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.

Recent moves in the industry include C-suite shuffle at Armis Biopharma, plus Voyager Therapeutics acquires chief financial officer from Vor Biopharma.

When loss-making biotech companies mix debt with sluggish sales, difficult options like restructuring and asset sales remain.

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.

IGBA's secretary general, in an interview with Scrip, bolsters the case for enabling single global development of off-patent medicines and the acceptance of foreign comparators in bioequivalence studies as complex and niche therapeutics increasingly dot pharma’s pipeline. The global off-patent industry association, she maintained, is also “paying attention” to patent quality in various regions.

In a major boost for the UK biotech sector, an impressive sum has been raised by Beacon Therapeutics to support its R&D activities in ophthalmic gene therapies.

Sutro Biopharma CEO Bill Newell spoke with Scrip about the company’s novel platform, its goal of improving folate receptor alpha-driven ovarian cancer and its business development strategy.

Scrip spoke with Amgen’s senior VP of US business operations about the impact of drug pricing and reimbursement pressures coming from government policy changes and commercial payers.

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.

Keytruda enjoyed its fifth consecutive quarter as the world’s top-selling drug in the first three months of 2024. As Comirnaty and Spikevax fell out of the list, Vertex’s cystic fibrosis pill Trikafta/Kaftrio became one of the top 10 best-selling drugs for the first time.

J&J topped the league table for CEO pay in 2023, a position it has held for three of the four past years. Meanwhile, the two companies that arguably generated the most buzz in 2023 neatly depict the stark contrast between the US and Europe when it comes to executive remuneration.

With several new drugs progressing for the estimated 70,000 patients in China with DMD, a recent setback for Nippon Shinyaku's contender and progress for Chinese gene therapy developers are adding both uncertainty and likely competition in an untapped market with pressing medical need.

An analysis of the most valuable research-stage products pinpoints several neurological candidates – and a deeper dive into this segment shows more CNS therapies that look to be worth big money.

Chairman Sir Nigel Rudd said re-registering as a private company is necessary to provide Destiny Pharma with a realistic chance of securing the capital required to progress XF-73 Nasal through clinical trials, without which “liquidation of the company is the most likely alternative.”

After missing statistical significance in PD-L1+ head-and-neck cancer, Immutep presents data showing eftilagimod with Keytruda can offer efficacy in PD-L1-negative patients.

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.

The drug maker said the US FDA issued a complete response letter for insulin icodec that included requests related to manufacturing process and the type 1 diabetes indication.

A modified-release formulation of the oral GLP-1 has been selected for development, Pfizer said. Dose-optimization studies will begin in the second half of the year.

Recent moves in the industry include C-suite shuffle at Armis Biopharma, plus Voyager Therapeutics acquires chief financial officer from Vor Biopharma.

Biotechs have had a difficult time raising cash through flotations over the past quarter, with one stepping away altogether.

Deal Snapshot: Ipsen has entered into a global licensing agreement with Foreseen Biotechnology potentially worth up to $1.03bn, its second antibody-drug conjugate tie-up this year, a few months after unveiling a partnership with Sutro.

Having initiated China-only Phase III trials with three oncology and autoimmune drug candidates, HUTCHMED is looking for partnerships to take the molecules to the clinic in the US.

The US Federal Trade Commission’s focus on potential anti-competitive behavior by pharmacy benefit managers picks up steam as Chair Lina Khan approaches the end of her term.

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.