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SEATTLE (January 10, 2022) – As the two-year anniversary of the pandemic approaches, a new commentary provides insights into reforming the “labyrinth of conflicting and uncoordinated actions among state and federal regulators” that in early 2020 hampered Seattle researchers from community testing for COVID-19. Latest News Commentary flu hindered offers reforms regulations SARSCoV2 Seattle study surveillance MORE
Biology blood find independent insulin levels regulating researchers route Salk sugarLA JOLLA—(January 4, 2022) The discovery of insulin 100 years ago opened a door that would lead to life and hope for millions of people with diabetes. MORE
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. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282. MORE
The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next MORE
267 The commission, along with agencies in Europe, Canada and the U.K., plans to take a broader view of the potential anti-competitive effects to drug company acquisitions MORE
regulator may be able to be commercialized without the black-box warnings that accompany so many TNF-? MyMD Pharmaceuticals’ TNF-? therapies MORE
Biology blood differences emerging pressure regulation sexAUGUSTA, Ga. 18, 2021) – Another difference between females and males appears to be a key mechanism in how they become hypertensive, scientists say, and consequently which antihypertensives should be most effective for them. MORE
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on. MORE
The news sparked headlines about an attempt by regulators to target big tech, but it could have serious implications for healthcare, too MORE
182 
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 MORE
The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals MORE
The post Why intelligent automation is the future for regulation appeared first on. Digital Market Access Views & Analysis Views and analysis Accenture automation regulation MORE
Medicine & Health avenue cell diseases immune inflammatory ligand receptor regulation therapeuticImmune cells play a key role in mediating inflammatory responses. MORE
Jude Children’s Research Hospital scientists have developed a highly efficient method to address a major challenge in biology–identifying the genetic ‘switches’ that regulate gene expression. MORE
European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. News Patients AstraZeneca ema regulation safety MORE
Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As MORE
A key committee of the EMA gave a positive review of Astellas and Fibrogen's roxadustat, as well as Bristol Myers Squibb's cell therapy Abecma and UCB's psoriasis drug Bimzelx MORE
A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical studies. Markets & Regulations MORE
The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week. Markets & Regulations MORE
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 MORE
Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation Mission Viejo, California, United States, Dec. MORE
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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. The post MHRA publishes guidance on medicine regulation after Brexit appeared first on. MORE
The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world MORE
The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks " MORE
Markets & RegulationsThe UKâs Competition and Markets Authority (CMA) is inviting comments on AstraZenecaâs $39bn acquisition of Alexion. MORE
The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days MORE
In the EU, the new EU MDR regulation came into force in May 2017 (2017/745) and will replace the current… The post FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling appeared first on Journal for Clinical Studies. MORE
52 
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. MORE
The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors MORE
Research team led by University of Göttingen investigates agroforestry systems in Madagascar Credit: Annemarie Wurz The cultivation of vanilla in Madagascar provides a good income for small-holder farmers, but without trees and bushes the plantations can lack biodiversity. MORE
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 MORE
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With $82 million in hand, Flare Therapeutics is looking to create precision cancer drugs by going after a type of protein called transcription factors MORE
Brainstem Neurons Identified as Regulator of Inflammation Brainstem Neurons Identified as Regulator of Inflammation Feinstein Institutes’ researchers publish in PNAS new avenue of bioelectronic nerve stimulation to control human body inflammation MANHASSET, N.Y.–(BUSINESS MORE
Credit: Martin Visser, Unsplash Humans in the 21st century spend most of their time indoors, but the air we breathe inside buildings is not regulated to the same degree as the food we eat and the water we drink. MORE
Cancer breast cancer discover mechanism regulates researchers spreadResearchers have known for decades that human cells migrate by circulating cell surface adhesion receptors from one part of the cell to another. MORE
The post Regulation optimisation could save thousands of life years appeared first on. Market Access Oncology Patients Views & Analysis Views and analysis cancer digital regulation MORE
From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services. Blog clinical trial patient recruitment decentralized trials hybrid trials patient centricity regulation changes MORE
October 05, 2020, 17h45 Publication made under article 15 of the law of May 2, 2007 relating to the disclosure of major holdings in issuers whose shares are admitted to trading on a regulated market and containing various provisions (Belgian … Continue reading → GlobeNewswire MORE
The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use MORE
October 12, 2020, 17h45 Please consult the erratum of the press release of October 5, 2020 attached and disregard the previous one. The change is at the level of the shareholder graph. Publication made under article 15 of the law … Continue reading → GlobeNewswire MORE
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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. MORE
Chemistry AND Physics epithelial homeostasis light Mechanical regulation researchers shed tissueAn international team of scientists, led by Professor Ana-Sun?ane ane Smith from the Croatian Ru?er er Boškovi? MORE
Regulation Related Topics 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
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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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
Bio Pharma Dive
MAY 21, 2021
The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world
Scienmag
JANUARY 14, 2022
Social & Behavioral Science electricity equity Justice regulation
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
Scienmag
OCTOBER 17, 2021
Biology blood differences emerging pressure regulation sexAUGUSTA, Ga. 18, 2021) – Another difference between females and males appears to be a key mechanism in how they become hypertensive, scientists say, and consequently which antihypertensives should be most effective for them.
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
Bio Pharma Dive
MAY 13, 2021
With $82 million in hand, Flare Therapeutics is looking to create precision cancer drugs by going after a type of protein called transcription factors
Bio Pharma Dive
MARCH 16, 2021
The commission, along with agencies in Europe, Canada and the U.K., plans to take a broader view of the potential anti-competitive effects to drug company acquisitions
Bio Pharma Dive
SEPTEMBER 1, 2021
The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors
Bio Pharma Dive
JUNE 10, 2021
The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next
Scienmag
JANUARY 4, 2022
Biology blood find independent insulin levels regulating researchers route Salk sugarLA JOLLA—(January 4, 2022) The discovery of insulin 100 years ago opened a door that would lead to life and hope for millions of people with diabetes.
|
Bio Pharma Dive
JUNE 25, 2021
A key committee of the EMA gave a positive review of Astellas and Fibrogen's roxadustat, as well as Bristol Myers Squibb's cell therapy Abecma and UCB's psoriasis drug Bimzelx
BioTech 365
DECEMBER 30, 2021
Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation Mission Viejo, California, United States, Dec.
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. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282.
Scienmag
JANUARY 10, 2022
SEATTLE (January 10, 2022) – As the two-year anniversary of the pandemic approaches, a new commentary provides insights into reforming the “labyrinth of conflicting and uncoordinated actions among state and federal regulators” that in early 2020 hampered Seattle researchers from community testing for COVID-19. Latest News Commentary flu hindered offers reforms regulations SARSCoV2 Seattle study surveillance
Bio Pharma Dive
DECEMBER 17, 2021
The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks "
Clairnes
DECEMBER 17, 2021
From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services. Blog clinical trial patient recruitment decentralized trials hybrid trials patient centricity regulation changes
Scienmag
NOVEMBER 24, 2021
Medicine & Health avenue cell diseases immune inflammatory ligand receptor regulation therapeuticImmune cells play a key role in mediating inflammatory responses.
Bio Pharma Dive
DECEMBER 2, 2020
The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days
Pharma Phorum
DECEMBER 14, 2021
The post Regulation optimisation could save thousands of life years appeared first on. Market Access Oncology Patients Views & Analysis Views and analysis cancer digital regulation
Scienmag
OCTOBER 1, 2021
Chemistry AND Physics epithelial homeostasis light Mechanical regulation researchers shed tissueAn international team of scientists, led by Professor Ana-Sun?ane ane Smith from the Croatian Ru?er er Boškovi?
Scienmag
JANUARY 22, 2021
Cryo-electron microscopy study allows researchers to visualize structural changes in an E.
Pharma Phorum
DECEMBER 9, 2021
Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As
Scienmag
MAY 6, 2021
Jude Children’s Research Hospital scientists have developed a highly efficient method to address a major challenge in biology–identifying the genetic ‘switches’ that regulate gene expression.
Pharma Phorum
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. The post MHRA publishes guidance on medicine regulation after Brexit appeared first on.
BioPharma Reporter
MAY 25, 2021
Markets & RegulationsThe UKâs Competition and Markets Authority (CMA) is inviting comments on AstraZenecaâs $39bn acquisition of Alexion.
BioPharma Reporter
MARCH 8, 2021
A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical studies. Markets & Regulations
Journal for Clinical Studies
APRIL 26, 2021
In the EU, the new EU MDR regulation came into force in May 2017 (2017/745) and will replace the current… The post FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling appeared first on Journal for Clinical Studies.
BioTech 365
OCTOBER 5, 2020
October 05, 2020, 17h45 Publication made under article 15 of the law of May 2, 2007 relating to the disclosure of major holdings in issuers whose shares are admitted to trading on a regulated market and containing various provisions (Belgian … Continue reading → GlobeNewswire
Scienmag
OCTOBER 21, 2020
Research team led by University of Göttingen investigates agroforestry systems in Madagascar Credit: Annemarie Wurz The cultivation of vanilla in Madagascar provides a good income for small-holder farmers, but without trees and bushes the plantations can lack biodiversity.
Pharma Phorum
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.
Scienmag
OCTOBER 18, 2021
Cancer breast cancer discover mechanism regulates researchers spreadResearchers have known for decades that human cells migrate by circulating cell surface adhesion receptors from one part of the cell to another.
Outsourcing Pharma
MAY 25, 2021
The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week. Markets & Regulations
Pharma Phorum
OCTOBER 2, 2020
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.
BioTech 365
NOVEMBER 10, 2020
Brainstem Neurons Identified as Regulator of Inflammation Brainstem Neurons Identified as Regulator of Inflammation Feinstein Institutes’ researchers publish in PNAS new avenue of bioelectronic nerve stimulation to control human body inflammation MANHASSET, N.Y.–(BUSINESS
Pharma Phorum
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.
Pharma Phorum
MARCH 11, 2021
European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. News Patients AstraZeneca ema regulation safety
Pharma Phorum
OCTOBER 6, 2020
The post Why intelligent automation is the future for regulation appeared first on. Digital Market Access Views & Analysis Views and analysis Accenture automation regulation
BioTech 365
OCTOBER 12, 2020
October 12, 2020, 17h45 Please consult the erratum of the press release of October 5, 2020 attached and disregard the previous one. The change is at the level of the shareholder graph. Publication made under article 15 of the law … Continue reading → GlobeNewswire
BioSpace
MAY 31, 2021
regulator may be able to be commercialized without the black-box warnings that accompany so many TNF-? MyMD Pharmaceuticals’ TNF-? therapies
Scienmag
MAY 13, 2021
Credit: Martin Visser, Unsplash Humans in the 21st century spend most of their time indoors, but the air we breathe inside buildings is not regulated to the same degree as the food we eat and the water we drink.
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