The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. Denmark posts guidance on decentralizing clinical trials. The guidance describes considerations and expectations for implementation of decentralized trials.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Biosimilars 52

FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

In 2021, he was caught again, this time for selling a concoction of sugar and garlic that he claimed could prevent a whole slew of infections. Given the broad range of products regulated by FDA, the laundry list of activities prohibited under the FDC Act, and the scope of strict liability misdemeanor exposure, we respectfully disagree.

FDA 52

FDA Regulations Doctors Trials 52

FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

Production 52

Production Clinical Trials FDA Drugs 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

FDA 59

FDA FDA Compliance Clinical Trials Production 59

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. In 2022 and 2021, the Spring Unified Agenda was released in early/mid June.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 18, 2021

Basel, May 18, 2021 — Sandoz, a Novartis division, today announces plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. About Sandoz.

Biosimilars 40

Biosimilars Government Production Pharmaceuticals 40

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms.

FDA 52

FDA Clinical Trials Trials Treatment 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. You see, Oncopeptides has has pending at the PTO since March 2021 a PTE application for U.S.

FDA 59

FDA Production FDA Approval Compliance 59

The Pharma Data

DECEMBER 3, 2021

The complete 12-month data from the zuranolone 30 mg cohort and original interim data from the zuranolone 50 mg cohort read out in early 2021. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. About Major Depressive Complaint (MDD).

Biosimilars 52

Biosimilars Treatment Disease Clinical Trials 52

The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. Remco Steenbergen, Chief Financial Officer of Deutsche Lufthansa AG since 2021, the largest airline group in Europe with approximately EUR 33 billion of sales in 2022.

Science 40

Science Doctors Government Compliance 40

The Pharma Data

JANUARY 26, 2021

27, 2021 10:02 UTC. 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. The full data analysis on 353 subjects would be available by the end of February 2021.

Hospitals 40

Hospitals Laboratories Pharmaceuticals Production 40

The Pharma Data

JULY 27, 2021

” In June 2021, AbbVie Inc. The acquisition is subject to customary closing conditions, including applicable regulatory approvals and is expected to close in the second half of 2021. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021. 2,3 In the U.S.,

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. In Wages and White Lion Investments (DBA Triton Distribution) v. FDA failed on each count.

FDA 115

FDA Production Regulations Marketing 115

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. , Reese , M.D.,

Trials 40

Trials Production Clinical Trials Government 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

Clinical Trials 52

Clinical Trials Production Trials Government 52

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Production 40

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. Percent on a GAAP Basis – Provides 2021 GAAP Diluted EPS Guidance Range of $6.69 to $6.89; Provides 2021 Adjusted Diluted EPS Guidance Range of $12.32

Production 52

Production International Clinical Trials Small Molecule 52

The Pharma Data

MAY 4, 2021

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS. Tue, 05/04/2021 – 06:45. Tuesday, May 04, 2021 – 06:45am. <!–*/. First-Quarter 2021 Revenues of $14.6 First-Quarter 2021 Reported Diluted EPS (1) of $0.86, Adjusted Diluted EPS (2) of $0.93. Anonymous (not verified). –*/. <!–*/.q4default.bwalignc

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021.

Production 52

Production Clinical Trials Trials Government 52

The Pharma Data

JULY 8, 2021

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 8, 2021. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

Disease 52

Disease Government Clinical Trials Research 52

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. excluding Northern Ireland) as of January 1, 2021. from the E.U.

International 40

International Regulations Production Marketing 40

The Pharma Data

MAY 14, 2021

Posted 14 May 2021 | By Michael Mezher . Chugai Presses on with Japan Development of 3 COVID-19 Drugs, Aims for Antibody Cocktail Filing in 2021: President ( PharmaJapan ). Pfizer publishes clinical trial diversity data from past decade, showing there’s much work to be done ( Endpoints ).

FDA 52

FDA Therapies Vaccine Biosimilars 52

Agency IQ

JULY 28, 2023

First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines. October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda.

FDA 40

FDA Science Biosimilars Regulations 40

The Pharma Data

MAY 3, 2021

Posted 03 May 2021 | By Michael Mezher . Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). Novavax plans to ship COVID-19 vaccines to Europe from late 2021 ( Reuters ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ).

Vaccine 52

Vaccine Biosimilars FDA Regulations 52

The Pharma Data

MAY 17, 2021

Posted 17 May 2021 | By Michael Mezher . Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ).

Trials 52

Trials Vaccine FDA Biosimilars 52