Theratechnologies Files SBLA For Trogarzo Intramuscular Method Of Administration With FDA

RTTNews | hace 580
Theratechnologies Files SBLA For Trogarzo Intramuscular Method Of Administration With FDA

(RTTNews) - Biopharmaceutical company Theratechnologies Inc. (THTX, TH.TO) announced Tuesday the filing of a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo (ibalizumab-uiyk) to the U.S. Food and Drug Administration (FDA) for review.

Trogarzo, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.

The Trogarzo IM sBLA submission follows the recent FDA approval of the Company's Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics.

The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo treatment regimen.

In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date.

read more
U.S. Factory Orders Pull Back Sharply In June

U.S. Factory Orders Pull Back Sharply In June

After reporting a substantial increase by new orders for U.S. manufactured goods in the previous month, the Commerce Department released a report on Monday showing factory orders pulled back sharply in the month of June. The Commerce Department said factory orders dove by 4.8 percent in June after soaring by an upwardly revised 8.3 percent in May.
RTTNews | hace 11 minutos
Weak Jobs Data Limits Dollar's Rebound

Weak Jobs Data Limits Dollar's Rebound

A smaller-than expected addition to non-farm payrolls curtailed the dollar's rally fueled by a hawkish Fed stance, higher-than-expected PCE-inflation readings, as well as anxiety ahead of the U.S.-China trade talks and the looming trade tariff deadline.
RTTNews | hace 13 minutos
Eurozone Investor Sentiment Weakens Unexpectedly

Eurozone Investor Sentiment Weakens Unexpectedly

Euro area investor confidence deteriorated unexpectedly in August as the newly reached trade deal with the U.S. deepened concerns about the current economic situation as well as the outlook, data from the behavioral research institute Sentix showed on Monday. The Sentix investor sentiment index fell steeply to -3.7 in August from 4.5 in July. The measure was expected to climb to 6.2.
RTTNews | hace 1h 31min
Bay Street Seen Opening On Cautious Note

Bay Street Seen Opening On Cautious Note

Canadian stocks may open on a mixed note on Monday with investors likely to stay cautious ahead of implementation of levies imposed by U.S. President Donald Trump, and a slew of earnings announcements due this week. Weak oil prices may weigh a bit.
RTTNews | hace 1h 39min
FTSE 100 Modestly Higher; Lloyds Banking Group Rises Nearly 8%

FTSE 100 Modestly Higher; Lloyds Banking Group Rises Nearly 8%

The UK market is up in positive territory on Monday with stocks from the financial sector contributing significantly to the upmove after the outcome from the UK's motor finance investigation turned out to less severe than feared, with potential compensation estimated at 9 billion pounds, much less than the expected quantum o 30 billion pounds.
RTTNews | hace 2h 30min
Indian Rupee Falls To 4-day Low Against U.S. Dollar

Indian Rupee Falls To 4-day Low Against U.S. Dollar

The Indian rupee weakened against the U.S. dollar in the European session on Monday, as investors await the announcement of the interest rate decision by the Reserve Bank of India (RBI) on Wednesday.
RTTNews | hace 2h 53min
CAC Moderately Higher As Stocks Recover From Recent Setback

CAC Moderately Higher As Stocks Recover From Recent Setback

The French stock market is up firmly in positive territory on Monday with several counters from across various sectors attracting buyers after last week's decline following a sweeping tariff announcement from U.S. President Donald Trump.
RTTNews | hace 2h 59min