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RSS FeedPosted by Michael Wonder on 20 Nov 2020
Lilly's neutralising antibody bamlanivimab (LY-CoV555) receives interim authorisation from Health Canada as a treatment for COVID-19
20 November 2020 - Bamlanivimab emerged from collaboration between Lilly and Vancouver-based AbCellera. ...
Posted by Michael Wonder on 20 Nov 2020
Imfinzi approved in the US for less-frequent, fixed-dose use
20 November 2020 - Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 20 Nov 2020
PTC Therapeutics announces key regulatory designations for PTC596 to advance treatment of two rare oncology indications
18 November 2020 - PTC Therapeutics today announced that the United States FDA has granted PTC596 both orphan drug designation and ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...
Posted by Michael Wonder on 20 Nov 2020
FDA authorises drug combination for treatment of COVID-19
19 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the drug baricitinib, in combination with ...
Posted by Michael Wonder on 19 Nov 2020
NICE recommends another medicine for patients with multiple myeloma
18 November 2020 - Recommended for listing in the Cancer Drugs Fund. ...
Posted by Michael Wonder on 19 Nov 2020
Lantheus announces FDA approval of Definity room temperature
18 November 2020 - Lantheus today announced the U.S. FDA has approved the supplemental new drug application for Definity Room ...
Posted by Michael Wonder on 19 Nov 2020
Alnylam receives approval for Oxlumo (lumasiran) in the European Union for the treatment of primary hyperoxaluria type 1 in all age groups
19 November 2020 - Oxlumo is the first therapeutic approved for the treatment of primary hyperoxaluria type 1, and the ...
Posted 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
EMA organises public meeting on COVID-19 vaccines
19 November 2020 - EMA will organise a public meeting on 11 December 2020 to inform European citizens about the ...
Posted by Michael Wonder on 19 Nov 2020
Pacira receives European Commission approval for Exparel (bupivacaine liposome injectable suspension) for the treatment of post-surgical pain
18 November 2020 - Approval based on four pivotal studies showing Exparel reduced pain scores and opioid use following surgery. ...
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
Knight Therapeutics announces filing of supplement to a new drug submission for Nerlynx (neratinib) to treat HER2-positive metastatic breast cancer
3 September 2020 - Knight Therapeutics Inc. announced filing of the supplement to a new drug submission (SNDS) of Nerlynx ...
Posted by Michael Wonder on 18 Nov 2020
TGA grants third provisional determination for a COVID-19 vaccine
18 November 2020 - On 16 November 2020 the TGA granted a provisional determination to Janssen Cilag in relation to ...