BioNTech

Novavax received FDA approval to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long hold. The Phase III trial will evaluate the CIC vaccine's efficacy in adults aged 65 and older, comparing its immune response to standard flu and Covid-19 vaccines. Novavax aims to commence enrolment by the end of 2024 with preliminary results by mid-2025.

Novavax's COVID-19-influenza combination vaccine and stand-alone influenza vaccine candidates have had their clinical hold removed by the FDA after addressing safety concerns. The serious adverse event initially reported was unrelated to the vaccine, allowing for plans to resume Phase 3 trials.

Robert F. Kennedy Jr. may lead health policies under Trump, focusing on 'clean up corruption,' returning agencies to 'gold standard' of science, and 'Make America Healthy Again.' Kennedy supports capping drug prices, opposes vaccine mandates, and aims to shift NIH funding towards preventive health. He also seeks to reform drug ads and address obesity and chronic disease, though his anti-vaccine stance and criticism of pharma profit from chronic illness have raised concerns.

Ryvu Therapeutics reports Q1-Q3 2024 operating revenues of USD 18.6 million, with accelerated RVU120 Phase II study enrollment due to increased clinical site activation. The company's cash position is USD 58.1 million, providing a runway through Q1 2026. An Investor Event on RVU120 Phase II progress is scheduled for December 12.

Northwest High School's 2024 Biotechnology and Health Career and Internship Fair on Dec 11th connects students with biotech leaders, offering career panels, organization booths, and networking opportunities.

Synaffix and BigHat Biosciences collaborate to develop next-gen ADCs, combining Synaffix's ADC platform with BigHat's AI/ML-powered Milliner. The partnership aims to create safer, more effective treatments for difficult-to-treat cancers, leveraging Synaffix's conjugation and linker-payload technologies. ADCs, a growing $11.3 billion market, are seen as more effective and safer than conventional treatments, targeting cancers like blood, breast, urothelial, and bladder.

BioNTech reports Q3 2024 revenues of €1.2 billion, net profit of €198.1 million, and diluted earnings per share of €0.81. The company launched variant-adapted COVID-19 vaccines and initiated Phase 2 trials for BNT327/PM8002 in small-cell lung cancer and triple-negative breast cancer. A Phase 2 trial for mRNA-based individualized cancer vaccine candidate autogene cevumeran is on track for high-risk muscle-invasive urothelial cancer. BioNTech ended Q3 with €17.8 billion in cash and cash equivalents plus security investments, expecting to be at the low end of its full-year 2024 revenue guidance range of €2.5-3.1 billion.

Pharma companies like Merck and Moderna spend significantly more on R&D than medtech firms, but higher spending doesn’t always correlate with more innovation output. Medtronic, with 8.45% R&D intensity, generated 443 patents and 305 publications in 2023, while Moderna, spending 70.75% of revenue on R&D, produced only 27 patents and 245 publications. Medtech firms consistently show higher patent output per R&D dollar invested.

Crescent Biopharma, a Paragon Therapeutics spinout, merges with GlycoMimetics, raising $200M to advance cancer immunotherapy targeting PD-1 and VEGF. Crescent aims to improve upon standard treatments like Keytruda, with initial data expected in 2026. The merger is set to close in Q2 2025.