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 …

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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. 

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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…
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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…

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J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

Get the full story at our sister site, Pharmaceutical Processing World.

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J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.

This comes as the latest blow to Emergent and J&J after news broke in April that a factory error…

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DePuy Synthes launches next-gen variable angle clavicle plate system

[Image from DePuy Synthes]Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it launched the 2.7 mm variable angle locking compression plate (VA LCP) clavicle plate system.

West Chester, Pa.-based DePuy Synthes designed the VA LCP clavicle plate system for the treatment of lateral, shaft and medial fractures for small, medium and large clavicles.

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

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DePuy Synthes launches next-gen variable angle clavicle plate system

[Image from DePuy Synthes)

Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it launched the 2.7 mm variable angle locking compression plate (VA LCP) clavicle plate system.

West Chester, Pa.-based DePuy Synthes designed the VA LCP clavicle plate system for the treatment of lateral, shaft and medial fractures for small, medium and large clavicles.

According to a news release, the new system offers plate shapes that reflect the correlation between patient stature and clavicle size to match the bow and contour of the clavicle while accommodating a wide range of anatomic variability of the clavicle with thinner plates, a more accurate plate-to-bone fit and reduced prominence.

DePuy Synthes looked at more than 600 clavicle CT scans from a broad-based patient population while analyzing 15 different parameters on the bone to identify the correlation between patient height and clavicle sh…

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AstraZeneca could enlist Catalent to produce COVID-19 vaccines

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md.

FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and has received emergency use authorization (EUA) in 168 other countries.

As a majority of U.S. citizens have already received at least one COVID-19 vaccine dose, officials at AstraZeneca are reportedly mulling the option of pursuing full approval of its vaccine instead of EUA, according to The Wall Street Journal.

The U.S. government required Emergent Biosolutions to halt production of the AstraZeneca vaccine after a production error forced Emergent to discard 15 million COVID-19 vaccine doses. Emergent intended to produce AstraZeneca’s and Johnson & Johnson’s adenovirus-vectored vaccines in the same f…

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J&J’s proposed opioid settlement framework eclipses its $2B talc penalty

The Supreme Court’s decision to deny reviewing a Johnson & Johnson talc lawsuit leaves the company on the hook for paying $2.5 billion, or $2.1 billion in damages plus interest.

But the talc litigation development also serves as a reminder that the company faces multiple litigation risks — some related to opioid litigation. The company has a proposed opioid settlement framework recommending a $5 billion payment to settle outstanding litigation. “If finalized, this would considerably reduce uncertainty related to J&J’s opioid exposures,” concluded a recent Moody’s report.

The company had initially agreed to a $4 billion settlement framework in negotiations with state attorneys general. Last October, the company agreed to pay an additional $1 billion as part of that framework.

The Supreme Court’s denial of a talc verdict appeal will leave Moody’s Aaa rating for J&J unchanged. “The company’s financial flexibility remains very strong, with gross …

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Almost one-quarter of Americans remain vaccine-hesitant

[Photo by Maksim Goncharenok from Pexels]

A study from Informa Pharma Intelligence and YouGov concluded that vaccine hesitancy remains a significant hurdle in the U.S. A separate study published in JAMA indicates vaccine hesitancy is falling. Specifically, the number of people who were suspicious about COVID-19 vaccines fell from 46% in October 2020 to 35% in March 2021.

Conversely, the Informa-YouGov survey from April 21 and 22 concluded that 23% of Americans were vaccine-hesitant. The study had 1,327 adult participants.

While approximately half of the U.S. public has received at least one vaccine dose, vaccinating the remainder of the eligible population could be a hurdle.

But the recent data from the Informa-YouGov survey indicate that achieving President Biden’s goal of providing at least one vaccine dose to 70% of the American adults by July 4 is at least feasible.

Another factor tha…

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U.K. authorizes J&J COVID-19 vaccine

The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business.

The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a news release.

Get the full story at our sister site, Pharmaceutical Processing World.

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