Moderna Opens Company’s First Overseas Beachhead In Switzerland 16/09/2020 Elaine Ruth Fletcher Geneva, Switzerland – Moderna, Inc., one of the leaders in the race to develop a new COVID-19 vaccine, has come home — again. The biotech startup, which raised a significant chunk of its initial US$ 100 million amongst a group of far-sighted Swiss investors and private bankers a decade ago, announced Wednesday that it would be establishing […] Continue reading -> Gilead Says Remdesivir Shortages Due To Supply Chain Issues, Civil Society Argues For Wider Licensing 03/09/2020 Svĕt Lustig Vijay As global stocks of remdesivir, one of the few promising therapeutics for COVID-19, run low, the drug’s maker Gilead Sciences says that voluntary licensing to enable more manufacturers to produce the drug will not help expand access, countering advocates’ calls. Rather, the lack of a “coordinated global supply chain” is to blame for worldwide shortages […] Continue reading -> Unwrapping The Biological Secrets Behind Moderna’s COVID-19 Vaccine Technology 02/09/2020 Elaine Ruth Fletcher Tal Zaks, chief medical officer at Moderna Therapeutics since 2015, which has become one of the front-runners in the race to develop a vaccine for COVID-19, is in fact an oncologist, not a virologist by training. And so it’s perhaps no accident that the innovative “messenger RNA” (mRNA) technology upon which the company’s vaccine candidate […] Continue reading -> US Food And Drug Administration Commissioner Walks Back Claims On Plasma Treatment For Coronavirus 26/08/2020 Grace Ren The US Food and Drug Administration Commission Stephen Hahn on Monday apologized for overstating the effectiveness of convalescent plasma as a treatment for COVID-19, after the agency faced backlash for Hahn’s claims that the treatment could reduce mortality by as much as 35%, made during an announcement of the FDA emergency approval of the therapy […] Continue reading -> Game-changing COVID-19 Saliva Test Receives Regulatory Approval In The United States 17/08/2020 Grace Ren An breakthrough new COVID-19 saliva test, named SalivaDirect, received emergency use approval from the US Food and Drug Administration, potentially opening the door to broader testing. The new FDA-approved test, developed by researchers from the Yale School of Public Health, is about as sensitive as a traditional COVID-19 test, but is less invasive to perform, […] Continue reading -> EU Orphan Drug Regulations Haven’t “Failed” But Reforms Needed, Says CEO Of European Rare Disease NGO 04/08/2020 Svĕt Lustig Vijay European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 […] Continue reading -> More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
Gilead Says Remdesivir Shortages Due To Supply Chain Issues, Civil Society Argues For Wider Licensing 03/09/2020 Svĕt Lustig Vijay As global stocks of remdesivir, one of the few promising therapeutics for COVID-19, run low, the drug’s maker Gilead Sciences says that voluntary licensing to enable more manufacturers to produce the drug will not help expand access, countering advocates’ calls. Rather, the lack of a “coordinated global supply chain” is to blame for worldwide shortages […] Continue reading -> Unwrapping The Biological Secrets Behind Moderna’s COVID-19 Vaccine Technology 02/09/2020 Elaine Ruth Fletcher Tal Zaks, chief medical officer at Moderna Therapeutics since 2015, which has become one of the front-runners in the race to develop a vaccine for COVID-19, is in fact an oncologist, not a virologist by training. And so it’s perhaps no accident that the innovative “messenger RNA” (mRNA) technology upon which the company’s vaccine candidate […] Continue reading -> US Food And Drug Administration Commissioner Walks Back Claims On Plasma Treatment For Coronavirus 26/08/2020 Grace Ren The US Food and Drug Administration Commission Stephen Hahn on Monday apologized for overstating the effectiveness of convalescent plasma as a treatment for COVID-19, after the agency faced backlash for Hahn’s claims that the treatment could reduce mortality by as much as 35%, made during an announcement of the FDA emergency approval of the therapy […] Continue reading -> Game-changing COVID-19 Saliva Test Receives Regulatory Approval In The United States 17/08/2020 Grace Ren An breakthrough new COVID-19 saliva test, named SalivaDirect, received emergency use approval from the US Food and Drug Administration, potentially opening the door to broader testing. The new FDA-approved test, developed by researchers from the Yale School of Public Health, is about as sensitive as a traditional COVID-19 test, but is less invasive to perform, […] Continue reading -> EU Orphan Drug Regulations Haven’t “Failed” But Reforms Needed, Says CEO Of European Rare Disease NGO 04/08/2020 Svĕt Lustig Vijay European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 […] Continue reading -> More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
Unwrapping The Biological Secrets Behind Moderna’s COVID-19 Vaccine Technology 02/09/2020 Elaine Ruth Fletcher Tal Zaks, chief medical officer at Moderna Therapeutics since 2015, which has become one of the front-runners in the race to develop a vaccine for COVID-19, is in fact an oncologist, not a virologist by training. And so it’s perhaps no accident that the innovative “messenger RNA” (mRNA) technology upon which the company’s vaccine candidate […] Continue reading -> US Food And Drug Administration Commissioner Walks Back Claims On Plasma Treatment For Coronavirus 26/08/2020 Grace Ren The US Food and Drug Administration Commission Stephen Hahn on Monday apologized for overstating the effectiveness of convalescent plasma as a treatment for COVID-19, after the agency faced backlash for Hahn’s claims that the treatment could reduce mortality by as much as 35%, made during an announcement of the FDA emergency approval of the therapy […] Continue reading -> Game-changing COVID-19 Saliva Test Receives Regulatory Approval In The United States 17/08/2020 Grace Ren An breakthrough new COVID-19 saliva test, named SalivaDirect, received emergency use approval from the US Food and Drug Administration, potentially opening the door to broader testing. The new FDA-approved test, developed by researchers from the Yale School of Public Health, is about as sensitive as a traditional COVID-19 test, but is less invasive to perform, […] Continue reading -> EU Orphan Drug Regulations Haven’t “Failed” But Reforms Needed, Says CEO Of European Rare Disease NGO 04/08/2020 Svĕt Lustig Vijay European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 […] Continue reading -> More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
US Food And Drug Administration Commissioner Walks Back Claims On Plasma Treatment For Coronavirus 26/08/2020 Grace Ren The US Food and Drug Administration Commission Stephen Hahn on Monday apologized for overstating the effectiveness of convalescent plasma as a treatment for COVID-19, after the agency faced backlash for Hahn’s claims that the treatment could reduce mortality by as much as 35%, made during an announcement of the FDA emergency approval of the therapy […] Continue reading -> Game-changing COVID-19 Saliva Test Receives Regulatory Approval In The United States 17/08/2020 Grace Ren An breakthrough new COVID-19 saliva test, named SalivaDirect, received emergency use approval from the US Food and Drug Administration, potentially opening the door to broader testing. The new FDA-approved test, developed by researchers from the Yale School of Public Health, is about as sensitive as a traditional COVID-19 test, but is less invasive to perform, […] Continue reading -> EU Orphan Drug Regulations Haven’t “Failed” But Reforms Needed, Says CEO Of European Rare Disease NGO 04/08/2020 Svĕt Lustig Vijay European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 […] Continue reading -> More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
Game-changing COVID-19 Saliva Test Receives Regulatory Approval In The United States 17/08/2020 Grace Ren An breakthrough new COVID-19 saliva test, named SalivaDirect, received emergency use approval from the US Food and Drug Administration, potentially opening the door to broader testing. The new FDA-approved test, developed by researchers from the Yale School of Public Health, is about as sensitive as a traditional COVID-19 test, but is less invasive to perform, […] Continue reading -> EU Orphan Drug Regulations Haven’t “Failed” But Reforms Needed, Says CEO Of European Rare Disease NGO 04/08/2020 Svĕt Lustig Vijay European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 […] Continue reading -> More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
EU Orphan Drug Regulations Haven’t “Failed” But Reforms Needed, Says CEO Of European Rare Disease NGO 04/08/2020 Svĕt Lustig Vijay European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 […] Continue reading -> More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
More “Skin In The Game” Needed To Defeat Tuberculosis 03/08/2020 Grace Ren Amidst the battle against a new infectious threat, the fight against tuberculosis, one of humankind’s oldest recorded infectious diseases, is also progressing. Pretomanid – only the second TB drug to hit the market in over two decades – received conditional marketing approval Monday from the European Commission as part of a new, three-drug treatment regimen […] Continue reading -> New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
New “One Health Global Leaders Group” Seeks Candidates To Help Combat Antimicrobial Resistance 30/07/2020 Atika Abd El-salam The United Nations Interagency Coordination Group (IACG) is seeking candidates for a “One Health Global Leaders Group” that will be established to fight the growing threat of antimicrobial resistance (AMR). Individuals from civil society and the private sector are invited to submit an application to serve in the Global Leaders Group by 31 August 2020. […] Continue reading -> Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
Pharma Reaps Billions Off Orphan Drug Designations, Says New Report By Dutch Investigative Group 30/07/2020 Svĕt Lustig Vijay Big pharma has reaped billions in profit off the back of European orphan drug regulations that are supposed to incentivize R&D for rare diseases, according to an analysis of 120 orphan medicines registered in the EU over the past two decades. Instead of incentivizing R&D for rare maladies, the EU’s orphan drug legislation has turned […] Continue reading -> Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts
Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs 28/07/2020 Svĕt Lustig Vijay Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading -> Posts navigation Older postsNewer posts