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15 Mar 2019, 9:47 am
For appraisal of drug safety, the first four patients received escalating doses of ICI 182780, starting with 100 mg in the first month and increasing to 250 mg i.m. from the second month onwards, following confirmation of lack of local or systemic drug toxicity at the 100 mg dose". [read post]
10 Mar 2019, 4:54 am
Anders ValentinOn 1 February 2019, the Danish Maritime and Commercial Court granted an injunction against Mylan AB’s sale of the product Tadalafil »Mylan« containing 5 mg tadalafil in Denmark. [read post]
3 Mar 2019, 12:38 pm
The license agreement granted MGI the right to distribute, promote, market, and sell the 0.25 mg and 0.75 mg doses of palonosetron in the United States. [read post]
21 Feb 2019, 2:00 pm
According to the company, rheumatoid arthritis patients taking a 10 mg dose of Xeljanz (tofacitinib) in an ongoing safety study are being moved to a 5 mg dose after the independent monitoring board determined that there was an imbalance in the rate of death between the 10 mg drug arm (twice daily) and both their 5 mg arm and a group taking a… [read post]
17 Feb 2019, 7:15 am
Patent 7,267,820 (the 820 Patent) discovered that about 20% of patients with the neurological disorder myasthenia gravis (MG) generate autoantibodies to a membrane protein called MuSK. [read post]
14 Feb 2019, 10:00 pm
As stated in Part 1, at issue in Athena was an admitted novel and non-obvious diagnostic test that worked for the 20% of the population suffering from myasthenia gravis (MG) to be diagnosed. [read post]
14 Feb 2019, 9:00 am
The latest volume of the Yearbook of International Humanitarian Law (Vol. 20, 2017) is out. [read post]
14 Feb 2019, 4:01 am
Periodically on Thursdays, we present a significant excerpt, usually from a recently published book or journal article. [read post]
11 Feb 2019, 10:00 pm
The method could diagnose MG in the 20% of individuals that every current diagnostic for which there was no current diagnostic. [read post]
11 Feb 2019, 12:15 pm
(collectively “Teva”) sought approval to market a generic 0.25 mg palonosetron product. [read post]
11 Feb 2019, 12:00 am
Howell was used as CPAD by the Opponents, since it described a Phase II clinical trial, in which a formulation containing 50 mg/ml fulvestrant in a castor oil-based vehicle was intramuscularly administered to patients having a tamoxifen-resistant breast cancer. [read post]
6 Feb 2019, 10:48 am
So, the key discovery here was the relationship between MuSK autoantibody production and MG. [read post]
4 Feb 2019, 2:01 am
In particular the claim specifies that the separator tube is either (1) a glass tube containing thixotropic gel and 0.10 M sodium citrate, or (2) a polyethylene terephthalate separator tube containing a highly thixotropic gel formed by a polymer mixture and anhydrous sodium citrate at 3.5 mg/mL. [read post]
1 Feb 2019, 6:19 am
” The report adds that “the toothpicks are often infused or coated with nicotine and can have as much as 3 mg of nicotine, compared to the about 1.5 mg of nicotine most smokers inhale from a cigarette. [read post]
31 Jan 2019, 8:32 am
In early 2000, Helsinn submitted protocols for Phase III clinical trials to the Food and Drug Administration (FDA), proposing to study a 0.25 mg and a 0.75 mg dose of palonosetron. [read post]
31 Jan 2019, 6:49 am
The Regulations also propose removing the partial prohibition on the export of waste containing PCBs in concentrations equal to, or greater than, 50 mg/kg. [read post]
31 Jan 2019, 1:00 am
(Teva) filed an abbreviated new drug application (ANDA) seeking FDA approval to market a generic version of Helsinn’s 0.25 mg palonosetron product. [read post]
15 Jan 2019, 4:00 pm
., 10 mg may be a safe dose for someone who is healthy and 25, but what about someone who is 65?). [read post]
11 Jan 2019, 9:05 pm
Results have shown levels of Paralytic Shellfish Poisoning (PSP) toxins above the limit of 0.8 mg/kg set by the agency. [read post]
9 Jan 2019, 1:05 pm
., received FDA approval to develop Bretylium Tosylate Injection USP, 500 mg/10 mL (50 mg/mL) Single-Dose Vials. [read post]