covid-19 Archives - Page 35 of 113 - Medical Design Sourcing

Biovac to make and distribute Pfizer-BioNTech COVID-19 vaccine in Africa

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) today announced an agreement with Biovac to manufacture the companies’ COVID-19 vaccine for distribution in Africa.

Cape Town, South Africa-based Biovac will perform manufacturing and distribution activities within Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network to aid in distribution within the African Union, according to a news release. The technical transfer, on-site development and equipment installation activities for Biovac will begin immediately.

Pfizer and BioNTech’s global vaccine supply chain and manufacturing network now spans three continents, the companies said, with more than 20 million manufacturing facilities.

They expect Biovac’s Cape Town facility to be incorporated into the COVID-19 vaccine supply chain by the end of 2021, with Biovac slated to obtain drug substance from European facilities. The manufacturing of finished doses will c…

J&J rises before hours on Street-beating Q2, raised guidance

Johnson & Johnson (NYSE:JNJ) shares ticked up before the market opened today on second-quarter results that topped the consensus forecast.

The New Brunswick, N.J.-based company posted profits of $6.3 billion, or $2.35 per share, on sales of $23.3 billion for the three months ended June 30, 2021, for a 73.1% bottom-line gain on sales growth of 27.1% year-over-year.

Adjusted to exclude one-time items, earnings per share were $2.48, 21¢ ahead of Wall Street, where analysts were looking for sales of $22.2 billion.

Johnson & Johnson saw the largest revenue increase in its medical device sales, with 57.8% growth attributed mainly to the market’s recovery from the COVID-19 pandemic this time a year ago and the uptick in procedures after many were deferred during the pandemic.

Additionally, the company saw 14.1% growth in its pharmaceutical arm and 10% growth in consumer health.

“Our second-quarter results showcase Johnson &…

Study estimates Pfizer COVID-19 vaccine is 78% effective in pregnant women

A retrospective study published in JAMA concluded that the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) offered statistically significant protection against SARS-CoV-2 infection.

The pivotal trial Pfizer used to win emergency use authorization for the vaccine excluded pregnant women. COVID-19, however, increases the risk of pregnancy-related complications — particularly in the third trimester.

To determine how the vaccine performs in pregnant women, researchers in Israel tracked 7,530 vaccinated and 7,530 unvaccinated expectant mothers. They counted 118 COVID-19 infections in the vaccinated group and 202 in the control group. Researchers recruited volunteers from Maccabi Healthcare Services (Tel Aviv).

Among the two groups of women with PCR-confirmed COVID-19 infections, between 83% and 84% were symptomatic.

Some 68 patients receiving the vaccine complained of adverse events. None of them, however, were severe.

The resea…

Diversified Medical Healthcare acquires RapidRona and its COVID-19 diagnostic tests

Diversified Medical Healthcare today announced that it has acquired RapidRona and its home wellness testing portfolio.

RapidRona received emergency use authorization in December last year for its SARS-CoV-2 diagnostic test. The home test uses a network of CLIA certified laboratories throughout the U.S. to deliver results to a patient in 48 hours or less.

Get the full story on our sister site, MassDevice.

Diversified Medical Healthcare acquires RapidRona and its COVID-19 diagnostic tests

Diversified Medical Healthcare today announced that it has acquired RapidRona and its home wellness testing portfolio.

RapidRona received emergency use authorization in December last year for its SARS-CoV-2 diagnostic test. The home test uses a network of CLIA certified laboratories throughout the U.S. to deliver results to a patient in 48 hours or less.

“We know that Covid-19, unfortunately, is something our population will continue to face,” Diversified Medical Healthcare founder and CEO Kevin Murdock said in a news release. “As recent reports show that the new variants spread faster, cause more severe symptoms, and are causing a decrease in vaccine efficacy, the acquisition of RapidRona is our logical next step in providing necessary solutions for the future of COVID-19. We’re proud to add at-home diagnostic and wellness testing to all that we offer at Diversified Medical Healthcare.”

The RapidRona test kits are designed to provide RT-PCR test results…

Israel recommends third COVID-19 vaccine dose for the immunocompromised

Photo by cottonbro from Pexels

Israel is following a similar path to the U.K. in its plans to administer a third dose of COVID-19 vaccine to a subset of patients.

U.K. officials recently announced their initiative to provide a booster to high-risk patients, but those plans are preliminary.

Both Israel and U.K. have concluded that fully vaccinated individuals are unlikely to require a booster dose later this year.

The Israeli government, however, is taking more definitive steps in issuing guidance for people who are immunocompromised to receive a third dose of the vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX). Some medical centers have already begun administering boosters to those who are severely immunocompromised including cancer patients and recipients of organ transplants. While the country is considering providing a third dose for those 60 and older, it hasn’t yet reached a d…

FDA links J&J vaccine to rare cases of Guillain–Barré

The Food and Drug Administration still believes the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, but has concluded that the vaccine is associated with rare cases of Guillain–Barré syndrome. A warning is forthcoming, according to media reports.

Researchers have also linked prior vaccines, including a swine flu vaccine introduced in the 1970s, with the syndrome, which destroys nerves and can cause paralysis and sometimes death. Most frequently, however, the syndrome predominantly affects the lower extremities before ascending to spread muscle weakness. Many people with the condition, however, recover.

Federal officials have concluded that recipients of the Johnson & Johnson COVID-19 vaccine are more likely to contract Guillain–Barré than the background population. A statement from Johnson & Johnson concluded that “the rate of reported cases exceeds the background rate by a small degree.”

FDA stopped short of e…

Private equity and SPACs in the biopharma and biotech landscape

During the past few years, the biopharma and biotech markets have seen rapid growth. The global biotechnology market was worth $266 billion in 2019 is projected to reach $505 billion by 2026.1 In those strategic and important markets, what roles do private equity and Special Purpose Acquisition Companies (SPACs) play?

An overview of the biotech sector

On Euronext, the biotech sector has been resilient despite the impact of COVID-19. In 2020, the market capitalization of the 62 biotech firms listed reached a record of €29 billion, up €5.3627 billion compared to 2019. The share price of listed biotech companies increased by 66.8% in the first half of 2020. In the second half of the year, it grew by 29.7%.

In the U.S., major biotech stock indices were also high in 2020. In addition, biotech IPOs were very strong both in value and number, with $14 billion raised in 74 deals.

The U.S. continues to lead the biopharma IPO market. Next in line is the China IPO m…

Meta-analysis finds some ivermectin benefits in COVID-19 patient

Ivermectin image from Wikipedia

An analysis published in Open Forum Infectious Diseases found a 56% reduced risk of mortality for COVID-19 patients taking the anti-parasitic drug ivermectin compared to standard of care or another therapy. The study pulled data from 24 randomized trials involving 3,328 patients with moderate to severe COVID-19.

The study also found that ivermectin was “associated with reduced inflammatory markers” and quicker viral clearance.

Ivermectin, a widely available inexpensive drug used to treat worm and scabies infections in humans and animals, has emerged as a COVID-19 treatment in several parts of the world. Its use, however, has been controversial. WHO has counseled against its use as a COVID-19 treatment outside of clinical trials. And Merck, an ivermectin manufacturer, released a statement in February saying there was no scientific evidence to support the use of ivermecti…

Why Bioclinica tapped AI in immunotherapy trials early in the pandemic

An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica.

Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results.

In previous years, the scientific community established that immunotherapy can rarely cause interstitial lung disease (ILD). An umbrella term covering several conditions such as pulmonary fibrosis that lead to scarring of the lungs, ILD also arises in some patients with COVID-19.

The fact that ILD can arise from COVID-19 and cancer immunotherapies complicated oncology clinical trials, recalled Gebow at Bioclinica, which provides clinical trial adjudication products and services. “Patients in immunotherapy clinical trials were showing up at the emergency room with some type of lung infection,” Gebow said. “You can imagine if you’re the pharmaceutical company…

IMF approves $650B to help countries pay for COVID-19 vaccines

The executive board of the International Monetary Fund (IMF) today approved a $650 billion allocation for COVID-19 vaccines.

IMF managing director Kristalina Georgieva issued a statement today confirming that the executive board concurred in her proposal for a new general Special Drawing Rights (SDR) allocation of $650 billion — the largest allocation in the IMF’s history — to address long-term needs for what she called “the worst crisis since the Great Depression.”

According to the statement, Georgieva will present the SDR allocation proposal to the IMF’s board of governors for their consideration and approval, which, if obtained, would lead to the expectation that the allocation is completed by the end of August.

“This is a shot in the arm for the world,” Georgieva said. “The SDR allocation will boost the liquidity and reserves of all our member countries, build confidence, and foster the resilience and stabili…

Johnson & Johnson launches research partnerships network

Johnson & Johnson (NYSE:JNJ) announced today that it has launched the J&J Centers for Global Health Discovery, a global network of research partnerships to address the world’s health challenges.

The first J&J Satellite Center for Global Health Discovery is at the London School of Hygiene & Tropical Medicine. The pharma and medtech giant plans to open additional J&J Centers through 2022.

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