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Marketed Products

October 17, 2023

Nicotine and Vapes

Marketed Products, Medical, Pharmacy

Stuart R. Gallant, MD, PhD Humans have been smoking tobacco for more than 10,000 years, but e-cigarettes (“vapes”) have only existed for less than two…

Stuart Gallant
September 27, 2023

So, You Want to Consult

CMC, Marketed Products, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning

Stuart R. Gallant, MD, PhD Consultation—offering your professional services to companies on a time-limited basis—can be a rewarding type of work.  It is gratifying to…

Stuart Gallant
January 18, 2023

Solving Drug Shortages

CMC, Finance, Marketed Products, Pharma Economics, Pharmaceutical Manufacturing, Pharmacy, Planning, Portfolio Management, Risk Management

Stuart R. Gallant, MD, PhD Imagine that you have an infection, and you need a common antibiotic, but you cannot find a drugstore that is…

Stuart Gallant
October 20, 2022

Vaccines for Lyme Disease

Clinical, Marketed Products, Parenteral Drugs, Pharma Economics, Pharmaceutical Development, Pharmacy, Vaccine

Stuart R. Gallant, MD, PhD In 1991, Helmut and Erika Simon, two German tourists hiking in the Alps near the Austrian/Italian border when they saw…

Stuart Gallant
September 29, 2022

Pharmaceutical Product Launch

CMC, Insurance, Marketed Products, Medical, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Planning

Stuart R. Gallant, MD, PhD Above is a photo from the 1947 launch of the M.V. St. Essylt at J.L. Thompson and Sons was a…

Stuart Gallant
September 24, 2022

Anti-TNF Medications

Clinical, Finance, Marketed Products, Medical, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmacy

Stuart R. Gallant, MD, PhD I have a weakness for old Hollywood movies.  The movie still that appears above this paragraph depicts John Carradine in…

Stuart Gallant
September 20, 2022

Pharmaceutical Patent Strategy

Clinical, CMC, Marketed Products, Patent, Pharmaceutical Development, Pharmacy, Planning, Portfolio Management, Risk Management

Stuart R. Gallant, MD, PhD When I think of patent law, I am reminded of a line from the play A Man for All Seasons. …

Stuart Gallant
September 16, 2022

Moderna’s Bivalent Booster

Clinical, Marketed Products, Medical, Parenteral Drugs, Pharmaceutical Development, Pharmacy

Stuart R. Gallant, MD, PhD Back in April, PharmaTopo posted on lipid nanoparticle formulations for Covid-19 vaccines [1].  Because the Moderna bivalent vaccine recently arrived…

Stuart Gallant
August 25, 2022

Pharmaceutical Design Focus:  Clot Busters (2 of 2)

Clinical, CMC, Finance, Marketed Products, Medical, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Portfolio Management, Raw Materials

Stuart R. Gallant, MD, PhD In the first part of this post, we looked at urokinase.  In the second part, we will look at tissue…

Stuart Gallant
August 25, 2022

Pharmaceutical Design Focus:  Clot Busters (1 of 2)

Clinical, CMC, Finance, Marketed Products, Medical, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Portfolio Management, Raw Materials

Stuart R. Gallant, MD, PhD This November will be the 35th anniversary of the approval of tissue plasminogen activator (tPA, alteplase) a leading treatment for…

Stuart Gallant
April 3, 2022

Lipid Nanoparticles for Covid-19 Vaccines

CMC, Covid-19, Marketed Products, Parenteral Drugs, Patent, Pharmaceutical Manufacturing, Pharmacy, Raw Materials

Stuart R. Gallant, MD, PhD Hopefully, you have received your Covid-19 vaccine.  If you did, there’s a pretty good chance it was delivered in lipid…

Stuart Gallant
March 27, 2022

Payment for Pharmaceuticals

Insurance, Marketed Products, Pharma Economics, Pharmacy

Stuart R. Gallant, MD, PhD The United States has a mixed public and private insurance system for health care.  Payments for pharmaceuticals are provided through…

Stuart Gallant
March 22, 2022

Pharmaceutical Design Focus:  Factor VIII (2 of 2)

Clinical, CMC, Finance, Marketed Products, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Manufacturing

Stuart R. Gallant, MD, PhD In the first part of this two-part post, we looked at the biochemistry of clotting factor Factor VIII and the…

Stuart Gallant
March 22, 2022

Pharmaceutical Design Focus:  Factor VIII (1 of 2)

Marketed Products, Parenteral Drugs, Pharma Economics, Pharmaceutical Manufacturing

Stuart R. Gallant, MD, PhD Today’s post is a big story involving genetic engineering, pharmaceuticals, intellectual property, and economics.  You will recall from the first…

Stuart Gallant
February 5, 2022

Pharmaceutical Design Focus:  Insulin

Marketed Products, Parenteral Drugs, Pharma Economics, Pharmaceutical Manufacturing

Stuart R. Gallant, MD, PhD Insulin is a subject on a lot of people’s minds—C&E News just came out with a cover story on insulin…

Stuart Gallant

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