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THE GOOD
Approvals & Labels

AstraZeneca Imfinzi lung cancer regimen approved by UK’s MHRA
Monoclonal antibody, lung cancer - Read more

Zevra Therapeutics gets 2nd shot at rare disease approval, FDA advisory committee convening in August
Small molecule, Niemann-Pick disease type C - Read more

Roche lands EU approval for AI-powered continuous glucose monitoring system
Glucose monitoring, medical device, diabetes - Read more

Alteogen lands approval from South Korea’s MFDS
Recombinant protein, anaesthetic, pain relief - Read more

Mirum Pharmaceuticals lands EMA approval for rare liver disease indication
Small molecule, progressive familial intrahepatic cholestasis - Read more

PharmaMar gets another approval chance after conflict of interest discovered on EMA’s initial review committee
Cyclic peptide, multiple myeloma, cancer - Read more

THE GOOD
Clinical Trials

uniQure flaunts Ph1/2 Huntington’s data, stock skyrockets
Gene therapy, Huntington’s - Read more

Kymera Therapeutics’ experimental disease drug sees expanded Ph2 interest from partner Sanofi
Small molecule, hidradenitis suppurativa, atopic dermatitis - Read more

Interius BioTherapeutics in-vivo CAR-T/CAR-NK Ph1 greenlit by Australian TGA
In-vivo cell therapy, CAR-T, CAR-NK, B cell malignancy, cancer - Read more

THE GOOD
Fundraises

SciRhom $70M Series A to bring novel inflammatory-fighting antibody to the clinic
SciRhom, rheumatoid arthritis, inflammatory bowel disease - Read more

Biovance Capital Partners fund launch, €51M ($55.1M)
Early-stage biotech investing, southern Europe - Read more

Dioseve $7M raise
Reproductive technology, induced pluripotent stem cells (iPSCs, iPS cells) - Read more

Heidelberg Epignostix €4.3M ($4.65M) Seed raise
Cancer diagnostics, AI, bioinformatics - Read more

Endoron Medical $10M Series A
Medical device, endograft solutions, abdominal aortic aneurysms - Read more

Courier Health $16.5M Series A
Customer relationship management, specialty pharma, patient access - Read more

THE GOOD
Lawsuits

J&J settles with Emergent BioSolutions, $50M
Manufacturing, Covid-19 vaccine - Read more

J&J avoids South Africa antitrust action by dropping TB med price by 40%
Small molecule, tuberculosis - Read more

THE GOOD
Mergers & Acquisitions

MedPharma and Tergus Pharma merger, contract services for topical and transepithelial pharmaceuticals
CDMO, contract service - Read more

THE GOOD
Partnerships

Evotec, Sandoz expand biosimilar manufacturing pact
Manufacturing, biosimilar, commercial supply - Read more

Moderna, Mitsubishi Tanabe partner on Japan promotional strategy for mRNA respiratory vaccines
mRNA, Covid-19 - Read more

THE GOOD
Research

Infinity Pharmaceuticals’ resurrected asset shows promise in lung viral infections; mice studies
Covid-19, methicillin-resistant staphylococcus aureus (MRSA) - Read more

Study identified super active vaccine adjuvant, potential impacts on future vaccine development and efficacy; mice studies
Small molecule, vaccine adjuvant - Read more 

THE GOOD
Strategic Plans

AEON Biopharma points lead compound towards biosimilar approval pathway with Abbvie’s BOTOX as reference
Botulinum toxin, cervical dystonia - Read more

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THE BAD
Clinical Trials

Amgen makes “business decision” to drop solid tumor-targeting bispecific engager in Ph1
Bispecific T cell engager, fusion protein, solid tumor, cancer - Read more

THE BAD
Patient Access

Survey finds “Screening Action Gap” in US women’s population - acknowledging the importance of preventative screening, but still delaying/skipping out - Read more

THE BAD
Strategic Plans

Pfizer R&D chief steps down - Read more

THE UGLY
Lawsuits

Intellia Therapeutics accused on infringing on BlueAllele’s patents, including through a $100M collab with Regeneron
Gene-editing, gene insertion, patent violation - Read more [Paywall]

Purdue Pharma’s Sackler family back to negotiating table, damages could be over $1 trillion if new settlement not reached
Opioid epidemic, oxycontin - Read more

THE UGLY
Patient Access

FTC holds nothing back against pharmacy supply managers
Anticompetitive, profiteering, drug supply chain - Read more

THE UGLY
Politics & Policy

US House speaker wants to move BIOSECURE Act into law this year
BIOSECURE ACT, protectionism, national security - Read more 

THE UGLY
Withdrawals & Recalls

Inspire Medical handed FDA Class 1 recall for sleep apnea device
Medical device, obstructive sleep apnea - Read more 

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

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