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THE GOOD
Approvals & Labels

Sangamo Therapeutics bullish on FDA accelerated approval odds for it’s Fabry disease gene therapy isaralgagene civaparvovec without registrational trial
Gene therapy, Fabry disease - Read more

Peytant Solutions airway stent lands FDA de novo clearance
Medical device, airway stent - Read more

THE GOOD
Business Development

Samsung Biologics signs monster $1.2B contract manufacturing deal with undisclosed “Asia-based” drugmaker
CDMO, contract manufacturing, biologics - Read more

MacroGenics sells commercial asset Margenza to TerSera Therapeutics for $40M upfront + $35M biobucks
Monoclonal antibody, breast cancer - Read more

Twist Bioscience makes royalty pact with XOMA Royalty, $15M upfront in exchange for half future milestones/royalties from existing partnerships
Antibody, drug discovery, royalty agreement - Read more

THE GOOD
Clinical Trials

Minghui Pharmaceuticals’ positive Ph1b/2 data with MHB018A fusion protein in thyroid eye disease
Fusion protein, thyroid eye disease - Read more

Otsuka Pharmaceuticals rare kidney disease mAb sibeprenlimab passes Ph3 with flying colors
Monoclonal antibody, IgA nephropathy, kidney disease - Read more

Innovent Biologics touts Ph2 data with Efdamrofusp alfa in nAMD
Fusion protein, neovascular age-related macular degeneration (nAMD) - Read more

Annexon showcases positive Ph2 data for ANX007 in geographic atrophy due to dry AMD
Monoclonal antibody, geographic atrophy (GA), dry age-related macular degeneration (AMD) - Read more

THE GOOD
Company Incubation

Rice University launches RBL LLC, a new biotech venture creation studio
Company creation, venture studio - Read more

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THE GOOD
Company Launches

Telix Pharmaceuticals, Heidelberg University Hospital launch new radiopharma developer Rhine Bio
Radiopharma, prostrate cancer, theranostic - Read more

Passkey Therapeutics launches with $20M and push to target “multi-factorial” diseases (beyond single protein - single molecule interactions)
Synergistic multifunctional therapeutics, drug discovery - Read more

THE GOOD
Fundraises

AvenCell $112M Series B
Cell therapy, myeloid leukaemia, CAR-T, cancer - Read more

Be Biopharma $82M Financing
Cell therapy, hemophilia B, hypophosphatasia, engineer B cells - Read more

THE GOOD
Partnerships

Editas Medicine, Genevant Sciences partner to develop LNP-delivered gene-editing platform
Gene-editing, platform development, in-vivo therapeutics - Read more

AFT Pharmaceuticals enters R&D agreement with two undisclosed partners for a “novel injectable medicine”
Undisclosed modality, undisclosed disease area - Read more

Molecular Partners, Orano Med strengthen radiopharma development agreement
Radiopharma, cancer, Radio-DARPin therapeutics - Read more

RedHill Biopharma partners with “leading academic medical center” to develop Opaganib as phosgene injury countermeasure
Small molecule, phosgene inhalation injury - Read more

Bright Minds Biosciences, Firefly Neuroscience partner to assess Ph2 trial of BMB-101
Small molecule(?), absence epilepsy, developmental epileptic encephalopathy - Read more

Nvidia, Aidoc partner to help healthcare systems better integrate AI workflows
AI, healthcare efficiency, healthcare IT - Read more

THE GOOD
Product Launches

Dotmatics launches new discovery/development software for therapeutic antibodies
Antibody, drug discovery, drug development, software - Read more

Amgen preps Eylea biosimilar launch as Regeneron loses blocking bid
Fusion protein, wet age-related macular degeneration (wet AMD), biosimilar - Read more

THE GOOD
Research

Rectify Pharma chooses lead candidate and presents promising mouse model data in rare liver disease PSC
Small molecule, primary sclerosing cholangitis, liver disease - Read more

THE GOOD
Strategic Plans

Editas goes full pivot, focusing on in-vivo gene editing and looks to offload ex vivo clinical stage asset reni-cel
Gene editing, sickle cell, beta thalassemia - Read more

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THE BAD
Approvals & Labels

Camurus’ octreotide extended release hit with FDA CRL due to 3rd-party manufacturing issues
Small molecule peptide, acromegaly - Read more

THE BAD
Business Development

Starboard Value provides details on Kenvue complaints
Consumer health, activist investor - Read more

Starboard Value also provides specific on proposed Pfizer turnaround, says that “the board needs to actively hold management accountable“
Big pharma, activist investor - Read more

THE BAD
Clinical Trials

Mitsubishi Tanabe Pharma’s edaravone Ph3 data in ALS disappoints, once daily dosing shows no difference between on/off standard-of-care regimen
Small molecule, amyotrophic lateral sclerosis (ALS) - Read more

THE BAD
Partnerships

Genentech (Roche) exits partnership with UCB surrounding anti-tau mAb bepranemab (UCB0107)
Monoclonal antibody, Alzheimer’s disease - Read more

THE BAD
Politics & Policy

Suspicion falls on Eli Lilly, Pfizer DTC platforms regarding potential for anti-kickback law violations, “inapporpriate prescribing”
Direct to consumer, drug prescribing, kickbacks - Read more

Biosecure Act likely to pass in lame duck congress; DC-focused lawyer opinion
Biosecure act, geopolitics - Read more [Paywall]

THE UGLY
Lawsuits

US DOJ calls Johnson & Johnson’s Texas talc bankruptcy attempt “a textbook example of bad faith”
Talc, ovarian cancer - Read more

THE UGLY
Public Health

FDA reports E. coli outbreak amongst McDonald’s quarter pounders
Food-borne illness, E. coli - Read more

THE UGLY
Regulatory

FDA’s Robert Califf accosts big pharma for high-priced weight loss meds
Obesity, weight loss, drug pricing - Read more [Paywall]

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

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