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THE GOOD
Approvals & Labels

Pfizer, BioNTech and Moderna updated COVID shots get FDA seal of approval
mRNA, COVID-19 vaccine - Read more

Biogen, Eisai’s Leqembi lands UK MHRA approval, though NICE isn’t convinced enough on dollar value to recommend
Monoclonal antibody, Alzheimer’s disease - Read more

Shanghai Henlius Biotech’s trastuzumab biosimilar (Herceptin, Genentech) nabs Health Canada approval
Monoclonal antibody, biosimilar, breast cancer, gastric cancer - Read more

Innovent Biologics Dupert small molecule scores China NMPA approval
Small molecule, lung cancer - Read more

THE GOOD
Business Development

WuXi Biologics keeps up the positive vibes despite Biosecure threats; added 61 new projects in H1 2024
CDMO, Biosecure act, manufacturing - Read more

THE GOOD
Clinical Trials

Skye Bioscience has high ambitions for cannabinoid receptor 1-based obesity approach; moves nimacimab into Ph2
Monoclonal antibody, obesity - Read more

Virogin Biotech to present updated VG201 Ph1 data at 2024 ESMO conference
HSV-1 oncolytic virus, solid tumor, cancer - Read more

Cognition Therapeutics publishes Ph2 data for CT1812
Small molecule, Alzheimer’s disease - Read more

THE GOOD
Company Launches

Borealis Biosciences launches, with Versant Ventures and Novartis backing ($150M raise + $100M biobucks), will operate out of former Chinook Therapeutics facility
RNA, kidney disease - Read more

THE GOOD
Fundraises

Illumina Ventures sets out to raise third fund, $300M aim
Venture capital, healthcare investing - Read more [Paywall]

XII Medical $45M Series B
Medical device, neuromodulation, sleep apnea - Read more

PhotonPharma $2.5M seed raise
Autologous cell therapy, solid tumor, cancer - Read more

Nadmed €3.5M ($3.9M) Series A
Blood test, colorimetric quantification, NAD testing - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
IPOs

Zenas BioPharma plans $100M (up to $150M) IPO
Bifunctional monoclonal antibody, IgG4-related disease, multiple sclerosis (MS), systemic lupus erythematosus (SLE) - Read more

Bicara Therapeutics aims for $200M IPO
Bifunctional antibody, head & neck cancer - Read more

THE GOOD
Mergers & Acquisitions

Rafael Holdings, Cyclo Therapeutics announce merger
Small molecule, cyclic oligosaccharide, Niemann-Pick disease type C1 - Read more

Vion Biosciences acquires Echelon Biosciences, terms not disclosed
Life science specialty reagents, drug discovery - Read more

BioIVT buys ZenBio, terms not disclosed
Biospecimen services, human and animal tissues - Read more

THE GOOD
Partnerships

Eli Lilly expands antibody discovery partnership with Oblique Therapeutics
Monoclonal antibody, drug discovery - Read more

Bridge Biotherapeutics, HitGen drug discovery partnership
Small molecule, drug discovery, oncology, cancer - Read more

THE GOOD
Public Health

Bavarian Nordic nabs 440k mpox vaccine order from unnamed European country
Vaccine, monkeypox (mpox) - Read more

THE GOOD
Research

Columbia University medical school lands $400M donation from former Merck & Co. chair and CEO
Medical research, donation - Read more [Paywall]

THE GOOD
Strategic Plans

Open Sesame as healthcare marketplace offers compounded semaglutide
GLP-1, weight loss, obesity - Read more

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THE BAD
Approvals & Labels

Intarcia’s FDA appeal rejected for their type 2 diabetes drug/device combo
GLP-1, medical device, type 2 diabetes - Read more [Paywall]

THE BAD
Earnings & Finances

Despite inking 61 new projects, WuXi Biologics net profit sinks 24% in H1 2024 (compared to H1 2023)
CDMO, Biosecure act, manufacturing - Read more

THE BAD
Lawsuits

Liquidia sues FDA over recent approval with exclusivity condition to competitor United Therapeutics
Small molecule, pulmonary arterial hypertension (PAH), PH associated with with interstitial lung disease - Read more

THE BAD
Politics & Policy

Texas federal judge overturns FTC’s recent non-compete decision, with healthcare implications
Noncompete clause - Read more

THE BAD
Regulatory

FDA mulls limiting PD-1 meds in stomach cancer, calls adcomm targeting approved meds from Merck & Co., Bristol Myers Squibb, BeiGene
Monoclonal antibody, stomach cancer, esophageal cancer - Read more

THE BAD
Strategic Plans

Tome Biosciences, despite $213M raise in December ‘23, is struggling bad, considering “strategic options”; anonymous sources
Gene editing, phenylketonuria (PKU), CAR-iNK cell therapy, autoimmune - Read more

THE UGLY
Marketing

Vertex Pharmaceuticals draws UK’s MHRA ire over regulation-breaching LinkedIn post
Drug marketing, Medicines and Healthcare products Regulatory Agency - Read more

THE UGLY
Opinions

US biopharma industry unprepared for Biosecure repercussion
Biosecure act, biopharma manufacturing, supply chain - Read more

THE UGLY
Patient Access

High GIP/GLP-1 costs in the US are driving some to tamper with injectors, dosing
GLP-1, obesity, weight loss - Read more [Paywall]

THE UGLY
Public Health

Thailand reports Asia’s first infection with latest mpox strain
Infectious disease, monkeypox (mpox) - Read more [Paywall]

THE UGLY
Regulatory

FDA defends former CDRH head after conflict of interest, ethics concerns raised by The New York Times
Medical device, Center for Devices and Radiological Health - Read more 

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

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