21:26 , Sep 29, 2017 |  BC Week In Review  |  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...
08:00 , Jan 12, 2015 |  BC Week In Review  |  Clinical News

Qnasl beclomethasone dipropionate nasal aerosol regulatory update

FDA approved an sNDA from Teva for 40 µg inhaled Qnasl beclomethasone dipropionate nasal aerosol to treat seasonal and perennial allergic rhinitis in patients ages 4-11 years. Teva said the dose will be available next...
07:00 , Aug 18, 2014 |  BC Week In Review  |  Company News

Soligenix, U.S. Department of Health and Human Services, NIH other news

Soligenix said NIH’s National Institute of Allergy and Infectious Diseases (NIAID) exercised an option to extend by one year a 2013 contract to support preclinical development of OrbeShield as a medical countermeasure to treat gastrointestinal...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Clinical News

Qnasl beclomethasone dipropionate nasal aerosol regulatory update

Teva said FDA accepted for review an sNDA for Qnasl beclomethasone dipropionate nasal aerosol to treat seasonal and perennial allergic rhinitis in children 4-11 years of age. The nasal aerosol non-aqueous formulation of beclomethasone dipropionate...
08:00 , Dec 16, 2013 |  BioCentury  |  Strategy

Out in the cold

New excluded drugs lists devised by pharmacy benefits managers are raising the hurdle for reimbursement of drugs the PBMs' pharmacy and therapeutics committees consider to be clinically equivalent to cheaper drugs. Drugs that are not...
08:00 , Dec 9, 2013 |  BC Week In Review  |  Clinical News

OrBec beclomethasone dipropionate: Phase II started

Soligenix began a double-blind, placebo-controlled Phase II trial to evaluate oral orBec for up to 16 weeks in about 40 patients who have received an allogeneic hematopoietic cell transplantation (HCT) >=100 days earlier, have documented...
07:00 , Sep 30, 2013 |  BC Week In Review  |  Company News

Soligenix, NIH other news

NIH's National Institute of Allergy and Infectious Diseases (NIAID) awarded Soligenix a contract worth up to $6.4 million to support preclinical development of OrbeShield as a medical countermeasure to treat gastrointestinal acute radiation syndrome (GI...
07:00 , Sep 23, 2013 |  BC Week In Review  |  Company News

Soligenix, U.S. Department of Health and Human Services other news

HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded Soligenix up to $26.3 million to develop OrbeShield as a medical countermeasure to treat gastrointestinal acute radiation syndrome (GI ARS). Soligenix will receive about $10.6 million...
01:59 , Sep 20, 2013 |  BC Extra  |  Company News

BARDA awards up to $222M for anthrax and GI ARS

HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) a four-year contract worth about $196 million to supply the U.S. government with 60,000 doses of anthrax drug raxibacumab. FDA approved raxibacumab...
07:00 , Jul 15, 2013 |  BC Week In Review  |  Clinical News

SGX203: Preliminary Phase I data

Preliminary data from the Phase I BDP-PCD-01 trial in 24 healthy volunteers ages 18-22 years showed that 6 mg oral twice-daily SGX203 for 7 days was well tolerated. The company plans to start a Phase...