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Regulatory

CYBN

Cybin Inc. has secured a US patent for its CYB005 phenethylamines program, focusing on non-hallucinogenic treatments for CNS disorders. This patent supports Cybin's innovative development beyond its clinical tryptamine programs. The company is also advancing its CYB003 and CYB004 programs, with significant upcoming trials and results expected in 2024.

Portfolio Pulse from Vandana Singh

October 24, 2024 | 11:01 am

CYBN

Cybin has announced the grant of its first U.S. Composition of Matter Patent for its CYB005 phenethylamines program, marking a significant milestone for the company.

Portfolio Pulse from Benzinga Newsdesk

October 24, 2024 | 11:00 am

MRK

Merck announced that the European Commission has approved two new indications for KEYTRUDA, its anti-PD-1 therapy, in gynecologic cancers. This includes the first EU approval for KEYTRUDA combined with chemotherapy for patients with primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status.

Portfolio Pulse from Benzinga Newsdesk

October 24, 2024 | 10:47 am

HALO

Halozyme Therapeutics announced that the European Patent Office's decision to revoke a Janssen co-formulation patent for DARZALEX will not impact its US or European royalty revenues from DARZALEX FASPRO and SC through 2032. The company reaffirmed its guidance.

Portfolio Pulse from Benzinga Newsdesk

October 24, 2024 | 10:33 am

MRK

The CDC has recommended Merck's CAPVAXIVE vaccine for adults aged 50 and older, expanding protection against invasive pneumococcal disease. This recommendation lowers the age for vaccination from 65 to 50 years. CAPVAXIVE covers 84% of disease-causing serotypes, compared to 52% by PCV20.

Portfolio Pulse from Benzinga Newsdesk

October 24, 2024 | 6:50 am

PHAR

Pharming Group reaffirms its 2024 revenue guidance of $280M-$295M, indicating 14% to 20% growth. The company plans to increase revenues through patient conversion to Joenja® therapy, expand leniolisib's market presence, and pursue regulatory approvals globally. They are also exploring acquisitions in rare diseases.

Portfolio Pulse from Benzinga Newsdesk

October 24, 2024 | 5:42 am

HIMS

LLY

NVO

Novo Nordisk has requested the FDA to halt the production of compounded versions of its drugs Wegovy and Ozempic due to safety concerns. The demand for these cheaper alternatives has increased due to shortages and high costs of the branded drugs. Novo Nordisk is also involved in legal actions against compounding pharmacies.

Portfolio Pulse from Shivdeep Dhaliwal

October 24, 2024 | 12:23 am

CTNT

Trading for an unspecified asset was halted at 7:50:00 p.m. ET due to pending news. The halt indicates that significant information is expected to be released, which could impact the asset's price.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2024 | 11:50 pm

AMGN

AZN

CTLT

GPCR

NVO

PFE

RHHBY

VKTX

Roche's Q3 sales rose 9% to $17.5 billion, driven by Ocrevus and Vabysmo. Roche urges regulators to block Novo Holdings' $16.5B acquisition of Catalent, citing potential negative industry impacts. The acquisition could affect competition in the GLP-1 market, where several companies, including Roche, have therapies in development.

Portfolio Pulse from Vandana Singh

October 23, 2024 | 11:05 pm

GRAL

GRAIL presented early results from the REFLECTION Real-World Evidence Study, showing that a veteran cohort had a cancer signal detection rate consistent with other populations using the MCED test. The findings were shared at the 2024 Early Detection of Cancer Conference.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2024 | 10:06 pm