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- Biotech & Pharma Updates | June 25 - 26, 2024
Biotech & Pharma Updates | June 25 - 26, 2024
Novo Nordisk's Wegovy lands China NMPA approval, big DNA edits without CRISPR, Curie.Bio raises $380M VC fund, SK Bioscience buys IDK Biologika controlling stake, and Novo Nordisk's $816M Ph3 oof
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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.
⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Novo Nordisk lands NMPA (China) approval for Wegovy
GLP-1, obesity, weight loss - Read more
NMPA also approves expanded label for AstraZeneca’s Tagrisso
Small molecule, lung cancer - Read more
FDA still open to handing Dizal Pharma an accelerated approval
Small molecule, lung cancer - Read more
Abbvie, Genmab handed FDA accelerated approval, label expansion
Bi-specific T-cell engager, follicular lymphoma, cancer - Read more
Verona Pharma scores FDA approval for COPD treatment
Small molecule, chronic obstructive pulmonary disease (COPD) - Read more
THE GOOD
Business Development
Just - Evotec Biologics lands $39M DOD project
Monoclonal antibody, accelerated development and manufacturing framework - Read more
THE GOOD
Clinical Trials
Savara reports positive lung disease Ph3 data
Recombinant protein, autoimmune pulmonary alveolar proteinosis - Read more
Allakos touts positive Ph1 data in mast cell inhibition therapy
Monoclonal antibody, mast cell-driven diseases, asthma - Read more
Werewolf Therapeutics has promising Ph1 IL-12 prodrug data
Small molecule, non-hodgkin lymphoma, solid tumor, cancer - Read more
THE GOOD
Fundraises
Curie.Bio $380M Pro Rata Series A Fund
Venture capital, therapeutics investment - Read more
Formation Bio $372M Series D
AI, asset acquisition, workflow automation - Read more
Augustine Therapeutics €17M ($18.1M) Series A
Small molecule, peripheral and CNS diseases - Read more
Taysha Gene Therapies $75 public offering
AAV gene therapy, Rett syndrome - Read more
THE GOOD
Investments
GenScript ProBio debuts new plasmid and viral vector manufacturing site
Cell therapy, gene therapy, manufacturing - Read more
THE GOOD
Mergers & Acquisitions
SK Bioscience buys controlling stake in IDK Biologika for ₩339B ($244M)
CDMO, vaccine manufacturing - Read more
Dr. Reddy’s buys nicotine replacement division from Haleon
Nicotine replacement, smoking cessation, consumer health - Read more
Insud Pharma and Agile Therapeutics agree on a merger
Small molecule, contraceptive, women’s health - Read more
THE GOOD
Partnerships
Slope and big pharma names come together for the Biospecimen Management Consortium
Biospecimen lifecycle and regulations, industry standardization - Read more
THE GOOD
Politics & Policy
Medicare patients poised to pay less on 64 drugs whose price increases outpaced inflation
Drug pricing, medicare rebates - Read more
Supreme Court poised to reject Idaho’s near-total abortion ban
Women’s health, abortion - Read more [Paywall]
THE GOOD
Public Health
CDC modifies up RSV vaccine recommendation for older adults
Vaccine, respiratory syncytial virus - Read more
THE GOOD
Regulatory
FDA publishes clinical trial diversity draft guidance
Clinical trial recruitment, patient population diversity - Read more
EMA outlines action plan to tackle GLP-1 shortages
GLP-1, obesity, diabetes, drug shortages - Read more
THE GOOD
Research
Large scale DNA editing but without CRISPR; a new tool does just that
Gene-editing, DNA bridges - Read more
3D printed meds? Might not be as far-fetched as you think; study
Additive manufacturing, quality by design, point-of-care - Read more
THE GOOD
Strategic Plans
Optum Rx might be the new biosimilar player in town
Biosimilars, prescription drug benefit provider - Read more [Paywall]
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
Novo Nordisk suffers an $816M oof after Ph3 kidney disease failure
Small molecule, kidney disease, systolic blood pressure - Read more
Moderna stock takes a beating after their RSV vaccine’s long-term efficacy doesn’t stand-up to rivals’
Vaccine, respiratory syncytial virus - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Clinical Trials
Lyell Immunopharma Ph1 patient death spurs change of plans
CAR-T, solid tumor, lung cancer, breast cancer - Read more
THE UGLY
Lawsuits
Amarin resurrects Hikma Pharmaceuticals patent lawsuit
Patent law, small molecule, cardiovascular risk, hypertriglyceridemia - Read more
Arkansas drags Optum and Express Scripts into opioid epidemic lawsuit
Pharmacy benefit manager, opioid epidemic - Read more
THE UGLY
Patient Access
Mail order drugs, turns out, are more expensive - Read more [Paywall]
You’re all caught up on the latest Pharma & Biotech News!
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