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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Pharmaceutical Technology

MAY 26, 2023

Mackey says that the global regulations surrounding the issue are still lagging compared to the speed at which the issue is growing. “I He says that if the US-wide over prescription of the drug that is causing the shortage is put to an end, more of the stimulant may be available in the legitimate supply chain.

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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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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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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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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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The Pharma Data

NOVEMBER 19, 2022

An arising roadmap to regulating sanitation services. First, regulations can help to more link sanitation services to public health protections. Second, as with public health regulation, profitable and performance regulation must concentrate on safe, inclusive service issues, irrespective of the structure used.

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Drug Discovery World

MARCH 23, 2023

These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the UK one of the best countries in the world to conduct clinical research. The post Biggest overhaul of UK clinical trial regulation for 20 years appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

DECEMBER 20, 2022

The collaborative spirit arising between pharmaceutical and biotechnology companies is leading to a new rapport with regulators, as well. Rather than regulatory bodies alone setting standards for approval, industry can provide real-world data and evidence to help optimize processes and shape regulations. Moving forward.

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Medical Xpress

MARCH 31, 2023

Long thought of as "brain glue," the star-shaped cells called astrocytes—members of a family of cells found in the central nervous system called glial that help regulate blood flow, synaptic activity, keep neurons healthy, and play an important role in breathing.

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Regulation 105

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 208

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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Pharmaceutical Technology

MAY 1, 2023

When it comes to vaccines, in addition to assessing the data, regulators also need to evaluate whether it is appropriate to vaccinate the target audience and if it will be effective in preventing disease, disabilities and deaths, says Sachiko Ozawa, PhD, a health economist at the University of North Carolina at Chapel Hill.

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Vaccination Vaccine Regulation Medicine 130

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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pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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Medical Xpress

OCTOBER 11, 2022

A molecularly-defined cell population of the hypothalamus constitutes a point of control in the regulation of the circadian rhythm in the brain and gates the effect of psychostimulants through its activity.

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Regulation Research 139

BioSpace

MAY 29, 2023

European Regulator Leaning Toward Rejecting Amylyx’s ALS Drug 5/30/2023

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Medical Xpress

NOVEMBER 1, 2022

The findings, published in Science Advances, build on previous work in which the group identified a gene called ZMYND8 as a regulator of breast tumor growth.In UT Southwestern researchers have identified a causative signaling pathway in breast cancer, providing potential new targets for treatment of the most common type of cancer in women.

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Cloudbyz

APRIL 19, 2023

Introduction: The new European Union (EU) Clinical Trial Regulation (CTR), Regulation (EU) No 536/2014, came into force in January 2022, replacing the previous EU Clinical Trials Directive (2001/20/EC). This eliminates the need for multiple submissions, streamlining the process and reducing the administrative burden on trial sponsors.

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Clinical Trials Clinical Trials Trials Regulation 52

Medical Xpress

MAY 9, 2023

An international group of doctors and public health experts have joined the clamor for a moratorium on AI research until the development and use of the technology are properly regulated.

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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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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.

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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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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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STAT News

MARCH 15, 2023

WASHINGTON — After years of struggling to regulate the drug middlemen that create pharmacy networks, the federal government could lean on states to rein them in — even, potentially, in Medicare. The Department of Justice has until next month to tell a federal appeals court where the administration stands on the issue.

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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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pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Fierce Pharma

MAY 26, 2023

EU regulators recommend yanking authorization for Novartis' sickle cell med Adakveo after phase 3 miss zbecker Fri, 05/26/2023 - 10:48

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Regulation 103

Cloudbyz

APRIL 20, 2023

The European Union (EU) Clinical Trial Regulation (CTR) No 536/2014, which came into effect in January 2022, has significantly changed the clinical trial landscape in the EU. This blog post outlines 10 key aspects of the new regulation that sponsors should be aware of when planning and conducting clinical trials in the EU.

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Clinical Trials Clinical Trials Trials Regulation 52

STAT News

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too.

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Medical Xpress

JANUARY 5, 2023

The findings provide new insights into the genetic regulation of IgA levels and its potential role in human disease. Increased levels of the antibody immunoglobulin A (IgA) are correlated with the manifestation of several diseases as well as African ancestry, according to findings published in Nature Communications.

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FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

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Medical Xpress

APRIL 24, 2023

Iron is important for life, and iron deficiency impairs development, but whether the iron level regulates neural differentiation remains elusive. Iron-regulatory proteins (IRPs), including IRP1 and IRP2, are the major regulators of cellular iron homeostasis.

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Pharma Tutor

APRIL 28, 2023

Expert Committee on Pharmacy Education, Law and Regulator admin Fri, 04/28/2023 - 15:45 ABOUT AUTHOR Dr. R. Thakur Chief Editor, Journal of Pharmaceutical Research Krupanidhi College of Pharmacy, Bengaluru, India. Email : drramsthakur@gmail.com

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

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Medical Xpress

DECEMBER 6, 2022

Nerve cells can regulate their sensitivity to incoming signals autonomously. A new study led by the University of Bonn has now discovered a mechanism that does just that. The German Center for Neurodegenerative Diseases and the Max Planck Institute for Neurobiology of Behavior were involved in the work.

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Regulation 76

Bio Pharma Dive

MARCH 13, 2023

SVB’s demise on Friday marked the nation’s largest bank failure since Washington Mutual collapsed in 2008, and sent shock waves through both the life sciences and tech sectors.

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