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THE GOOD
Approvals & Labels

Samsung Bioepis’s Soliris (AstraZeneca) biosimilar gets FDA approval
Monoclonal antibody, paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, biosimilar - Read more

Johnson & Johnson aims for monotherapy label expansion for antidepressant Spravato
Small molecule, depression - Read more

Almost a DREAMM come true for GSK as EMA accepts marketing authorization application for Blenrep in multiple myeloma
Antibody-drug conjugate, multiple myeloma, cancer - Read more 

Tulavi Therapeutics clears phantom-pain prevention hydrogel cap for amputees
Medical device, hydrogel, phantom pain - Read more

THE GOOD
Business Development

Tonix Pharmaceuticals lands $34M US DoD contract to develop experimental antiviral
Small molecule, broad spectrum antiviral - Read more

THE GOOD
Clinical Trials

Ionis Pharmaceuticals plans for bigger Angelman syndrome trials after smaller trial success
Antisense oligonucleotide, Angelman syndrome, rare disease - Read more

Innovent Biologics Type 2 diabetes drug (partnered with Eli Lilly) sticks Ph3 landing in China study
GLP-1, type 2 diabetes - Read more

Also in China, Gan & Lee Pharmaceuticals boast Ph2 success in GLP-1 agonist obesity trial
GLP-1, obesity, weight loss - Read more

BrainStorm Cell Therapeutics aligns with FDA on upcoming Ph3b trial for ALS, looking to overcome data disappointments from late 2023
Autologous stem cell therapy, amyotrophic lateral sclerosis (ALS) - Read more

THE GOOD
Fundraises

Antheia $17M raise
Biomanufacturing, pharmaceutical ingredients, fermentation - Read more

Lario Therapeutics $6M grant from The Michael J. Fox Foundation for Parkinson’s Research
Precision medicine, epilepsy, Parkinson’s disease - Read more

Cell BioEngines $2M fundraise
Allogeneic stem cell-derived therapy - Read more

Zaka VC closes €15M ($16.2M) Fund 1
B2B software in biotech/healthtech, AI - Read more

Cellectar Biosciences $19.4M (up to $73.3M) in gross proceeds after Tranche exercise
Small molecule, radiopharma, “Phospholipid Drug Conjugate”, cancer - Read more

THE GOOD
Marketing

CSL Vifor looks to make EU antitrust amends with “comprehensive” marketing campaign
Antitrust, anticompetitive, drug marketing - Read more

THE GOOD
Mergers & Acquisitions

Agilent Technologies expands CDMO offering with $925M acquisition of BIOVECTRA
CDMO, oligonucleotide, small molecule, API - Read more

Hepion Pharmaceuticals merges with Pharma Two B
Small molecule, liver disease, Parkinson’s disease, cancer - Read more

Grünenthal acquires Valinor Pharma (and associated US constipation med rights) for $250M
Small molecule, opioid-induced constipation - Read more

HI-Bio spills the tea on why Biogen bought them out less than five months after a $95M Series B
Monoclonal antibody, primary membranous nephropathy, lupus, autoimmune - Read more [Paywall]

THE GOOD
Partnerships

Aligos Therapeutics clinical trial partnership with Xiamen Amoytop Biotech, Ph1b
Small molecule, hepatitis B, antiviral - Read more

THE GOOD
Patient Access

Valneva and Coalition for Epidemic Preparedness Innovations (CEPI) expand partnership on chikungunya vaccine post-marketing trial by $41.3M, aiming to support broader vaccine access in low- and middle-income countries.
Vaccine, chikungunya virus - Read more

THE GOOD
Politics & Policy

President Biden bows out of presidential race, touts drug pricing achievements during his tenure including Medicare price negotiations through the 2022 Inflation Reduction Act
Drug pricing, Inflation Reduction Act (IRA) - Read more 

North Carolina Medicaid to begin covering weight-loss meds
GLP-1, obesity, weight-loss - Read more

THE GOOD
Product Launches

Takeda’s Eohilia launch looks to be paying off, according to physician survey when compared to Sanofi, Regeneron's blockbuster Dupixent
Small molecule, eosinophilic esophagitis, inflammatory disease - Read more

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THE BAD
IPOs

Actuate Therapeutics cuts upcoming IPO plans in half by reducing # of available shares, expected raise now $22M
Small molecule, pancreatic cancer - Read more

THE BAD
Layoffs

RAPT Therapeutics cuts 40% of workforce (47 positions) after shutting down pair of autoimmune studies after FDA clinical hold
Small molecule, atopic dermatitis, asthma, autoimmune - Read more

Sino Biopharm's invoX restructuring could affect up to 60 roles
Bispecific antibody, cancer, asthma, chronic obstructive pulmonary disease - Read more [Paywall]

THE BAD
Politics & Policy

WuXi AppTec triples Biosecure Act lobbying to $360k
Biosecure act, protectionism, national security - Read more [Paywall]

Echoing Vertex Pharmaceuticals issues, bluebird bio receives HHS thumbs down for gene therapy fertility support program
Gene therapy, fertility, Department of Health & Human Services - Read more

THE BAD
Strategic Plans

MEI Pharma seeking “strategic alternatives” after failed merger with Infinity Pharma last year
Small molecule, cancer - Read more 

THE UGLY
Criminal Acts

Allarity Therapeutics hit with SEC Wells notice over alleged securities law violations
Security trading laws, small molecule, renal cell carcinoma, cancer - Read more

THE UGLY
Patient Access

Audits finds that PBM Express Scripts overcharged US Postal Service employees’ prescription meds by $45M between 2016 and 2021.
Pharmacy Benefit Manager, drug pricing - Read more [Paywall]

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