Search This Blog

Monday, June 1, 2020

Lilly Begins Human Trial of Antibody Against Covid-19

Eli Lilly and Co. said Monday that it has begun human trials of an antibody treatment for Covid-19.
The Indianapolis-based pharmaceutical company developed the treatment, called LY-CoV5555, with AbCellera. It is based on antibodies found in the blood of a recovered Covid-19 patient.
Phase 1 trials are taking place at medical centers including in New York City and Los Angeles. If the trials show that the treatment is safe, Eli Lilly plans additional trials both in non-hospitalized patients and in people who are not sick, to test the medicine’s value as a preventative.
If the trials are successful, the company said it hopes to have several hundred thousand doses available by the end of the year.

https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Begins-Human-Trial-of-Antibody-Against-Covid-19-30703692/

FDA OKs expanded use of AstraZeneca’s Brilinta

The FDA approves AstraZeneca’s (NYSE:AZN) blood thinner Brilinta (ticagrelor), combined with aspirin, for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
The med was first approved in the U.S. in July 2011 for acute coronary syndrome.
https://seekingalpha.com/news/3578904-fda-oks-expanded-use-of-astrazenecas-brilinta

Chi-Med to submit surufatinib NDA in U.S.

Hutchison China MediTech (NASDAQ:HCM) has held its pre-New Drug Application (NDA) meeting with the FDA for surufatinib for the treatment of patients with advanced neuroendocrine tumors.
Chi-Med has initiated preparatory work for the U.S. NDA and intends to utilize a rolling submission under Fast Track Designation Status.
The planned start of the NDA submission is late 2020.
https://seekingalpha.com/news/3578884-chi-med-to-submit-surufatinib-nda-in-u-s

FDA OKs Lilly’s Cyramza as first-line treatment for lung cancer

The FDA has approved Eli Lilly’s (NYSE:LLY) CYRAMZA (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
With this approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers.
https://seekingalpha.com/news/3578886-fda-oks-lillys-cyramza-first-line-treatment-for-lung-cancer

FDA OKs expanded use of Lilly’s Taltz

The FDA approves the use of Eli Lilly’s (NYSE:LLY) Taltz (ixekizumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpa) in patients with objective signs of inflammation, the sixth indication approved in the U.S. for the IL-17A antagonist.
Nr-axSpa is a type of arthritis affecting the spine and sacroiliac joints.
The FDA approved the use of the med in radiographic axial spondyloarthritis in August 2019.
https://seekingalpha.com/news/3578899-fda-oks-expanded-use-of-lillys-taltz

AbbVie teams up with Jacobio Pharma in cancer

AbbVie (NYSE:ABBV) will collaborate with Beijing-based Jacobio Pharmaceuticals on developing and commercializing novel cancer therapies based on the inhibition of a protein called Src homology region 2-containing protein tyrosine phosphatase 2 (SHP2) that plays a key role in abnormal cancer cell growth, cytokine production and immune cell response. Inhibiting SHP2 may reduce cancer cell growth while modulating immune responses.
Under the terms of the partnership, AbbVie will have an exclusive license to Jacobio’s SHP2 portfolio, including JAB-3068 and JAB-3312, both oral small molecule SHP2 inhibitors. Jacobio will be responsible for early-stage studies, while AbbVie will cover R&D expenses. Afterward, AbbVie will assume global development and commercialization. Jacobio will have the option to develop and commercialize SHP2 candidates in mainland China, Hong Kong and Macau. Financial terms are not disclosed.
https://seekingalpha.com/news/3578882-abbvie-teams-up-jacobio-pharma-in-cancer

Immutep reports encouraging preliminary data on lead drug

Immutep Limited (NASDAQ:IMMP) jumps 36% premarket on average volume in reaction to preliminary results from a Frankfurt, Germany-based Phase 1 clinical trial evaluating the combination of lead candidate eftilagimod alpha and Pfizer (NYSE:PFE) and Merck KGaA’s (OTCPK:MKGAY) PD-L1 inhibitor avelumab in 12 heavily pretreated patients with solid tumors, primarily gastrointestinal cancers. The data were virtually presented at ASCO.
At data cutoff, the response rate was 33% (n=4/12), all partials, while one patient showed stable cancer, implying a disease control rate of 42% (n=5/12). Four patients progressed and three have yet to be assessed.
On the safety front, the combo was well-tolerated with no dose-limiting toxicities.
#ASCO20
https://seekingalpha.com/news/3578885-immutep-reports-encouraging-preliminary-data-on-lead-drug-eftilagimod-alpha