Regulatory Filings and Submissions

Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).

The decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

FDA has granted breakthrough therapy designation to padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy keytruda (pembrolizumab).

If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.

The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.

The report details OPQ’s accomplishments over the past five years.

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Givlaari (givosiran) be granted marketing authorization in the European Union.

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

The sNDA was accepted after positive results from a Phase III trial were published in September 2019 that concluded the drug reduced the incidence of cardiovascular death or the worsening of heart failure versus placebo.

The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.

Pressures on FDA will affect industry’s success in bringing new therapies to market.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.