Expert insights. Personalized for you.
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. In their paper … Continue reading → #news MORE
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The post UK regulator backs Amarin’s cardiology drug Vazkepa appeared first on. 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
254 The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. The post EU safety regulators clear J&J COVID shot despite tiny clot risk appeared first on. MORE
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
EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. Professional. FRIDAY, Jan. MORE
Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Apoptosis Regulator BAX – Drugs In Development, 2021” drug pipelines has been added to ResearchAndMarkets.com’s offering. 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
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 post Why intelligent automation is the future for regulation appeared first on. Digital Market Access Views & Analysis Views and analysis Accenture automation regulation MORE
The post Predicting the Future of Data Privacy Regulation appeared first on Intouch Solutions. Get our summary of a discussion between the Coalition for Healthcare Communication and Alison Pepper, EVP of Government Relations at the 4A's, about the current data-privacy landscape. MORE
52 
Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators MOUNTAIN VIEW, Calif., 08, 2021 (GLOBE NEWSWIRE) — Underdog Pharmaceuticals, Inc. Underdog), a pre-clinical stage pharmaceutical company focusing on the treatment and reversal … Continue reading → GlobeNewswire MORE
40 
Markets & RegulationsThe European Medicines Agency (EMA) concludes that Celltrionâs monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease. MORE
Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes. 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
Credit: Nina Brooks Like superheroes capable of seeing through obstacles, environmental regulators may soon wield the power of all-seeing eyes that can identify violators anywhere at any time, according to a new Stanford University-led study. 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
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
Markets & RegulationsThe UKâs Competition and Markets Authority (CMA) is inviting comments on AstraZenecaâs $39bn acquisition of Alexion. MORE
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. Crucial is that the cutting can initiate the formation of roots, a process … Continue reading → #news MORE
Chemistry AND Physics advising apply biotherapeutic developer live mindset product regulators similar 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 long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review process for clinical trials via a centralized portal, is finally knocking at our doors. MORE
Piqray in combination with fulvestrant is the first treatment for tumours with a PIK3CA mutation MORE
94 
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
211 
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
It does, however, regulate toxins in other consumer products including arsenic, lead and cadmium, and the agency previously declared them dangerous to human health, particularly to babies and children. 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
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
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
40 
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
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
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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
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
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
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
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
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
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?
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
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.
BioPharma Reporter
MAY 25, 2021
Markets & RegulationsThe UKâs Competition and Markets Authority (CMA) is inviting comments on AstraZenecaâs $39bn acquisition of Alexion.
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.
Scienmag
JANUARY 22, 2021
Cryo-electron microscopy study allows researchers to visualize structural changes in an E.
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.
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.
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.
Scienmag
SEPTEMBER 8, 2021
Chemistry AND Physics advising apply biotherapeutic developer live mindset product regulators similar
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
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
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
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
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
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.
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
Scienmag
APRIL 19, 2021
Credit: Nina Brooks Like superheroes capable of seeing through obstacles, environmental regulators may soon wield the power of all-seeing eyes that can identify violators anywhere at any time, according to a new Stanford University-led study.
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
BioTech 365
SEPTEMBER 8, 2021
Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators MOUNTAIN VIEW, Calif., 08, 2021 (GLOBE NEWSWIRE) — Underdog Pharmaceuticals, Inc. Underdog), a pre-clinical stage pharmaceutical company focusing on the treatment and reversal … Continue reading → GlobeNewswire
CATO Research
JUNE 15, 2021
The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review process for clinical trials via a centralized portal, is finally knocking at our doors.
The Pharma Data
NOVEMBER 18, 2020
Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes.
The Pharma Data
JANUARY 29, 2021
EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. Professional. FRIDAY, Jan.
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. In their paper … Continue reading → #news
BioPharma Reporter
MARCH 29, 2021
Markets & RegulationsThe European Medicines Agency (EMA) concludes that Celltrionâs monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.
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. Crucial is that the cutting can initiate the formation of roots, a process … Continue reading → #news
Intouch Solutions
JUNE 3, 2021
The post Predicting the Future of Data Privacy Regulation appeared first on Intouch Solutions. Get our summary of a discussion between the Coalition for Healthcare Communication and Alison Pepper, EVP of Government Relations at the 4A's, about the current data-privacy landscape.
Pharma Times
JULY 30, 2020
Piqray in combination with fulvestrant is the first treatment for tumours with a PIK3CA mutation
BioTech 365
JULY 15, 2021
Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Apoptosis Regulator BAX – Drugs In Development, 2021” drug pipelines has been added to ResearchAndMarkets.com’s offering.
Pharma Phorum
APRIL 21, 2021
The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. The post EU safety regulators clear J&J COVID shot despite tiny clot risk appeared first on.
XTalks
MARCH 26, 2021
It does, however, regulate toxins in other consumer products including arsenic, lead and cadmium, and the agency previously declared them dangerous to human health, particularly to babies and children.
Pharma Phorum
APRIL 23, 2021
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The post UK regulator backs Amarin’s cardiology drug Vazkepa appeared first on.
Let's personalize your content