Stefan Oschmann, Merck KGaA CEO (Sipa USA via AP Images)
February 5, 2021 11:28 AM EST
Coronavirus
Manufacturing

Mer­ck KGaA ex­pands its deal with Pfiz­er/BioN­Tech with an eye on a key vac­cine man­u­fac­tur­ing bot­tle­neck

Nicole DeFeudis

Associate Editor

Conner Mitchell

As Pfizer and BioNTech’s vaccine delivery runs behind schedule in the EU, Merck KGaA is aiming to boost production by accelerating its supply of custom lipids to BioNTech.

The Darmstadt, Germany-based biotech has promised to expand its production of lipids, which are critical in getting the mRNA technology into the body. Complicating matters further is that only a select few manufacturers are currently equipped to manufacture the lipids in standards consistent enough for vaccine production.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)
March 4, 2021 08:51 AM ESTUpdated 10:33 AM
Deals

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

John Carroll

Editor & Founder

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)
March 4, 2021 06:57 AM ESTUpdated 4 hours ago
Discovery
In Focus

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Jason Mast

Editor

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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March 3, 2021 08:33 AM EST
Deals

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

John Carroll

Editor & Founder

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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March 4, 2021 08:27 AM EST
Cell/Gene Tx
Manufacturing

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

John Carroll

Editor & Founder

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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March 4, 2021 09:11 AM EST
Coronavirus
Manufacturing

No­var­tis pairs up with Cure­Vac to help dri­ve Covid-19 shot pro­duc­tion but may miss the show in the US, EU

Kyle Blankenship

Managing Editor

With the pandemic potentially entering its later stages, major drugmakers like Merck have jumped in to aid in the gargantuan task of manufacturing other companies’ vaccines. Now, after a relatively quiet year, Novartis is teaming up with one of the mRNA players to help the production crunch.

Novartis will help manufacture bulk drug substance for CureVac’s mRNA-based Covid-19 shot, dubbed CVnCoV, at its Kundl, Austria site with plans to produce up to 50 million doses by the end of 2021, the Swiss drugmaker said Thursday.

Hal Barron, Endpoints UKBIO19
March 3, 2021 10:48 AM EST
R&D
Coronavirus

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

Kyle Blankenship

Managing Editor

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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Cedric Francois, Apellis CEO (Apellis)
March 4, 2021 04:51 PM EST
R&D
Coronavirus

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

John Carroll

Editor & Founder

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.

March 4, 2021 07:12 AM EST
Coronavirus

Covid-19 roundup: EMA starts rolling re­view of Rus­si­a's Sput­nik V; No­vavax says shot is 51% ef­fec­tive against vari­ant in South Africa 

Amber Tong

Senior Editor

The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19.

Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.

March 4, 2021 06:45 AM EST
R&D

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

John Carroll

Editor & Founder

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Mer­ck KGaA ex­pands its deal with Pfiz­er/BioN­Tech with an eye on a key vac­cine man­u­fac­tur­ing bot­tle­neck

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

No­var­tis pairs up with Cure­Vac to help dri­ve Covid-19 shot pro­duc­tion but may miss the show in the US, EU

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

Covid-19 roundup: EMA starts rolling re­view of Rus­si­a's Sput­nik V; No­vavax says shot is 51% ef­fec­tive against vari­ant in South Africa 

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch