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