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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., IMPORTANT SAFETY INFORMATION .

Drugs 110
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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

FDA Law Blog

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. How, pray tell, does this relate to PTEs you ask?

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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., IMPORTANT SAFETY INFORMATION.

Drugs 69
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Tauriga Sciences Inc. Sets New Daily E-Commerce Records for Both: Revenue Generated [$9,514.49] and Individual Online Orders [103 Total]

The Pharma Data

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. for the co-development of a rapid, multiplexed, Novel Coronavirus (COVID-19) test with superior sensitivity and selectivity. . . The Patent, filed with the U.S.P.T.O.

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FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions

FDA Law Blog

Please see our previous blog postings on various software regulatory developments ( here, here, and here ). This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17 Act). corrections and removals).