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How to make COVID-19 clinical trial statistics meaningful to the public

[Photo by Fusion Medical Animation on Unsplash]

COVID-19 has brought a newly heightened awareness of the need to better understand clinical trial statistics and their direct impact on the public. I cannot remember when statistical data was more in the limelight than now. The pandemic’s first wave put many countries into lockdown. All governments and their local representatives delivered press conferences regularly to update the masses on the newest statistics and safety precautions. There were statistics on how many people caught the disease, how many deaths, how many ICU beds were still available, and just about every interesting statistic you could think of related to the pandemic. 

Data collected from the COVID-19 pandemic continues to be used to inform decisions and make future projections related to drug development and beyond. Individuals are also using pandemic statistics to decide how to live th…

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New COVID-19 variants could diminish vaccine efficacy


COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.  

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call. 

The Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) vaccines promise 95% efficacy at reducing symptomatic disease when it comes to the SARS-CoV-2 strains that were dominant in 2020. But it’s plausible the efficacy number could drop to 85% or beyond. “I am definitely not saying that the vaccines would be non-functional anymore or would drop to less than 50% efficacy,” Crotty said.

While Pfizer recently released data suggesting their vaccine w…

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Pharma researcher charged with theft of trade secrets  

Image from Bill Oxford via Unsplash

A former director of medical and scientific affairs at Merck (NYSE:MRK) faces criminal charges in federal court in New Jersey for allegedly stealing and transmitting trade secrets.

Shafat A. Quadri has been released on $100,000 unsecured bond. He was most recently employed at AstraZeneca (NSDQ:AZN).

The single count of trade secret theft carries a maximum potential penalty of up to 10 years in prison and a fine as high as $250,000, or double the total financial gain or loss, according to Rachael A. Honig, acting U.S. attorney for the District of New Jersey.

The complaint describes Quadri’s former employer as “Company 1,” stating that the organization reached out to the FBI in Oct. 2019 to report suspicious activity regarding its sensitive intellectual property. Quadri had been employed at that company until Sept. 30, 2019.

The suit alleges that Quadri …

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Norway investigating deaths of 23 individuals who received COVID-19 vaccine

Image from Mark König on Unsplash

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

To date, it has analyzed data from 13 of those individuals.

The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.

The agency said in a statement that it had expected deaths close to the time of vaccination, given its plan to vaccinate elderly patients, many of whom have “serious underlying diseases.” Some 400 people in Norway die each week in nursing homes and long-term care facilities.

While it is clear that elderly individuals have a higher risk of mortality from all causes, it will take time to determine what role a vaccine might play, said Updesh Dosanjh, practice le…

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Here’s what molecular shape can tell you about pharma innovation

Photo by Anna Shvets from Pexels

Is it possible that pharmaceutical innovation has accelerated over the past two decades — with the novelty of small molecule and peptide drugs steadily increasing?

That’s the conclusion suggested by a recent study published in ACS Medicinal Chemistry Letters, which found roughly 65% of FDA-approved drugs in 2020 were structurally novel. Last year’s drug approvals even included at least one new molecular entity based on a novel molecular shape. 

The finding flies in the face of the talk of an innovation crisis in the pharmaceutical industry. Before COVID-19 struck, pharma industry observers tended to chide the industry’s recent innovation track record. R&D costs per drug have increased significantly, while drug blockbusters have grown more scarce. Despite the pharma’s historically high-profit margins, the sector generally trailed the S&P 500 in the …

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3 notable types of innovative drugs from 2020

Chemical structure of the COVID-19 therapy remdesivir. Image is from Wikipedia.

Last year, FDA approved 53 drugs, leading the industry to describe 2020 as “a strong year for new drug therapy.”

There are several drugs that stand out, according to Todd Wills, the co-author of a study that analyzes how innovative drugs are based on their structure.

The drugs that follow are examples of notable innovative therapies.

[Related: Here’s what molecular shape can tell you about pharma innovation]

1. COVID-19 therapies

One of the prominent drugs that stands out as structurally novel is remdesivir from Gilead Sciences (NSDQ:GILD). The first COVID-19 treatment to win FDA approval, remdesivir (Veklury), was first developed as an Ebola treatment. But the broad-spectrum antiviral also showed promise against the SARS-CoV-2 virus.

Gilead recently announced that sales of remdesivir beat …

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Catalent to acquire Acorda’s manufacturing and packaging operations

Catalent (NYSE:CTLT) has entered into a definitive agreement to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility from Acorda Therapeutics (NSDQ:ACOR).

The acquisition will enable Catalent to establish a center of excellence for spray-dried dispersion for DPI capsule manufacturing. The transaction will also expand Catalent’s existing U.S.-based commercial-scale capabilities in metered-dose inhalers and nasal inhalation technologies. 

To get the whole story, check out our sister site Pharmaceutical Processing World. 

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What’s behind the severe allergic reactions from COVID-19 vaccines?

(Image by Sam Moqadam on Unsplash)

Reports of severe allergic reactions to COVID-19 vaccines have made consistent headlines in recent weeks. Still, such anaphylactic reactions are rare, occurring in approximately 11 out of every million doses for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), according to CDC.

While that is roughly 10 times the flu vaccine rate, COVID-19 vaccines so far have been generally well-tolerated in the vast majority of patients.

“The anaphylaxis rate for COVID-19 vaccines may seem high compared to flu vaccines, but I want to reassure you that this is still a rare outcome,” said Dr. Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases in a recent call with reporters.

More recent CDC data suggests a lower rate of anaphylactic reactions of 5.5 per 1 million injected vaccine doses.

Anaphylaxis, a severe …

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Phastar wins investment from Charterhouse Capital Partners

The contract research organization Phastar (London) plans to expand its statistics and data science services with funding from Charterhouse Capital Partners, a European private equity firm. Phastar will also use the funds to expand its international footprint, opening an office in China.

“We continue to see strong growth across pharma and biotech services,” said Kevin Kane, CEO of Phastar over email. “Pharma companies are looking to specialist suppliers with experienced staff to provide functional service provision (FSP) services as the larger full-service CROs fail to deliver on quality, and biotechs continue to need strong statistical and data science support for their drug development projects, recognizing that experts in these areas can design better trial programs with fewer patients.

The company already had operations in the U.S., U.K, continental Europe, Africa, Japan and Australia. Last year, the firm opened offices in San Diego and To…

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Facial swelling and COVID-19 vaccines: 4 facts

Image from Nataliya Vaitkevich via Pexels

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines.

To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna (NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

We reached out to Dr. Whitney Bowe, a board-certified dermatologist and expert injector, to shed light on the topic.

1. Facial fillers ≠ Botox

Delayed inflammation is possible for patients who receive either hyaluronic acid or non-hyaluronic acid fillers. The former option, comprising brands such as Juvéderm from AbbVie subsidiary Allergan (NYSE:ABBV) and Restylane from Galderma Laboratories, is the most common.

Facial fillers, however, are distinct from Boto…

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Pfizer-BioNTech COVID-19 vaccine apparently effective against ‘UK strain’ 

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) seems to offer protection against the new, more transmissible variant of the novel coronavirus identified in the U.K., according to a study from Pfizer and the University of Texas Medical Branch. 

The study has not been currently peer-reviewed. 

In additional testing, the Pfizer-BioNTech vaccine appeared to be effective against 15 other strains of SARS-CoV2. 

The so-called “UK variant” of COVID-19, also known as the B.1.1.7 strain, has spooked the world in recent weeks, given its potential to exacerbate the pandemic. While the U.K. and South African strains may be transmitted more readily than others, researchers have not linked them to increased severity of COVID-19 infections. 

Some commentators had suspected that the mutations would be unlikely to have a significant impact on COVID-19 vaccine performance. 

For one thing, the mutations have not led to substantia…

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Medtronic’s Kowal explains how remote medtech got its groove back

In this week’s DeviceTalks Weekly Podcast, Dr. Robert Kowal CMO of Medtronic’s cardiac rhythm and heart failure business and vice president of medical affairs, explains how new tech, savvy patients, eager physicians and, yes, COVID-19, has fueled a renaissance for remote technology, once seen as a mature, staid business.

Kowal, who left clinical practice to join Medtronic in 2017, identifies the building blocks that have allowed companies like Medtronic to provide devices that provided essential connectivity during the ongoing pandemic.

“Five or 10 years ago we were all saying cardiac implantable devices were a mature market, not much happening,” Kowal says. “Now, between the technology, these new devices and digital interconnectivity I don’t see it as mature any more. It’s a spry, young area once again. It’s. a lot of fun to be working in it right now.”

Kowal shares stories on how connectivity migh…

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FDA warns about COVID-19 molecular test false negatives as virus mutates

The FDA is warning that false negatives may occur with molecular tests used to detect SARS-CoV-2 if a mutation has occurred in the virus’s genome.

According to the FDA, the warning comes as public health officials warn about the new B.1.1.7 variant that appears to be more transmissible than the COVID-19 virus from 2020.

Three molecular tests that have received emergency use authorization have been analyzed by the FDA whose performance could be impacted by the new SARS-CoV-2 genetic variant:

Mesa Biotech’s Accula SARS-CoV-2 test performance may be impacted when a SARS-CoV-2 virus patient sample has a genetic variant at position 28881 when tested. The FDA said the impact does not appear to be significant. Thermo Fisher Scientific’s TaqPath COVID-19 Combo Kit (also labeled as the TaqPath COVID-19 Combo Kit advanced) has significantly reduced sensitivity due to certain mutations in the SARS-CoV-2 virus, including one of the mutations int he r…
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HHS seals plan to sunset regulations 10 years or older

(Image by Michael Longmire on Unsplash)

The U.S. Department of Health and Human Services (HHS) today issued a final rule giving it five years to review and potentially sunset regulations that have been in place for at least 10 years.

With some exceptions, the agency will look into whether regulations cause financial harm to a substantial number of small entities. It will also do a more detailed review to determine whether the regulation is still needed, is too complex, has drawn complaints, duplicates or conflicts with other rules, and whether technological, economic and legal changes have passed it by.

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

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CES 2021: Medical technologies you need to know

There are fewer mobile health devices and wearables to check out as this year’s CES goes virtual — with a trend toward medtech to slow the spread of COVID-19.

Scheduled for Jan. 11–14, CES 2021 will feature 419 digital health and 219 wearable devices, down from 546 and 635 devices, respectively, presented at CES 2020.

CES 2021 will include portable air purifiers, hands-free body temperature thermometers, EEG brain mapping devices and more.

Here are seven companies exhibiting digital health and wearable products at this year’s show.

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As organs-on-chips advance, their potential for drug discovery grows

Cortical neuron staining in the Emulate Brain-Chip. Image courtesy of Emulate Inc.

Engineered microchips with living human cells have the potential to accelerate drug development and replace animal testing, said Dr. Donald Ingber, the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University.

The organ-on-a-chip technology could also enable the industry to rethink its business model, Ingber said in a webinar from the Boston-based startup Emulate. While critics routinely criticize the pharmaceutical industry for price gouging, the blockbuster business model’s demise has threatened many firms’ profitability in the sector. R&D costs are another pressure. “It costs over $3 billion to go from the bench to the clinic at this point,” said Dr. Donald Ingber, the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University.


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FDA authorizes fingerstick COVID-19 antibody test

Nirmidas Biotech announced this week that it received FDA emergency use authorization (EUA) for its COVID-19 test in point-of-care settings.

Palo Alto, Calif-based Nirmidas Biotech’s MidaSpot rapid COVID-19 antibody combo detection kit uses fingerstick serology testing to detect IgG/IgM antibodies related to the SARS-CoV-2 virus causing COVID-19, according to a news release.

MidaSpot, touted by Nirmidas as the first point-of-care fingerstick COVID-19 test to receive EUA, can now be administered widely in CLIA-waived settings (such as doctor’s offices, urgent care facilities, ERs, pharmacies and more) with results yielded in 15-20 minutes.

In point-of-care testing, the test detects and differentiates antibody IgG and IgM post-COVID-19 infection. MidaSpot demonstrated 100% sensitivity for IgG after 14 days post-symptom onset and 100% sensitivity for IgM after seven days post-symptom onset in clinical studies.

Nirmidas previously deployed…

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Hologic says revenue nearly doubled in Q1

Hologic (NSDQ:HOLX) announced today that its revenues nearly doubled year-over-year in the first quarter of fiscal 2021.

Marlborough, Mass.-based Hologic expects to report revenues of more than approximately $1.6 billion, an increase of 89.3% from the first quarter of 2020. That tops the company’s November guidance of between $1.35 billion and $1.425 billion for the quarter ended Dec. 26, 2020, according to a news release.

“Hologic’s strong momentum continued in the first quarter of fiscal 2021 as organic revenue more than doubled, well ahead of our prior expectations,” Hologic chairman, president & CEO Steve MacMillan said in the release. “Thanks to the incredible efforts of our diagnostics team, we provided almost 30 million COVID-19 tests to global customers in the quarter. Importantly as well, our breast Health and surgical businesses showed remarkable strength, with each franchise posting growth in all major geographies – the United States, Europ…

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Tela Bio names clinical development VP

Soft-tissue reconstruction company Tela Bio (NSDQ:TELA) announced the appointment of Dr. Bruce Freedman as VP of clinical development.

Freedman has practiced 32 years as a general surgeon specializing in hernia repair and abdominal wall reconstruction. He joined Tela Bio after having used its OviTex material in his practice.

The Malvern, Penn.-based company’s tech platform is based on polymer interwoven through layers of biologic tissue in a patented pattern that it claims creates a unique, embroidered construction. The biological material is derived from ovine rumen, the company said, and is intended to reduce foreign body response, minimize inflammation and enable functional tissue remodeling.

“As a surgeon who has performed thousands of hernia repairs with plastic mesh over the past three decades, I fully understand the clinical limitations of using synthetic mesh to repair human tissue,” Freedman said in a news release. “Unfortunately, plastic mesh h…

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Ablacon raises $30m in Series B fundraising round

Ajax Health-backed Ablacon announced that it closed a Series B financing round worth $30 million with a new lead investor.

Zeus Health joined as the new lead investor in the financing, while the company announced that Beaumont Health (Royal Oak, Mich.) Heart Rhythm Center director Dr. David Haines was appointed to Ablacon’s scientific advisory board, according to a news release.

Menlo Park, Calif.-based Ablacon plans to put the new funds toward its product portfolio in an effort to expand patient access to its CE Marked Ablamap system. Part of Haines’ new role on the SAB will be to help map out a clinical research strategy to demonstrate the promise of using the system in treating Afib.

“I’m thrilled to have Zeus Health join Ablacon as we work to bring this game-changing technology to market,” Ablacon CEO Duke Rohlen said in the release. “I welcome Dr. Haines to the team – he is a true innovator in the field of electro…

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Locate Bio lands FDA breakthrough nod for bone infection device

Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis.

Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma related amputations. Currently, the standard treatment for chronic osteomyelitis is surgical debridement, long-term, high-dose administration of antibiotics, and — for larger defects — bone grafting, which often requires a second surgical procedure to remove the non-resorbable bone graft.

Get the full story on our sister site, Drug Delivery Business News.




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