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- Biotech & Pharma Updates | September 30 - October 1, 2024
Biotech & Pharma Updates | September 30 - October 1, 2024
Kailera launches with $400M and big obesity dreams, Biohaven’s $250M public offering, SK pharmteco drops $260M for new manufacturing site, Zephyrm Bioscience files for Hong Kong stock exchange IPO, BioMarin signs RNA R&D deal with CAMP4, FDA and FTC both urged by US senators to do more (in different ways), J&J, Bayer, Pfizer all post new layoffs (totally 500 jobs), Gritstone bio considers the dreaded “strategic alternatives” as cash pile dwindles, Amgen casually forgets to mention $10.7B in back taxes to investors; class-action suit ensues
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
GE Healthcare nets FDA approval for Flyrcado PET imaging agent
Small molecule, radioimaging, cardiac, PET scan - Read more
THE GOOD
Clinical Trials
Enliven Therapeutics touts positive Ph1 results for ELVN-001 in leukaemia
Small molecule, chronic myeloid leukaemia, cancer - Read more
Santhera Pharmaceuticals posts “promising” top-line results for DMD-associated cardiac complications med
Small molecule, Duchenne’s muscular dystrophy, cardiomyopathy - Read more
Cytokinetics presents additional Ph3 data analyses for aficamten in cardiomyopathy
Small molecule, symptomatic obstructive hypertrophic cardiomyopathy - Read more
Myrtelle touts “significant biomarker change” in Canavan disease patients treated with rAAV-Olig001-ASPA in Ph1/2 trial
Gene therapy, Canavan disease - Read more
Clinical trial recruitment portal European Clinical Trials Information Network launches
Clinical trial recruitment, decentralized clinical trials - Read more
THE GOOD
Company Launches
Kailera Therapeutics launches with $400M and obesity dreams, four assets from Jiangsu Hengrui Pharmaceuticals
GLP-1/GIP, obesity - Read more
Florey Biosciences launches with pre-seed funding to tackle gut microbiome dysfunction caused by antibiotic use
Genentically modified yeast, microbiome dysfunction - Read more
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⬇️ The Good News (Cont’d) ⬇️
THE GOOD
Fundraises
Cartherics private financing round, AUD 15M ($10M)
Cell therapy, solid tumor, ovarian cancer, natural killer cell - Read more
Biohaven $250M public offering
Bispecific antibody, small molecule, inflammation, cancer - Read more
Vicore Pharma to receive SEK 100M ($9.7M) strategic raise from Sanofi
Small molecule, idiopathic pulmonary fibrosis - Read more
IN8Bio $12.4M private placement
Cell therapy, acute myeloid leukemia, cancer, gamma-delta T cell - Read more
Vaxess receives NIH grant
GLP-1, type 2 diabetes - Read more
THE GOOD
Investments
SK pharmteco commits $260M for new South Korea-based small molecule, peptide plant
CDMO, small molecule, peptide manufacturing - Read more
Piramal Pharma Solutions earmarks Lexington, KY facility expansion to tune of $80M
CDMO, antibody-drug conjugate, fill-finish, manufacturing - Read more
THE GOOD
IPOs
Zephyrm Bioscience files IPO on Hong Kong Stock Exchange
Cell therapy, acute graft-versus-host disease, interstitial lung disease - Read more
THE GOOD
Mergers & Acquisitions
Tharimmune announce intent to acquire Intract Pharma
Biologics, drug delivery, gastrointestinal tract - Read more
Life science procurement and supplier orchestration software Science Exchange acquired by Waud Capital Partners
Life science procurement - Read more
THE GOOD
Partnerships
BioMarin Pharmaceutical signs R&D deal with CAMP4 Therapeutics
RNA, drug discovery, suboptimal protein expression - Read more
Metsera, Amneal sign drug development and supply agreement, including new peptide synthesis & sterile fill-finish facility build
GLP-1, obesity, metabolic disease, drug development - Read more
Lupin nabs Canada distribution rights to Aytu BioPharma’s ADHD meds
Small molecule, attention deficit hyperactivity disorder, sale & distribution - Read more
Shionogi lands Japan distribution and sales rights to Nxera Pharma’s Quviviq insomnia med
Small molecule, insomnia, sales & distribution - Read more
PDRadiopharma (PeptiDream subsidiary), Curium partner on clinical development through commercialization for radiopharm assets 177Lu-PSMA-I&T and 64Cu-PSMA-I&T
Radiopharm, prostrate cancer, drug development - Read more
Sun Pharmaceutical Industries signs worldwide licensing agreement for Philogen’s anti-cancer immunotherapy Fibromun
Antibody fusion protein, sarcoma, glioblastoma, cancer - Read more
THE GOOD
Politics & Policy
US Senator Bill Cassidy (R-LA) pushes FDA to provide concrete guidance regarding patent inclusion in Orange Book, calls FTC Orange Book patent actions “an extraordinary abdication of [FDA] authority”
Drug patents, federal trade commission - Read more
FTC urged by US Senators to expand PBM investigations into “additional anti-competitive practices”
Pharmacy benefit manager, prescription drugs, drug pricing - Read more
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⬇️ The Bad News ⬇️
THE BAD
Earnings & Finances
Activist investor EcoR1 Capital now controls 10% of Galapagos’ outstanding share
Cell therapy, lymphoma, leukemia, cancer, CAR-T - Read more
THE BAD
Layoffs
Spate of layoffs, nearly 500 jobs, disclosed by Johnson & Johnson, Bayer (New Jersey sites, 231 and 57 positions respectively), and Pfizer (Ireland sites, 210 positions)
Big pharma layoffs - Read more
Shattuck Labs cuts 40% of staff as part of strategic reorg
Monoclonal antibody, cancer, inflammatory bowel disease - Read more
THE BAD
Strategic Plans
CVS Health considers corporate break-up as investor pressure mounts
Consumer health, health insurance - Read more [Paywall]
Gritstone bio is exploring the dreaded “strategic alternatives” as cash dwindles
Cancer vaccine, colorectal cancer - Read more
IGM Biosciences makes rapid pivot to autoimmunity, investor aren’t pleased
Bispecific T-cell engager, rheumatoid arthritis, systemic lupus erythematosus, myositis, autoimmune - Read more
ViiV Healthcare halts development of HIV antiviral asset VH3739937
Small molecule, human immunodeficiency virus - Read more [Paywall]
⬇️ The Ugly News ⬇️
THE UGLY
Lawsuits
Amgen forced to face the tax liability music, as New York judge denies dismissal request for $10.7B back tax class action lawsuit
Back taxes, tax liability - Read more
You’re all caught up on the latest Pharma & Biotech News!
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