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Biogen tweaks confirmatory trial of Alzheimer’s drug Aduhelm

pharmaphorum

Subjects in the trial will also have to have evidence of amyloid plaques at enrolment as well as mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease, something that was required in the CMS’ initial decision but not the approved FDA labelling for Aduhelm.

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Tranexamic Acid

RX Note

Dermatology Use (Off-label) When used in melasma , the reported success rate is up to 89%, with results appearing as early as 8 weeks. Dosage varies, according to the heaviness and duration of bleeding: 1 to 1.5 g 3 or 4 times daily for the first 3-5 days of each cycle.

Dosage 40
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Monkeypox cases are rising. Should we be worried?

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SIGA Technologies’ oral drug Tpoxx (tecovirimat) is approved for smallpox, monkeypox and cowpox in Europe, and in the US and Canada for smallpox, although it can be used off-label for the other disease. In 2003, the US experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa.

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Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

PharmaShots

Through the inclusion of Pharmacia’s products along with a strong performance, Pfizer’s pharmaceutical and animal health revenue was boosted by 40% and 43% respectively In the year 2003, Johnson & Johnson generated a revenue of $41.9B which depicted a growth of 15.3% as compared to the previous year. from last year.

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

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That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” Broad label questioned.

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Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

PharmaShots

In August 2021, the FDA approved an expanded label for Lyumjev® (insulin lispro-aabc injection) 100 units/mL to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. Paul joined Eli Lilly & Co in 2003. The primary objective was noninferiority (noninferiority margin [NIM]=0.4%

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NSAIDs

RX Note

A 2003 study shows that the incidence of endoscopically detected ulcers was significantly lower with etoricoxib 120 mg than with ibuprofen 2400 mg. The selective inhibition of the other isoform, COX-2, by NSAIDs such as celecoxib and etoricoxib, may cause less gastrotoxicity than the non-selective inhibition of the traditional NSAIDs.