Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By geographical region, the global CRO services market in 2023 was dominated by North America.

Clinical Trials 52

Clinical Trials Clinical Research Laboratories Trials 52

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Positive January 2023 Azacitidine Kabi (azacitidine)** Fresenius Kabi Deutschland GmbH Positive January 2023 Krazati (adagrasib) Mirati Therapeutics B.V.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. for the years 2020 to 2022.

Biosimilars 40

Biosimilars FDA Production Treatment 40

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.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . The rolling review idea is based on the experience of authorizing COVID-19 vaccines. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Biosimilars 52

The Pharma Data

SEPTEMBER 10, 2020

(NYSE:PFE) announced today that more than 50 abstracts representing data from nine approved and investigational Pfizer medicines, including several biomarker-driven and immuno-therapies, will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 being held from September 19-21, 2020. Sridhar S. . .

Therapies 52

Therapies Production Clinical Trials Trials 52

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

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 40

Regulations Production Biosimilars Clinical Trials 40

Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

Regulations 40

Regulations Pharmaceuticals Production Compliance 40

The Pharma Data

FEBRUARY 1, 2021

Plegridy is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”. In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms.

FDA Approval 40

FDA Approval FDA Clinical Trials Biosimilars 40

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

JANUARY 26, 2021

Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr.

Hospitals 40

Hospitals Laboratories Pharmaceuticals Biosimilars 40

Agency IQ

OCTOBER 27, 2023

” Manufacturing and Translation of ATMPs and Tissue – & Cell-based products Webinar/ Seminar ( OPEN ) Paul-Ehrlich-Institut – Federal Institute for Vaccines and Biomedicines Notable Comment Periods Closing in November Below are various deadlines regarding E.U.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA 40

FDA Science Regulations Compliance 40

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

FEBRUARY 8, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Q1 2021 sales increase of 2.4% Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6%

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

The Pharma Data

APRIL 7, 2023

BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. The approval was based on COLUMBUS, a randomized, active-controlled, open-label, Phase 3 trial.

FDA 40

FDA FDA Approval Small Molecule Drugs 40

The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

Disease 52

Disease Government Clinical Trials Research 52

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 40

FDA Science Regulations Production 40

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Adjusted Income (2).

Vaccine 40

Vaccine Production FDA Biosimilars 40

The Pharma Data

AUGUST 21, 2020

Top Russian doctor quits over questionable ethics that rushed through coronavirus vaccine approval. Professor Alexander Chuchalin has quit the Russian Health Ministry’s ethics council due to the quick approval process for the country’s coronavirus vaccine. Poseida suspends CAR T therapy trial in prostate cancer due to patient death.

Biosimilars 52

Biosimilars Pharmacy Vaccine Pharmaceuticals 52

The Pharma Data

MAY 14, 2021

Fully vaccinated people can shed their masks in most places – CDC ( Reuters ) ( STAT ). US diplomats: Send vaccine overseas now or China, Russia will win out ( Politico ). WHO urges rich countries to donate shots instead of vaccinating children ( Reuters ). India’s Dr. .

FDA 52

FDA Therapies Vaccine Biosimilars 52

The Pharma Data

MAY 3, 2021

Feds rethink vaccination strategy as slowing demand reveals stark divide ( Politico ). US to launch trade talks on COVID-19 vaccine distribution ( AP ) ( CNBC ). Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). In Focus: US.

Vaccine 52

Vaccine Biosimilars FDA Regulations 52

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 130

Small Molecule Biosimilars Drugs Vaccine 130