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THE GOOD
Accidents & Natural Disasters

Baxter offers reopening timelines for Helene-battered IV solution plant
Manufacturing, intravenous solutions - Read more

THE GOOD
Approvals & Labels

CSPC Pharmaceutical lands Chinese NMPA marketing approval for Enyitan (Xolair biosim, Genentech & Novartis)
Monoclonal antibody, chronic spontaneous urticaria - Read more

Novavax’s updated COVID-19 vaccine nabs EC reauthorization
Vaccine, COVID-19 - Read more

Ipsen’s Iqirvo nabs UK’s MHRA approval
Small molecule, primary biliary cholangitis - Read more

Healgen’s at-home combo flu/COVID-19 test kit handed full FDA approval
At-home testing, influenza, COVID-19 - Read more

THE GOOD
Business Development

SK bioscience acquires$3M stake in Fina Biosolutions
Conjugate vaccines, infectious disease, pneumoniae, meningococcal, typhoid - Read more

Astellas digs deeper into gene therapy with up to $2B biobucks deal with AviadoBio
Gene therapy, frontotemporal dementia with progranulin mutations - Read more

Bio-Thera, Gedeon Richter sign commercialization agreement for latter’s BAT2206 (Stelara biosimilar, Johnson & Johnson); Bio-Thera to receive $8.5M upfront, $101.5M biobucks
Monoclonal antibody, inflammation, autoimmune - Read more

ModeX Therapeutics multispecific antibodies land additional $35M from BARDA
Multispecific antibody, COVID-19 - Read more

Galecto acquires leukemia preclinical asset BRM-1420 from Bridge Medicines
Small molecule(?), acute myeloid leukemia - Read more

AstraZeneca pays CSPC Pharmaceutical $100M upfront (+$1.92B biobucks) for preclinical dyslipidaemia asset YS2302018
Small molecule, dyslipidaemia - Read more

THE GOOD
Clinical Trials

Aurigene Oncology touts Ph1 data for India’s first autologous BCMA directed CAR-T
Cell therapy, multiple myeloma, CAR-T - Read more

Intellia Therapeutics begins Ph3 for CRISPR med NTLA-2002 in angioedema
CRISPR gene-editing, hereditary angioedema - Read more

Hansa Biopharma posts “robust” Ph1 data for HNSA-5487 in reducing IgG levels
Enzyme, IgG-cleaving enzyme, autoimmune - Read more

Scholar Rock makes some noise with stellar Ph3 results for apitegromab in spinal muscular atrophy
Monoclonal antibody, spinal muscular atrophy - Read more

Merck & Co. aims for head & neck cancer dominance with new Keytruda Ph3 clinical trial read out
Monoclonal antibody, head and neck squamous cell carcinoma, cancer - Read more

Biogen touts Phase 2/3 win in higher dose Spinraza trial in spinal muscular atrophy
Oligonucleotide, spinal muscular atrophy - Read more

PTC Therapeutics trial extension efforts might pay off, as fresh vatiquinone data is “highly statistically significant”
Small molecule, Friedreich ataxia - Read more

AstraZeneca and partner Avillion Life Sciences run to FDA early as their asthma med Airsupra shows “overwhelming efficacy” in Ph3b
Small molecule, persistent asthma - Read more

Biomed Industries showcases Ph1 data for small molecule obesity hopeful NA-931
Small molecule, obesity - Read more

Insmed showcases Ph3 subgroup analysis for brensocatib in bronchiectasis
Small molecule, non-cystic fibrosis bronchiectasis - Read more

InnoCare Pharma’s psoriasis small molecule ICP-488 hits Ph2 goal in China
Small molecule, psoriasis - Read more

Viatris’ Effexor yields positive Ph3 topline data in generalized anxiety disorder
Small molecule, generalized anxiety disorder - Read more

Viking Therapeutics touts positive Ph1b data for VK0214 in X-linkedin adrenoleukodystrophy
Small molecule, X-linked adrenoleukodystrophy - Read more

Clearside Biomedical’s CLS-AX for wet AMD hits primary & secondary outcomes in Ph2b
Small molecule, neovascular age-related macular degeneration (wet AMD) - Read more

GSK’s RSV shot Arexvy shows effectiveness over three years in longer term Ph3
Vaccine, respiratory syncytial virus - Read more

THE GOOD
Company Incubation

Healthworx Accelerator announces 2024 cohort
Healthcare accelerator, company building - Read more

THE GOOD
Company Launches

Judo Bio launches with RNA-driven kidney disease ambitions and $100M
RNA, kidney disease - Read more

City Therapeutics launches also in the RNA space (in siRNA) with a $135M Series A
RNA, small-interfering RNA - Read more

clobk.bio launches with $5.3M Seed raise and an “Atlas of Rejuvenation”
Small molecule, longevity medicine - Read more

⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

MARAbio $19M Series A
Blood test, autism spectrum disorder, diagnostics - Read more

Rege Nephro planned $17M Series B, first $15M payment received
Cell therapy, kidney disease, induced pluripotent stem cells (iPSC, iPS cells) - Read more

Moncyte Health €1M ($1.1M) Seed raise
Diagnostics, cardiovascular disease, cholesterol - Read more

Amprion first $6M close of $15M Series B
Diagnostics, Parkinson’s disease, Lewy body dementia, Alzheimer’s disease - Read more

a:head bio “7-digit EUR“ Pre-Series A raise
Drug development, brain disorders - Read more

Basecamp Research $60M raise
Drug discovery, AI, “programmable” genetic medicines - Read more

Generare €5M ($5.5M) Seed raise
Drug discovery, bacteria, high-throughput screening - Read more

Purespring Therapeutics $105M Series B
Gene therapy, kidney disease - Read more

Somagenetix CHF10M ($11.7M) Series A
Gene therapy, phagocyte disorders - Read more

InterVene $13M Series A
Medical device, cerebral/cortical visual impairment - Read more

ShiraTronics $66M Series B
Medical device, chronic migraines, neuromodulation - Read more

Scholar Rock $300M public offering
Monoclonal antibody, spinal muscular atrophy - Read more

Arda Therapeutics $43M Series A
Single-cell-based drug discovery, platform technology - Read more

Crinetics up to $460M public offering
Small molecule, acromegaly, carcinoid syndrome, congenital adrenal hyperplasia, Cushing’s disease - Read more

Orasis Pharmaceuticals $78M raise
Small molecule, presbyopia - Read more

Inhibikase Therapeutics $110M private placement
Small molecule, pulmonary arterial hypertension - Read more

Vicore Pharma SEK 100M ($9.6M) raise via new shares
Small molecule, idiopathic pulmonary fibrosis - Read more

Alpha Fusion ¥1.02B ($6.9M) Series B
Targeted alpha therapy, cancer - Read more

THE GOOD
Investments

Afton Scientific Virginia plant expansion to the tune of $200M + 200 new jobs
CDMO, sterile fill-finish, contract manufacturing - Read more

THE GOOD
IPOs

CAMP4 Therapeutics aims for $75M IPO
RNA, urea cycle disorders, metabolic disorders, CNS disorders - Read more

Upstream Bio aims for $200M IPO
Monoclonal antibody, severe asthma, chronic rhinosinusitis, chronic obstructive pulmonary disease - Read more

CeriBell aims for $101M IPO
Medical device, emergency seizure care - Read more

SPAC Oaktree Acquisition III Life Sciences aims for $175M IPO
Healthcare special purpose acquisition company (SPAC) - Read more

THE GOOD
Lawsuits

GSK shells out whopping $2.2B to settle 93% of Zantac-related cases out of court
Small molecule, colorectal cancer - Read more

Novo Nordisk and partners Mylan Pharmaceuticals, Natco settle patent dispute involving Ozempic generic
GLP-1, obesity, type 2 diabetes, generic - Read more

Liquidia share gain on Supreme Court rejection of United Therapeutics’ patent claim to Yutrepia
Small molecule, pulmonary arterial hypertension, pulmonary hypertension - Read more 

THE GOOD
Market Reports

AbbVie’s Skyrizi captures more than double the market share of competitor Eli Lilly’s Omvoh, though Johnson & Johnson’s Tremfya waits in the wings
Monoclonal antibody, ulcerative colitis - Read more

THE GOOD
Mergers & Acquisitions

Rumor mills spin-up again as AstraZeneca reportedly contacts Gilead Sciences for potential merger
Big pharma merger - Read more

Concentra makes offer to acquired struggling Kezar Life Sciences 
Small molecule, lupus nephritis - Read more

Vizgen, Ultivue merger
Single-cell spacial genomics, proteomic biomarker, spatial multi-omics - Read more

Actylis aquires Pharm-Rx
Life science specialty ingredients, consumer health - Read more

THE GOOD
Partnership

Eli Lilly, insitro sign AI-driven drug discovery & development pact
Antibody, RNA, metabolic dysfunction-associated steatotic liver disease, AI, drug development - Read more

MediLink Therapeutics, Amgen sign clinical trial collab combining former’s ADC YL201 and latter’s bispecific Imdelltra
Antibody-drug conjugate, bispecific T-cell engager, lung cancer, clinical trial collab - Read more

MiNK Therapeutics, Autonomous Therapeutics sign solid tumor-directed drug development partnership
Cell therapy, RNA, solid tumor, colorectal cancer, drug development - Read more

Merck & Co. joins Mestag Therapeutics’ RAFT to identify new inflammatory disease targets, up to $1.9B deal
Inflammatory disease, drug discovery - Read more

BPGbio, University of Oxford’s protein degrader strategic collaboration
Protein degrader, cancer, CNS disorders, research & development - Read more

Sonnet BioTherapeutics, Alkem Laboratories partner on SON-080 development in India
Recombinant protein, diabetic peripheral neuropathy, neuropathy - Read more

Tonix Pharmaceuticals, X-Chem announce AI-driven antiviral drug discovery collab
Small molecule, antiviral, AI, drug discovery - Read more

Bayer, Moma Therapeutics sign oncology drug development agreement targeting “highly dynamic proteins”
Small molecule, cancer, drug development - Read more

Boehringer Ingelheim, Circle Pharma sign cyclin inhibitor R&D partnership
Small molecule macrocycles, cancer, research & development - Read more

THE GOOD
Patient Access

Orchard Therapeutic, Er-Kim partner on broadening Libmeldy access to Turkey and other Eurasian countries
Gene therapy, metachromatic leukodystrophy, autologous hematopoietic stem cell gene therapy - Read more

GEMMABio partners with Fiocruz to bring rare disease gene therapies to Brazil
Gene therapy, GM1 gangliosidosis (GM1), Krabbe disease, metachromatic leukodystrophy - Read more

Pfizer (with a global Hub in Tampa) pledges financial and medical support in Florida as Hurricane Milton approaches
Natural disaster, essential medicines - Read more

GSK’s ViiV Healthcare to expand HIV prevention med access in Africa
Small molecule, human immunodeficiency virus, antiretroviral - Read more

THE GOOD
Product Launches

Illumina unmasks smaller, more convenient sequencer
DNA sequencing, instrumentation - Read more

THE GOOD
Research

Nobel Prize in Physiology or Medicine goes to discovery of microRNA and it’s post-transcriptional role
microRNA, post-transcriptional gene regulation - Read more

Nobel Prize in Chemistry awarded “for computational protein design”, one-half award to two co-founders of Google DeepMind
Computational protein design, AI - Read more

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THE BAD
Approvals & Labels

Zealand Pharma handed second CRL from FDA for dasiglucagon
Hormone, hypoglycaemia, congenital hyperinsulinism - Read more

Takeda fruquintinib doesn’t get NICE recommendation
Small molecule, colorectal cancer - Read more

Stealth BioTherapeutics adcomm approval recommendation looks slim for elamipretide after FDA briefing docs posted
Small molecule, Barth syndrome - Read more 

THE BAD
Clinical Trials

Johnson & Johnson halts bladder cancer Ph3 after interim data look delivers disappointment
Small molecule, bladder cancer, drug-device combo - Read more

Sage Therapeutics’ dalzanemdor for Alzheimer’s fails in Ph2
Small molecule, Alzheimer’s disease - Read more

THE BAD
Layoffs

Kaleo cuts 85 roles
Small molecule, allergic reaction, medical device - Read more

Universal Cells (Astellas subsidiary) to open new site in Japan, but cuts 24 roles at original Seattle location
Cell therapy, research & development - Read more

THE BAD
Mergers & Acquisitions

Psyence Biomedical walks from Clairvoyance acquisition after wrapping up due diligence
Small molecule, adjustment disorder, psychedelic - Read more

THE BAD
Politics & Policy

Congressional Budget Office report pins hypothetical Medicare obesity med coverage at $35B over 8 years
GLP-1, obesity - Read more

THE BAD
Public Health

Roche-sponsored survey, 8700 people across EU/Latin America, finds half of those polled lack awareness of HPV, cervical cancer risk
Human papillomavirus, cervical cancer - Read more

THE BAD
Strategic Plans

Pfizer looks to end ReViral acquisition chapter, as last clinical trials for sisunatovir shuttered
Small molecule, respiratory syncytial virus - Read more

Black Diamond Therapeutics seeks partner for deprioritized BDTX-4933 asset, drops related Ph1 lung cancer trial and hints at layoffs
Small molecule, lung cancer - Read more

Vincerx reprioritizes pipeline, seeks partner for VIP236
Small molecule-drug conjugate, solid tumor - Read more

THE UGLY
Earnings & Finances

Pfizer and activist investor Starboard Capital scrap continues, now with messy lawsuit allegations
Activist investor - Read more

THE UGLY
Healthcare Equity

Pulse oximeter racial bias likely to continue despite FDA intervention
Medical device, racial bias - Read more

THE UGLY
Lawsuits

Compounding pharmacies profiting off of Mounjaro, Zepbound (Eli Lilly) shortages suddenly miffed when shortages end; compounding group sues FDA
GLP-1, obesity, compounding - Read more

UnitedHealth Group, CVS Health, Cigna ask federal judge to remove FTC chair Lina Khan and two other dem FTC commissioners from PBM lawsuit
Pharmacy benefit manager, drug pricing - Read more [Paywall]

THE UGLY
Withdrawals & Recalls

Medtronic’s insulin pump handed FDA Class 1 recall over potentially shortened battery life
Medical device, diabetes, insulin pump, hyperglycemia - Read more

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

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