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Bayer announces €3 million disaster relief fund for Ukraine

Image courtesy of Bayer

Bayer (ETR:BAYN) will offer additional support to international and local humanitarian aid organizations serving Ukraine and neighboring countries.

Immediately after Russia’s invasion of Ukraine, Bayer had pledged to spend €300,000 in aid. Now, it has committed €3 million in additional humanitarian aid.

Roche, Sanofi and Novo Nordisk have announced similar initiatives for Ukraine.

Bayer has successfully shipped antibiotics and sterile medical items to the war-ravaged country.

In addition, Bayer employees have donated more than €600,000 in additional funding for Ukraine. The company has vowed to match employees’ donations.

Soon after the invasion, Bayer CEO vowed to do “everything in our power to support our colleagues and their families in Ukraine.”

Bayer also has given cash to support its employees based in Ukraine.

The trade organization PhR…

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

Bayer abandons plans to produce first-generation CureVac vaccine

Bayer (ETR:BAYN) had planned to retool a facility in Wuppertal, Germany, to produce CureVac’s (NSDQ:CVAC) COVID-19 vaccine. But Leverkusen, Germany–headquartered Bayer has put those plans on ice, according to the German paper Leverkusener Anzeiger.

Bayer had planned on producing 160 million doses of the vaccine annually.

In June, CureVac reported that its COVID-19 vaccine was 48% efficacious in an international Phase 2b/3 study focused on various age groups. Despite having lower efficacy than the mRNA vaccines from rivals Moderna and Pfizer/BioNTech, CureVac had assumed in July that it would receive marketing authorization to distribute the vaccine in Europe.

The company announced it would withdraw its first-generation vaccine candidate, CVnCoV, from regulatory review at the European Medicines Agency. CureVac also canceled an existing advanced purchase agreement with the European Commission related to the CVnCoV vaccine.

Earlier this week, CureVac…

34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021.

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma

Adhansia XR (methylp…

Gene therapy specialist Viralgen opens new facility in Spain’s Basque Country

San Sebastián, Spain–headquartered Viralgen, has opened a new factory in Basque Country in northern Spain.

The company focuses on manufacturing adeno-associated virus (AAV) vectors, which are used in gene therapy and some vaccines.

Since 2018, Viralgen has offered AAV manufacturing for customers working in preclinical through Phase 2 development programs. The company has licensed its Pro10 AAV platform from AskBio.

The first phase of investment in the facility represents a €70 million investment (approximately $83 million). The company plans on spending a total of €120 million (roughly $142 million) after the construction of two additional buildings is completed.

A total of 250 people will work in the facility in 2022. Of that total, some 130 will be new hires.

The inauguration of Viralgen’s new facility occurred on June 30, 2021.

Formed in 2017, Viralgen was a joint venture…

Bayer moves forward with cell and gene therapies for Parkinson’s disease

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies.

Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability study.

Additionally, Bayer said its wholly-owned, clinical-stage adeno-associated virus (AAV) gene therapy company, Asklepios BioPharmaceutical (AskBio), is currently recruiting and evaluating patients in an ongoing Phase 1b clinical study to assess the safety and preliminary efficacy of a parallel gene therapy program for Parkinson’s disease.

BlueRock will enroll 10 patients across the U.S. and Canada. Those enrolled will undergo surgical transplantation of the dopamine-producing cells into the putamen deep brain structure, with a…

50 of 2020’s best-selling pharmaceuticals

Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year.

AbbVie’s injectable biologic Humira brought in nearly $20 billion in sales in 2020, with $16 billion in the U.S. alone. A year earlier, sales of the drug were $19.17 billion.

Get the full story from our sister site, Drug Discovery & Development.

MedTech 100 roundup: Stocks were practically unchanged last week

Despite plenty of ups and downs coming in the stock market for the medtech industry, there was hardly any movement from week to week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.6 points at the end of last week (Aug. 21). Overall, medtech stocks saw a -0.2% decrease from the 89.77-point total at the same time a week prior (Aug. 14).

Once again, the index nearly reached a high point during the COVID-19 pandemic, as on Aug. 18, it hit 90.4 points for the second time in as many weeks, a total that nearly poked past the previous mid-pandemic high (90.45), which came on Aug. 5.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -2.9% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 0.72% increase from Aug. 14 to Aug. 21, having reached record highs on Aug. 18. Meanwhil…

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

DeviceTalks Weekly, powered by MassDevice

In this week’s episode of the DeviceTalks Weekly podcast, co-hosts Tom Salemi, editorial director of DeviceTalks, and Chris Newmarker, executive editor of life sciences, review this week’s Top 5 medtech stories, aka “Newmarker’s Newsmakers,” with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer.

We also hear from two executives from Fractyl Laboratories — CEO Dr. Harith Rajagopalan and CFO Lisa Davidson — about its recent $55 million Series E round of financing and the strides they’re making in developing a device to treat diabetes.

In a second interview, bioelectronic device company Cala Health CEO Renee Ryan gives us an update on the Cala Trio’s clinical success in treating essential tremors and how the start-up is working through COVID-19.

Finally, Chris and Tom hint at an upcoming event for the DTW communit…

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer.

We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is making great strides in developing a device to treat diabetes.

Cala Health CEO Renee Ryan returns to the podcast to give us an update on the Cala Trio’s clinical success in reducing essential tremors and how the start-up is working through COVID-19.

Finally, Chris and Tom hint at an upcoming event for the DTW community.

Subscribe today on Apple Podcasts, Spotify, and other players.

DeviceTalks by MassDevice · Can Fractyl Labs and Cala Health go where only drugs have gone before?

The top 5 MassDevice stories of the week — August 21, 2020

COVID-19 continues to dominate medical device industry news on MassDevice.

The pandemic is causing more major lawsuit settling — as well as efforts to offer more medtech to enable better management of the coronavirus.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. CureVac raises more than $200M in IPO

CureVac (NSDQ:CVAC) — a Germany-based biotech outfit — is developing a COVID-19 vaccine with backing from the Bill and Melinda Gates Foundation. Read the full story.

4. This telemedicine system could get medtech sales reps back to ORs

Avail Medsystem’s telemedicine system could prove a more efficient way for sales reps to sit in on surgeries, especially as the COVID-19 pandemic continues to hinder access to hospitals. Read the full story.

3. FDA clears ClearMask transparent surgical mas…

BREAKING: Bayer settles 90% of Essure claims for $1.6B

Bayer (ETR:BAYN) announced today that settled approximately 90% of U.S. claims involving women alleging injuries related to its Essure device.

Leverkusen, Germany-based Bayer reached agreements with plaintiff law firms on about 90% of the nearly 39,000 filed and unfiled U.S. Essure claims from women who allege device-related injuries, according to a news release. Settlements include all jurisdictions with significant volumes of Essure cases, and the company will pay approximately $1.6 billion to resolve the claims.

Settling claimants will be required to dismiss their cases or not file, according to the company, and there is no admission of wrongdoing or liability by Bayer in the agreements. The other terms of the settlements are confidential and the settlement amount is covered by existing provisions. The U.S. settlements have no impact on pending litigation in other countries.

Bayer said virtually all its U.S. Essure litigation is now resolved, adding t…