2026 and Clinical Development - Drug Discovery Digest

TaiGen Announces FDA Approval of IND for Its Flu Antiviral TG-1000

The Pharma Data

OCTOBER 31, 2020

With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. billion USD by 2026 at a CAGR of 11.5%. Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. in the near future.”

FDA Approval

FDA Approval FDA Clinical Development Virus

Lessons From A Private Funding Round: Science, Relationships, And Experience

LifeSciVC

APRIL 2, 2024

We have milestones on the horizon, and we want investors to stay close to the Sionna story even if we don’t need capital until 2026. The insights from these internal discussions refined our messaging and helped demonstrate the compelling opportunity we have to advance a truly groundbreaking clinical development program.

Science

Science Small Molecule International Clinical Development

Novartis announces new organizational structure

The Pharma Data

APRIL 6, 2022

“With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” ” Integrating Pharmaceuticals and Oncology business units.

International

International Pharmaceuticals Drug Development Marketing

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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BridgeBio Pharma, Inc. Prices Upsized Offering of $650 Million Convertible Senior Notes

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

Marketing Disease Clinical Trials Clinical Development

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Comments are due September 23, 2024.

Biosimilars

Biosimilars Science FDA Production

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. 2 EvaluatePharma, World Preview 2020, Outlook to 2026. AstraZeneca PLC. _.

Regulations

Regulations International Disease Small Molecule

Analysis Life Sciences Thank You A deep dive into MDR and IVDR implementation: Where we are and where we’re going

Agency IQ

AUGUST 18, 2023

Expert panels have two main tasks under the MDR and IVDR, which is to provide opinions and view as part of the clinical and performance evaluation consultation procedures (MDR Article 54 / IVDR Article 48). The second is ad hoc advice on clinical development plans and clinical investigation proposals.

Science

Science Regulations Laboratories Production

Elliott Advisors (UK) letter to GSK

The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. The £33 billion sales ambition is before any significant revenue contribution from early-stage pipeline assets or any contribution from business development. Cash generated from operations is expected to exceed £10 billion by 2026.

Government

Government Vaccine Production Science

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA

FDA Production Regulations Vaccine

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

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. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

Vaccine

Vaccine Therapies Trials Clinical Trials

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. billion to be paid upon the achievement of certain paediatric clinical development milestones. The consideration for the acquisition comprises an upfront payment of $2.1 The transaction is expected to close in the third quarter of 2022.

Vaccine

Vaccine Immune Response Clinical Trials Disease

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. billion to be paid upon the achievement of certain paediatric clinical development milestones. The consideration for the acquisition comprises an upfront payment of $2.1 The transaction is expected to close in the third quarter of 2022.

Vaccine

Vaccine Immune Response Clinical Trials Disease

Abelacimab: the next frontier in safer anticoagulation therapy

Drug Target Review

MARCH 20, 2025

This potential breakthrough could transform both drug discovery and clinical treatment strategies, with the possibility of enhancing patient safety and improving outcomes in thrombotic conditions like atrial fibrillation. NYSE: MRK), which included leadership roles in early and late clinical development and cardiovascular discovery.

Therapies

Therapies Trials Clinical Development FDA

Drug Discovery Digest

TaiGen Announces FDA Approval of IND for Its Flu Antiviral TG-1000

Lessons From A Private Funding Round: Science, Relationships, And Experience

Webinars

Trending Sources

Novartis announces new organizational structure

Webinars

BridgeBio Pharma, Inc. Prices Upsized Offering of $650 Million Convertible Senior Notes

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

Analysis Life Sciences Thank You A deep dive into MDR and IVDR implementation: Where we are and where we’re going

Elliott Advisors (UK) letter to GSK

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

Abelacimab: the next frontier in safer anticoagulation therapy

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