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SUMMARY: Three House Democrats on a key committee voted against the measure to lower drug prices as PhRMA ramped up its lobbying dollars to buy politicians. MORE
The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. MORE
COLUMBIA, Mo. While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman. When she asked what happened, the woman told Bullock a refrigerator had fallen on her while cleaning the kitchen. Credit: MU COLUMBIA, Mo. MORE
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The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test MORE
Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed MORE
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. MORE
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug MORE
SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times. MORE
Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right. MORE
?According to the study, people who get sick enough to be hospitalized due to the virus might eventually suffer from a full-blown autoimmune disease later on MORE
84 
SUMMARY: Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high. MORE
The much-anticipated data arrive two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine MORE
SEPTEMBER 16, 2021
Results of a new study led by the University of Maryland School of Public Health show that people infected with the virus that causes COVID-19 exhale infectious virus in their breath – and those infected with the Alpha variant (the dominant strain circulating at the time this study was conducted) put 43 to 100 times […]. MORE
The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC. MORE
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19 MORE
Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer, according to late breaking results of the MONALEESA-2 trial presented at the ESMO Congress 2021. (1) MORE
The study found that the shots’ effectiveness in preventing hospitalization fell to 77 percent from 91 percent four months after full vaccination. Vaccination and Immunization Drugs (Pharmaceuticals) Research BioNTech SE Centers for Disease Control and Prevention Pfizer Inc MORE
?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy MORE
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used MORE
Follicular lymphoma, a sub-type of indolent B cell non-Hodgkin lymphoma (NHL), accounts for approximately 20% of the total NHL cases. It is the most frequently diagnosed indolent lymphoma. On average, each year, 15,000 new Follicular lymphoma cases are diagnosed in the US alone. MORE
Pfizerâs mRNA flu vaccine joins candidates from Moderna and Sanofi in hoping to provide greater protection against influenza than existing vaccines. Bio Developments MORE
What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes. MORE
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This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics MORE
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SEPTEMBER 16, 2021
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies. Markets & Regulations MORE
Physics researchers at the University of Bath in the UK discover a new physical effect relating to the interactions between light and twisted materials – an effect that is likely to have implications for emerging new nanotechnologies in communications, nanorobotics and ultra-thin optical components. MORE
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months MORE
Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. MORE
Seagen and Genmab Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021 Seagen and Genmab Present Interim Results From the innovaTV 205 Study for … Continue reading → Business Wire MORE
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Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer With the MONALEESA-2 final analysis, only … Continue reading → GlobeNewswire MORE
Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily. MORE
Lugano, Switzerland, 19 September 2021 – A novel combination of well-known drugs prolongs survival in patients with hormone/castration-sensitive prostate cancer, according to late breaking research presented at the ESMO Congress 2021. MORE
Bio Pharma Dive
SEPTEMBER 17, 2021
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19
World of DTC Marketing
SEPTEMBER 16, 2021
SUMMARY: Three House Democrats on a key committee voted against the measure to lower drug prices as PhRMA ramped up its lobbying dollars to buy politicians.
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Bio Pharma Dive
SEPTEMBER 15, 2021
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months
World of DTC Marketing
SEPTEMBER 15, 2021
SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times.
Camargo
SEPTEMBER 14, 2021
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.
Pharma Mirror
SEPTEMBER 16, 2021
What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes.
Clinical Research Informer brings together the best content for pharmaceutical professionals from the widest variety of industry thought leaders.
Bio Pharma Dive
SEPTEMBER 14, 2021
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used
Scienmag
SEPTEMBER 16, 2021
Results of a new study led by the University of Maryland School of Public Health show that people infected with the virus that causes COVID-19 exhale infectious virus in their breath – and those infected with the Alpha variant (the dominant strain circulating at the time this study was conducted) put 43 to 100 times […].
Pharma Phorum
SEPTEMBER 14, 2021
The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC.
BioSpace
SEPTEMBER 13, 2021
This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics
World of DTC Marketing
SEPTEMBER 14, 2021
SUMMARY: Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.
Scienmag
SEPTEMBER 17, 2021
COLUMBIA, Mo. While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman. When she asked what happened, the woman told Bullock a refrigerator had fallen on her while cleaning the kitchen. Credit: MU COLUMBIA, Mo.
Pharma Phorum
SEPTEMBER 15, 2021
Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right.
Outsourcing Pharma
SEPTEMBER 16, 2021
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies. Markets & Regulations
Bio Pharma Dive
SEPTEMBER 15, 2021
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test
NY Times
SEPTEMBER 17, 2021
The study found that the shots’ effectiveness in preventing hospitalization fell to 77 percent from 91 percent four months after full vaccination. Vaccination and Immunization Drugs (Pharmaceuticals) Research BioNTech SE Centers for Disease Control and Prevention Pfizer Inc
Delveinsight
SEPTEMBER 17, 2021
Follicular lymphoma, a sub-type of indolent B cell non-Hodgkin lymphoma (NHL), accounts for approximately 20% of the total NHL cases. It is the most frequently diagnosed indolent lymphoma. On average, each year, 15,000 new Follicular lymphoma cases are diagnosed in the US alone.
Pharma Phorum
SEPTEMBER 16, 2021
Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced.
Scienmag
SEPTEMBER 19, 2021
Physics researchers at the University of Bath in the UK discover a new physical effect relating to the interactions between light and twisted materials – an effect that is likely to have implications for emerging new nanotechnologies in communications, nanorobotics and ultra-thin optical components.
Bio Pharma Dive
SEPTEMBER 15, 2021
The much-anticipated data arrive two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine
NY Times
SEPTEMBER 15, 2021
Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.
BioTech 365
SEPTEMBER 19, 2021
Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer With the MONALEESA-2 final analysis, only … Continue reading → GlobeNewswire
Pharma Phorum
SEPTEMBER 15, 2021
The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week.
Scienmag
SEPTEMBER 19, 2021
Lugano, Switzerland, 19 September 2021 – A novel combination of well-known drugs prolongs survival in patients with hormone/castration-sensitive prostate cancer, according to late breaking research presented at the ESMO Congress 2021.
Bio Pharma Dive
SEPTEMBER 17, 2021
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug
BioPharma Reporter
SEPTEMBER 16, 2021
Pfizerâs mRNA flu vaccine joins candidates from Moderna and Sanofi in hoping to provide greater protection against influenza than existing vaccines. Bio Developments
BioTech 365
SEPTEMBER 19, 2021
Seagen and Genmab Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021 Seagen and Genmab Present Interim Results From the innovaTV 205 Study for … Continue reading → Business Wire
Pharma Phorum
SEPTEMBER 15, 2021
Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily.
Scienmag
SEPTEMBER 19, 2021
Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer, according to late breaking results of the MONALEESA-2 trial presented at the ESMO Congress 2021. (1)
Bio Pharma Dive
SEPTEMBER 13, 2021
Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed
BioSpace
SEPTEMBER 14, 2021
?According to the study, people who get sick enough to be hospitalized due to the virus might eventually suffer from a full-blown autoimmune disease later on
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