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Big pharma resists international corporate tax proposal

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Pharma companies are resisting a tentative agreement between 130 countries to create a minimum corporate tax of 15%. The plan intends to combat tax inversion and other forms of tax avoidance.

Some U.S. industries, including Big Tech, have backed the plan given its potential to simplify accounting — even if it increases their tax rate.

But the pharma industry is highlighting its role in developing COVID-19 vaccines and other therapies in their opposition to the plan. Arguing that higher taxes would curb their ability to innovate, drug companies are worried about the proposal’s threat to their bottom line. Large pharma companies could see their tax bill increase by hundreds of millions of dollars annually if the plan is finalized. Moreover, pharmaceutical companies could see a larger tax hike than some other industries given their global presenc…

Pfizer and Moderna to expand clinical trials for school-aged children

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization.

In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech.

Since then, FDA has substantiated the risk of myocarditis, or heart inflammation, from mRNA vaccines, which is rare and tends to be minor.

According to The New York Times, federal regulators concluded that the proposed clinical trials to study the Pfizer and Moderna vaccines in school-aged children were insufficiently powered to detect rare side effects, including heart inflammation.

[Related: AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study]

Pfizer (NYSE:PFE) and BioNTech (NASDAQ: BNTX) announced in June that it was expanding its COVID-19 vaccine trial to include up to 4,…

MedTech 100 roundup: Return to normal after last week’s spike

After rising more than 31 points to heights never before reached, the medtech industry returned to normal this past week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 23) at 115.54 points, a total that, had it not been for last week, would be the index’s all-time high.

However, the index finished the previous week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception — and perhaps an anomaly. Although the index slid by -20.8%, it remains in a stronger position than ever before, last week notwithstanding.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 25.2% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). It remains well ahead of the mid-pandemic low…

AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study

A recent Canadian pre-print study found that AstraZeneca’s Vaxzevria vaccine was 82% effective in preventing hospitalization or death from the Beta and Gamma SARS-CoV-2 virus variants. Using the same benchmark, its efficacy against the Alpha and Delta variants was 87% and 90%, respectively, 21 days after administering the first dose.

The BNT162b2 vaccine from Pfizer and BioNTech had a similar efficacy after 21 days. In terms of protecting against the Beta and Gamma variants, a single dose of the BNT162b2 vaccine was 83% effective at protecting against hospitalization and death after 21 days. One dose of Moderna’s mRNA-1273 vaccine was 94% effective at the same interval.

A second dose of the Pfizer-BioNTech vaccine boosted its efficacy considerably. It was 98% effective at preventing hospitalization or death from the Beta and Gamma variants 14 days after the second dose. Its protection against other variants was similar following the second dose.

There wa…

Man experiences facial palsy twice after receiving both COVID-19 vaccine doses

Representational Bell’s palsy image courtesy of Wikipedia

The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine.

The journal reports that the case report is the first to describe unilateral facial nerve palsy after both doses of the Pfizer-BioNTech vaccine.

In the Phase 3 trial for the Pfizer-BioNTech vaccine, four patients who received the injection developed Bell’s palsy while none in the placebo arm did. There were approximately 38,000 participants in that study.

In the case of the 61-year-old man, he experienced facial paralysis on the right side five hours after receiving the first dose. The …

How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials. DeviceTalks [Image from Unsplash] Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future? A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC. Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulatory affairs at Hologic. Go to our sister site Medical Design & Outsourcin…

How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.

[Image from Unsplash]

DeviceTalks

Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future?

A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC.

Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulator…

Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

[Image courtesy of Wikipedia]Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

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

Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

Pfizer-BioNTech vaccine [Image courtesy of Wikipedia]

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

Pfizer and BioNTech expect to deliver the additional doses from October 2021 through April 2022, bringing the total doses purchased by the U.S. government for the American public to…

Mix-and-match COVID vaccines attract support and backlash

Image courtesy of Pexels

Several countries have embraced the idea of using distinct COVID-19 vaccines for the first and second doses. But a death in Korea is fueling concerns about the strategy, and some public authorities have warned against the practice.

Canada, Korea, Thailand and Germany have authorized the use of a heterologous prime-boost COVID-19 vaccination strategy to manage supply constraints.

A police officer in South Korea, however, has died after receiving first an AstraZeneca vaccine dose followed by a Pfizer dose, according to The Korea Times. Health authorities there will investigate the death of the 52-year-old officer, who passed away three days after receiving his second vaccine dose.

A recent preprint study published in The Lancet suggested that combinations of AstraZeneca and Pfizer vaccines were effective. Data, however, are preliminary.

Germany, Canada and Thailand…

China rebuffs WHO’s plan to continue investigating origins of COVID-19

The possibility that SARS-CoV-2 resulted from a laboratory accident has gained a degree of plausibility among several world leaders.

But China has rejected calls for further investigation into the matter, saying such allegations disregard “common sense,” as Zeng Yixin, vice-minister of the National Health Commission (NHC), said at a press briefing.

White House press secretary Jen Psaki criticized China’s stance, adding in a press briefing that “their position is irresponsible and, frankly, dangerous.”

China has also entertained a theory that Fort Detrick, an Army base in Maryland, is the source of the pandemic.

While the Fort Detrick lab researches infectious viruses, there is no evidence it is the outbreak’s source.

After initially discounting the possibility of the lab-leak scenario, the WHO has recommended further studies in China. Recently, the organization sought to audit laboratories and markets in Wuhan.

The investigation into…

COVID-19 testing boosts Abbott in Street-beating Q2

Abbott (NYSE:ABT) shares took a small dip despite second-quarter results that topped the consensus forecast.

The Abbott Park, Ill.-based company posted profits of $1.2 billion, or 66¢ per share, on sales of $10.2 billion for the three months ended June 30, 2021, for a more-than doubled bottom-line on sales growth of 39.5%.

Adjusted to exclude one-time items, earnings per share were $1.17, 15¢ ahead of Wall Street, where analysts were looking for sales of $9.7 billion.

The company’s medical device segment achieved 51.3% sales growth year-over-year. Its diagnostic business, spearheaded by COVID-19 testing, saw its revenues increase 62.8% from the second quarter of 2020 on the back of $1.3 billion in global COVID-19 testing-related sales.

“We’re achieving very strong growth across our portfolio,” Abbott president & CEO Robert B. Ford said in a news release. “Perhaps most impressively, excluding COVID testing-related …