has submitted a MAA to the EMA for voretigene neparvovec, an investigational, one-time gene therapy for the treatment of patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa

The FDA published draft guidance to help ensure child-resistant packaging (CRP) statements in drug labels are clear, useful, informative and, to the extent possible, consistent in content and format.

The FDA finalized guidance first drafted in 2013 to assist sponsors in the development of new antibacterial drugs for the treatment of serious bacterial diseases in patients with an unmet medical need.

Amgen and Allergan have submitted a BLA to the FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).

In other news…

Bristol-Myers Squibb has agreed to acquire Boston-based IFM Therapeutics for an upfront payment of $300m to strengthen its oncology pipeline.

ICON plc has acquired Mapi Group. The deal makes ICON the world’s second largest provider of late phase drug development services.

Diagnostics company LabCorp is acquiring contract research organization (CRO) Chiltern International for more than one billion dollars:

Takeda Pharmaceutical and Cardurion Pharmaceuticals have created a new cardiovascular development partnership.


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