Regulation and Trials - Clinical Research Informer

Panel recommends programme for uniform high standard drug regulation nationwide

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2025

A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.

Regulation

Regulation Drugs Vaccination Vaccine

Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

Bio Pharma Dive

JANUARY 10, 2022

A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

Trials

Trials Regulation

GSK antibody drug reduces COPD attacks in trial

Bio Pharma Dive

SEPTEMBER 6, 2024

New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.

Trials

Trials Antibody Regulation Drugs

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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PCI frames new regulations based on amendments under Jan Vishwas Act

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.

Regulation

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

New EU trial regulations could expedite approvals and address shortages

Pharmaceutical Technology

FEBRUARY 27, 2025

New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials in Europe.

Regulation

Regulation Trials Clinical Trials Clinical Trials

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

Bio Pharma Dive

SEPTEMBER 17, 2021

Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug. With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline.

Trials

Trials Drugs Regulation

National Commission for Homoeopathy notifies BHMS regulations

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 13, 2022

The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Homoeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy).

Regulation

Regulation Medicine Research Clinical Trials

MHRA revamps UK clinical trial regulation with the promise of faster timelines

Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

Clinical Trials

Clinical Trials Clinical Trials Regulation Trials

Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

AUGUST 29, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Regulation

SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 14, 2024

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs

Drugs Clinical Trials Clinical Trials Branding

Enhancing Access and Retention in Global, Cross-Border Rare Disease Clinical Trials

XTalks

APRIL 8, 2025

Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Clinical Trial Manager/Sr. These measures enhance recruitment, retention and overall trial success.

Clinical Trials

Clinical Trials Clinical Trials Trials Gene Therapy

CDSCO empowers regulators & boosts exports through comprehensive training programmes

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as […]

Regulation

Regulation Drugs Clinical Trials Clinical Trials

FDA clears Pfizer to restart Duchenne gene therapy trial, with new safeguards

Bio Pharma Dive

APRIL 28, 2022

The regulator has asked Pfizer to closely monitor patients in a hospital setting for a week as part of a deal to end a study suspension that's lasted more than four months.

Gene Therapy

Gene Therapy Gene Regulation Trials

Tamibarotene Fails in Phase III Trial for a Subset of Higher-Risk MDS

XTalks

NOVEMBER 15, 2024

Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8

Trials

Trials HR Immune Response FDA Approval

Another Astellas gene therapy trial paused by FDA after side effect report

Bio Pharma Dive

JUNE 27, 2022

The regulator suspended testing of Astellas’ Pompe disease treatment after one patient experienced peripheral nerve damage. Both of the pharma’s clinical-stage gene therapies are now on hold.

Gene Therapy

Gene Therapy Gene Regulation Trials

Health ministry issues draft rules for compounding of certain offences under drug regulations

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 21, 2024

The Union health ministry has issued a draft notification framing the rules related to compounding of offences for minor offences under the drug regulations.

Regulation

Regulation Cosmetics Drugs Clinical Trials

Including Patients with Borderline Personality Disorder in Clinical Trials

Worldwide Clinical Trials

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

FDA Approval

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Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

Bluebird says gene therapy 'very unlikely' cause of cancer case in trial

Bio Pharma Dive

MARCH 10, 2021

and European regulators in hopes of resuming study of the treatment as well as sales of a related product. The biotech is discussing its findings with U.S.

Gene Therapy

Gene Therapy Gene Sales Regulation

Planning strategies for transitioning to the Clinical Trials Regulation

pharmaphorum

MARCH 1, 2024

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation.

Clinical Trials

Clinical Trials Clinical Trials Regulation Trials

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

Development

Development Regulation Manufacturing Drugs

MASH Clinical Trials: New Approaches and Methodologies

XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Nicola Owen, PhD, MBBS, Medical Directorthey shared insights into the operational and medical strategies that support the design and conduct of MASH clinical trials.

Clinical Trials

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BioMarin reports cancer case in hemophilia gene therapy trial

Bio Pharma Dive

SEPTEMBER 13, 2022

Drug regulators have not ordered a trial hold, however. The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S.

Gene Therapy

Gene Therapy Trials Gene Regulation

Gynaecologists call for regulating IVF costs & enabling queer, single men to avail services under ART Act

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2022

Even though Assisted Reproductive Technology (Regulation) Act, 2021 has been enacted to regulate ART clinics and banks and protect donors and women undergoing ART from the health consequences related to risky and illegal treatments, the Act has fallen short of addressing several grave concerns including costs of the services and prohibiting single (..)

Regulation

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PTC’s drug for PKU succeeds in late-stage clinical trial

Bio Pharma Dive

MAY 17, 2023

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

Clinical Trials

Clinical Trials Clinical Trials Regulation Trials

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials

Trials Clinical Trials Clinical Trials Regulation

NPPA looks into fixation of retail price of drugs under phase IV clinical trials

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Move to relax clinical trial norms will cut Indian pharma’s human studies cost, lower drug prices for patients

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials

Trials Clinical Trials Clinical Trials Drugs

FDA delays decision on Moderna RSV vaccine

Bio Pharma Dive

MAY 10, 2024

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

Vaccination

Vaccination Vaccine Regulation Trials

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Amylyx, faced with longer FDA path for promising ALS drug, gets major cash infusion

Bio Pharma Dive

JULY 20, 2021

A $135 million investment will help the small biotech potentially prepare to launch the treatment in Canada and Europe as well as fund another trial requested by U.S. regulators.

Regulation

Regulation Trials Drugs

Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 24, 2023

An MoU […]

Regulation

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Sarepta, with new Duchenne results, to broach 'possibility' of speedy gene therapy approval

Bio Pharma Dive

JANUARY 10, 2022

regulators, CEO Doug Ingram said Monday, though it still expects to need data from an ongoing late-stage trial to win approval. The biotech will take new Phase 2 data to U.S.

Gene Therapy

Gene Therapy Gene Regulation Trials

FDA clears Novavax's COVID-19 vaccine as 4th option in US

Bio Pharma Dive

JULY 13, 2022

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.

Regulation

Regulation Vaccination Vaccine Trials

CE Act should be adopted on priority basis to effectively regulate path labs in the country: Dr. Arvind Lal

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2023

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities.

Regulation

Regulation Clinical Trials Clinical Trials Clinical Research

Regulatory considerations for biosimilar clinical efficacy trials

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

Trials

Trials Clinical Trials Clinical Trials Production

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

Trials

Trials Drugs Cosmetics Development

Biotechs investigate ways to adapt to new clinical trial regulation and economic flux

Pharmaceutical Technology

SEPTEMBER 20, 2024

The Outsourcing in Clinical Trials New England conference will gather pharma experts to discuss the current clinical trial landscape.

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

SEC recommends waiver of local phase III and IV trials for Sanofi’s orphan drug to treat Pompe disease

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

Trials

Trials Clinical Trials Clinical Trials Drugs

World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Worldwide Clinical Trials

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

Genetics

Genetics In-Vitro Drugs Clinical Trials

Arrowhead shares soar on liver disease data from four patients

Bio Pharma Dive

SEPTEMBER 16, 2020

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

Clinical Trials

Clinical Trials Clinical Trials Regulation Trials

Panel recommends programme for uniform high standard drug regulation nationwide

Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

Webinars

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GSK antibody drug reduces COPD attacks in trial

Webinars

PCI frames new regulations based on amendments under Jan Vishwas Act

The New Age of Decentralized Clinical Trials

New EU trial regulations could expedite approvals and address shortages

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

National Commission for Homoeopathy notifies BHMS regulations

MHRA revamps UK clinical trial regulation with the promise of faster timelines

Psychedelic clinical trials: What sponsors should know when designing new protocols

SEC recommends approval for MSN Laboratories’ sleep disorder drug

Enhancing Access and Retention in Global, Cross-Border Rare Disease Clinical Trials

CDSCO empowers regulators & boosts exports through comprehensive training programmes

FDA clears Pfizer to restart Duchenne gene therapy trial, with new safeguards

Tamibarotene Fails in Phase III Trial for a Subset of Higher-Risk MDS

Another Astellas gene therapy trial paused by FDA after side effect report

Health ministry issues draft rules for compounding of certain offences under drug regulations

Including Patients with Borderline Personality Disorder in Clinical Trials

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Bluebird says gene therapy 'very unlikely' cause of cancer case in trial

Planning strategies for transitioning to the Clinical Trials Regulation

FDA rejects two China-developed cancer drugs

MASH Clinical Trials: New Approaches and Methodologies

BioMarin reports cancer case in hemophilia gene therapy trial

Gynaecologists call for regulating IVF costs & enabling queer, single men to avail services under ART Act

PTC’s drug for PKU succeeds in late-stage clinical trial

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

NPPA looks into fixation of retail price of drugs under phase IV clinical trials

Move to relax clinical trial norms will cut Indian pharma’s human studies cost, lower drug prices for patients

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

FDA delays decision on Moderna RSV vaccine

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

Amylyx, faced with longer FDA path for promising ALS drug, gets major cash infusion

Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation

Sarepta, with new Duchenne results, to broach 'possibility' of speedy gene therapy approval

FDA clears Novavax's COVID-19 vaccine as 4th option in US

CE Act should be adopted on priority basis to effectively regulate path labs in the country: Dr. Arvind Lal

Regulatory considerations for biosimilar clinical efficacy trials

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

Biotechs investigate ways to adapt to new clinical trial regulation and economic flux

SEC recommends waiver of local phase III and IV trials for Sanofi’s orphan drug to treat Pompe disease

World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Arrowhead shares soar on liver disease data from four patients

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