Regulatory Filings and Submissions

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

EC has granted approval of Pfizer’s VIZIMPRO (dacomitinib) as a monotherapy for the first-line treatment of adult patients with advanced or non-small cell lung cancer (NSCLC).

NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

The CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria-Palynziq (pegvaliase).

Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.

The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.

A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.

As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.

The agency clarified the process for development programs for regenerative medicine therapies.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

The guidance explains the process of applying for competitive generic therapy designation.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.

The approval expands the indications for Sprycel (dasatinib) in Europe.

Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.