UK MHRA strengthens regulations on fluoroquinolone antibiotics
Pharmaceutical Technology
JANUARY 23, 2024
The UK MHRA has introduced further restrictions on the usage of fluoroquinolone antibiotics, strengthening the previous regulations.
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IRA lawsuits will test US’ ability to regulate social pricing in pharma
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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Antitrust regulators aim to revamp merger guidelines, signaling threat to health sector deals
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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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.
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Smaller regulators grasp innovation through international collaboration
Pharmaceutical Technology
APRIL 23, 2024
At the Swiss Biotech Day Conference, key opinion leaders discussed ways to reduce disparities caused by reduced regulatory capacities.
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In the News: August 2021 Regulatory and Development Updates
Camargo
SEPTEMBER 8, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”.
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Three regulators accept Bristol Myers’ applications for myeloma therapy
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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Regulators develop five principles for machine learning-enabled medical devices
Pharma Times
OCTOBER 27, 2023
The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes
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Clinical Trial Regulations in the United States
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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#news #biotech DNA methylation regulator QSER1 identified
BioTech 365
APRIL 9, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: DNA methylation regulator QSER1 identified.A has identified a DNA methylation regulator called QSER1. team of researchers from a number of institutions in the U.S.
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#news #biotech How promiscuous protein droplets regulate immune genes
BioTech 365
JULY 22, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: How promiscuous protein droplets regulate immune genes.Biochemists at Emory are achieving insights into how an important regulator of the immune system switches its function, based on its … Continue reading →
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#news #biotech Rooting regulators are evolutionarily conserved
BioTech 365
JUNE 1, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Rooting regulators are evolutionarily conserved.Many plants can easily be regenerated and multiplied using cuttings.
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Wellcome funds work on regulating digital mental health tools
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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Macau regulator accepts Everest’s NDA for ulcerative colitis therapy
Pharmaceutical Technology
MARCH 11, 2024
Macau has accepted a NDA of Everest Medicines for VELSIPITY, a treatment for adults with active ulcerative colitis (UC).
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BioTech 365
FEBRUARY 4, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Study uncovers structural features regulating mRNA processing.RNA is the central tenet of molecular biology, the stepping-stone between DNA and proteins. from Biotechnology News – Biology News [link].
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Biggest overhaul of UK clinical trial regulation for 20 years
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. The post Biggest overhaul of UK clinical trial regulation for 20 years appeared first on Drug Discovery World (DDW).
#news #biotech Two genes regulate social dominance
BioTech 365
NOVEMBER 10, 2020
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Two genes regulate social dominance.Rank in social hierarchy is a condition not solely claimed by humans. In the animal kingdom, male peacocks exhibit brightly colored plumes to … Continue reading →
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#news #biotech Researchers discover that protein switches functions to regulate DNA replication
BioTech 365
JULY 23, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Researchers discover that protein switches functions to regulate DNA replication.One protein. from Biotechnology News – Biology News [link]. One mechanism of action.
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#news #biotech Regulating the ribosomal RNA production line
BioTech 365
JANUARY 22, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Regulating the ribosomal RNA production line.The enzyme that makes RNA from a DNA template is altered to slow the production of ribosomal RNA (rRNA), the most abundant … Continue reading →
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In the News: October 2021 Regulatory and Development Updates
Camargo
NOVEMBER 15, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. In the News: October 2021 Regulatory and Development Updates. In the News: September 2021 Regulatory and Development Updates.
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#news #biotech Regulation of the genome affects its 3D structure
BioTech 365
JUNE 2, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Regulation of the genome affects its 3D structure.All the cells of an organism share the same DNA sequence, but their functions, shapes or even lifespans vary greatly. … Continue reading →
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#news #biotech Transporter protein regulates root gravitropism in Arabidopsis
BioTech 365
FEBRUARY 26, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Transporter protein regulates root gravitropism in Arabidopsis.In
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Global regulators seek permanent working group on AI
pharmaphorum
AUGUST 17, 2021
The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments. The post Global regulators seek permanent working group on AI appeared first on.
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#news #biotech Researchers discover novel non-coding RNAs regulating blood vessel formation
BioTech 365
MAY 6, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Researchers discover novel non-coding RNAs regulating blood vessel formation.Researchers at the University of Eastern Finland have discovered previously unknown non-coding RNAs (ncRNAs) involved in regulating the gene … Continue (..)
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Top Food News of 2023 on Xtalks.com
XTalks
DECEMBER 19, 2023
As we reflect on this dynamic year, it’s exciting to revisit the food news of 2023 that captivated our readers’ imaginations and sparked the most discussions. It’s a stark reminder of the varying food safety and health regulations that exist worldwide. What Ever Happened to Coke with Stevia?
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MHRA publishes guidance on medicine regulation after Brexit
pharmaphorum
SEPTEMBER 2, 2020
The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If
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Opinion: New price transparency regulations for hospitals, insurers empower patients
STAT News
JULY 22, 2022
On July 1, new price transparency regulations took effect to lift the veil on a sector that accounts for nearly 20% of the U.S. Without a true health care marketplace based on price transparency, Americans will continue to make uninformed decisions that result in spiraling costs for everyone. Read the rest…
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BioTech 365
MARCH 9, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ex-Intercept CMO Campagna lands at immune regulation biotech Q32.Ex-Intercept
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Juul exec slams FDA over its approach to regulating vaping
STAT News
SEPTEMBER 30, 2022
WASHINGTON — A Juul executive fiercely criticized the Food and Drug Administration’s approach toward regulating vaping companies during a tobacco industry conference Thursday.
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STAT+: Some European regulators are starting to take steps to ensure clinical trial results are reported
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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After nearly 4 years of deliberation, FDA punts on how to regulate CBD
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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Are drug regulators sufficiently independent from the companies they are meant to regulate?
Scienmag
JUNE 29, 2022
Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of new medicines before they hit the market.
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BioTech 365
MARCH 25, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Researchers reveal how lipids and water molecules regulate 5-HT receptors.Serotonin, or 5-hydroxytryptamine (5-HT), is a kind of neurotransmitter.
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STAT+: Would the federal government defer to states to regulate PBMs?
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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#news #biotech Truncated immune system receptors may regulate cellular activity
BioTech 365
OCTOBER 29, 2020
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Truncated immune system receptors may regulate cellular activity.MIT Media Lab researchers have discovered that shortened versions of immunity-related protein receptors, long written off as incomplete and therefore … Continue (..)
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#news #biotech CROs embracing tech to decentralize trials and speed enrollment as regulators show support ‘with their feet’
BioTech 365
JANUARY 20, 2022
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: CROs embracing tech to decentralize trials and speed enrollment as regulators show support ‘with their feet’ CROs embracing tech to decentralize trials and speed enrollment as regulators show … Continue reading (..)
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#news #biotech Machine learning algorithm predicts how genes are regulated in individual cells
BioTech 365
JUNE 30, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Machine learning algorithm predicts how genes are regulated in individual cells.A team of scientists at the University of Illinois Chicago has developed a software tool that can … Continue reading →
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#news #biotech UCB races to regulators after $2.5B rare disease bet delivers data for attack on AstraZeneca and argenx
BioTech 365
FEBRUARY 4, 2022
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: UCB races to regulators after $2.5B rare disease bet delivers data for attack on AstraZeneca and argenx.UCB races to regulators after $2.5B rare disease bet delivers data … Continue reading →
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Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show
pharmaphorum
MARCH 16, 2021
European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. The post Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show appeared first on.
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Opinion: A watershed year for biosimilars — if regulators and policymakers step up
STAT News
JANUARY 31, 2023
But without support from regulators and policymakers to make all biosimilars available on formularies, the full promise of these price-cutting drugs could be lost, costing the U.S. Several more Humira biosimilars will also be released this year. health care system $133 billion in the next three years.
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BioTech 365
JANUARY 6, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Researchers use deep learning to identify gene regulation at single-cell level.Scientists at the University of California, Irvine have developed a new deep-learning framework that predicts gene regulation … Continue reading (..)
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#news #biotech Researchers discover a new diet-dependent mechanism for regulating RNA maturation
BioTech 365
APRIL 29, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Researchers discover a new diet-dependent mechanism for regulating RNA maturation.Particularly sensitive to chemical modifications, messenger RNAs (mRNAs) are molecules responsible for transmitting the information encoded in our (..)
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STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight
STAT News
FEBRUARY 23, 2023
In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move.
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Pharma Pulse 5/1/24: Tailoring AI Regulation in Healthcare, OpenAI and Microsoft Sued Over AI & more
Pharmaceutical Commerce
MAY 1, 2024
The latest news for pharma industry insiders.
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