2012, Biosimilars and Vaccine - Drug Discovery Digest

Article EMA Thank You What we expect European regulators to do in December 2023

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Q4 2023 Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) [E.U.] Title Call for Evidence Closes Comments Close Planned Adoption Draft E.U. Q2 2022 E.U.

Regulations

Regulations Clinical Trials Production Biosimilars

Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

JULY 8, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Enzalutamide Viatris (enzalutamide)** Viatris Limited Positive August 2024 Nilotinib Accord (nilotinib)** Accord Healthcare S.L.U.

Regulations

Regulations Pharmaceuticals Production Compliance

Article EMA Thank You What we expect European regulators to do in March 2024

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials. For implementing acts, the Commission is required to consult with a committee before adoption.

Regulations

Regulations Biosimilars Clinical Trials Production

Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

Regulations

Regulations Production Biosimilars Clinical Trials

Article EMA Thank You What we expect European regulators to do in June 2024

Agency IQ

MAY 31, 2024

There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries. Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations

Regulations Production Compliance Pharmaceuticals

Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations

Regulations Clinical Trials Production International

New Sandoz Board of Directors appointed

The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.

Science

Science Doctors Government Compliance

Roche reports good half-year results

The Pharma Data

JULY 21, 2021

Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 Outlook confirmed for 2021.

Biosimilars

Biosimilars Pharmaceuticals FDA Disease

Collaboration between AbbVie, Biogen and Pfizer creates world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease

The Pharma Data

JULY 15, 2021

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Disease

WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

The Pharma Data

JULY 8, 2021

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Disease

Disease Government Clinical Trials Research

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA

FDA Science Regulations Production

How Recent Drug Pricing Laws Impact Drug Discovery (H.R. 5376)

Drug Hunter

APRIL 24, 2023

Due to elimination of out of pocket patient costs for vaccines covered by Medicare/Medicaid access to adult vaccines will improve. million Medicare beneficiaries received a vaccine in 2022 and half of states did not cover all vaccines recommended by the Advisory Committee on Immunization Practices. For perspective, 4.1

Small Molecule

Small Molecule Biosimilars Drugs Vaccine

Drug Discovery Digest

Article EMA Thank You What we expect European regulators to do in December 2023

Article EMA Thank You What we expect European regulators to do in July 2024

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Article EMA Thank You What we expect European regulators to do in March 2024

Article EMA Thank You What we expect European regulators to do in April 2024

Article EMA Thank You What we expect European regulators to do in June 2024

Article EMA Thank You What we expect European regulators to do in August and September 2024

New Sandoz Board of Directors appointed

Roche reports good half-year results

Collaboration between AbbVie, Biogen and Pfizer creates world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease

WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

How Recent Drug Pricing Laws Impact Drug Discovery (H.R. 5376)

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