A new technology offers treatment for HIV infection through a single injection - World Pharma News

According to the article:

"Currently, the researchers explain, there is no genetic treatment for AIDS, so the research opportunities are vast. Dr. Barzel concludes: "We developed an innovative treatment that may defeat the virus with a onetime injection, with the potential of bringing about tremendous improvement in the patients' condition. When the engineered B cells encounter the virus, the virus stimulates and encourages them to divide, so we are utilizing the very cause of the disease to combat it. Furthermore, if the virus changes, the B cells will also change accordingly in order to combat it, so we have created the first medication ever that can evolve in the body and defeat viruses in the 'arms race'.

Based on this study we can expect that over the coming years we will be able to produce in this way a medication for AIDS, for additional infectious diseases and for certain types of cancer caused by a virus, such as cervical cancer, head and neck cancer and more."

Read the full source article: A new technology offers treatment for HIV infection through a single injection - World Pharma News

FDA Approves First Long-Acting HIV Drug Combo - VOA

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According to the article:

"The two-injection combination treatment is called Cabenuva. The drug is expected to make it easier for people to receive their HIV medicines and to do so with more privacy. The injections mark a big change from methods used in the past. Those treatments required patients to take multiple pills several times a day, carefully timed around meals.

Dr. Steven Deeks is an HIV specialist at the University of California, San Francisco. He told The Associated Press that the new treatment can make patients’ lives better because it is only needed once a month. “People don’t want those daily reminders that they’re HIV infected,” Deeks said."

Read the full source article:  FDA Approves First Long-Acting HIV Drug Combo - VOA

Injections given every 8 weeks suppress HIV just as well as daily pills, trial finds - ScienceAlert

Updated December 21, 2021

You might also be interested in:

FDA approves first injectable HIV prevention drug - Rather than as a daily pill, the newly approved drug, Apretude, is given to patients every two months - NBC News

---  the original post follow below  ---

Read the full article: Injections given every 8 weeks suppress HIV just as well as daily pills, trial finds - ScienceAlert:

"Formulated to be long-acting and injected together, these two drugs suppressed the virus at a comparable rate to a combination of similar-acting pills taken daily. Patients received one shot either every four weeks, or every eight weeks, and the virus suppression rates were basically the same, although patients with monthly injections complained more about pain at the injection site – the most common side effect of this treatment."

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FDA Makes Zometa Inj Orange Book Decision

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Updated Dec 17, 2020
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations


- -  original post below  - -

The Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."

According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).

Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.

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