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THE GOOD
Approvals & Labels

Legend Biotech lands China NMPA approval for cilta-cel CAR-T therapy
CAR-T cell therapy, multiple myeloma, cancer - Read more

JW Therapeutics also lands China NMPA approval for their CAR-T cell therapy Carteyva
CAR-T cell therapy, lymphoma, cancer - Read more

Roche’s once-monthly PiaSky nabs European Commission approval
Monoclonal antibody, paroxysmal nocturnal haemoglobinuria - Read more

Basilea Pharmaceutica scores European Commission pediatric use decision for Cresemba, triggers CHF10M ($11.9M) milestone payment from Pfizer
Small molecule, fungal infection, invasive aspergillosis, mucormycosis - Read more

ARS Pharmaceuticals’ Eurneffy (adrenaline nasal spray) gains European Commission approval
Small molecule, adrenaline, sever allergic reaction - Read more

Janssen (Johnson & Johnson) lands indication extension for Rybrevant (in combination with chemo) for lung cancer
Bispecific monoclonal antibody, lung cancer - Read more

Insulet’s automated insulin pump cleared for type 2 diabetes by FDA
Medical device, insulin delivery, type 2 diabetes - Read more

Illumina lands FDA approval for cancer biomarker test
Cancer detection, biomarker, diagnostics - Read more

THE GOOD
Business Development

Salubris Pharmaceuticals secures in-China rights to YolTech Therapeutics gene-editing clinical asset YOLT-101 for CN¥205M ($28.7M)
Gene editing, base editing, heterozygous familial hypercholesterolemia (FH), established atherosclerotic cardiovascular disease, uncontrolled low-density lipoprotein cholesterol - Read more

THE GOOD
Clinical Trials

Vaderis Therapeutics’ touts positive Ph1 data with VAD044 in reducing nosebleed caused by hereditary hemorrhagic telangiectasia
Small molecule, hereditary hemorrhagic telangiectasia, bleeding disorder - Read more

Invivyd’s COVID-19 prophylaxis therapy Pemgarda succeeds in Ph3, though FDA tempers expectations with variant comment
Monoclonal antibody, COVID-10, prophylaxis - Read more

Merck & Co. initiaties Ph3 trial for bomedemstat in rare blood disorder
Small molecule, essential thrombocythemia - Read more

THE GOOD
Company Launches

Navigator Medicines launches with $100M Series A, backed by RA Capital and Forbion, with assets in-licensed from IMBiologics
Bispecific antibody, rheumatoid arthritis, autoimmune - Read more

Tern Therapeutics launches with $15M and two gene therapies in-licensing agreement with Regenxbio
Gene therapy, CLN2 disease, Batten Disease - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Redalpine closes $200M fund, investment goals include biotech
Venture capital, biopharma funding - Read more

Elektrofi aiming for $112M Series C ($96M raised thus far)
Biologics, drug delivery - Read more [Paywall]

Arcus Biosciences secures up to $250M loan facility
Monoclonal antibody, cancer - Read more

Two groups at University of Illinois Urbana-Champaign lands $54M in grants from US Advanced Research Projects Agency for Health (ARPA-H)
Cancer research, 3D tumor model, tumor removal verification, AI - Read more

Dewpoint Therapeutics lands Target ALS Foundation grant
Condensate-modifying compound, amyotrophic lateral sclerosis (ALS) - Read more

Ensysce receives $14M NIH grant for further developing PF614-MPAR
Small molecule, pain relief, opioid use disorder - Read more

THE GOOD
Investments

AstraZeneca plans manufacturing site expansion in Södertälje, Sweden, $135M earmarked
Drug manufacturing, biologics - Read more

THE GOOD
IPOs

Duality Biologics files for IPO in Hong Kong
Antibody-drug conjugate, solid tumor, cancer - Read more [Paywall]

THE GOOD
Partnerships

Indivior takes on future development for unnamed clinical asset targeting substance use disorder as part of Addex Therapeutics partnership; $300M biobucks + royalties
Small molecule, substance use disorder - Read more

GC Cell, DewCell BioTherapeutics partner on manufacturing stem-cell based allogeneic cell therapies
Stem cell-derived cell therapy, allogeneic cell therapy, CDMO, drug manufacturing - Read more [Original press release in Korean]

THE GOOD
Strategic Plans

Pfizer launches direct-to-consumer (DTC) telehealth and prescription med service
Direct-to-consumer, medication access, telehealth - Read more

Eli Lilly to offer single-vials of of Zepbound (without the autoinjector) at a nearly 50% discount
GLP-1, obesity - Read more

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THE BAD
Clinical Trials

A name change didn’t save COSCIENS Biopharma’s macimorelin Ph3 trial, misses primary endpoint
Small molecule, childhood onset growth hormone deficiency - Read more

Molecular Partners identifies “sub-optimal exposure” as explanation to limited response rate in MP0533 Ph1/2a trial
Tetra-specific T-cell engager, myeloid leukemia, myelodysplastic syndrome, cancer - Read more

THE BAD
Lawsuits

Trade org BIO files amicus brief against IRA drug pricing controls
Inflation reduction act, drug pricing - Read more

Ipsen sues Conjupro Biotherapeutics over alleged Onivyde patent infringement
Small molecule, pancreatic cancer - Read more [Paywall]

THE BAD
Layoffs

Emergent BioSolutions to cut up to 70 roles at Lansing, Michigan site
CDMO, small molecule, opioid overdose reversal - Read more [Paywall]

THE BAD
Politics & Policy

Expanding Medicare access of Novo Nordisk’s semaglutide to patients with cardiovascular disease who are obese/overweight could cost $145B annually; study
GLP-1, obesity, weight loss, cardiovascular disease - Read more

THE BAD
Regulatory

FDA’s CGT “platform” tech draft guidance needs clarification, says US BARDA and select biopharma players
Cell therapy, gene therapy, platform technology, draft guidance - Read more [Paywall]

THE UGLY
Approvals & Labels

Nearly half of 521 FDA approved AI/ML-enabled medical devices lack clinical validation data; study
Medical device, AI, machine learning - Read more

THE UGLY
Clinical Trials

Oculis shutters a OCS-01 Ph3 trial due to a “third-party administrative error” (though existing data is good enough to submit according to FDA)
Small molecule, diabetic macular edema, post-operative inflammation and pain following ocular surgery - Read more

THE UGLY
Criminal Acts

US district judge states that price-fixing trial can proceed against Jazz Pharmaceuticals, Hikma Pharmaceuticals regarding alleged delayed Xyrem generic market entry
Small molecule, narcolepsy, generic, price fixing - Read more

THE UGLY
Politics & Policy

SCOTUS Chevron doctrine overturning has grave biopharma implications
Chevron doctrine, drug regulations - Read more

THE UGLY
Public Health

US reports first 21 cases of sloth fever, oropouche virus
Viral infection, infectious disease - Read more

THE UGLY
Withdrawals & Recalls

Sanofi halts China flu vaccine roll-out (Vaxigrip and VaxigripTetra) due to declining potency concerns
Flu vaccine, vaccine distribution - Read more

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

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