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After regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), some regulatory authorities wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

The history of using viruses as vectors dates back to the mid-1970s when scientists Dr. J. Michael Bishop and Dr. Harold Varmus demonstrated that gamma-retroviruses could acquire cellular genes.

Researchers began creating adenoviral vectors in the 1980s, testing replication-de…

FDA approves Bristol-Myers Squibb immunotherapy for gastric cancer

The FDA announced today that it approved Opdivo (nivolumab) in combination with chemotherapy to treat gastric cancer, among other diseases.

Opdivo, developed by Bristol-Myers Squibb, when used in combination with certain types of chemotherapy is designed to treat advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is now the first FDA-approved immunotherapy for the first-line treatment of gastric cancer, according to a news release.

The monoclonal antibody is designed to enhance T-cell function to inhibit tumor growth. In a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, the 789 patients who received Opdivo with chemotherapy lived longer on average than the 792 patients who received chemo alone.

Median survival for patients who received Opdivo plus chemotherapy c…

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

Adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson are currently in limited use, given concerns that they could cause rare but serious blood clotting problems.

The mRNA vaccines from Moderna and Pfizer/BioNTech also have a head start, and U.S. officials expect 600 million doses of the vaccines to be delivered by the end of July.

It will be “a stretch for adenoviral-vector vaccines to have any material uptake,” in the U.S., said Navin Jacob, a senior equity research analyst at UBS. “And you can’t really give boosters with the adenoviral-vector vaccin…

Thermo Fisher to buy PPD for $17B

Thermo Fisher Scientific (NYSE:TMO) announced today that it agreed to acquire PPD (NSDQ:PPD) for $17.4 billion.

The boards of directors for both companies approved the definitive agreement which will see Thermo Fisher buy PPD at a price of $47.50 per share, totaling the $17.4 billion, plus the assumption of approximately $3.5 billion of net debt, according to a news release. That represents a premium of approximately 24% to the unaffected closing price of PPD’s common stock as of Tuesday, April 13, 2021.

Wilmington, N.C.-based PPD offers clinical research and laboratory services to enable customers to accelerate innovation and increase drug development productivity. The company has more than 26,000 colleagues operating across 50 countries and it produced revenue of $4.7 billion in 2020. It will become a part of Thermo Fisher’s laboratory products and services business segment.

Waltham, Mass.-based Thermo Fisher expects the transaction to be i…

Vaccine panel postpones vote on J&J COVID-19 vaccine clot connection

A CDC advisory committee decided not to vote on how Johnson & Johnson’s COVID-19 vaccine should be deployed, reasoning that it needs more time to review data related to rare blood clots potentially linked to the vaccine.

The Advisory Committee on Immunization Practices (ACIP) could ultimately help the CDC decide whether to continue using the vaccine, constrain it or discontinue it altogether.

The cases of cerebral venous sinus thrombosis in J&J COVID-19 recipients deserve serious attention, said Dr. Sarah Long, an ACIP member in the meeting. “Even though it is a very small risk, it is very serious,” explained Long, who is also a professor of pediatrics at the Drexel University College of Medicine. The blood clotting disorder could pose “severe consequences,” Long said.

Several members on the panel stressed they did not want to indefinitely pause the use of the J&J vaccine.

But continuing to roll out the vaccine without more data and…

U.S. government on the hook for COVID-19 vaccine liability

[Image by Sam Moqadam on Unsplash]

There have multiple surges in malpractice claims following each wave of COVID-19 infections.

According to Victor Bornstein, CEO of Justpoint (New York City), the vast majority of those claims have targeted medical malpractice, an AI company specializing in malpractice. “The healthcare system was under a lot of stress, and more mistakes tend to happen,” Borstein said.

There hasn’t been a surge in cases related to the pandemic against pharmaceutical companies, whose COVID-19 therapies are legally shielded from lawsuits.

But the FDA’s and CDC’s joint decision to pause the use of Johnson and Johnson’s COVID-19 vaccine could lead to renewed focus on potential adverse events linked to COVID-19 vaccines.

Pharmaceutical companies themselves “cannot be sued for money damages in court” over possible injuries related to COVID-19 vaccines or therapeutics.…

EU won’t renew J&J, AstraZeneca vaccine contracts, report says

[Photo by Daniel Schludi on Unsplash]

Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson.

According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the current year expire, with Brussels reportedly emphasizing its focus on mRNA vaccines like those produced by Pfizer/BioNTech and Moderna.

The report quoted an EU Commission spokesperson as saying the commission is keeping all options open to prepare for the next stages of the pandemic, but it can’t comment on contractual matters.

Later on today, the EU Commission president stated that the EU was in talks with Pfizer and BioNTech over a new contract for 1.8 billion doses as well, …

Pfizer to boost vaccine production for U.S. by 10%

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Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday.

The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot formation in women.

Pfizer will deliver 220 million doses of its two-dose vaccine by the end of May and supply the full 300 million it agreed to for the end of July two weeks early, CEO Albert Bourla tweeted. “In the fight against COVID-19, we’re in this together,” he added.

As of Monday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewi…

Researcher: Neuroinflammation may be behind tinnitus reports in some COVID-19 vaccine recipients

Photo by Mark Paton on Unsplash

Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona.

Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments.

Some 0.65% of COVID-19 vaccine recipients who filed reports in CDC’s Vaccine Adverse Event Reporting System (VAERS) reported the issue. Although VAERS is not exhaustive, those 369 reports out of a total of 56,722 VAERS entries represent a tiny fraction of 190 million COVID-19 vaccine doses that have been administered in the U.S. to date.

Six volunteers in J&J’s Phase 3 trial for its COVID-19 vaccine complained of tinnitus. FDA, however, concluded there was insufficient evidence to link the issue t…

6 assumptions about COVID-19 vaccines as AstraZeneca and J&J face safety scrutiny

[Photo by Daniel Schludi on Unsplash]

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus.

But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed blood clot disorders.

Officials in both the EU and the U.S. suspect there could be a link between adenovirus-based COVID-1 vaccines and blood clotting problems such as cerebral venous sinus thrombosis. Authorities in both countries have either temporarily halted or constrained the use of adenovirus vaccines.

Russia’s Sputnik V and China’s CanSino Biologics also have COVID-19 vaccines based on an adenovirus platform.

1. The blood clotting problems seems rare but more common in women

Even though blood clotting problems have gotten a substantial amount of att…

What is needed to develop disease-modifying therapies for Parkinson’s and Alzheimer’s

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Developing disease-modifying therapies for neurodegenerative diseases remains a pressing need.

The incidence of neurodegenerative disease is ramping up in the U.S. and elsewhere as much of the global population ages. One out of three seniors dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association.

Parkinson’s disease is also becoming more widespread. Between 2015 and 2040, the number of people with Parkinson’s could nearly triple, rising from 6.3 to 17.5 million.

But developing drugs that can slow or stop the progression of such diseases poses a significant challenge for drug developers. Eli Lilly’s donanemab, for instance, showed promise earlier this year in treating Alzheimer’s in a Phase 2 study summarized in NEJM.

Another Alheimer’s candidate, aducanumab from Biogen, has also shown promise, although late l…

Feds halt Johnson & Johnson COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause of administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among those doses, there have been six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine. The CDC and FDA are reviewing data involving these cases.

In such cases, a form of blood clot known as cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia), according to the joint statment. All six cases were in women between ages 18 and 48, with symptoms occurring between six and 13 days after vaccination.

Treatment for CVST is different from that which may typically be administered, which is an anticoagulant drug called heparin. In these cases, heparin may be dangerous and alternative treatments are needed,…

Analyzing FDA guidance on DDI studies for therapeutic proteins

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The co-administration of drugs is commonplace for therapeutic proteins (TP). Yet, drug developers may face delays or ambiguity in preparing for clinical trials if they don’t plan for preliminary analysis of drug-drug interactions (DDI). Fortunately, the U.S. Food and Drug Administration (FDA) released in August 2020 new draft guidance for DDI assessment of TPs. The resulting shift in DDI experimental design and criteria will require teams to take a risk-based testing approach to accurately predict the effects of DDIs during future in-human trials.

DDI studies provide a preliminary analysis and risk potential for drug developers compiling Investigational New Drug (IND) applications and candidates of Biologics License Applications (BLA), though the new guidance is recommended but not required. By applying the insights provided by this guidance, developers can achieve a …

Pfizer asks FDA to authorize its COVID-19 vaccine for younger teens

Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.

FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.

The agency will likely extend its prior authorization to younger adolescents “if the data submitted support it,” according to Dr. Arnold Monto, acting chair of the Vaccines and Related Biological Products Advisory Committee meetings related to the Pfizer-BioNTech.

Pfizer plans to seek permission from other regulatory agencies to administer the vaccine to children 12 and over in the coming weeks.

The company currently has a Phase 3 trial underway involving 2,260 adolescents 12 to 15. The vaccine was 100% effective in that study, besting the results of a separate trial involving volunteers aged 16 to 25.

All 50 states plan to open up vaccine eligibility to those over 16 starting April 19.

Pfizer and BioNTech a…

EMA begins investigation of J&J COVID-19 vaccine’s blot clotting potential

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.

EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.

Four recipients of the Johnson & Johnson vaccine have had such blood clotting events. One of those individuals has died.

A Johnson & Johnson summary of the Ad26.COV2.S vaccine clinical trial cited a “numerical imbalance” for deep vein thrombosis (DVT) and pulmonary embolism (PE) between vaccine and placebo recipients. In the vaccine arm, there were five cases of DVT and four cases of PE. By contrast, there were two DVT reports and one of PE in the study’s placebo arm.

The company has stressed that it has found no causal relationship between the rare blood clotting events and its vaccine.

European regul…

The quest for a disease-modifying drug for Parkinson’s disease continues

Image courtesy of iStock

The need for therapies that change the course of Parkinson’s disease is considerable.

“There are zero disease-modifying treatments for Parkinson’s,” said Dr. Allan Levey, professor and chairman of Emory University’s department of neurology.

Parkinson’s disease affects some 10 million people worldwide, according to the Parkinson’s Foundation.

Current drugs for Parkinson’s make it possible to “reverse symptoms pretty well for many people for many years,” Levey said. “But the reality is their symptoms are sort of masked. The disease is still getting worse on a daily basis.”

Most Parkinson’s treatments focus on managing dopamine levels in the brain. The basis of that strategy traces back to formative research in the 1960s involving levodopa. Today, levodopa-based therapies continue to b…

When can computer models replace animal trials?

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The pandemic has forced a rethink of clinical research, but the pharma industry continues to rely on animal testing. While pundits have observed that computer modeling and techniques such as microdosing can reduce animal testing, animal testing continues to be integral in preclinical studies.

But computer models are now sufficiently accurate to predict the response of many drugs, said David Harel, CEO of CytoReason (Tel Aviv, Israel). “We are getting to the point that computer models of certain diseases can generate better predictions than animal models,” he said.

But there are caveats. It could take longer to move from animal-based safety testing, which often involve rodents. Such animal trials tend to be limited in size. “They’re not a big burden. And they’re not super expensive,” Harel said. And regulators frequently consider animal data when evaluating drug safety. But …

Icosavax wins $100M in funding for clinical trials for bivalent RSV/hMPV vaccine candidate

Virus-like particle (VLP) technology specialist Icosavax has closed $100 million in Series B financing, which it will use for clinical studies and continued development of a SARS-CoV-2 vaccine candidate.

One focus of the clinical research will be clinical trials for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine.

RSV is a common respiratory virus that generally causes mild illness but can cause serious complications in infants and the elderly. In a similar vein, hMPV generally causes symptoms consistent with other upper respiratory tract illnesses, but severe infections can require hospitalization. Both viruses are common causes of viral pneumonia. No vaccines are available for either virus.

“VLP vaccines have the potential to be extremely effective,” said Adam Simpson, CEO of Icosavax. “For example, naturally occurring VLPs have delivered effective licensed vaccines, including against human papi…

Google, Varian partner on AI to boost cancer radiation therapy

Varian (NYSE: VAR) announced today that it is working with Google Cloud to build an AI-based diagnostic platform.

The companies’ focus is on AI models for organ segmentation—a crucial, labor-intensive step in radiation oncology that can often turn into a clinical workflow bottleneck. Organ segmentation can take hours per patient. It involves identifying the organs and tissues in diagnostic images that must be targeted or protected during radiation therapy.

Varian is using Google Cloud AI Platform’s Neural Architecture Search (NAS) technology to create an AI segmentation engine that it’s training — using Varian’s proprietary treatment planning image data — to create customized auto-segmentation models for organs in the body. Varian plans to incorporate the new models into its treatment planning software tools in cancer centers worldwide.

“At Varian, we are working towards a world without fear of cancer, where high-quality can…

How can medtech companies use more patient input to improve clinical trials?

The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.

Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.

Get the full story at our sister site, Medical Design & Outsourcing.

How can medtech companies get more patient input in clinical trials?

The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.

In the report, MDIC cited that FDA guidance, which defined patient engagement as “intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” Effective engagement, according to the administration, could result in faster recruitment, enrollment and completion for studies, greater participant commitment and less follow-up loss, greater compliance, fewer protocol revisions, streamlined data collection and more relevant data on important patient outcomes.

Patient input, according to MDIC, …

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