Islet transplantation for type 1 diabetes: Do regulators have it right?
Pharmaceutical Technology
OCTOBER 9, 2023
Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.
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2022 in review: Regulation starts to catch up with AI in pharma
Pharmaceutical Technology
DECEMBER 21, 2022
But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances. This could spell high-stake consequences for consumers whose privacy and safety could be at risk if AI models are not regulated. Major AI deals in 2022.
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What does Biden’s executive order mean for worldwide AI regulation?
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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FDA Pharmacovigilance Regulations Update
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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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).
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Amylyx's ALS drug Albrioza rebuffed by EU regulator—again
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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How Will AI in Hiring Be Regulated?
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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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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European regulators revoke Covid-19 business continuity status
Pharmaceutical Technology
MAY 11, 2023
The business continuity plan was introduced in 2020 to allow European regulators to prioritise the assessment of Covid-19 therapeutics and vaccines while also handling other responsibilities.
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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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AstraZeneca deal for Alexion to close soon as UK regulator clears acquisition
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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European regulators back hemophilia gene therapy
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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The drug industry continues to dare regulation
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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Drug discovery trends: From regulation to embracing AI
Drug Discovery World
NOVEMBER 23, 2023
This is the latest episode of the free DDW narrated podcast, “Drug discovery trends: From regulation to embracing AI”, which covers two articles written for Volume 23 – Issue 4, Fall 2022 of DDW. Listen here: The post Drug discovery trends: From regulation to embracing AI appeared first on Drug Discovery World (DDW).
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Europe's drug regulator links J&J's vaccine to rare clots as US pause continues
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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Navigating Ad Regulations: Digital Compliance for Pharma Marketers
Pharma Marketing Network
OCTOBER 13, 2023
In the ever-evolving digital landscape, pharma marketers must stay up to date with the latest ad regulations. Navigating the complex web of rules and regulations requires careful consideration and preparation. This includes understanding the various laws and regulations that govern digital advertising.
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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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Mapping the landscape of clinical trial regulation
pharmaphorum
AUGUST 25, 2023
Mapping the landscape of clinical trial regulation Mike.Smith Fri, 25/08/2023 - 10:00 Bookmark this
Sanofi invests in MeiraGTx and its gene-regulating technology
Bio Pharma Dive
OCTOBER 30, 2023
In addition to Sanofi’s investment, the biotech signaled it’s weighing deals with “multiple” other companies that have expressed interest in its work.
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Incyte withdraws cancer drug from FDA review after discussions with regulator
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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European regulator recommends Bavarian Nordic's vaccine for monkeypox
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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How competitors are collaborating to shape biopharma best practices and regulations of the future
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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A months-long landfill fire in Alabama reveals waste regulation gaps
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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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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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.
Biggest overhaul of UK clinical trial regulation for 20 years
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).
European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
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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More federal regulators investigating Biogen's Alzheimer's drug
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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Astrocytes: The 'stars' in the brain may be information regulators
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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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 (..)
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PTC's first gene therapy gains European regulator's backing
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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States look to regulate weed alternatives like delta-8 as sales explode
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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Four things you need to know about FDA regulations and digital health
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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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.
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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations
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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It’s About Time: FDA’s Proposed Rule to Amend Prior Notice Regulations
FDA Law Blog
NOVEMBER 9, 2023
Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.
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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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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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Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies
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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European drugs regulator signals rejection likely for Biogen's Aduhelm
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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Proposed changes to EU regulation risks progress on orphan drugs
Drug Discovery World
OCTOBER 3, 2023
Plans to overhaul the EU regulation on rare disease therapies risk undermining two decades of progress, a new report claims. The European Orphan Medicinal Product Regulation was introduced in 2000 to incentivise the development of new medicines for people living with rare disease.
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European Regulator Leaning Toward Rejecting Amylyx’s ALS Drug
BioSpace
MAY 29, 2023
European Regulator Leaning Toward Rejecting Amylyx’s ALS Drug 5/30/2023
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Illegal online pharmacies gain traction as regulators lag behind
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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Exploring genetic regulation of immunoglobulin A
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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