As it navigates product transition in ophthalmology against biosimilar and branded rivals, Regeneron seems to have a simpler challenge in another major therapeutic area.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

ArsenalBio closed one of the largest VC rounds so far in 2024, raising $325m in series C funding, while Vaxcyte grossed $1.3bn in a follow-on offering. Also, Circle Pharma closed a $90m series D round and Jazz priced an $850m note sale, but IN8bio revealed a prioritization plan and job cuts.

Recent moves in the industry include C-suite shuffle at Quantum Biopharma, Affimed and GH Research, plus Belite Bio and Dyne Therapeutics get new chief medical officers.

Human milk could have a role in preventing Alzheimer’s disease and other ailments linked to the gut microbiome, says former Pfizer VP and Hilleman CEO Davinder Gill. He also talks about a halal meningitis vaccine, and tailwinds for an oral cholera vaccine now launched by Bharat Biotech in this fascinating interview

“For 20 or 30 years, we were not seen as a scientific leader,” the French major’s CEO tells Scrip. Now, things have started to change with several positive readouts coming out of its immunology portfolio.

Following the pivotal data on Alnylam’s Amvuttra, all eyes turn to the next amyloidosis readout – that of AstraZeneca and Ionis’ Wainua. And the UK major’s ambitions do not stop there.

The company has created a single end-to-end cancer R&D organization to help it meet its ambitious oncology goals. Its chief medical officer Cristian Massacesi talks to Scrip about how developments in conducting clinical trials will help.

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.

Lilly and Novo Nordisk were top performers among large-cap pharma stocks, while the stock prices of Bristol Myers and Gilead declined the most.

Six biopharma companies have filed to list their shares on US exchanges so far this year, but the sums they are seeking are small.

Without a mega-merger like 2023’s Pfizer/Seagan takeout, M&A deals grew smaller during the first half of 2024, while volume rose. In alliance deals, H1 2024 activity somewhat mirrored activity from H1 2023.

GSK’s ultra-long-acting biologic cuts asthma attacks, but misses on all the secondary endpoints in the twin SWIFT trials could limit its appeal.

The cash-strapped Danish biotech has got some positive news flow on its vaccines for gonorrhea and melanoma and believes that Phase II data on the latter in particular will attract attention at the major oncology conference kicking off in Barcelona this week.

As it navigates product transition in ophthalmology against biosimilar and branded rivals, Regeneron seems to have a simpler challenge in another major therapeutic area.

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

In a multiple-ascending dose Phase I trial, Terns’ oral GLP-1 agonist showed 4.9% placebo-adjusted weight loss at 28 weeks, with no severe gastrointestinal side effects.

The firm is planning a head-to-head trial against AstraZeneca’s Truqap after RLY-2608 showed better safety and efficacy in a Phase I trial, including a four-month PFS benefit.

The Roivant-owned company announced positive Phase II data for batoclimab in Graves’ disease and plans to advance next-generation IMVT-1402 into Phase III.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Human milk could have a role in preventing Alzheimer’s disease and other ailments linked to the gut microbiome, says former Pfizer VP and Hilleman CEO Davinder Gill. He also talks about a halal meningitis vaccine, and tailwinds for an oral cholera vaccine now launched by Bharat Biotech in this fascinating interview

Ivonescimab has shown significant and "extremely commercially meaningful" improvements in progression-free survival versus Keytruda as a first-line therapy for lung cancer in a trial in China, potentially positioning it as a new chemo-free solution for all PD-L1-positive patients in this setting.

In this week's podcast edition of Five Must-Know Things: J&J interested in differentiated obesity assets; Kerendia hits in heart failure; strong HERCULES data keep Sanofi’s MS plans alive; WCLC preview; and Mankind sets eyes on 5x growth.

Survival and other benefits with J&J’s EGFR/MET inhibitor Rybrevant plus EGFR inhibitor Lazcluze relative to AstraZeneca’s Tagrisso in first-line EGFR-mutant NSCLC continued to improve at 31.1 months.