April 6, 2022 06:50 AM EDTUpdated April 7, 07:18 AM
In Focus

Af­ter Covid-19 suc­cess, pa­tients with the world’s ‘most stig­ma­tized’ in­fec­tion push for their own Op­er­a­tion Warp Speed

Jason Mast

Editor

When Kimberly woke one morning in the final days of 2020 and couldn’t pee without pain, she had no idea what it might be. But as the symptoms persisted, she gathered a possible hunch, even as she frantically googled for alternative explanations.

She was married, on paper, but they were separated and there had been a new man one night a month ago. He said he was tested and STI-free, but that was just his word.

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January 29, 2023 10:10 PM EST
People
Pharma

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Kyle LaHucik

Associate Editor

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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January 28, 2023 07:15 AM EST
Weekly

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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January 30, 2023 11:32 AM EST

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

John Carroll

Editor & Founder

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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January 30, 2023 03:42 PM EST
R&D
Pharma

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Nicole DeFeudis

Editor

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

January 30, 2023 03:41 PM EST
Pharma
Law

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

Zachary Brennan

Senior Editor

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

January 30, 2023 02:53 PM EST
Pharma
Law

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

Nicole DeFeudis

Editor

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Chad Mirkin, Flashpoint co-founder
January 30, 2023 11:35 AM ESTUpdated 12:55 PM
R&D

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Lei Lei Wu

News Reporter

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)
January 30, 2023 07:29 AM ESTUpdated 02:21 PM
Pharma

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

Zachary Brennan

Senior Editor

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)
January 30, 2023 03:30 PM EST
Pharma
Marketing

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Beth Snyder Bulik

Senior Editor

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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Af­ter Covid-19 suc­cess, pa­tients with the world’s ‘most stig­ma­tized’ in­fec­tion push for their own Op­er­a­tion Warp Speed

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty