The Pharma Data

APRIL 30, 2021

April 30, 2021 /PRNewswire/ — AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2021. “We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations,” said Richard A. .

FDA 40

FDA Production Treatment International 40

Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. In all, around 130 clinical trials are ongoing for oligonucleotides.

Production 130

Production Pharma Companies Clinical Trials FDA 130

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 2021, the number of PPD employees exceeded 30,000 globally, and Thermo Fisher Scientific Inc.

Clinical Trials 52

Clinical Trials Clinical Research Laboratories Trials 52

The Pharma Data

MAY 3, 2021

Posted 03 May 2021 | By Michael Mezher . DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. © 2021 Regulatory Affairs Professionals Society.

Science 52

Science Clinical Trials Biosimilars FDA 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

FDA 105

FDA Compliance Clinical Trials Drugs 105

Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

Science 40

Science Biosimilars FDA Production 40

Drug Discovery World

OCTOBER 20, 2022

Similarly, biosimilars are expected to grow. Two years later, in 2021, the university and the Dutch firm extended the collaboration, entering a seven-year strategic research contract to explore remote training of anesthesiologists and to deploy artificial intelligence to analyse chronic heart disease. References . link] ). .

International 130

International Drugs Science Government 130

The Pharma Data

OCTOBER 26, 2021

Commencing a strategic review of Sandoz to maximize shareholder value , options range from retaining the business to separation 2021 Group guidance² unchanged. Sandoz is a global leader in generic pharmaceuticals and biosimilars. billion) and Entresto (at least USD 5.0 billion) and Entresto (at least USD 5.0 billion (+8%, +7% cc).

Biosimilars 52

Biosimilars Clinical Trials Treatment Marketing 52

The Pharma Data

NOVEMBER 17, 2021

The CHMP is anticipated to borrow a formal opinion on the Marketing Authorization Operation at its December meeting (December 13-16, 2021). Treatment with ADUHELM should be initiated in cases with mild cognitive impairment or mild madness stage of complaint, the population in which treatment was initiated in clinical trials.

Clinical Trials 52

Clinical Trials Biosimilars Treatment Trials 52

The Pharma Data

MARCH 16, 2022

(Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease. In June 2021, the U.S.

Disease 52

Disease Clinical Trials Trials Biosimilars 52

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.”. . Denmark posts guidance on decentralizing clinical trials.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Biosimilars 52

FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

After a brief trial, on Friday Nov. First, as is more common under the CPSC, the Gree Companies agreed to pay civil penalties for failing to make the required reporting to the CPSC. At the time, in 2016, the Gree Companies’ settlement for $15.45 million in civil penalties set a new record for CPSC.

Production 104

Production Government Trials Marketing 104

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

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

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

The Pharma Data

FEBRUARY 1, 2021

01, 2021 (GLOBE NEWSWIRE) — Biogen Inc. In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms. Available at: [link] Accessed: January 2021. Available at: [link] Accessed: January 2021. Posted: February 2021. CAMBRIDGE, Mass.,

FDA Approval 40

FDA Approval FDA Clinical Trials Biosimilars 40

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. Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs.

FDA 52

FDA Regulations Doctors 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

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

Therapies 52

Therapies Clinical Trials Production Treatment 52

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. Zuranolone is being estimated in the Geography and NEST clinical trial programs. About Major Depressive Complaint (MDD). Zuranolone has been granted Advance Remedy Designation by theU.S.

Biosimilars 52

Biosimilars Treatment Clinical Trials Disease 52

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Biosimilars International 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

FDA 59

FDA Production FDA Approval Compliance 59

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 Biosimilars Pharmaceuticals 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

Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. 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., not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Compliance 40

The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

DECEMBER 9, 2020

Aducanumab, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

The Pharma Data

OCTOBER 29, 2020

Food and Drug Administration with Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. About Aducanumab.

Marketing 40

Marketing Disease Clinical Trials Treatment 40

Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. Read the AgencyIQ analysis here.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . About Aducanumab. You should not place undue reliance on these statements or the scientific data presented.

Disease 40

Disease FDA Clinical Trials Licensing 40

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. Outlook for 2021 confirmed. Based on the good results of the first half of 2021, we confirm the outlook for the full year.”.

Biosimilars 52

Biosimilars Pharmaceuticals FDA Disease 52

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

FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. In August 2021, FDA issued a press release announcing the denial of 55,000 flavored e-cigarette applications en masse. FDA also directed manufacturers to produce detailed marketing plans.

FDA 115

FDA Production Regulations Marketing 115