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Government

Policy
Pfizer and BioNTech Ink $1.95 Billion COVID-19 Vaccine Deal with U.S. Government
Only days after announcing a COVID-19 vaccine production deal with the UK government, New York-based Pfizer and Germany-based BioNTech signed an even bigger deal with the U.S. government.
July 22, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
July 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
July 20, 2020
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2 min read
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BioSpace Editorial Staff
Policy
FDA Action Alert: Jazz, ANI and Ultragenyx
Wrapping up the month of July, there are three PDUFA dates on the U.S. Food and Drug Administration (FDA) calendar.
July 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.
July 16, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Federal Government Should Provide Additional $75 Billion for COVID-19 Diagnostics, Report Says
A dramatic increase in COVID-19 testing and tracing is needed in order to put the United States on a surer path through the pandemic. But that diagnostics increase comes with a significant price tag of about $75 billion from the federal government, the Rockefeller Foundation said in its latest report.
July 16, 2020
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2 min read
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Alex Keown
It's a yes for GSK’s multiple myeloma drug belanta
Policy
FDA Advisory Committee Votes 12-0 to Recommend GSK’s Multiple Myeloma Drug Belantamab Mafodotin
“We are pleased the committee recognized the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options,” said Axel Hoos, senior vice president and heat of Oncology R&D for GSK.
July 15, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.
July 14, 2020
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5 min read
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BioSpace Editorial Staff
Policy
U.S. Official: COVID-19 Vaccine Manufacturing Could Begin By Late Summer
An unnamed U.S. official told the news agency that vaccine manufacturing under development in conjunction with the federal government’s Operation Warp Speed program is likely to begin within the next four to six weeks.
July 14, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: July 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 13, 2020.
July 13, 2020
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3 min read
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BioSpace Editorial Staff
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PRESS RELEASES
Policy
Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants
February 6, 2019
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7 min read
Policy
Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions
February 6, 2019
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3 min read
Policy
The Michael J. Fox Foundation Submits 107,000 Community Signatures Urging the EPA to Ban Herbicide Linked to Parkinson’s
February 6, 2019
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3 min read
Business
Immunexpress Secures BARDA Contract for the Continued Development of SeptiCyte™ for the Rapid and Accurate Diagnosis of Sepsis
February 6, 2019
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3 min read
Deals
/R E P E A T -- Media Advisory - Government of Canada to announce major investment in cutting-edge genomics research/
February 4, 2019
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1 min read
Policy
Tax Tip - Did you know you may be eligible to claim medical expenses?
February 1, 2019
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2 min read
Policy
Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application
February 1, 2019
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4 min read
Policy
Media Advisory - Government of Canada to announce major investment in cutting-edge genomics research
February 1, 2019
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1 min read
Policy
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition
January 30, 2019
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6 min read
Business
Saudi Arabia Delivers Ship-to-Shore Crane, Opens Greenhouses and Breaks Ground on Schools in Yemen
January 29, 2019
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2 min read
Policy
PCMA Offers Policy Solutions to Reduce Prescription Drug Costs
January 28, 2019
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7 min read
Policy
Public Health Notice - Outbreaks of Salmonella infections linked to raw chicken, including frozen raw breaded chicken products - January 25, 2019
January 25, 2019
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8 min read
Policy
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D. on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues
January 25, 2019
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12 min read
Policy
Acerus Receives Notice of Deficiency – Withdrawal Letter from Health Canada Regarding Gynoflor™ Application
January 25, 2019
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2 min read
Policy
The Alliance To Fight The 40 Applauds Reintroduction Of Bipartisan Legislation To Protect The Health Care Coverage Of 181 Million Americans
January 24, 2019
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5 min read
FDA
FDA statement from Commissioner Scott Gottlieb, M.D. announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications
January 24, 2019
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6 min read
Business
Governments of Canada and Ontario Sign Agreements to Improve Health Care and Services for Substance Use Disorder
January 23, 2019
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2 min read
Policy
Update on New Drug and Medical Device Authorizations - New Treatment Options for Canadians recently approved by Health Canada
January 23, 2019
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6 min read
Policy
Health Canada Encourages Young Adults to Break It Off with Cigarettes
January 23, 2019
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3 min read
Policy
The governments of Canada and Northwest Territories collaborate to improve access to treatment for people with substance use disorders
January 22, 2019
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2 min read
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