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  • Biotech & Pharma Updates | June 24 - 25, 2024

Biotech & Pharma Updates | June 24 - 25, 2024

Otsuka and Lundbeck’s PTSD sNDA filing accepted, Exsilio launches with $82M and big name investors, Zealand Pharma ups equity offering to $1B, Eli Lilly & OpenAI sign an antibiotic drug discovery pact, and Abbvie's Parkinson's med gets hit with a CRL

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MINOR HOUSEKEEPING
How these updates are formatted

The newsletter is split into three main sections:

  • THE GOOD - good news (eg. fundraises, product approvals)

  • THE BAD - negative news (eg. clinical trial failures, layoffs)

  • THE UGLY - negative but atypical news (lawsuits, product recalls, scandals)

Within each of the three above parts, there are additional sections for easier navigation:

  • Eg. There will be multiple “The Good” sections covering things like Fundraises, Approvals, Partnerships etc.

  • There will be also additional tags within these sections (Eg. fundraises may mention Stage, product approvals may mention drug name and disease area.)

See something you want to get into further? Click the Read More (goes out to either a news article or a press release).

One last thing; I know paywalls can be annoying, so there’s a [Paywall] tag for any news stories behind one.

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Otsuka and Lundbeck’s sNDA FDA filing accepted, PDUFA date set
Small molecule, post-traumatic stress disorder (PTSD) - Read more

ExCellThera lands accelerated EMA Market Authorisation Application (MAA) assessment
Cell therapy, stem cell, hematological malignancies, cancer - Read more

Endotronix’s heart failure sensor lands FDA approval
Medical device, heart failure, implant - Read more 

THE GOOD
Clinical Trials

AstraZeneca notches a Ph3 bladder cancer win (and a Ph3 lung cancer lose)
Monoclonal antibody, lung cancer, bladder cancer - Read more

Wave Life Sciences posts promising clinical data and hopes for an FDA accelerated approval
Antisense oligonucleotide, Huntington’s - Read more

Intellia Therapeutics dose-escalating Ph1 shows that re-dosing gene-editing therapies is possible
Gene therapy, gene-editing, CRISPR, transthyretin amyloidosis (ATTR-CM) - Read more

Arrowhead Pharmaceuticals moves RNAi-based therapy into cardiovascular-focused Ph3 trial
RNAi, hyperlipidemia, atherosclerotic cardiovascular disease - Read more

THE GOOD
Company Launches

Exsilio Therapeutics launches with $82M with Novartis and CRISPR Therapeutics as investors, and led by Moderna’s former CMO
mRNA, gene insertion, drug delivery - Read more

TwoStep Therapeutics launches with $6.5M and Nobel laureate scientific co-founder
Peptide, solid tumors, cancer - Read more

THE GOOD
Fundraises

Zealand Pharma upsized $1B equity offering
GLP-1/GCG, obesity, weight loss - Read more

EvolutionaryScale $142M fundraise
Protein modelling, drug discovery, AI - Read more

Endogenex $88M Series C
Medical device, type 2 diabetes - Read more

Frontier Medicine $20M Series C Extension
Small molecule, machine learning, cancer - Read more

SkyCell $116M Series D
Supply chain, pharmaceutical logistics - Read more

Cypris Therapeutics >$500k Pre-seed round
Small molecule, drug discovery, natural product - Read more

THE GOOD
Investments

Jubilant Radiopharma invests $50M into PET manufacturing network expansion
Radiopharmaceuticals, positron emission tomography - Read more

THE GOOD
Mergers & Acquisitions

Sanofi wants consumer health division bidders to submit bids by mid-July; estimated price could be >$20B
Consumer health - Read more

Altaris takes Sharecare private to the tune of $518M
Digital therapeutics, diabetes, anxiety - Read more

THE GOOD
Opinions

Doctors are a-ok with you doing that at-home test; survey - Read more

THE GOOD
Partnerships

Eli Lilly and OpenAI sign drug discovery pact
Drug discovery, antimicrobial resistance, infectious disease - Read more

AstraZeneca and BenevolentAI collaboration bears second drug target fruit
Drug discovery, systemic lupus erythematosus - Read more

THE GOOD
Research

Tern Pharmaceuticals shelved MASH drug (with semaglutide) shows promising, and somewhat unique, weight loss results; mice studies
Small molecule, metabolic dysfunction-associated steatohepatitis, obesity, weight loss - Read more

⬇️ The Bad News ⬇️

THE BAD
Approvals

Abbvie’s Parkinson’s med gets hit with an FDA no again, this time due to manufacturing issues
Small molecule, Parkinson’s, complete response letter - Read more

THE BAD
Clinical Trials

Pfizer cuts a Ph2 trial short after missed primary endpoint
Monoclonal antibody, giant cell arteritis - Read more

Boehringer Ingelheim discontinues three separate Ph2 trails
Small molecule, clin­i­cal­ly sig­nif­i­cant por­tal hy­per­ten­sion - Read more, and more, and more

THE BAD
Politics & Policy

Amgen fights back against proposed Colorado drug price cap
Fusion protein, autoimmune, drug pricing - Read more [Paywall]

⬇️ The Ugly News ⬇️

THE UGLY
Politics & Policy

Big pharma snubs FTC, doesn’t remove so-called “junk” patents
Pharma patents, antitrust - Read more

In terrorism-funding suit, the US Supreme Court gives big pharma a chance to defend itself - Read more

Teva Pharmaceuticals settles 2008 to 2020 Israeli tax saga with a $750M payout - Read more

THE UGLY
Public Health

Gun violence is a public health crisis; Surgeon General - Read more [Paywall]

THE UGLY
Withdrawals & Recalls

Glenmark Pharmaceuticals’ batches of low potassium drug recalled due to being a little too good at raising potassium levels
Small molecule, hypokalemia - Read more

You’re all caught up on the latest Pharma & Biotech News!

Season 5 Fridge GIF by Friends

June 26th is World Refrigeration Day! Yes, this is really a thing. | Gif: friends on Giphy

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