The Pharma Data

MAY 2, 2023

Starting in 2026, this facility will develop manufacturing processes for active pharmaceutical ingredients and produce drugs for use in clinical trial phases.

Small Molecule 40

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 40

The Pharma Data

APRIL 15, 2022

In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. New GSK reaffirms its full-year 2022 guidance, the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**, and long-term sales ambition.

Treatment 52

Treatment FDA Approval Trials Clinical Trials 52

National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 27, 2022

Three grants will support trials of the effectiveness of recovery supports or the planning of such trials. And another grant will support the planning of a multi-site trial to examine the effectiveness of recovery community centers serving Black communities to support people using MOUD.

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Research Treatment Science Trials 52

The Pharma Data

NOVEMBER 18, 2020

. Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial. 59 patients enrolled as of 18 November 2020. Financial Highlights.

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Trials Clinical Supply Production Therapies 40

The Pharma Data

JANUARY 25, 2021

The Company may not redeem the notes prior to February 6, 2026. The initial conversion price of the notes represents a premium of approximately 47.5% over the last reported sale price of the Company’s common stock of $65.79 per share on January 25, 2021.

Marketing 52

Marketing Disease Clinical Trials Clinical Development 52

The Pharma Data

MAY 15, 2023

Work is set to begin this year, with full operations provisionally planned for late 2026. In addition, Sandoz recently signed a Memorandum of Understanding to build a new biologics production plant in Slovenia – an expected investment of at least USD 400 million to support increasing global demand for biosimilar medicines.

Biosimilars 40

Biosimilars Production Government Clinical Trials 40

The Pharma Data

OCTOBER 14, 2020

Felker’s research focus is on clinical trials in acute and chronic heart failure and the use of biomarkers as diagnostics, prognostic, and therapeutic tools in heart failure. and EU5 by 2026. market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years.

Clinical Trials 40

Clinical Trials Therapies Clinical Research Trials 40

Agency IQ

JANUARY 4, 2024

The current approved objectives cover the years 2023 – 2026, laying out the regulator’s approach to surveillance, international cooperation, support of innovation, and how its activities will be funded. The TPA requires the Swissmedic Agency Council to create strategic objectives for approval by the Federal Council.

Marketing 40

Marketing Regulations Clinical Trials International 40

Agency IQ

AUGUST 23, 2024

At a high level, the pilot program was intended to offer sponsors of certain drug products that would need a CDx with the opportunity to submit information about their Clinical Trial Assay (CTA) – the assay they’re using in a pivotal trial – to the FDA [see here for background on that topic].

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

FEBRUARY 2, 2024

Class A (lowest risk) devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. Companion diagnostics (CDx) and cancer trials: In 2023, the MDCG published guidance documents on classifying CDx.

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FDA Laboratories Regulations Production 40

Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JANUARY 26, 2024

Class A devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. In-house tests (in the U.S. called laboratory-developed tests manufactured and used in a single lab) had until May 26, 2024.

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

JUNE 9, 2023

The low prevalence of individual orphan diseases poses challenges for building a scientific knowledge base and poses hurdles for clinical trial conduct, though collectively the diseases have a big impact. population) is considered heterogenous due to the developing physiological characteristics which makes clinical trial conduct challenging.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

AUGUST 18, 2023

Otherwise, EUDAMED has been proceeding with finishing testing on the remaining modules in order to complete the minimum viable product (MVP) for the complete database by the end of the year, for a database audit in Q1/Q2 2024 and all modules mandatory to use by Q2 2026. We haven’t seen these revisions come through yet.

Science 40

Science Regulations Laboratories Production 40

Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. During the lead-in period, all patients are assigned to the reference product followed by randomization to either the “switching arm” or “non-switching arm” of the study. Comments are due September 23, 2024. If and when this new draft guidance is finalized, Q.I.20

Biosimilars 40

Biosimilars Science FDA Production 40

FDA Law Blog: Biosimilars

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

Production 45

Production FDA Clinical Trials Marketing 45

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40

Codon

SEPTEMBER 29, 2024

2026 Another lab, one with a greater appreciation for what machine learning could pull from noisy, high-throughput biological data, stumbled across the 2025 paper and discussed it in a Monday morning lab meeting. The average pass rate of phase I trials went up by 5 percent. A flurry of new, promising therapeutic targets arose.

Engineering 144

Engineering Virus DNA Therapies 144

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. A Phase 3 trial is ongoing.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

APRIL 8, 2024

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. While the electronic submission of ICSRs in the latter case is voluntary, the first is not.

FDA 40

FDA Production Regulations Vaccine 40

Drug Hunter

APRIL 24, 2023

A landmark part of the act is the requirement of Medicare to negotiate the prices for the 15 drugs with highest Medicare spend without generic and/or biosimilar substitutions across Part B (hospital drugs) and D (at-home drugs), with negotiated price implementation starting in 2026.

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Small Molecule Drugs Biosimilars Vaccine 130

The Pharma Data

JUNE 2, 2022

” In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. Phase I/II clinical trials to assess the use of the vaccine in paediatrics are planned to begin later this year. Phase III is expected to start in the short term.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

The Pharma Data

MAY 31, 2022

In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. Phase I/II clinical trials to assess the use of the vaccine in paediatrics are planned to begin later this year. Phase III is expected to start in the short term.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

Drug Target Review

MARCH 20, 2025

While the AZALEA trial primarily focused on safety, with efficacy data anticipated from the ongoing LILAC trial conducted by Anthos Therapeutics, the observed reductions in major and gastrointestinal (GI) bleeding are significant. Eliquis, Xarelto) which prevent abnormal blood clots at the expense of an increase in bleeding risk.

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Therapies Clinical Development Trials FDA 52