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

Amazon, Apple, Walmart, Others Shut Stores, Cut Operations In Protest-Hit Areas

A number of companies in the United States have decided to shutter their retail outlets and scale back on business in cities most disrupted by the protests organized in the wake of George Floyd’s death.

Apple

Apple Inc. AAPL 0.1% said it was keeping a number of its stores in the country closed on Sunday in light of the protests, without specifying how many stores, CNBC reported. It didn’t say whether the closures would be extended beyond Sunday if the protests continued.
The company has only been operating about half of its 271 U.S. stores due to the novel coronavirus (COVID-19) pandemic.
The move follows the looting of a number of Apple retail outlets across the country, including in Minneapolis, Washington D.C., and Brooklyn.
Amazon
Amazon.com Inc. AMZN 1.72% sent out a notice to its part-time delivery executives across a dozen cities, including Minneapolis, Chicago, and Los Angeles, working under the Flex program, to stop making deliveries “immediately” and return home, as reported by CNBC.
The company adjusted the Flex schedule, under which drivers can deliver Amazon products using their own vehicles as an independent contractor and get paid, to match curfew timings across cities, CNBC noted.
Amazon’s subsidiary supermarket chain Whole Foods also said it was temporarily closing or reducing operating hours at a number of outlets across the country.

Walmart

Walmart Inc. WMT 0.21% had closed some of its stores in Minneapolis and Atlanta on Friday, after a few of them became a target of looting.
The retailer on Sunday said it was further closing several hundred stores across the country, according to CNBC.
Walmart said it would access the situation on an everyday basis, and some of the outlets could be reopened as soon as Monday if there’s no physical damage.

Target

Target Corporation TGT 3.36%, in a statement late Saturday, said it was shuttering 175 stores and reducing hours at a few others until further notice.
Chief Executive Officer Brian Cornell said the company was working to ensure that workers displaced as a result of the protests, including more than 200 from its Minneapolis Lake Street store, are supported, including “receiving full pay and benefits in the coming weeks.”
Among other retailers, Nike Inc. NKE 0.07% said it has temporarily shut some of its stores, and Adidas AG ADDYY 1.66% closed all its outlets, the Wall Street Journal reported.
https://www.benzinga.com/news/20/06/16146370/amazon-apple-walmart-other-retailers-shutter-stores-scale-back-operations-in-areas-worst-hit-with-pr

South Korea’s Celltrion: COVID-19 drug shows drop in viral load in animal testing

South Korea’s Celltrion Inc said on Monday its experimental treatment of COVID-19 demonstrated a 100-fold reduction in viral load of the disease in animal testing.
Drugmakers worldwide are rushing to develop treatments and vaccines for the illness that has caused more than 371,000 deaths globally.

The pre-clinical study of the drug showed improved recovery in runny nose, cough and body aches after the first day of treatment, and clearing of lung inflammation within six days, the company said in a statement.
Celltrion has research experience with other types of coronavirus conditions such as Middle East Respiratory Syndrome (MERS). It hopes to commence first in-human clinical trials for the COVID-19 treatment in July, said Kwon Ki-Sung, head of the firm’s research and development unit.

“(Celltrion) has the capability to roll out mass production of the therapeutic antibody treatment once it is ready,” Kwon said.
https://www.reuters.com/article/us-health-coronavirus-treatment-celltrio/south-koreas-celltrion-says-covid-19-drug-shows-drop-in-viral-load-in-animal-testing-idUSKBN238116