Moderna shares positive data regarding COVID-19 vaccine boosters

Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]

Initial data from a Moderna (NSDQ:MRNA) Phase 2 trial found two versions of its COVID-19 vaccine increased neutralizing titers against SARS-CoV-2 and two variants in previously vaccinated clinical trial volunteers.

A third dose of the company’s existing mRNA-1273 appears to improve immune response against the B.1.351 variant that first emerged in South Africa. But a booster dose of mRNA-1273.351, which was developed based on the South African variant, led to higher titers against B.1.351. Both vaccines also appear to offer superior protection against P.1, the lineage first identified in Brazil.

Moderna announced that both boosters were generally well tolerated.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have a Phase 1/2/3 trial underway testing the use of a third dose of their COVID-19 vaccine. The two companies have also plan…

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BREAKING: Biden administration calls for waiving IP protections for COVID-19 vaccines

U.S. Trade Representative Katherine Tai announced on Twitter that the Biden administration supports a COVID-19 vaccine IP waiver.

U.S. Trade Representative Katherine Tai announced this afternoon that the Biden administration supports waiving IP protections for COVID-19 vaccines.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement.

Get the full story on our sister site Pharmaceutical Processing World. 

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BREAKING: Biden administration calls for waiving IP protections for COVID-19 vaccines

U.S. Trade Representative Katherine Tai announced on Twitter that the Biden administration supports a COVID-19 vaccine IP waiver.

Stocks of major COVID-19 vaccine makers Moderna and Pfizer are down today after U.S. Trade Representative Katherine Tai announced that the Biden administration supports waiving IP protections for COVID-19 vaccines.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement.

Tai said the U.S. will actively participate in World Trade Organization text-based negotiations to make the IP protections waiver happen, though she added that such discussions will take time given the complexity of the WTO.

Moderna (Nasdaq:MRNA) shares are down more than –6% to $162.76 apiece, and Pfizer shares are down more than –1% to $39.53 apiece on the news this afternoon.

Even a…

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Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

Image courtesy of Wikipedia

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

Get the full story at our sister site, Drug Discovery & Development.

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Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

Image courtesy of Wikipedia

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

Bourla said the company is submitting a Biologics License Application to the FDA in search of full approval for the vaccine in individuals 16 years of age and older and plans to submit for EUA for two cohorts — children between age 2-5 and children between age 5-11 — in September 2021.

The company is awaiting a response from the FDA regarding its application for expanded EUA that would ext…

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Elizabeth Holmes wants to blame Silicon Valley startup culture for Theranos fiasco

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]Ex-Theranos CEO Elizabeth Holmes’ lawyers want to present evidence about Silicon Valley startup culture as part of her federal fraud trial defense, according to media reports.

“Silicon Valley exaggeration occurs, there’s going to be natural discussion of startup companies and how they operate,” Judge Edward Davila said during a hearing yesterday in federal court in San Jose, Calif. Davila found that the defense won’t be able argue that prosecutors are unfairly signaling out Holmes and Theranos’ practices, CNBC reports.

The hearing marked the first time that Holmes has appeared in person in court in 15 months.

Trial jury selection — delayed multiple times because of the COVID-19 pandemic and then Holmes’ pregnancy — is slated to start Aug. 31.

The prosecution and defense ar…

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TransMedics slides on Q1 earnings miss

TransMedics (NSDQ:TMDX) shares took a massive hit today on first-quarter results that missed the consensus earnings forecast.

TMDX shares were down -12.4% at $24.58 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -1.2%.

The Andover, Mass.-based organ transplant technology developer posted losses of -$7.9 million, or -29¢ per share, on sales of $7.1 million for the three months ended March 31, 2021, for a 10.6% bottom-line gain on a sales decline of -6.3%.

TransMedics’ EPS of -29¢ came in 1¢ shy of projections on Wall Street, although the company’s revenues topped analysts’ estimates by 1.8%.

“We are pleased with our progress as we advance quickly toward several near term regulatory and commercial catalysts expected in 2021,” TransMedics president & CEO Dr. Waleed Hassanein said in a news release. “…

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Silk Road Medical sinks despite Street-beating Q1, raised guidance

Silk Road Medical (NSDQ:SILK) shares took a big hit today despite first-quarter results that beat the consensus forecast.

SILK shares were down -10% at $55.30 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -0.9%.

The Sunnyvale, Calif.-based company posted losses of -$10.7 million, or -31¢ per share, on sales of $22.1 million for the three months ended March 31, 2021, for a -12.9% bottom-line slide despite sales growth of 16.5%.

Silk Road’s EPS of -31¢ came in 9¢ ahead of Wall Street projections, while sales numbers topped analysts’ estimates by 3.1%.

“Our first-quarter results were characterized by meaningful progress on several commercial and operational initiatives and strong financial performance,” Silk Road president & CEO Erica Rogers said in a news release. “Procedure trends are improving, and we are workin…

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Varex shares jump 8% on Street-beating Q2 results

Varex Imaging (NSDQ:VREX) yesterday posted second-quarter results that beat the overall consensus on Wall Street.

The Salt Lake City-based imaging company reported profits of $3.2 million, or 8¢ per share, on sales of $203.5 million for the three months ended April 2, for a sales growth of 3.3% compared with Q2 2020.

Adjusted to exclude one-time items, earnings per share were 35¢, 18¢ ahead of The Street, where analysts were looking for sales of $187 million.

“Financial results for the second quarter of the fiscal year 2021 were stronger than our expectations and exceeded pre-COVID revenue levels. Driving this was continued strong global CT tube sales and higher sales of industrial digital detectors. We also had higher demand for our other medical imaging products related to certain elective medical procedures,” CEO Sunny Sanyal said in a news release. “We also continued to have strong expense management, which led to excellent bottom-line results.”

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Alcon dips despite Q1 earnings beat

Alcon (NYSE:ALC) shares took a hit in pre-market trading today on first-quarter earnings that beat the consensus forecast.

ALC shares were down -6.2% at $69.88 in pre-market trading today.

The Geneva, Switzerland-based company posted earnings per share of 17¢ on sales of $1.9 billion for the three months ended March 31, 2021, registering revenue growth of 4.8% year-over-year.

Adjusted to exclude one-time items, earnings per share were 49¢, 4¢ ahead of projections made by Wall Street analysts.

The company’s surgical segment registered 9.5% growth year-over-year in revenues, while its vision care business dipped -0.6% from its Q1 2020 sales numbers.

“The first quarter was a solid start to the year, with healthy sales, a return to 2019 core margin levels and the substantial completion of our separation activities. Strong commercial execution of our new product launches continues to drive market share gains despite the continued imp…

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Bruker reports nearly 31% sales growth in Q1, increases full-year guidance

Bruker Corp. (NSDQ:BRKR) posted first-quarter results today that beat the overall consensus on Wall Street and raised its full-year guidance as a result.

The Billerica, Mass.-based company reported profits of $56.7 million, or 37¢ per share, on sales of $554.7 million for the three months ended March 31, for a bottom-line gain of 440% sales growth of 30.83% compared with Q1 2020.

Adjusted to exclude one-time items, earnings per share were 44¢, 12¢ ahead of The Street, where analysts were looking for sales of $513.06 million.

“Bruker had an excellent start to 2021, with strong year-over-year revenue growth and remarkable operating performance improvements. During the quarter, we experienced strong revenue growth for our Project Accelerate products and solutions, particularly for proteomics and biopharma solutions, as well as for our core scientific instruments from strengthening academic, applied, industrial and semiconductor markets,” president and…

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Inogen beats Wall Street EPS consensus by 22¢ in Q1 results

Inogen (NSDQ:INGN) posted first-quarter results yesterday that beat the overall consensus on Wall Street.

The Goleta, Calif.-based company reported losses of -$732,000, or -3¢ per share, on sales of $86.932 million for the three months ended March 31, for a sales loss of -1.76% compared with Q1 2020.

Earnings per share were -3¢, 22¢ ahead of The Street, where analysts were looking for sales of $79.39 million.

“While the COVID-19 pandemic continued to have an impact on our business in the first quarter of 2021, we saw sequential growth in all four channels, and sequential growth of 17.5% in total revenue for the reported quarter,” president and CEO Nabil Shabshab said in a news release. “Additionally, our focus on the rental channel continues to produce strong operating performance with rental revenue growing significantly in the first quarter of 2021 versus the comparable period in the prior year. We continue to be focused on creating long-term value by …

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