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RSS FeedPosted by Michael Wonder on 21 Sep 2020
Lynparza recommended for approval in EU by CHMP as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
21 September 2020 - Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. ...
Posted by Michael Wonder on 21 Sep 2020
PBS process improvements – Stage 2 Fact Sheet
21 September 2020 - Pending Government decision, the implementation of Stage 2 PBS process improvements are expected to commence from ...
Posted by Michael Wonder on 21 Sep 2020
Bristol Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer
18 September 2020 - Application based on results from the Phase 3 CheckMate -9LA trial, which showed significantly improved overall survival ...
Posted by Michael Wonder on 21 Sep 2020
Democratic chairman says White House blocked FDA commissioner from testifying
19 September 2020 - The White House blocked FDA Commissioner Stephen Hahn from testifying before the House panel overseeing the ...
Posted by Michael Wonder on 20 Sep 2020
Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
18 September 2020 - Recommendation is based on the results of the IMbrave150 study, in which the Tecentriq combination improved overall ...
Posted by Michael Wonder on 20 Sep 2020
For insulin and other medications, rising costs aren’t slowing down
20 September 2020 - Michael Costanzo, a Colorado farmer diagnosed with multiple sclerosis in 2016, has a well-honed ritual: every ...
Posted by Michael Wonder on 20 Sep 2020
Crohn's sufferers running out of treatment options lobby PHARMAC for new drugs
20 September 2020 - An 11 year-old could languish in pain and lose more of her bowel without a drug ...
Posted by Michael Wonder on 20 Sep 2020
Ardelyx announces FDA acceptance for filing of its new drug application of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
15 September 2020 - New drug application supported by data from expansive clinical development program demonstrating tenapanor's use as foundational therapy. ...
Posted by Michael Wonder on 20 Sep 2020
In ‘power grab,’ Health Secretary Azar asserts authority over FDA
19 September 2020 - Experts said the memo would make it more difficult for the F.D.A. to issue new rules, but ...
Posted by Michael Wonder on 19 Sep 2020
US FDA grants once daily dosing option for Nityr (nitisinone) tablets for HT-1 patients
14 September 2020 - Cycle Pharmaceuticals is pleased to announce that the U.S. FDA has approved the once daily dosing ...
Posted by Michael Wonder on 19 Sep 2020
Agenus initiates rolling BLA submission of balstilimab for recurrent/metastatic cervical cancer
18 September 2020 - Agenus announced the initiation of the rolling submission of its biologics license application to the U.S. FDA ...
Posted by Michael Wonder on 18 Sep 2020
CHMP recommends approval of Lilly's baricitinib for the treatment of adults with moderate to severe atopic dermatitis
18 September 2020 - Positive opinion is the first regulatory action for baricitinib as an atopic dermatitis medicine. ...
Posted by Michael Wonder on 18 Sep 2020
Highlights from 14-17 September CHMP meeting
18 September 2020 - Seven new medicines recommended for approval. ...
Posted by Michael Wonder on 18 Sep 2020
BMS' Opdivo wins new NICE lung cancer backing
18 September 2020 - NICE has published draft guidance recommending Bristol-Myers Squibb's Opdivo (nivolumab) as a second-line treatment option for ...
Posted by Michael Wonder on 18 Sep 2020
NICE U-turn sees Akcea's Waylivra win NHS funding
18 September 2020 - Akcea Therapeutics UK's Waylivra (volanesorsen), the first and only therapy for Familial Chylomicronaemia Syndrome (FCS), will ...