BeiGene's tislelizumab meets OS endpoint in interim analysis of lung cancer study

• As recommended by the independent Data Monitoring Committee, BeiGene (BGNE +1.8%) has announced interim data from Phase 3 (RATIONALE 303) trial evaluating tislelizumab versus docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer who progressed on prior platinum-based chemotherapy.
• The 805-study met its primary endpoint of overall survival (OS) in the intention-to-treat patient population.
• Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.
• https://seekingalpha.com/news/3637202-beigenes-tislelizumab-meets-os-endpoint-in-interim-analysis-of-lung-cancer-study
  

PLx Pharma Submits Supplemental NDA for Valazore to FDA

-- FDA sets estimated completion review date for the end of February 2021 --

-- Targeting launch of VAZALORE for third quarter 2021 –

PLx Pharma Inc. (NASDAQ: PLXP), a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products, announced today that two chemistry and manufacturing control (“CMC”) supplemental New Drug Applications (“sNDAs”), one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as “VAZALORE”), were submitted to the U.S. Food and Drug Administration (“FDA”) in October for regulatory approval.

The 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and also contains a bioequivalence (“BE”) clinical study report with the required data and analyses from the recently completed BE study. The submission for the 81 mg dose provided for a new product strength of VAZALORE and builds off the information in the original approved NDA (New Drug Application) and the recent sNDA submitted for VAZALORE 325 mg.

The Company received acknowledgement letters from the FDA, officially confirming the receipt of the submissions and setting the estimated completion date for its reviews for VAZALORE 325 mg and VAZALORE 81 mg for the end of February 2021. If approved, the Company plans to bring both doses of VAZALORE to market in the third quarter of 2021.

“We are delighted to have achieved this major milestone for the submissions of our two sNDAs to the FDA earlier than previously announced. This is a significant step for PLx and the millions of patients with vascular disease who can benefit from a novel aspirin therapy. We are highly confident our submissions are supported by strong and compelling data that FDA requires for CMC submissions and we look forward to their review,” stated Natasha Giordano, President and Chief Executive Officer of PLx. 

VAZALORE 325 mg is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy with faster, reliable and more predictable platelet inhibition as compared to enteric-coated aspirin, while also reducing the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. PLx’s supplemental New Drug Applications for VAZALORE 325 mg and VAZALORE 81 mg dose strengths, submitted in October 2020 to the U.S. Food and Drug Administration, are currently under regulatory review.

https://finance.yahoo.com/news/plx-pharma-inc-submits-supplemental-210100322.html

Moderna downgraded at BMO as 'corona catalysts built in'

• Moderna (MRNA -5.5%) shares shed a bit of yesterday's run-up to a record high, as BMO Capital's George Farmer backs away from the stock's 400% 52-week surge and recommends taking profits, downgrading to Market Perform from Outperform with a $109 price target.
• Farmer had been bullish on the stock, expecting the company's COVID-19 vaccine would match or exceed Pfizer's 90% effective rate; yesterday, the company reported a vaccine efficacy of 94.5% in a phase 3 study protocol.
• But the analyst now sees limited upside following yesterday's rally on the positive vaccine outcome, and the current stock price mostly reflects a "near-term best-case scenario," including expectations for emergency use authorization before year-end and a full approval mid-2021.
• "Although we recommend taking some profits... the now proven potential of MRNA's RNA/LNP platform establishes the company as a new vaccine development powerhouse," Farmer writes.
• Today's decline would snap a four-day surge that has seen the stock surge by 30%.
• https://seekingalpha.com/news/3637145-moderna-downgraded-bmo-corona-catalysts-built-in
  

RedHill Biopharma on go with mid-stage study with 2nd COVID-19 candidate

• The FDA has signed-off RedHill Biopharma's (NASDAQ:RDHL) Phase 2/3 study evaluating RHB-107 (upamostat) in patients with symptomatic COVID-19 who do not require hospitalization.
• RHB-107 is an orally administered potent inhibitor of several serine proteases. RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma.
• The Phase 2/3 study is expected to start enrolling patients early next year, and primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.
• Yesterday, the company concluded patient enrollment in U.S. Phase 2 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia.
• https://seekingalpha.com/news/3637080-redhill-biopharma-on-go-mid-stage-study-second-covidminus-19-candidate
  

Samsung BioLogics mass producing Eli Lilly's COVID-19 treatment

• Samsung BioLogics announced that it is mass-producing a COVID-19 antibody treatment developed by Eli Lilly (NYSE:LLY), as the U.S. began distributing the drug last week after emergency-use nod for bamlanivimab earlier this month.
• The FDA said the drug can be used for people aged 65 and over who have recently been diagnosed with mild-to-moderate COVID-19 and those aged 12 and over who have underlying health conditions putting them at risk of serious illness.
• Lilly aims to manufacture up to 1M doses by year end, and expects supply to increase substantially from the first quarter of 2021 as additional manufacturing resources come online.
• Samsung said it has a long-term manufacturing contract with Lilly, with details not disclosed.
• https://seekingalpha.com/news/3637101-samsung-biologics-mass-producing-eli-lillys-covidminus-19-treatment
  

CVS, Walgreens, Rite Aid tumbling after Amazon's Pharmacy launch

• The move by Amazon may have been anticipated for a while, but - at least for now - it wasn't fully priced in to brick-and-mortar pharmacy players.
• CVS (NYSE:CVS) is down 6.4%, Walgreens (NASDAQ:WBA) 10%, and Rite Aid (NYSE:RAD) 9.8% premarket. There's also drug distribution names like Cardinal Health (NYSE:CAH), which is lower by 2.5%, McKesson (NYSE:MCK) down 2.3%, and AmerisourceBergen (NYSE:ABC) off 1.1%.
• And don't forget recently gone-public online drug comparison player GoodRx (NASDAQ:GDRX), down 16.6% premarket.
• https://seekingalpha.com/news/3636997-cvs-walgreens-and-rite-aid-are-all-tumbling-after-amazons-pharmacy-launch
  

Amazon launches online pharmacy in new contest with drug retail

Amazon.com Inc on Tuesday launched an online pharmacy for delivering prescription medications in the United States, increasing competition with drug retailers such as Walgreens, CVS and Walmart.

Called Amazon Pharmacy, the new store lets customers price-compare as they buy drugs on the company's website or app. Shoppers can toggle at checkout between their co-pay and a non-insurance option, heavily discounted for members of its loyalty club Prime.

The move builds on the web retailer's 2018 acquisition of PillPack, which Amazon said will remain separate for customers needing pre-sorted doses of multiple drugs.

Over the past two years, Amazon has worked to secure more state licenses for shipping prescriptions across the country, which had been an obstacle to its expansion into the drug supply chain, according to analyst notes from Jefferies Equity Research.

The company founded as an online bookseller has disrupted industries including retail, computing and now potentially pharmaceuticals, drawing criticism of its size and power from labor groups and lawmakers along the way.

TJ Parker, PillPack's CEO and vice president of Amazon Pharmacy, said in a statement the retailer aimed to bring "customer obsession to an industry that can be inconvenient and confusing."

Amazon faces entrenched competition from Walgreens Boots Alliance Inc, CVS Health Corp, Walmart Inc, Rite Aid Corp, Kroger Co and others. Take-up of online ordering of drugs has been low, according to market research from J.D. Power.

Should Prime members prefer buying in person, Amazon said its discounts on non-insurance purchases apply at more than 50,000 brick-and-mortar pharmacies - including those run by rivals. Inside Rx, a subsidiary of Cigna Corp's Evernorth, administers that benefit, Amazon said.

Still, the pandemic may help bring drug orders online. E-commerce has surged this year as governments told people to stay home to stave off infections of COVID-19, and Prime members - more than 150 million globally - may be receptive to buying medication online now that it's from Amazon.

The company said Prime subscribers get up to 80% off generic and up to 40% off brand drugs when they pay without insurance, as well as two-day delivery.

Amazon's online pharmacy is not yet available in Illinois, Minnesota, Louisiana, Kentucky, and Hawaii, a spokeswoman said.

https://www.marketscreener.com/quote/stock/AMAZON-COM-INC-12864605/news/Amazon-launches-online-pharmacy-in-new-contest-with-drug-retail-31800503/