Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

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The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” Denmark posts guidance on decentralizing clinical trials. The guidance describes considerations and expectations for implementation of decentralized trials. Those measures are due to expire on 1 December.

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Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. Similarly, biosimilars are expected to grow. Regulatory .

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The Pharma Data

DECEMBER 13, 2020

Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). The drug is an anti-CD20 antibody.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. It draws upon 150 years of collective experience and expert scientific advisory board members to deeply understand clinical trial requirements.

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Drug Discovery World

JULY 25, 2023

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. The guidance is for pharmaceutical companies conducting paediatric clinical trials in the EU using the PIP procedure.

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). Throughout its journey, PPD has been committed to consistent quality and execution, customer-aligned service, and continuous innovation to accelerate clinical trial execution. with full-year revenue of US$23.04

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The Pharma Data

MARCH 23, 2022

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. Etrasimod was developed by Arena Pharmaceuticals, which was recently acquired by Pfizer. The safety profile was consistent with previous Phase 2 studies. Results from the ELEVATE 52 study will be available by the end of Q1.

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The Pharma Data

MARCH 29, 2022

The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial. About Etrasimod.

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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).

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Conversations in Drug Development Trends

JULY 9, 2024

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. Ethical Considerations During clinical trials, participants are either already on a stable, maintenance dose or are provided with the GLP-1 medication for the study’s duration.

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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.

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The Pharma Data

NOVEMBER 10, 2020

Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions. that are fast progressing clinical trials. Yong-Jun Liu , the newly appointed President of Innovent also made his first public appearance on the virtual R&D day.

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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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.

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FDA Law Blog: Biosimilars

JULY 24, 2024

Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities. s Kurt R.

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The Pharma Data

OCTOBER 26, 2021

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. billion) and Entresto (at least USD 5.0 Innovative Medicines net sales were USD 10.6

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Biosimilars Clinical Trials Treatment Marketing 52

Agency IQ

AUGUST 2, 2024

September 30, 2024 Upcoming (or overdue) legislative requirements due as of August and September Congress often asks the FDA to release or hold guidance documents, regulation, reports, meetings, hearings or pilot programs as of specific dates.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label.

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Biosimilars Government Production Pharmaceuticals 40

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.

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Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. 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.

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The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd. Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex.

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Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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The Pharma Data

MARCH 28, 2022

Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. This Phase 1 study was a randomized, placebo-controlled, dose-escalating trial to evaluate BIIB078 administered intrathecally to adults (n=106) with C9orf72-associated ALS. About Ionis Pharmaceuticals, Inc. Biogen Inc.

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The Pharma Data

DECEMBER 13, 2020

The company has established a diversified R & D pipeline comprising 26 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurologic, and infectious diseases.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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Agency IQ

OCTOBER 27, 2023

BY SIERRA MILAM, KARI OAKES, KIRSTEN MESSMER, PHD, RAC, COREY JASEPH, MS, RAC | OCT 25, 2023 5:20 PM CDT What we expect to be talking about in November: The proposed revised pharmaceutical directive and regulation: On November 7, the European Parliament Committee on the environment, public, health and food safety (ENVI) will be meeting to negotiate (..)

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Agency IQ

MAY 31, 2024

.: Hands-on training course Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/03/2024 EUCOPE’s Life Science Lectures – Episode Five (Joint Clinical Assessments) Webinar/Seminar ( OPEN ) EUCOPE 6/04/2024 6/04/2024 EUDAMED, the pathway to compliance Webinar/Seminar ( OPEN ) Team Person Responsible for Regulatory Compliance (TEAM-PPRC) 6/04/2024 6/04/2024 News (..)

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Regulations Production Compliance Pharmaceuticals 40

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.

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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. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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Agency IQ

SEPTEMBER 22, 2023

patient, caregiver) in the use of their medications (including both pharmaceuticals and biological products) would be considered PDURS. Similarly, the agency simply notes that it would review potential biosimilar or interchangeable products consistent with its existing regulatory expectations for licensure.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

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Science Doctors Government Compliance 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.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

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