Rahul Singhvi, Resilience CEO

Re­silience col­lab­o­rates with the Mayo Clin­ic to man­u­fac­ture rare and com­plex dis­ease drugs

After netting its Series D round of funding in June, Resilience is not sitting around and resting on its laurels.

The Bob Nelsen-backed contract manufacturer on Monday announced a new strategic collaboration with the Mayo Clinic. The relationship is centered around manufacturing biotherapeutics for rare and complex conditions, with the focus on biologics including those based in cells, blood, enzymes, tissues, genes or genetically engineered cells.

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Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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RA Cap­i­tal-backed non-vi­ral gene ther­a­py start­up Sum­ma­tion Bio to shut down

As a string of new gene therapy startups aims to create treatments without the go-to shuttling method of an AAV virus, and as multiple gene editing biotechs look to do the same, one such startup is coming to a close.

Summation Bio, backed by at least $24 million in Series A funds, is “terminating operations” next month, per an employee’s LinkedIn profile update. (According to their LinkedIn profile, an employee said the company raised $60 million in the round.) Another employee took to the networking site last week to say the circumstances were “insurmountable,” noting that “despite all-out effort and error-free execution, the science, this time, was elusive.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Man­u­fac­tur­ing roundup: Astel­las to sell Dutch fa­cil­i­ty to Del­pharm; Au­ri­gene in­vest­ing $40M in­to In­dia man­u­fac­tur­ing fa­cil­i­ty

Astellas Pharma is selling its manufacturing plant in Meppel, the Netherlands, to contract manufacturer Delpharm.

Astellas said last week it’s transferring the facility to Delpharm as part of a wider shift for the pharma’s technology and manufacturing business. As part of the deal, for which financial details were not disclosed, Delpharm plans to continue to produce the products that are made in the Meppel plant for Astellas. The employees at the site will also transfer to Delpharm as well. The deal is expected to close by the end of the year.

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