Australia Grants Provisional Registration for Moderna COVID-19 Vaccine

 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. Delivery of Moderna’s COVID-19 vaccine to Australia is expected to commence in the second half of September. The Australian government has previously secured 10 million doses of COVID-19 Vaccine Moderna for delivery in 2021, through a supply agreement announced on May 12, 2021, as well as an option to procure 15 million doses in 2022.

https://finance.yahoo.com/news/australian-therapeutic-goods-administration-grants-140500511.html

Impel NeuroPharma: Publication of Pivotal Phase 3 Study of Migraine Treatment

 Study Shows TRUDHESA™ Was Well Tolerated and Delivered Rapid, Consistent Symptom Relief

Exploratory Patient-Reported Outcomes Data Indicated More Than One Third of Patients Experienced Pain Freedom and Two Thirds Had Pain Relief Two Hours Following TRUDHESA™ Administration

Among the 38 Percent of Patients Who Self-Reported Two-Hour Pain Freedom for Their First TRUDHESA™- Treated Attack, only 7.1 Percent and 14.3 Percent of Patients Reported Recurrence of Migraine at 24 and 48 hours post TRUDHESA™ Administration, Respectively

The U.S. FDA Has Accepted TRUDHESA™ for Review with a Target PDUFA Date of September 6, 2021

https://finance.yahoo.com/news/impel-neuropharma-announces-publication-pivotal-120000075.html

Moderna halves August COVID-19 vaccine shipments to S.Korea

 South Korea's health minister apologised for COVID-19 vaccine shortages on Monday, saying U.S. drugmaker Moderna Inc would deliver less than half its planned shipment this month due to production issues.

Suffering a fourth wave of infections, South Korea has posted record numbers of new cases in recent weeks, while its inoculation campaign has been dogged by vaccine shortages and shipment delays.

Health Minister Kwon Deok-cheol said Moderna had informed South Korea that it would only be able to deliver less than half the 8.5 million doses it had been due to ship in August.

"I once again apologise for causing concerns among the people because of Moderna's vaccine supply problems," Kwon told a briefing.

The U.S. drugmaker had already missed its late-July shipment, saying some manufacturing partners were facing delays due to laboratory testing operations.

Kwon said the government had complained to Moderna, and a high-level delegation would be visiting the company to discuss how best to remedy the situation.

He said Moderna had apologised and pledged to work to make good the promised shipments.

Moderna did not immediately respond to a request for comment.

South Korea has a contract to buy 40 million doses from Moderna, and just about 2.4 million have arrived so far, according to the Korea Disease Control and Prevention Agency (KDCA).

The delays came as South Korea is set to open vaccine reservations for all adults over 18 years for the first time late on Monday, with vaccinations using Moderna or Pfizer/BioNTech products to start on Aug. 26.

The reservations will proceed as planned, but it will take six weeks to get a second shot after the first dose, instead of four weeks, KDCA chief Jeong Eun-kyeong said.

South Korea was praised for its handling of earlier major outbreaks with thorough tracing and testing, but a slow vaccination uptake has overlapped with a surge in more transmissible variants.

Some 45% of the 52 million population have had at least one dose of vaccine, while just 15% have been fully vaccinated as of Sunday midnight, KDCA data showed.

South Korea aims to immunise over 70% of the population by September.

President Moon Jae-in told a meeting with senior aides that despite vaccine shortages, the goal will be reached by maximising the efficiency of available supplies.

The KDCA reported 1,492 new coronavirus cases for Sunday, raising total infections to 212,448, with 2,125 deaths.

https://finance.yahoo.com/news/1-korea-apologises-moderna-halves-083348995.html

Editas upped to Buy from Hold by Truist

 Target to $80 from $45

https://finviz.com/quote.ashx?t=EDIT

U.S. judge says Florida can't ban cruise ship's 'vaccine passport' program

 A U.S. judge has allowed Norwegian Cruise Line Holdings Ltd. to demand that passengers show written proof of coronavirus vaccination before they board a ship, dealing a major blow to Florida Governor Ron DeSantis's effort to ban "vaccine passports." 

  In a preliminary ruling issued on Sunday, U.S. District Judge Kathleen Williams in Miami said Norwegian would likely prevail on its argument that the "vaccine passport" ban, signed into law by DeSantis in May, jeopardizes public health and is an unconstitutional infringement on Norwegian's rights. 

  The judge blocked DeSantis from enforcing the law against Norwegian, allowing the cruise ship operator to proceed with a plan to resume port activity in Miami on Aug. 15. Violations of the law could have triggered a penalty of $5,000 per passenger, potentially adding up to millions of dollars per cruise. 

  Raymond Treadwill, a lawyer for DeSantis, did not immediately respond to a request for comment. 

  The ruling comes as big business and some government entities are responding to the rapid spread of the Delta variant of the coronavirus with vaccination requirements, prompting legal challenges from vaccine skeptics and civil libertarians. 

  "We are pleased that Judge Williams saw the facts, the law and the science as we did and granted the Company's motion for preliminary injunction allowing us to operate cruises from Florida with 100% vaccinated guests and crew," the company's executive vice president Daniel S. Farkas said in the statement. 

  Norwegian has said Florida's law would prevent the company from ensuring at least 95% of passengers were vaccinated so it could comply with health regulations when it conducts its first post-pandemic voyage from Miami on Aug. 15. 

  DeSantis has become a national figure for opposing pandemic restrictions, even as the Republican governor's state has become a hotbed of infections and hospitalizations have hit record levels. 

He has argued that Florida law prevents discrimination and protects privacy by preventing businesses, schools or governments from demanding proof of immunity in return for service. 

  Norwegian has said the law was not about protecting passengers but scoring political points. 

  Norwegian is ramping up its return to cruises, which the Centers for Disease Control and Prevention (CDC) shut down in March 2020 with its "No Sail" order. 

  In order to sail, Norwegian has attested to the CDC it would confirm that at least 95% of passengers have been vaccinated. 

  Norwegian said the law violates the company's First Amendment right to interact with customers and does not prevent discrimination because the company would have to segregate and mask passengers who declined to prove they were vaccinated. 

  The state argued that Norwegian could have opted, as rival cruise operators did, to seek CDC approval through a process of running simulated voyages and applying other COVID-19 protocols such as masking indoors. 

https://news.yahoo.com/norwegian-cruise-says-u-judge-003608127.html

Axsome Says FDA Finds Deficiencies With AXS-05 Application

 Axsome Therapeutics Inc. on Monday said the U.S. Food and Drug Administration has flagged deficiencies related to the company's AXS-05 new drug application that could delay approval of the proposed treatment of major depressive disorder, sending shares of the biopharmaceutical company tumbling in premarket trading.

New York-based Axsome said the FDA recently notified the company that it had found unspecified deficiencies that currently preclude the discussion of labeling and post-marketing requirements and commitments.

Axsome said it is attempting to learn the nature of the deficiencies with the goal of addressing them, but it said the development may lead to a delay in the potential approval of AXS-05.

The FDA in April granted priority review to AXS-05 for the treatment of major depressive disorder and set a target action date of Aug. 22 for the application.

Axsome is also studying AXS-05 in Alzheimer's disease agitation and smoking cessation.

https://www.marketscreener.com/quote/stock/AXSOME-THERAPEUTICS-INC-24949017/news/Axsome-Says-FDA-Finds-Deficiencies-With-AXS-05-Application-36111771/

BioNTech says has supplied over 1B COVID-19 vaccine doses

 

BioNTech and partner Pfizer have supplied more than one billion doses of their COVID-19 vaccine as per July 21, a bigger number than delivered by competitor AstraZeneca, the German biotech group said on Monday.

The supply tally, up from more than 700 million doses announced by the biotech firm in June, compares with AstraZeneca saying late last month that it and manufacturing partner Serum Institute of India had supplied a billion doses to 170 countries at the time.

Based on delivery contracts for over 2.2 billion doses so far, BioNTech said in a statement it expects to accrue 15.9 billion euros ($18.7 billion) in revenue from the vaccine this year, up from a May forecast of 12.4 billion euros.

That includes sales, milestone payments from partners and a share of gross profit in its partners' territories, the company added.

Pfizer late last month raised its forecast for its share of 2021 vaccine sales to $33.5 billion.

BioNTech added on Monday that it and Pfizer believe a third dose, following the established two-shot regimen, "has the potential to preserve the highest levels of protective efficacy against all currently tested variants, including Delta", underscoring similar remarks made by its partner.

Still, it reiterated plans to start testing a vaccine adjusted to the highly infectious Delta variant of the virus on humans this month, part of a "comprehensive strategy to address variants, should the need arise in the future".

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-BioNTech-says-has-supplied-more-than-1-billion-COVID-19-vaccine-doses-so-far-36110869/