Eric Sagonowsky| FiercePharma

Johnson & Johnson's COVID-19 vaccine rollout has been slower than expected in the U.S., with just 6.8 million doses delivered to states in the first month. Now, The New York Times has revealed behind-the-scenes details into an unfortunate mix-up in the production process.

Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing around 15 million doses, the Times reports. The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site, according to the newspaper. In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April.

Federal investigators have ruled that the episode was the result of "human error," NYT reports.

Moving forward, J&J is moving to implement tighter controls at its manufacturing partner, the company's statement said. J&J and AstraZeneca, another leading COVID-19 vaccine player, tapped the contract manufacturer in their production ramp-up efforts last year.

J&J has met its goal to ship 20 million doses to the U.S. government by the end of March, the company said in its statement. CDC data show that just 6.8 million doses have been delivered to states, and 3.3 million doses have been administered.

The company said its manufacturing ramp-up "includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards." That process identified a batch that didn't meet standards at the Emergent site, which J&J noted has not yet been authorized.

Emergent spotted the issue and notified the FDA, J&J said.

Moving forward, as the company and Emergent seek an FDA manufacturing authorization for the site, J&J is "providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine."

Working with officials at HHS, the company plans to ship 24 million doses of the vaccine in April, the statement said. J&J has leaned on its vaccine plant in the Netherlands to help with production while its U.S. supply chain comes online. For the first half of the year, J&J is aiming to deliver 100 million doses to the U.S.

ΦΑΡΜΑΚΕΥΤΙΚΟ ΜΑΡΚΕΤΙΝΓΚ: Με πιστοποιητικό επιμόρφωσης του Πανεπιστημίου Αθηνών

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Με πιστοποιητικό επιμόρφωσης του Πανεπιστημίου Αθηνών

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Amgen cuts 500 U.S. jobs, primarily sales reps, as COVID-19 speeds a shift to digital

 

Amgen is cutting 500 jobs, and its U.S. sales teams are bearing the brunt of it. The California-based drugmaker confirmed Wednesday that it is shrinking its workforce, "primarily in the U.S. sales force," as it pivots to upcoming drug launches and adopts pandemic-time digital marketing tools for the long run. A spokesperson confirmed the total number of jobs is approximately 500.

"We made these changes to better enable Amgen to make additional investments we believe are needed to take advantage of patient-focused opportunities, including launching new products, and investing in R&D," the company said in an emailed statement. "These decisions are never easy, and we are committed to helping those impacted with transitional support."

The 22 most influential people in the fight against COVID-19

 

Πηγή: FiercePharma

Over the last seven to eight months, lives across the globe have changed in unforeseen ways. More than a million lives have been lost, and tens of millions of people have contracted COVID-19. The coronavirus upended daily life, slammed the economy, and sent businesses scrambling to cope.

For the pharma world, it's been a crisis with a purpose. Scientists, regulators, biotech companies and drugmakers large and small have taken center stage as they hunt for drugs, vaccines, diagnostic tests and other aids in halting the pandemic.

We've chosen 22 of them to feature here, some working behind the scenes, others very much in the spotlight. We focused on people whose names aren’t necessarily in the news regularly, highlighting experts attacking COVID from all angles.   

Some are part of the record-shattering vaccine development process. Others are testing drugs new and old against the newly emerged virus. Still others have focused on improving diagnostics, manufacturing needed supplies or improving public health.

They've been working around the clock—literally, some of them—to bring the pandemic to an end. There’s plenty more work to do, but their progress is already tangible. We hope you enjoy reading their stories. — Eric Sagonowsky

The 22 most influential people in the fight against COVID-19

• • Stéphane Bancel
  • Diana Brainard
  • Thomas Breuer and John Shiver
  • Larry Corey and Kathleen Neuzil
  • Daria Donati
  • Scott Gottlieb
  • Peter Horby
  • Leah Lipsich
  • Fred Lowery
  • Peter Marks
  • Julie Sawyer Montgomery
  • Deepak Nath
  • David Persing
  • Jeremy Rassen
  • Uğur Şahin
  • Hanneke Schuitemaker
  • Pamela Siwik
  • Daniel Skovronsky
  • Moncef Slaoui
  • Tonya Villafana
  
  

Ten biggest pharmaceutical companies in the world in 2020

In a world dominated by a pandemic, you might wonder how its affecting the 10 biggest pharmaceutical companies in the world in 2020. The pharmaceutical industry is a trillion dollar industry globally, achieving the milestone for the first time in 2014, and the biggest companies are getting a huge piece of the pie.

The pharma industry can vary significantly from country to country, based on the laws regulating it. After all, there is a huge question of balancing the importance of saving lives of people with profits and the money needed for research and development to develop such drugs. This is why many countries across the world regulate the maximum price at which a drug can be sold, to allow the companies high margins and profits, while enabling more people to be able to purchase the drug as well.

Unsurprisingly, the United States is not one of those countries. In the US, there are no regulations on raising prices, which is why you have people like Martin Shkreli, who jacked the price of an important drug by 700% and cause an outrage, even though the outrage was purely on a moral level, as legally, his opponents did not have a leg to stand on. He is the poster boy of Big Pharma, a term coined for the biggest pharmaceutical companies in the US who are said to do anything, even if its immoral or illegal, to fill their coffers rather than actually focus on saving lives. They haven't paid over $2 billion in taxes in the US, and are able to fill the image of the typical capitalist US company.

Φαρμακεία: Μειώθηκαν οι πωλήσεις την εβδομάδα 18-24 Μαΐου

Νέα μείωση καταγράφουν οι πωλήσεις φαρμάκων, προϊόντων OTC, καλλυντικών και προϊόντων διατροφής που πωλούνται στα φαρμακεία σύμφωνα με τα IQVIA Weekly Data.  Η μείωση αφορά την εβδομάδα 18/05 - 24/05 που αποτυπώνει την επίπτωση των τελευταίων γεγονότων στην αγοραστική συμπεριφορά των ασθενών και καταναλωτών, από τα φαρμακεία λιανικής. Ειδικότερα, οι κύριες προϊοντικές κατηγορίες που διακινούνται μέσω ιδιωτικών φαρμακείων κινήθηκαν σε πωλήσεις τεμαχίων, σε σχέση με την αμέσως προηγούμενη εβδομάδα (11/05 – 17/05), ως εξής:

Φάρμακα: -12,1% (-1 εκατομ. τμχ.)	Προϊόντα διατροφής: -8,8% (-6,4 χιλ. τμχ.)
Προϊόντα OTC: -6,7% (-111 χιλ. τμχ.)	Προϊόντα φροντίδας ασθενών: +14,6% (+58 χιλ. τμχ.)
Καλλυντικά: -8,4% (-78 χιλ. τμχ.)

Ενδεικτικά, κάποιες από τις υποκατηγορίες με τη μεγαλύτερη μεταβολή σε σχέση με το 2019 ειναι:

Φάρμακα Η κατηγορία των Αναπνευστικών (R0) η οποία μειώνεται κατά -30,8% (-192 χιλ. τμχ.)	Προϊόντα διατροφής Η κατηγορία Ειδικής Διατροφής Ενηλίκων (36) μειώνεται κατά -13,3% (-7,8 χιλ. τμχ.)
Προϊόντα OTC Τα Παυσίπονα/ Αντιπυρετικά (02) μειώνονται κατά -27,5% (-196 χιλ. τμχ.)	Προϊόντα Φροντίδας ασθενών Τα Ιατρικά/Χειρουργικά Βοηθήματα (57) αυξάνονται κατά +139,0% (+84 χιλ. τμχ.).
Καλλυντικά Τα προϊόντα Ομορφιάς (83) αυξάνονται κατά +38,3% (+75 χιλ. τμχ.)

Σημειώνεται ότι τα IQVIA Weekly Data συλλέγονται από 2000+ φαρμακεία, σε όλη την Ελλάδα, και αποτυπώνουν την αγορά σε 70 περιοχές.

Hey, pharma reps: Most docs still want contact amid COVID-19 pandemic

As the COVID-19 pandemic continues, the relationship between pharma sales reps and physicians is starting to settle into a new normal. Digital interactions are on the rise, and doctors are increasingly welcoming contact with reps, according to ongoing polling from healthcare consultancy ZoomRx.

The group began asking doctors weekly about the impact of COVID-19 on their practices beginning March 14, fielding its most recent survey of similar questions a period ending May 5.

In the latest survey—its fifth—78% of physicians said they want to maintain some contact with pharma reps, up from just 64% when ZoomRx originally began polling doctors. While most physicians (43%) prefer a similar level of contact as before the pandemic began, 14% would actually like more outreach from pharma.

The top 20 pharma companies by 2019 revenue

The top players in pharma know how to adapt. After M&A, selloffs, cost cuts and therapeutic rejigs, the companies on this list may largely wear the same names, but none entered it looking exactly as they did for last year's edition.

Whether because of buyouts or reorgs or both, companies atop the rankings this year generally have a strong presence in cancer, but immunology and rare diseases are also strongholds. Takeda gained its place on the list thanks to a Shire buyout that added rare diseases to its broader lineup.

Vaccines are important, too: Companies with leading vaccine outfits all made the top 10. Cell and gene therapies continue making advances across the industry, including at Novartis and Roche.