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 (..)

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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.

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Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. For example, the regulatory and ethics reviews of clinical trial applications will be integrated.

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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.

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Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5

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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 […]

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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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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STAT News

SEPTEMBER 26, 2022

Regulators in half a dozen European countries are now taking steps to enforce requirements that clinical trial sponsors make study results public, although three other countries have so far taken little to no action, a new analysis finds. Continue to STAT+ to read the full story…

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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.

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pharmaphorum

DECEMBER 19, 2022

The EU has published new recommendations aiming to encourage the use of decentralised clinical trials (DCTs) – and to make sure patients who participate in them have their sights an wellbeing safeguarded.

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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.

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Drug Discovery World

OCTOBER 16, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. According to the plans, initial applications for the lowest-risk Phase III and IV trials will be processed by the MHRA within 14 days instead of the statutory 30 days.

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STAT News

MARCH 22, 2023

Medicines and Healthcare products Regulatory Agency announced sweeping changes to regulations governing clinical trials , Pharmaphorum explains. Among the changes will be a facility to run regulatory and ethics reviews of clinical trial applications in parallel and to reduce the time it takes to get a study up and running.

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Pharmaceutical Technology

APRIL 18, 2023

Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients.

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Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. The post Potentially game-changing schizophrenia drug enters Phase I trials appeared first on Drug Discovery World (DDW).

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Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., This blog explores what it takes for an EAC/CEC to adequately support worldwide clinical trials. The Nigerian Data Protection Regulation (NDPR). The Global Reach of EACs and CECs.

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Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

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Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. These vaccines can also be designed to help elicit immunological memory for long-lasting tumour control.

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pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. Personal approach. About the author.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 23, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.The drug regulator, in (..)

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2023

The pharmaceutical industry in the country is waiting for the positive government response on the suggestions on the draft notification about the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945 and laid down specific provisions for its regulation in the country.

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Imperical Blog

JANUARY 9, 2024

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

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XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. It’s very positive and it’s going to help move forward the pathway for new drugs.”

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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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 22, 2022

Indian drug regulators have sought pharmacovigilance (PV) for neuropathic pain drugs gabapentin and pregabalin due to cardiovascular related adverse event citing a study by American medical journal Cardiovascular Diabetology.

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Drug Discovery World

FEBRUARY 7, 2024

Astellas has submitted a supplemental new drug application (sNDA) in Japan for Padcev (enfortumab vedotin (genetical recombination)) with Keytruda (pembrolizumab (genetical recombination)) for the first-line treatment of advanced bladder cancer. The sNDA is based on results from the Phase III EV-302 clinical trial.

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BioSpace

JUNE 14, 2023

Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.

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Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). Phase IIb/III of the Phase II/III trial is currently being conducted in Asia, chiefly in Japan.

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Pharmaceutical Technology

APRIL 20, 2023

Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Drug development had to change. The face of clinical research is evolving.

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Drug Discovery World

MAY 29, 2023

Scientists are calling for tighter regulation of stem cell treatments, claiming clinics worldwide are offering unproven ‘therapies’ for conditions as varied as hair loss and Parkinson’s. They are calling on regulators to halt these products until they can be proven safe and effective in clinical trials.

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