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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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GE biopharma brands are now part of Cytiva, a Danaher Corporation Life Sciences company.
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Industry News
The joint public-private initiative will provide $4 million in funding to a Johns Hopkins-led research team exploring therapeutic uses of blood plasma from recovered COVID-19 patients.
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Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.
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Supplier News
Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name.
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Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.
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Bio/Pharma News
Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.
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AstraZeneca has revealed that it will collaborate with Silence Therapeutics on the discovery, development, and commercialization of small interfering RNA (siRNA) therapeutics for the treatment of cardiovascular, renal, metabolic, and respiratory diseases.
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Regulatory News
The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.
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AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).
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Featured Topics |
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FORMULATION
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
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QUALITY SYSTEMS
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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PEER-REVIEWED RESEARCH
It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
Interphex 2020 has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
Validation University has been rescheduled for August 2020.
CPhI North America has been rescheduled for September 2020.
CPhI Japan has been rescheduled for September 2020
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
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eBOOKS
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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