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RSS FeedPosted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted by Michael Wonder on 19 Nov 2020
Omeros submits its biologics license application to U.S. FDA for narsoplimab in HSCT-TMA
18 November 2020 - Omeros Corporation announced that it has completed the rolling submission of its biologics license application to ...
Posted by Michael Wonder on 18 Nov 2020
Pfizer will seek regulatory review ‘within days’ for its vaccine
18 November 2020 - The coronavirus vaccine being developed by Pfizer and German biotechnology firm BioNTech is 95% effective at ...
Posted by Michael Wonder on 18 Nov 2020
The vaccines will probably work. Making them fast will be the hard part.
18 November 2020 - Front-runners in the coronavirus vaccine race won’t make nearly as many doses this year as were predicted, ...
Posted by Michael Wonder on 18 Nov 2020
Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 18 Nov 2020
Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia
18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...
Posted by Michael Wonder on 18 Nov 2020
FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...
Posted by Michael Wonder on 18 Nov 2020
Alkermes receives FDA complete response letter related to ALKS 3831 manufacturing records review
17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval. ...
Posted by Michael Wonder on 18 Nov 2020
FDA authorises first COVID-19 test for self-testing at home
17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...
Posted by Michael Wonder on 18 Nov 2020
Pfizer has enough safety data about its coronavirus vaccine and is preparing to submit for FDA authorisation, CEO says
17 November 2020 - Pfizer has accumulated enough safety data on its COVID-19 vaccine and is preparing to file for ...
Posted by Michael Wonder on 18 Nov 2020
Does remdesivir actually work against COVID-19?
17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...
Posted by Michael Wonder on 17 Nov 2020
ViiV Healthcare receives FDA breakthrough therapy designation for investigational, long-acting cabotegravir for HIV prevention
17 November 2020 - ViiV Healthcare today announced that the US FDA has granted breakthrough therapy designation for long-acting, injectable cabotegravir ...
Posted by Michael Wonder on 17 Nov 2020
Sommetrics receives FDA breakthrough device designation for its aerSleep II product to treat sleep apnea
17 November 2020 - Sommetrics today announced its lead sleep apnea product, aerSleep II, has received FDA breakthrough device designation. ...
Posted by Michael Wonder on 17 Nov 2020
Genentech files to block marketing of Centus' bevacizumab biosimilar
18 November 2020 - The reference product rights holder contends that Centus has not provided complete information about its manufacturing ...
Posted by Michael Wonder on 17 Nov 2020
FDA’s ongoing commitment to transparency for COVID-19 EUAs
17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...