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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.
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Industry News
The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.
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The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases.
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Supplier News
The center will offer expertise in fill-finish optimization and analytical testing.
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A new clinical and commercial partnership expands Experic’s presence while providing PCI with advanced powder-filling equipment.
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Bio/Pharma News
Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.
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The collaboration will focus on novel therapeutics targeting RNA-modifying proteins for cancer treatment.
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June is PDA ATMPs Month! Each Tuesday and Thursday for the remainder of the month, PDA is hosting a webinar focused on a specific topic related to advanced therapy medicinal products (ATMPs). There is still time to participate in these virtual forums to look at innovations in the industry and the successful stewardship of cell and gene therapies to approval and beyond.
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Regulatory News
The agency has added a COVID-19 innovation resource page and an education resources page to its website.
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Johnson & Johnson’s Janssen Pharmaceutical Companies has received a positive opinion in Europe for its two-dose Ebola vaccine regimen.
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Featured Topics |
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OUTSOURCING
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
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DEVELOPMENT
The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.
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MANUFACTURING
Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.
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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
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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