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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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The company announced that it has been issued a task order under a present contract with BARDA to use its contract development and manufacturing capabilities and knowledge to assist in the US government’s efforts to deliver COVID-19 vaccines.
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Industry News
Despite the clear danger of COVID-19 to global health, vaccine opponents have gained ground, as fearful populations lose faith in the capabilities of industry and government to protect public health.
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Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.
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Supplier News
The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19
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Bio/Pharma News
The acquisition gives Novovax an annual operating capacity of more than one billion doses of COVID-19 vaccine antigen.
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Merck will acquire Themis Bioscience and collaborate with IAVI and Ridgeback Bio on COVID-19 vaccines and therapies.
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June is PDA ATMPs Month! Each Tuesday and Thursday throughout the month of June, PDA is hosting a webinar focused on a specific topic related to advanced therapy medicinal products (ATMPs). Come together in these virtual forums to look at innovations in the industry and the successful stewardship of cell and gene therapies to approval and beyond. Register now.
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Regulatory News
The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.
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The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.
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Featured Topics |
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OUTSOURCING
Quick approval pathways challenge teams to balance compliance with the need for speed.
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DEVELOPMENT
Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.
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MANUFACTURING
Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.
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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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ON DEMAND WEBCASTS
In-vitro Skin Models: Development of Topical and Transdermal Formulations
On Demand
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Innovation, Collaboration, and Technology Development - Leveraging the Thermo Fisher Ecosystem to Accelerate Platform Improvements in Biopharmaceutical Manufacturing
On Demand
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WEBCASTS
Discovery, Formulation, and Performance of Self-Emulsifying Drug Delivery Systems (SEDDS)
Thursday June 4, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP <381> and <382>
Part II: Wednesday, July 22, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Comprehensive Analysis into Disintegration Mechanisms: How Reliable Are Textbook Recommendations?
Wednesday, June 10, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Your Clinical Results Look Promising, but are you ready for launch? How to build a Robust Packaging Strategy for Rapid Commercialization
Wednesday, June 17, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
Moderator: Rita Peters, Editorial Director, Pharmaceutical Technology
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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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