Eisai’s art-driven MBC project continues with new ‘fearLESS’ theme drawing on patients’ individual stories

Eisai’s patient portrait and story-drive metastatic breast cancer campaign was shot in Flagstaff, AZ this year

Eisai’s metastatic breast cancer patient portrait campaign ‘This is MBC’ began seven years ago to bring metastatic cancer stories and conversations into the open.

Its latest iteration with partner advocacy group METAvivor is called ‘fearLESS’ and features 10 women with MBC who lived in a house together in Flagstaff, AZ during the campaign photo shoot. Patient portraits – a hallmark of the long-running campaign – this year show the women posed against the dramatic and beautiful southwestern landscapes.

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Their Staying Power Lies in their Patient-Centricity

Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.

Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.

Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.

Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.

For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.

More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.

All the big R&D trends are on display in this new, record-topping list of drug approvals for 2021. Plus one.

Add up everything OK’d from CDER and CBER, and you have 61 new drug approvals for last year, topping the 59 OKs that had tied a record in 2020. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.

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Susan Sweeney, Amgen SVP of global marketing, access and capabilities

Susan Sweeney spent more than two decades in drug commercialization at Bristol Myers Squibb before moving to Amgen in September 2019, just a few months before the Covid-19 pandemic.

Sweeney, now Amgen’s senior VP of global marketing, access and capabilities, didn’t know of course what was about to happen any more than anyone else, but her longtime drug launch expertise – which included blockbusters like Opdivo and Eliquis – meant she’d weathered more ups and downs in pharma commercialization than most.

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Pfizer pitched some early New Year’s resolutions with Covid-related rules in LinkedIn and Facebook video posts just before the end of the year. Resolution rule number one was a suggestion for those who didn’t have a promise yet for 2022 to take the vow: ‘I will do my part to stop the pandemic.’

Its second rule suggestion? ‘Please do not make it your 2022 goal to learn more of the Greek alphabet’ in a reference to the naming convention of Covid-19 variants selected by the World Health Organization. Lastly, the Covid-19 mRNA vaccine maker, along with partner BioNTech, offered suggestions for a good toast: ‘Here’s to a great 2022!’ along with a bad idea for a toast: ‘It can’t get any worse!’

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When the FDA lifted a clinical hold on Applied Therapeutics’ lead program in galactosemia last February, the New York biotech signaled that they were then on a smooth road toward an accelerated approval, with plans to file an NDA in the third quarter of 2021.

Regulators, though, apparently changed their mind.

Applied has decided to hold on submitting an NDA for AT-007 as a treatment for galactosemia, the company disclosed, following discussions with the FDA in which the agency indicated that ‘clinical outcomes data will likely be required for approval.’

As part of Seqirus and Families Fighting Flu’s campaign, people are making online pledges to get a flu vaccination.

Is there a twindemic deja vu in the works? Although last year’s double whammy of Covid-19 and flu infections never panned out, CSL’s Seqirus wants to make sure it doesn’t happen this year, especially as flu cases are already on the rise.

As pandemic restrictions relax – more indoor meetups and travel and less mask wearing – the potential for a real twindemic is certainly possible. While reports of influenza are still lower than normal, cases are ramping up, according to the CDC’s Fluview monitoring system. The increase is happening, however, even as three in five people in the US say they plan to skip or delay a flu vaccine this season.

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Piramal CEO Peter DeYoung (Credit: Piramal Pharma Solutions via Youtube)

During a typically quiet holiday break in biotech, Piramal Pharma made some noise, and it’s starting off 2022 with yet another big announcement.

The CDMO will invest millions into creating a high-throughput screening facility that will enhance the already existing in vitro biology capabilities at its Ahmedabad, India drug discovery site. The new expansion is scheduled to go live in Q3 of this year, and couple its biology services with chemistry capabilities already in operation.
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