Biopharmaceuticals

Uppsala, Sweden – September 04, 2026 -- Orexo AB has reached a non-binding agreement in principle with the US Department of Justice to pay USD 4 million in installments over several years, closing a federal investigation that began in 2020.

Orexo agrees to capped contingent payment tied to 2030-2031 sales thresholds

Beyond the fixed USD 4 million payment, Orexo would accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales-related thresholds are met in 2030 and 2031 and Orexo's commercial products perform successfully in the market. The company is in the final stages of negotiating the settlement but cautions there is no assurance the deal will be finalized on these terms.

Uppsala, Sweden – September 04, 2026 -- Orexo AB has struck a non-binding agreement in principle with the US Department of Justice to settle a federal investigation that has run since 2020, the Swedish pharmaceutical company said.

Orexo to pay $4 million in installments over several years

Under the tentative terms, Orexo would pay USD 4 million in installments spread across multiple years. The company would also accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales thresholds are met in 2030-2031 and contingent on Orexo's commercial products performing well in the market.

STOCKHOLM – September 04, 2026 -- Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for patients with mild cognitive impairment or mild dementia due to early Alzheimer's disease, BioArctic AB's partner Eisai announced.

Final recommendation follows agency reconsideration process

The decision comes after CDA-AMC reconsidered its position on the drug, marking a step toward broader patient access in Canada. Negotiations will now proceed through the pan-Canadian Pharmaceutical Alliance, followed by individual reimbursement decisions from public drug plans across Canada's provinces and territories.

Sydney – September 04, 2026 -- Kazia Therapeutics Limited (NASDAQ: KZIA) has closed an oversubscribed, tranched public offering that generated approximately $40 million in upfront gross proceeds, with total potential proceeds reaching approximately $120 million if milestone-linked warrants are fully exercised.

Offering priced above market with milestone-triggered warrant premiums

The combined offering price was set at $15.50 per American Depositary Share (ADS), with both warrant tranches priced at premiums to that level. Series A Warrants carry an exercise price of $17.825 per ADS, a 15% premium, tied to Kazia's Stage IV triple-negative breast cancer (TNBC) data readout expected in the second half of 2027. Series B Warrants carry an exercise price of $19.375 per ADS, a 25% premium, tied to the company's HR+/HER2- breast cancer data readout expected in the first half of 2028.

INDIANAPOLIS – September 03, 2026 -- Eli Lilly and Company reported that combining Taltz (ixekizumab) with Zepbound (tirzepatide) sustained or deepened efficacy at 52 weeks in patients with psoriatic disease and obesity, building on statistically superior results already seen at Week 36 versus Taltz alone.

Combination therapy nearly triples complete skin clearance response rates

In the TOGETHER-PsO trial, 30.6% of patients on the combination achieved PASI 100 plus at least 10% weight loss at Week 52, compared with 4.4% on Taltz monotherapy. Complete skin clearance alone (PASI 100) was maintained by 40.5% of combination patients versus 29.1% on monotherapy.

Dublin – September 03, 2026 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that Ziihera (zanidatamab-hrii) combined with chemotherapy produced a statistically significant and clinically meaningful overall survival (OS) benefit versus trastuzumab plus chemotherapy in a second interim analysis of the Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive gastroesophageal adenocarcinoma (GEA).

OS hazard ratio for Ziihera plus chemotherapy improved versus the first interim analysis

The company said the survival advantage strengthened compared with earlier data, reinforcing Ziihera's position following its FDA approval on August 25, 2026. No new safety signals emerged relative to previously reported HERIZON-GEA-01 data or the known profiles of the individual agents.

Hong Kong – September 03, 2026 -- Ascletis Pharma Inc. has dosed the first participant in a global Phase III program for ASC30, an oral small molecule GLP-1 receptor agonist for chronic weight management, the Hong Kong Stock Exchange-listed biotech confirmed.

Trial enrolls 4,600 participants across three continents

The program comprises two pivotal trials, AURORA-1 and AURORA-2, spanning clinical sites in the U.S., Europe, and Canada. AURORA-1 targets participants with obesity or overweight without type 2 diabetes, while AURORA-2 enrolls those with type 2 diabetes; both trials test 20 mg, 40 mg, and 60 mg maintenance doses against placebo over 72 weeks, with the primary endpoint measuring percentage change in body weight from baseline to Week 72.

NEW HAVEN, Conn. -- Aug. 31, 2026 -- Yale School of Medicine has secured a nearly $25 million grant from the Aligning Research to Impact Autism (ARIA) initiative to build the first high-resolution map of the developing human brain and pinpoint where autism diverges from typical neural development.

The award, part of ARIA's Human Developmental Neurobiology Research Hub, funds two Yale-led projects within a four-project collaboration that also involves Harvard University. Combined, the initiative targets a gap researchers say has stalled autism drug and diagnostic development for decades: no detailed reference map exists for how the human brain wires itself in the first years of life.

Incheon, South Korea and Zug, Switzerland --

MASON, Ohio -- September 01, 2026 -- Prasco, LLC has acquired a 130,000-plus square foot distribution facility in Carey, Ohio, expanding the pharmaceutical commercialization company's automation, cold-chain and secure storage capacity beyond its existing Mason, Ohio operations. The deal, announced Aug. 31, 2026, adds a second Ohio campus for the company, which works with more than 65 brand partners and supplies medications to over 70,000 pharmacies nationwide. Prasco specializes in Authorized Generics and end-to-end commercialization services for global drug brands.

The Carey site sits inside what Prasco describes as the Midwest pharmaceutical and logistics corridor, giving the company direct highway access to CDMOs, national distribution centers and major health systems. Prasco said the location strengthens its footprint in Ohio, a state it identified as one of the most active life sciences markets in the country.