BioCentury | Sep 29, 2017
Clinical News

FDA approves Teva's QVAR RediHaler new formulation

FDA approved QVAR RediHaler beclomethasone dipropionate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) for maintenance treatment of asthma as a prophylactic therapy in patients 4 years and older. Teva said it expects to launch...
BioCentury | Sep 5, 2016
Clinical News

Flutiform fluticasone propionate/formoterol: Phase III data

Top-line data from the double-blind, international Phase III EFFECT trial in 1,767 COPD patients ages >=40 showed that twice-daily 250/10 ug inhaled flutiform for 52 weeks missed the primary endpoint of reducing annual rate of...
BioCentury | Oct 19, 2015
Company News

Medical Developments International, Mundipharma deal

Medical Developments granted Mundipharma exclusive rights in Europe to develop and commercialize Penthrox to treat emergency pain. The deal excludes Hungary, Ireland and the U.K. MDI will receive $7 million up front and is eligible...
BioCentury | Oct 27, 2014
Clinical News

Fluticasone propionate/formoterol: Phase III data

A double-blind Phase III trial in 512 patients with asthma ages >=5 and <12 showed that twice-daily flutiform met the co-primary endpoints of superiority to fluticasone propionate (treatment difference of 0.07 L, p<0.001) and non-inferiority...
BioCentury | Aug 18, 2014
Strategy

Breathing room

AstraZeneca plc 's acquisition of Almirall S.A. 's respiratory assets should buy the pharma time while its respiratory pipeline matures. The deal not only gives AstraZeneca a faster route to market in the COPD combination...
BioCentury | Feb 17, 2014
Company News

SkyePharma, Mundipharma sales and marketing update

SkyePharma said Mundipharma launched flutiform fluticasone/formoterol in France to treat asthma. The launch triggered a €3 million ($4.1 million) milestone payment to SkyePharma from Mundipharma. The price for flutiform is €30.88 ($42.14) per inhaler for...
BioCentury | Nov 25, 2013
Strategy

AstraZeneca BD 3.0

AstraZeneca plc 's latest iteration of business development is pushing the center of gravity even further toward R&D. After a 2012 restructuring put search and evaluation for early stage assets into the hands of researchers,...
BioCentury | Nov 25, 2013
Company News

SkyePharma, Kyorin sales and marketing update

Kyorin launched Flutiform fluticasone/formoterol in Japan to treat bronchial asthma. The Japanese National Health Insurance price for Flutiform is ¥2,735 ($27.35) per inhaler for the 50 µg fluticasone/5 µg formoterol dose and ¥2,193 ($21.93) per...
BioCentury | Sep 23, 2013
Clinical News

Flutiform fluticasone/formoterol: Phase III started

SkyePharma said Mundipharma began the placebo-controlled, double-blind, international Phase III EFFECT trial to compare 125/5 and 250/10 µg doses of inhaled flutiform twice daily vs. 12 µg inhaled formoterol twice daily for 52 weeks in...
BioCentury | Sep 23, 2013
Clinical News

Flutiform fluticasone/formoterol regulatory update

SkyePharma and Kyorin said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Flutiform fluticasone/formoterol to treat bronchial asthma in patients aged >=16 years who require combination therapy with inhaled corticosteroids plus inhaled, long-acting adrenergic...
Items per page:
1 - 10 of 59
BioCentury | Sep 29, 2017
Clinical News

FDA approves Teva's QVAR RediHaler new formulation

FDA approved QVAR RediHaler beclomethasone dipropionate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) for maintenance treatment of asthma as a prophylactic therapy in patients 4 years and older. Teva said it expects to launch...
BioCentury | Sep 5, 2016
Clinical News

Flutiform fluticasone propionate/formoterol: Phase III data

Top-line data from the double-blind, international Phase III EFFECT trial in 1,767 COPD patients ages >=40 showed that twice-daily 250/10 ug inhaled flutiform for 52 weeks missed the primary endpoint of reducing annual rate of...
BioCentury | Oct 19, 2015
Company News

Medical Developments International, Mundipharma deal

Medical Developments granted Mundipharma exclusive rights in Europe to develop and commercialize Penthrox to treat emergency pain. The deal excludes Hungary, Ireland and the U.K. MDI will receive $7 million up front and is eligible...
BioCentury | Oct 27, 2014
Clinical News

Fluticasone propionate/formoterol: Phase III data

A double-blind Phase III trial in 512 patients with asthma ages >=5 and <12 showed that twice-daily flutiform met the co-primary endpoints of superiority to fluticasone propionate (treatment difference of 0.07 L, p<0.001) and non-inferiority...
BioCentury | Aug 18, 2014
Strategy

Breathing room

AstraZeneca plc 's acquisition of Almirall S.A. 's respiratory assets should buy the pharma time while its respiratory pipeline matures. The deal not only gives AstraZeneca a faster route to market in the COPD combination...
BioCentury | Feb 17, 2014
Company News

SkyePharma, Mundipharma sales and marketing update

SkyePharma said Mundipharma launched flutiform fluticasone/formoterol in France to treat asthma. The launch triggered a €3 million ($4.1 million) milestone payment to SkyePharma from Mundipharma. The price for flutiform is €30.88 ($42.14) per inhaler for...
BioCentury | Nov 25, 2013
Strategy

AstraZeneca BD 3.0

AstraZeneca plc 's latest iteration of business development is pushing the center of gravity even further toward R&D. After a 2012 restructuring put search and evaluation for early stage assets into the hands of researchers,...
BioCentury | Nov 25, 2013
Company News

SkyePharma, Kyorin sales and marketing update

Kyorin launched Flutiform fluticasone/formoterol in Japan to treat bronchial asthma. The Japanese National Health Insurance price for Flutiform is ¥2,735 ($27.35) per inhaler for the 50 µg fluticasone/5 µg formoterol dose and ¥2,193 ($21.93) per...
BioCentury | Sep 23, 2013
Clinical News

Flutiform fluticasone/formoterol: Phase III started

SkyePharma said Mundipharma began the placebo-controlled, double-blind, international Phase III EFFECT trial to compare 125/5 and 250/10 µg doses of inhaled flutiform twice daily vs. 12 µg inhaled formoterol twice daily for 52 weeks in...
BioCentury | Sep 23, 2013
Clinical News

Flutiform fluticasone/formoterol regulatory update

SkyePharma and Kyorin said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Flutiform fluticasone/formoterol to treat bronchial asthma in patients aged >=16 years who require combination therapy with inhaled corticosteroids plus inhaled, long-acting adrenergic...
Items per page:
1 - 10 of 59