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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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The decision is part of the Takeda’s goal to divest $10 billion in non-core assets and focus on its key business areas.
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Industry News
A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.
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A report into the Swiss biotech sector has shown that there is continued growth in the sector, which has received investments from public and private companies worth CHF 1.2 billion (US$1.2 billion).
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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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Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.
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Bio/Pharma News
MicrofluidX has raised £1.4 million (US$1.7 million) in seed funding, which it will use to develop its novel cell bioprocessing technology for cell and gene therapy.
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A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.
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Regulatory News
The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.
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With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
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Featured Topics |
FORMULATION
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
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QUALITY SYSTEMS
Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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ON DEMAND WEBCASTS
Integrated Preformulation Studies for Fast Advancement of Drug Candidates to Human Clinical Studies On Demand
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WEBCASTS
Through Container Verification of Pharmaceutical Raw Materials with the New Agilent Vaya Handheld Raman System Europe Broadcast: Thursday, May 14, 2020 at 9am EDT | 2pm BST | 3pm CEST
US Broadcast: Thursday, May 14, 2020 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific Broadcast: Friday, May 15, 2020 at 8:30am IST | 11am CST | 12pm JST | 1pm AEST
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OTC Trends, Monograph Reform, and Innovation Tuesday, May 5, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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When Drug Meets Device: How to Assess Compatibility Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Bulletproof your Supply Chain: Hope for the Best, Prepare for the Worst Monday, May 18, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Ensuring Integrity of Drug Formulation from Development to QC Thursday, May 21, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Analysis of Genotoxic Nitrosamine Impurities in Pharmaceutical Products under GMP Conditions using High-Resolution Accurate Mass (HRAM) Mass Spectrometry Wednesday, May 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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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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The Pharmacopoeia Compliance Series features a description of ways bio/pharma companies can participate in monograph development, a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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