Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

Up­dat­ed: BioN­Tech sends mR­NA Covid-19 vac­cines to Chi­na for 20,000 ex­pats

Chi­na has opened up its doors to a for­eign Covid-19 vac­cine for the first time, though not for its own cit­i­zens, a Ger­man gov­ern­ment spokesper­son told Reuters on Wednes­day.

BioN­Tech’s mR­NA vac­cines have been sent to Chi­na to meet the goal of vac­ci­nat­ing 20,000 Ger­man ex­pa­tri­ates there, a spokesper­son for the Ger­man em­bassy in Wash­ing­ton con­firmed to End­points News. There will be ad­di­tion­al ship­ments, the spokesper­son said, with­out pro­vid­ing de­tails on when or how many dos­es would be de­liv­ered. The shots will be pro­vid­ed free to Ger­mans over 12 years old and will be shipped to Ger­man em­bassies and com­pa­nies across the coun­try.

About 11,500 dos­es ar­rived re­cent­ly for Ger­man ex­pa­tri­ates in Bei­jing, Shang­hai, Guangzhou, Shenyang and Cheng­du, BioN­Tech said Thurs­day.

The news comes over a month af­ter Ger­man Chan­cel­lor Olaf Scholz an­nounced in Bei­jing that an agree­ment had been made be­tween the two coun­tries to al­low the vac­cine’s use in Chi­na for ex­pats. Scholz said at the time that he hoped the Chi­nese gov­ern­ment would al­low its own cit­i­zens to use the vac­cine, ac­cord­ing to Reuters.

Ear­li­er in De­cem­ber, the Ger­man gov­ern­ment au­tho­rized Chi­nese cit­i­zens liv­ing in Ger­many to have ac­cess to Chi­na’s Sino­vac shot, one of the first vac­cines au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment in 2020. A 2021 study in Chi­na found that two dos­es and a boost­er of Sino­vac’s shot didn’t pro­duce ad­e­quate lev­els of pro­tec­tive an­ti­bod­ies against the omi­cron vari­ant.

Chi­nese cit­i­zens pre­vi­ous­ly on­ly had ac­cess to vac­cines de­vel­oped in their home coun­try, and none of the vac­cines ap­proved for wide do­mes­tic use in Chi­na are mR­NA-based, ac­cord­ing to a re­port from BNN Bloomberg.

In Oc­to­ber, Mod­er­na backed out of on­go­ing ne­go­ti­a­tions to send its mR­NA vac­cines be­cause Chi­na asked for all of the in­tel­lec­tu­al prop­er­ty rights. Hand­ing over de­tailed IP is one of on­ly two ways that Chi­na cur­rent­ly al­lows for­eign vac­cines. The oth­er op­tion is to build a man­u­fac­tur­ing com­pa­ny in the coun­try with a Chi­nese part­ner.

There have been some ex­cep­tions in the coun­try’s spe­cial ad­min­is­tra­tive re­gions.

BioN­Tech part­nered with Shang­hai Fo­s­un Phar­ma­ceu­ti­cal and an­nounced in No­vem­ber that the Health Bu­reau of the Hong Kong Spe­cial Ad­min­is­tra­tive Re­gion is­sued an Emer­gency Use Au­tho­riza­tion for a boost­er dose of BioN­Tech’s Omi­cron BA.4/BA.5-adapt­ed bi­va­lent vac­cine.

And Macau al­so grant­ed the boost­er a Spe­cial Im­port Au­tho­riza­tion.

Ed­i­tor’s note: Up­dat­ed with a state­ment from BioN­Tech.

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

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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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

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.

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

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:

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

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

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

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

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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