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).

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Pharmaceutical Technology

JANUARY 16, 2024

As the deadline nears for the government to reveal its proposed prices, pharmaceutical companies are continuing to fight regulation.

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Regulation 173

Bio Pharma Dive

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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Regulation Sales Marketing Drugs 177

Pharmaceutical Technology

NOVEMBER 8, 2023

The executive order highlights the US sentiment towards AI regulation, but presents a fragmented approach with possibility of discord.

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Regulation 130

Pharmaceutical Technology

DECEMBER 7, 2023

GlobalData’s report assesses the drugs in the Apoptosis Regulator BAX pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Regulation Development Drugs 130

Pharmaceutical Technology

DECEMBER 7, 2023

GlobalData’s report assesses the drugs in the Apoptosis Regulator BAX pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Regulation Development Drugs 130

Bio Pharma Dive

JULY 14, 2021

The go-ahead from British regulators was the last hurdle standing in the way of the two companies wrapping up their $39 billion deal announced last year.

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Regulation 258

pharmaphorum

SEPTEMBER 6, 2024

Understanding the impact of Medtech regulations on balancing innovation and safety is crucial for the industry. Discover how compliance with regulations plays a vital role in fostering innovation while ensuring patient safety in the field of medical technology.

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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.

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Clinical Trials Clinical Trials Regulation Trials 147

Bio Pharma Dive

DECEMBER 16, 2022

The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti.

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Bio Pharma Dive

APRIL 20, 2021

Regulators in the U.S. The EMA reiterated the vaccine's benefits outweigh its risks but recommended a warning be added to highlight the rare, but serious side effect. are expected to soon make a similar decision.

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Regulation Vaccination Vaccine Drugs 267

pharmaphorum

AUGUST 7, 2024

Learn about the innovative technologies and how companies are navigating evolving regulations in this rapidly advancing field. Explore how artificial intelligence and machine learning are revolutionising the medical devices sector.

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Regulation 102

BioPharma Reporter

MARCH 19, 2024

With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.

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XTalks

JULY 30, 2024

By focusing on these proactive measures, EU regulations aim to prevent Salmonella contamination before poultry products reach consumers. The contrasting approaches to Salmonella control in the US and EU highlight the importance of evaluating food safety regulations.

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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. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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Clinical Trials Clinical Trials Regulation Trials 115

Bio Pharma Dive

JANUARY 19, 2022

The news sparked headlines about an attempt by regulators to target big tech, but it could have serious implications for healthcare, too.

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Regulation 200

Bio Pharma Dive

JULY 22, 2022

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.

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Regulation Vaccination Vaccine Medicine 342

FDA Law Blog

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. California Stem Cell Treatment Center, Inc., Stem Cell Clinic, LLC , 998 F.3d

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Regulation Drugs Licensing Containment 57

World of DTC Marketing

FEBRUARY 21, 2022

The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. With over 80% of voters aligned that drug prices are too high big pharma continues to act recklessly as if to say, “we’ll do what’s best for investors and us regardless of the effects on society.”

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Bio Pharma Dive

JANUARY 26, 2022

The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals.

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Regulation Drugs Marketing 152

ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Regulation Trials 52

Bio Pharma Dive

MAY 6, 2024

With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.

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Regulation Drugs 258

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Clinical Trials Clinical Trials Regulation Trials 96

ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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Regulation Marketing Drugs Research 52

BioSpace

SEPTEMBER 20, 2023

With 88% of life sciences organizations using or planning to use AI in recruitment and/or hiring, AI regulation is a priority for the industry.

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Regulation Life Science 96

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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Bio Pharma Dive

FEBRUARY 4, 2022

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.

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Regulation Drugs Marketing 294

Bio Pharma Dive

APRIL 12, 2024

The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.

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Regulation Drugs Medicine 177

Fierce Pharma

OCTOBER 13, 2023

Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

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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 (..)

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ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Regulation Trials 105

NPR Health - Shots

MARCH 12, 2023

Neighbors were inundated with smoke and left wondering why the site wasn't regulated in the first place. An unregulated landfill that accepts vegetative waste has burned underground for months. Image credit: Zoe McDonald/WBHM)

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Regulation 128

Bio Pharma Dive

MAY 20, 2022

The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year.

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Bio Pharma Dive

DECEMBER 15, 2023

While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.

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Bio Pharma Dive

NOVEMBER 17, 2021

A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month

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Regulation Drugs Medicine 324

NPR Health - Shots

JULY 30, 2022

And a lack of federal regulation or guidance has states stepping in. Delta-8 is a hemp product designed to get users high, but misleading labels or added chemicals have caused people to get sick.

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Regulation Sales Production 144

Bio Pharma Dive

JULY 10, 2023

Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.

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Regulation Drugs 286