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UK MHRA: Early Access continues during the coronavirus (COVID-19) pandemic

The MHRA is committed to speeding up access to innovative new medicines for patients. The MHRA is committed to speeding up access to innovative new medicines for patients. The Early Access to Medicines Scheme (EAMS) gives patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there [...]

2021-04-16T20:00:52+00:0016.04.2021|Drug Development Strategy|

FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

The U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis. “The authorization of the first [...]

2021-04-14T21:18:56+00:0014.04.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]

FDA Continues to Advance Over-the Counter and Other Screening Test Development

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for [...]

2021-04-07T20:51:41+00:0007.04.2021|Drug Development Strategy, Regulatory Affairs|

EMA: EU recommendations for 2021-2022 seasonal flu vaccine composition

EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2021. Manufacturers of egg-based or live attenuated trivalent vaccines for the 2021/2022 season should include these three virus strains: an A/Victoria/2570/2019 (H1N1)pdm09-like virus; an A/Cambodia/e0826360/2020 (H3N2)-like virus; a B/Washington/02/2019 (B/Victoria lineage)-like virus [...]

2021-04-06T22:22:50+00:0006.04.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]

FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment [...]

2021-03-31T10:02:04+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]

FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 [...]

2021-03-31T09:53:21+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who [...]

2021-03-31T09:45:00+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

EMA issues advice on use of regdanvimab for treating COVID-19

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody regdanvimab (also known as CT-P59) to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation. The Agency concluded that [...]

2021-03-31T09:32:05+00:0031.03.2021|Drug Development Strategy, Regulatory Affairs|

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. “Today’s [...]

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021

Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2021 meeting. The Committee recommended granting a marketing authorisation for Copiktra (duvelisib) for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL). The CHMP adopted a positive opinion for Ponvory (ponesimod) for the treatment of active [...]

2021-03-29T20:48:13+00:0029.03.2021|Drug Development Strategy, Regulatory Affairs|

UK MHRA pilots patient involvement in new applications

A pilot project that puts patient involvement at the heart of clinical trials and medicine development has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA). From today, when new applications for selected medicines (new active substances and new indications) are received, the applicant company will be asked for evidence on the patient [...]

2021-03-28T11:22:21+00:0028.03.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an [...]

2021-03-23T20:39:46+00:0023.03.2021|Drug Development Strategy, Regulatory Affairs|

Pharmacovigilance Specialist based in Barcelona

Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]

ANSM: Anticorps monoclonaux: l’ANSM permet l’utilisation en accès précoce de deux bithérapies contre la COVID-19

L’ANSM permet l’utilisation en accès précoce de deux bithérapies d’anticorps monoclonaux dans un cadre sécurisé pour traiter les patients adultes à risque de forme grave de la COVID-19 dès l'apparition des symptômes. Il s’agit des bithérapies casirivimab/imdevimab  du laboratoire Roche et bamlanivimab/etesevimab du laboratoire Lilly France. Nous avons mis en place deux autorisations temporaires d’utilisation de cohorte (ATUc) pour [...]

2021-03-20T13:34:57+00:0020.03.2021|Drug Development Strategy, Regulatory Affairs|

EMA Management Board – highlights of March 2021 meeting

Update on COVID-19 The Management Board heard an update from EMA on the ongoing assessment activities for COVID-19 vaccines and treatments. The Board was informed that EMA and the European medicines regulatory network are facing an unprecedented workload related to the pandemic response. In view of the number of vaccines and therapeutics in the pipeline, the upcoming assessments [...]

2021-03-18T21:31:42+00:0018.03.2021|Drug Development Strategy, Regulatory Affairs|

EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesevimab for COVID-19

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesevimab which are being developed by Eli Lilly to be used in combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone. The decision to start the rolling review is based on preliminary [...]

2021-03-17T21:13:34+00:0017.03.2021|Drug Development Strategy, Regulatory Affairs|