Search This Blog

Tuesday, January 5, 2021

Moderna: Israel Approved COVID Vaccine, First Deliveries Expected This Month

 U.S. drugmaker Moderna Inc said on Monday that Israel's Health Ministry had authorized its COVID-19 vaccine, marking the vaccine's third regulatory authorization and the first outside North America.

"Israel's Health Ministry has secured 6 million doses and first deliveries (are) expected to begin in January," Moderna said in a statement.

Moderna has received authorization for its COVID-19 vaccine in the United States and Canada and additional authorizations are currently under review in the European Union, Singapore, Switzerland and the United Kingdom.

Israel has begun to vaccinate its population at one of the quickest rates in the world, and it aims to reach all vulnerable citizens by late January. Authorities started vaccinations on December 19 using the vaccine developed by Pfizer and BioNTech.

https://www.haaretz.com/israel-news/israel-s-health-ministry-authorizes-use-of-moderna-s-covid-19-vaccine-1.9423689

Biogen in deal for ophthalmic gene therapy development

 ViGeneron GmbH, a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. (Nasdaq: BIIB, Cambridge, Mass., USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. The companies will use ViGeneron’s proprietary vgAAV, novel engineered AAV capsids, to efficiently transduce retinal cells via intravitreal injections.

https://finance.yahoo.com/news/vigeneron-signs-global-collaboration-agreement-070000766.html

Monday, January 4, 2021

EU drugs agency still undecided on Moderna COVID vaccine

 The European Medicines Agency (EMA) has not been able to reach a decision on the approval of Moderna’s COVID-19 vaccine on Monday, the Dutch national medicines authority said.

The EMA’s human medicines committee (CHMP) had called an unscheduled meeting Monday afternoon to discuss Moderna’s vaccine, two days ahead of its originally planned meeting on Wednesday.

The Dutch medicines regulator CBG said approval could still follow at the meeting on Jan 6.

It said it was not clear why a decision was not reached on Monday.

“This is how it goes, of course we had hoped for more, but we knew it could be impossible to answer all questions in detail in one meeting”, CBG chairman Ton de Boer told reporters.

“I hope there will be a decision on Wednesday. But I don’t know.”

The agency has set a Jan. 12 deadline for whether to recommend Moderna’s vaccine. It recommended a COVID-19 vaccine from Pfizer and its German partner BioNTech on Dec. 21.

https://www.reuters.com/article/us-health-coronavirus-vaccine-moderna/eu-drugs-agency-still-undecided-on-moderna-covid-vaccine-dutch-regulator-idUSKBN2991I6

'Premature' to change authorized COVID-19 vaccines dosing, schedules: FDA

 The U.S. Food and Drug Administration said on Monday that the idea of changing the authorized dosing or schedules of COVID-19 vaccines was premature and not supported by the available data.

The FDA said it had been following discussions and news reports about reducing the number of doses, extending the length of time between doses, cutting the dosage in half, or mixing and matching vaccines in order to immunize more people.

Although these were “reasonable” questions to consider, the U.S. regulator said, “at this time suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence.”

“Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk,” the agency said in a statement.

Pfizer and partner BioNTech SE as well as Moderna Inc recently won U.S. emergency use authorization for their vaccine candidates.

The available data continues to support the use of two specified doses of each authorized vaccine at specified intervals, the FDA said.

"For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose," the FDA said on Monday bit.ly/38g9IsC.

In a departure from other countries’ strategies, the British government said last week people could on rare occasions be given a mix-and-match of two COVID-19 shots, for example if the same vaccine dose was out of stock.

https://www.reuters.com/article/us-health-coronavirus-usa-vaccine-fda/premature-to-change-authorized-covid-19-vaccines-dosing-schedules-fda-says-idUSKBN29A05M

NY Businesses Balk at Minimum Wage Boost During Covid-19

 New York state leaders have moved ahead with minimum-wage increases over objections from some groups who said businesses battered by the coronavirus pandemic couldn't afford the increased labor costs.

New York is gradually raising its minimum wage to $15 an hour, and as of Dec. 31 employers on Long Island and in Westchester County were required to start paying workers at least $14 an hour, up from $13. The minimum rose to $12.50 from $11.80 an hour in the rest of New York state outside New York City, where all employers hit the $15 hourly wage requirement at the end of last year.

State law requires the New York Division of the Budget to analyze the impact of recent minimum-wage increases and the health of the economy before the state moves forward with scheduled increases. A 2016 law, which raises the minimum wage over several years to $15 an hour, is scheduled to reach the threshold in Long Island and Westchester next year.

Roberta Reardon, commissioner of the New York State Department of Labor, had the option of delaying the wage boost but said the labor markets affected by the increase -- meaning those outside New York City -- are leading the state's economic recovery.

The unemployment rate for Long Island and Westchester, for example, fell to 7.1% in October from its pandemic peak of 15.4% in April, according to the report. The national unemployment rate was 6.9% in October, according to the U.S. Labor Department.

Minimum-wage workers, such as those employed in the retail, leisure and hospitality industries, have been disproportionately harmed by the pandemic and need support, Ms. Reardon said in explaining her decision to move forward with the minimum-wage increase.

"We will rebuild our economy while continuing to lead the nation in the fight for economic justice," she said in a statement. "This investment in our workers once again proves that in New York we believe a fair day's work deserves a fair day's pay."

Steve Wangel, president of the Lynbrook Chamber of Commerce on Long Island, said he supported delaying the minimum-wage increase. Mr. Wangel, who owns a kitchen cabinet and design company, isn't affected by the change because he pays his employees on commission.

"Especially now, because of coronavirus and businesses suffering such a decrease in business, it becomes much, much harder to pay the higher wages," he said.

Some business groups said the higher labor costs could slow the state's jobs recovery.

"It just increases the cost of doing business at a time when sales are at an all-time low, revenue is at an all-time low and many businesses are simply closed in New York state or operating under severe capacity restrictions," said Greg Biryla, New York director of the National Federation of Independent Business.

Elizabeth Wellington, vice president of the trucking company Wellie The Transporter, based in Elmont on Long Island, said she supported raising the minimum wage because many workers are having a hard time paying their living expenses. Ms. Wellington, who has two employees, said the wage increase won't have a significant impact on her business.

"Some people don't even have food," said Ms. Wellington, who is also deputy director of Nassau County for the Long Island African American Chamber of Commerce. "Some workers in the African-American community have to hold three jobs in order to survive."

The state budget division's report found that minimum-wage increases over the last four years didn't adversely affect employment in New York, with the statewide unemployment rate falling below 4% just before the pandemic. The statewide rate was 8.1% in November, the most recent data available, down from a high of 16% in July, according to the state labor department.

In addition to New York, 19 other states and 32 cities and counties raised their minimum wages Jan. 1, according to a report by the National Employment Law Project, a nonprofit research group that advocates for low-wage workers. The statewide new minimum wages range from $8.75 an hour in Montana to $14 an hour in California.

In New Jersey, the minimum rose to $12 an hour from $11 on Jan. 1. A law signed last year by Gov. Phil Murphy, a Democrat, will gradually increase the state's minimum wage to $15 an hour for most workers by 2024.

https://www.marketscreener.com/news/latest/Some-New-York-Businesses-Balk-at-Minimum-Wage-Boost-During-Covid-19--32119348/

Oncology biotech Cullinan Management sets terms for $150M IPO

 Cullinan Management, a Phase 1/2a biotech developing and investing in oncology therapies, announced terms for its IPO on Monday.


The Cambridge, MA-based company plans to raise $150 million by offering 8.3 million shares at a price range of $17 to $19. Existing shareholders intend to purchase $7.5 million worth of shares in the offering. At the midpoint of the proposed range, Cullinan Management would command a fully diluted market value of $750 million.

The company is developing a diversified pipeline of targeted oncology and immuno-oncology therapies for cancer patients. Its lead candidate, CLN-081, is an orally available small molecule designed as a next generation, irreversible EGFR inhibitor designed to selectively target cells expressing mutant EGFR variants. CLN-081 is currently in a Phase 1/2a trial for as a treatment for adult NSCLC patients with EGFRex20ins mutations. Its most advanced immuno-oncology candidates include CLN-049, a bispecific antibody targeting FLT3 and CD3; and CLN-619, a monoclonal antibody designed to stimulate NK and T cell responses.

Cullinan Management was founded in 2016 and was previously named Cullinan Oncology. It plans to list on the Nasdaq under the symbol CGEM. Morgan Stanley, SVB Leerink, and Evercore ISI are the joint bookrunners on the deal. It is expected to price during the week of January 4, 2021.

Carlyle LBO Ortho Clinical Diagnostics files for estimated $800M IPO

 Ortho Clinical Diagnostics, a Carlyle-backed global provider of in vitro diagnostic products, filed on Monday with the SEC to raise up to $100 million in an initial public offering. However, this is likely a placeholder for a deal we estimate could raise up to $800 million.


Acquired by The Carlyle Group (Nasdaq: CG) in 2014, Ortho Clinical Diagnostics is a pure-play in vitro diagnostics (IVD) business that provides diagnostic testing solutions to the clinical laboratory and transfusion medicine communities, impacting approximately 800,000 patients every day. The company has a global presence, with more than 4,500 employees that support customers across more than 130 countries and territories, and it generates revenue through its broad portfolio of tests and diagnostic instrument consumables. 

The Raritan, NJ-based company was founded in 1939 and booked $1.7 billion in sales for the 12 months ended September 30, 2020. It plans to list on the Nasdaq under the symbol OCDX. J.P. Morgan, BofA Securities, Goldman Sachs, Barclays, Morgan Stanley, Citi, Credit Suisse, UBS Investment Bank, Evercore ISI, and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.