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…

Read more
  • 0

MedTech 100 roundup: Industry continues climb

One week after hitting an all-time best mark, the medtech industry has done it again, reaching new heights on Wall Street.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — continued its rise, finishing the week (July 9) at 114.79 points, a rise of 0.2% from the 114.59-point mark registered a week prior on July 2.

The new high comes in was just 0.21 points ahead of the 114.58-point mark set in April — the industry’s all-time best performance before last week beat it by one point.

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 24.3% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.6% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The positive movement in medtech aligns with an uptick in the overall markets this past week, as the S&P 500 Index ri…

Read more
  • 0

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. 

Read more
  • 0

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.

Each Satellite Center will focus on entrenched and emerging health threats that are pressing and have a high unmet need. Think tuberculosis (TB), dengue fever, flavivirus, coronavirus and antimicrobial resistance (AMR).

“COVID-19 has shown us that investments in early-stage research, such as novel vaccine technologies, are critical to accelerate our fight against pandemic threats. The J&J Centers for Global Health Discovery are the latest chapter in our efforts to turn science into solutions for diseases that continue to threaten communities …

Read more
  • 0

Emergent BioSolutions facing a shareholder lawsuits

The Baltimore-based company Emergent BioSolutions (NYSE:EBS) is the subject of at least four lawsuits asking for refunds and pushing for change in the company’s executive ranks. Some of the lawsuits targeting Emergent accuse the company of securities fraud and insider trading.

Emergent has denied the allegations. “Our executives strictly follow the law and our own internal policies to prevent any improper securities trading,” Emergent spokesperson Matt Hartwig told The New York Times.

In any event, the past year has not been kind to Emergent BioSolutions, the multinational biopharma company focused on vaccines and antibody therapeutics.

After initially scoring the support of Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN) to manufacture their respective COVID-19 vaccines, the company saw its stock leap to a peak value of $133.42 on Aug. 14, 2020.

In afternoon trading today, its stock’s value was $61.87.

The drop in valuation resu…

Read more
  • 0

J&J COVID-19 vaccine protects against Delta variant

Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months.

The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in the company’s Phase 3 ENSEMBLE study, which it used to win emergency use authorization in the U.S. That study concluded that a single dose of the vaccine led to a higher neutralizing antibody activity against the Delta variant than the Beta variant (B.1.351) that first emerged in South Africa.

Rival Moderna is developing a vaccine known as mRNA-1273.351 based on the Beta variant.

J&J also announced that its vaccine elicited a robust immune response to other common SARS-CoV-2 variants.

The company also said that its vaccine led to a strong neutralizing antibody response that…

Read more
  • 0

Why Janssen believes next-gen drug Tremfya can meet unmet needs in psoriasis and beyond

Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects.

But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught us that psoriasis was an immunologic disease,” said Dr. Lloyd Miller, vice president, immunodermatology at Janssen Research & Development (NYSE:JNJ).

After researchers determined that psoriasis, which affects some 125 million patients worldwide, results from excess inflammatory cytokines, drug developers began to test the potential of inhibitors of tumor necrosis factor (TNF) and interleukin 17 (IL-17) in treating the disease.

FDA approved TNF blockers such as Janssen’s Remicade (infliximab) for psoriasis and psoriatic arthritis in the mid-2000s. IL-17A antagonists …

Read more
  • 0

Ethicon launches curved jaw tissue sealer

[Image from Ethicon]Ethicon — part of Johnson & Johnson (NYSE:JNJ) — announced today that it launched the Enseal X1 curved jaw tissue sealer.

Cincinnati-based Ethicon developed the Enseal as a new advanced bipolar energy device designed to increase procedural efficiency and provide stronger sealing and better access to more tissue than Medtronic’s LigaSure Maryland, according to a news release.

Indications for the device include colorectal, gynecological, bariatric surgery and thoracic procedures. It includes separate seal and cut capabilities, a 360-degree continuous shaft rotation that enables easy access to targeted tissue. Ethicon’s adaptive tissue technology allows the device to continuously sense changes in the condition of tissue and respond accordingly with the optimal amount of energy to minimize lateral thermal spread.

Enseal X1 curved jaw marks the first of a series of new advanced laparoscopic bipolar devices set to launch from E…

Read more
  • 0

Assessing pharma headwinds and tailwinds in mid-2021

Pfizer-BioNTech COVID-19 vaccine. Image courtesy of Wikimedia Commons.

Now that we have passed the year’s midway mark, pharma continues to be in a unique position.

While COVID-19 gave the industry an opportunity for a reputational reset in 2020, the pandemic is now a net positive for the industry, according to the recent Moody’s report, “Solid demand, lift from COVID-19 products continue to drive positive outlook.”

While demand for COVID-19 vaccines has ebbed recently in the U.S., Moody’s projects strong vaccine sales overall for the remainder of 2021. Pfizer (NYSE:PFE) upped their guidance for vaccine sales to $26 billion in their first-quarter earnings report. “Their approach to guidance for revenue is based on contracts that have been signed,” said Michael Levesque, lead author of the report. Thus, any future contracts that Pfizer signs after that guidance update will further expand their guidance …

Read more
  • 0

What medtech’s top executives learned from their dads

[Image from Pixabay]For better or worse, parents including dads play a major role in who we become. As we approach Father’s Day in the U.S., MassDevice and MDO reached out to some of medtech’s top executives to ask what they learned from their dads.

Go to our sister site Medical Design & Outsourcing to read what they said. 

Read more
  • 0

What medtech’s top executives learned from their dads

[Image from Pixabay]

For better or worse, parents including dads play a major role in who we become. As we approach Father’s Day in the U.S., Medical Design & Outsourcing and MassDevice reached out to some of medtech’s top executives to ask what they learned from their dads.

Here’s what they said:

“My father built a business in the defense technology sector with some long-term colleagues as co-founders. Around the dinner table and over coffee for years, we’ve discussed the need for leadership excellence, technology excellence and empathy in bringing science-based business to the market. What a wonderful stroke of luck to have him in my life.”  – Gary S. Guthart, CEO of Intuitive

Medtronic CEO Geoff Martha’s father, during his young days. [Image courtesy of Medtronic]

“My Dad has always been a strong s…
Read more
  • 0

Top J&J exec moves to Moderna

Moderna (NSDQ:MRNA) announced today that former Johnson & Johnson executive Dr. Paul Burton will join as chief medical officer.

Cambridge, Mass.-based Moderna said in a news release that Burton assumes the role of CMO effective July 6, 2021, and he will serve on the company’s executive committee and report to CEO Stéphane Bancel.

“Paul’s extensive medical experience in the global pharmaceutical and biotech industry will be important to Moderna as we expand internationally and continue our journey as a commercial company,” Bancel said in the release. “As we work to deliver on the promise of mRNA science to create a new generation of transformative medicines for patients, Paul’s expertise across multiple therapeutic areas and his proven track record leveraging data science and digital technologies to reimagine medical engagement will be invaluable. I look forward to working with Paul and re-inventing how medical affairs should be built and run i…

Read more
  • 0