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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

Insulin 328
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Analyzing biosimilar market dynamics in different patient populations

Drug Patent Watch

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. ” Diabetes: Addressing a Global Epidemic With diabetes affecting millions worldwide, the advent of biosimilar insulins has been particularly impactful.

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Eli Lilly Partners with Amazon Pharmacy for Home Delivery of Drugs

XTalks

LillyDirect Pharmacy Solutions, Eli Lilly’s direct-to-consumer (DTC) drugs website, is teaming up with Amazon Pharmacy to deliver select medications to people’s homes. The drugs include Lilly’s newly approved GLP-1 obesity drug Zepbound (tirzepatide), around a dozen of the company’s insulins and migraine drug Emgality (galcanezumab).

Pharmacy 111
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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

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Amazon’s Pharmacy Doesn’t Break Big Pharma’s Hold of America’s Neck

Pharmacy Checkers

Not only do drug manufacturers have patents: they have special international trade protections where companies cannot import these same drugs from foreign wholesalers who charge much lower prices in Canada, not to mention the even lower prices in the UK and European Union countries – unless the drug manufacturers do the importing or authorize it.