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RSS FeedPosted by Michael Wonder on 06 May 2020
Immunicum receives regenerative medicine advanced therapy designation from FDA for ilixadencel in kidney cancer
6 May 2020 - Immunicum announced today that it has received regenerative medicine advanced therapy designation from the U.S. FDA for ...
Posted by Michael Wonder on 06 May 2020
Antabio receives FDA qualified infectious disease product designation for MEM-ANT3310, a novel broad-spectrum combination therapy targeting WHO’s priority pathogens
6 May 2020 - QIDP is granted to Antabio’s MEM-ANT3310 for major hospital indications including nosocomial pneumonia. ...
Posted by Michael Wonder on 06 May 2020
FDA approves first targeted therapy to treat aggressive form of lung cancer
6 May 2020 - Today, the U.S. FDA approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung ...
Posted by Michael Wonder on 06 May 2020
Bristol Myers Squibb provides update on biologics license application for lisocabtagene maraleucel
6 May 2020 - Bristol Myers Squibb today announced that the U.S. FDA has extended the action date by three ...
Posted by Michael Wonder on 06 May 2020
Chiesi files resubmission to address FDA Bronchitol (mannitol) inhalation powder complete response letter
5 May 2020 - Pharmaxis today announced its US licensee Chiesi has filed a resubmission that addresses the issues raised ...
Posted by Michael Wonder on 06 May 2020
Kala Pharmaceuticals resubmits new drug application for Eysuvis for dry eye disease
4 May 2020 - Kala Pharmaceuticals today announced that it has resubmitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 05 May 2020
FDA approves new treatment for a type of heart failure
5 May 2020 - Today, the U.S. FDA approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection ...
Posted by Michael Wonder on 05 May 2020
Pfizer and Biontech dose first participants in the U.S. as part of global COVID-19 MRNA vaccine development program
5 May 2020 - Pfizer and BioNTech ramping up manufacturing capabilities to further increase production capacity in 2020/2021. ...
Posted by Michael Wonder on 05 May 2020
Overlap weighting: a propensity score method that mimics attributes of a randomised clinical trial
5 May 2020 - Evidence obtained from clinical practice settings that compares alternative treatments is an important source of information about ...
Posted by Michael Wonder on 05 May 2020
GeneTx and Ultragenyx announce GTX-102 granted fast track designation by US FDA for treatment of Angelman syndrome
4 May 2020 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted fast track designation to GTX-102 ...
Posted by Michael Wonder on 05 May 2020
Teva and Celltrion Healthcare announce the launch of Truxima (rituximab-abbs) injection for rheumatoid arthritis, the only biosimilar to Rituxan (rituximab) available in the United States for this indication
4 May 2020 - Truxima is also now available for the treatment of granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis. ...
Posted by Michael Wonder on 05 May 2020
Gilead's drug pricing in the crosshairs again in wake of OK to use remdesivir against COVID-19
4 May 2020 - Gilead plans to spend $1 billion on its COVID-19 drug remdesivir. Now some members of Congress ...
Posted by Michael Wonder on 04 May 2020
Randomised clinical trials and COVID-19: managing expectations
4 May 2020 - Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating ...
Posted by Michael Wonder on 04 May 2020
U.S. law makers question Jaguar Health on price hike of drug that may help treat COVID-19 patients
4 May 2020 - The chair of a House of Representatives committee and a fellow Democratic committee member on Monday ...
Posted by Michael Wonder on 04 May 2020
How remdesivir, new hope for COVID-19 patients, was resurrected
4 May 2020 - The drug failed as a treatment for hepatitis and Ebola. With federal funding, scientists trained it on ...