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THE GOOD
Approvals & Labels

Two times the charm for ARS Pharmaceuticals, landing FDA approval for epinephrine nasal spary
Small molecule, epinephrine, anaphylaxis - Read more

Alfasigma lands September FDA adcomm
Small molecule, primary biliary cholangitis (PBC), autoimmune, liver disease - Read more [Paywall]

THE GOOD
Business Development

Merck & Co. pays up to $1.3B for bispecific antibody asset from Curon Biopharmaceutical
Bispecific antibody, lymphoma, leukaemia, cancer - Read more

Gilead thinks they’re sitting on something big, buys out Johnson & Johnson royalty rights to PBC med for $320M
Small molecule, primary biliary cholangitis (PBC), autoimmune, liver disease - Read more

Humanetics lands $3M from US Department of Defense (DOD) 
Small molecule, radiation countermeasure - Read more

THE GOOD
Clinical Trials

Visen Pharmaceuticals’ hypothyroidism med smashes primary and secondary endpoints
Small molecule, hypoparathyroidism - Read more

Avidity Biosciences positive Ph1/2 DMD readout might have Sarepta Therapeutics a bit concerned
Biologic, oligomer, Duchenne muscular dystrophy (DMD) - Read more

Neuren Pharmaceuticals posts positive Ph2 Angelman syndrome trial data
Small molecule, Angelman syndrome - Read more

4D Molecular Therapeutics Fabry disease gene therapy FDA clinical hold lifted
Gene therapy, Fabry disease - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Company Launches

Kano Therapeutics launches with a “new class of biomaterial”
Single strand DNA, gene correction - Read more [Paywall]

THE GOOD
Earnings & Finances

Novartis spin-off Sandoz raises 2024 guidance as Humira biosimilar sales chung along
Monoclonal antibody, biosimilar, autoimmune - Read more

THE GOOD
Fundraises

Zevra Therapeutics public offering up to $60M
Small molecule, urea cycle disorder, attention-deficit/hyperactivity disorder (ADHD) - Read more

Mind Medicine (MindMed) public offering
Small molecule, psychedelic, anxiety disorder, autism spectrum disorder - Read more

Arrowhead Pharmaceuticals $500M strategic financing
RNA, lipid disorders - Read more

THE GOOD
Investments

Amgen to open new office in India - Read more

Vivint Pharma to build $48M injectable manufacturing plant in India
Manufacturing, injectables - Read more

THE GOOD
Mergers & Acquisitions

North­east Phar­ma­ceu­ti­cal Group begins proceedings to purchase controlling stake in Bei­jing DC­TY Biotech
CAR-T cell therapy, TCR-T cell ther­a­py, solid tumor, cancer - Read more (original press release in Chinese)

THE GOOD
Partnerships

Chimeric Therapeutics enters development/manufacturing partnership with Cell Therapies
CDMO, cell therapy, manufacturing - Read more

THE GOOD
Regulatory

German vaccine advisory panel recommends either GSK’s or Pfizer’s RSV vaccine for adults aged 75 or older
Vaccine, respiratory syncytial virus (RSV) - Read more

Big pharma players including Gilead, Genentech voice feedback on FDA’s new research inspections draft guidance
Site inspections, draft guidance - Read more [Paywall]

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THE BAD
Clinical Trials

Inovio Pharmaceuticals hits manufacturing issue during BLA submission process
DNA-based medicine, Human papillomavirus (HPV) related diseases, recurrent respiratory papillomatosis (RRP) - Read more

Cabaletta Bio reports CAR-T adverse event in autoimmune trial
CAR-T cell therapy, lupus, autoimmune - Read more

THE BAD
Lawsuits

Another IRA suit dismissed, this one brought by the US Chamber of Commerce
Inflation reduction act - Read more 

THE BAD
Layoffs

AN2 Therapeutics to cut half of staff by EOY, drops their lead asset in Ph2/3
Small molecule, Mycobacterium avium complex (MAC) lung disease - Read more

THE BAD
Strategic Plans

With COVID vaccines’ money-making era basically over, Novavax looks to offload a manufacturing site
COVID-19 vaccine, manufacturing - Read more

23andMe cuts drug discovery arm and instead turns to…hawking GLP-1 prescriptions?
GLP-1, obesity, genetic testing - Read more [Paywall]

Zentalis Pharmaceuticals discontinues leukaemia combo therapy development
Small molecule, leukaemia, cancer - Read more

THE UGLY
Marketing

Novo Nordisk runs afoul of UK drug marketing rules (again)
Obesity, weight loss - Read more

THE UGLY
Research

Lykos Therapeutics’ (self-inflicted) insult to injury as redactions hit 3 of their published papers
Small molecule, MDMA-assisted psychotherapy, psychedelic, post-traumatic stress disorder (PTD) - Read more

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

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