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Best CDMO Practices for Startups: Navigating the Complex World of Contract Development and Manufacturing

Drug Patent Watch

The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation. In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharma companies were the originators in only 28% of approvals[4].

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Q&A: The IND Journey Phase I – Navigating Success

Advarra

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The sponsor-initiated IND is conducted by a pharma company seeking commercial approval.

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Scaling Phage Therapy

Codon

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

Therapies 135
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Which Arthritis Painkiller Works the Fastest?

The Pharma Data

Unfortunately, I learned the hard way that the “Big Pharmacompanies don’t care about their patients. Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. It’s all about the bottom line, at any cost.