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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

While the government said that Gilead secured its PrEP approvals only after CDC’s research on the topic, the company stated that there already were published materials on the potential use of antiretroviral therapies as PrEP prior to this. Gilead markets both Truvada and its successor Descovy.

Drugs 264
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FDA approves marketing of nicotine pouches

Medical Xpress

Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products. Nicotine pouchessmall synthetic fiber pouches containing nicotineare designed to be placed between a person's gum and lip. Following an extensive scientific review, the U.S.

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Likmez: First FDA-Approved Liquid Option of the Antibiotic Metronidazole

XTalks

Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.

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Wainua (Eplontersen) Now FDA-Approved for Rare Disease ATTRv-PN

XTalks

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

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VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot

XTalks

And in another first, VBI’s shot is the only approved three-antigen HBV vaccine for adults in the US. PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens. Prior to the FDA approval, PreHevbrio was only approved in Israel. percent from 2019 to 2026 and hit a market value of $2.13

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Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking.

Drugs 318
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The future of the gene therapy market: driving innovations in biotherapeutics

Pharmaceutical Technology

The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.