Pharmaceuticals & Biopharmaceuticals

XellSmart's Parkinson's Cell Therapy Completes Phase II Enrollment

Image
XellSmart's Parkinson's Cell Therapy Completes Phase II Enrollment

Seoul – October 18, 2026 -- XellSmart's off-the-shelf Parkinson's cell therapy XS411 improved OFF-state motor scores by an average of more than 30 points at six months in all nine Phase I participants, and its 30-patient Phase II trial in China has completed enrollment.

The data were presented at the International Congress of Parkinson's Disease and Movement Disorders (MDS). The company says the results showed no dose-limiting toxicities, serious adverse events or adverse events related to XS411.

Phase I data show motor and imaging gains in nine patients

The single-arm, open-label trial used a 3+3 dose-escalation design across three cohorts. Participants had moderate-to-advanced disease, a mean duration of about 10 years, end-of-dose wearing-off and OFF-state Hoehn-Yahr stages of 3 to 4. Cells were transplanted into the bilateral posterior putamen.

FDA Grants Orphan Drug Status to Vivacta Bio's In Vivo CAR-T GT801

Image
FDA Grants Orphan Drug Status to Vivacta Bio's In Vivo CAR-T GT801

Shanghai – October 17, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to GT801, the lead in vivo CAR-T candidate of Vivacta Biotechnology (Shanghai) Co., Ltd., for autoimmune hemolytic anemia (AIHA). Vivacta Bio was spun out of Beijing Grit Biotherapeutics' in vivo CAR-T platform on June 25, 2025.

Designation opens tax credits, fee exemption and seven-year exclusivity

Sponsors of designated products may be eligible for tax credits on qualified clinical trial expenses and an exemption from marketing application user fees. They may also receive seven years of orphan drug market exclusivity after marketing approval, subject to applicable requirements.

AbbVie Presents 20 IBD Abstracts at UEGW 2026 in Barcelona

North Chicago – October 17, 2026 -- AbbVie (NYSE: ABBV) is presenting 20 new scientific abstracts from its inflammatory bowel disease (IBD) portfolio at the 2026 United European Gastroenterology (UEG) Week, held October 17-20 in Barcelona, Spain. The data cover long-term and real-world outcomes for Skyrizi (risankizumab) and Rinvoq (upadacitinib) in Crohn's disease (CD) and ulcerative colitis (UC).

Risankizumab maintains remission in UC through week 96

In the COMMAND study, patients on risankizumab 180 mg reached as-observed clinical remission rates of 54.0%-73.1% at week 96. Endoscopic remission rates were 38.8%-53.5%. The ranges span advanced therapy-naïve and advanced therapy-experienced patients, and the study reports up to three years of maintenance treatment.

FDA Approves UCB's ZILBRYSQ Autoinjector for gMG; Launch Set for Q1 2027

Image
FDA Approves UCB's ZILBRYSQ Autoinjector for gMG; Launch Set for Q1 2027

Atlanta – October 16, 2026 -- The U.S. Food and Drug Administration (FDA) has approved a once-daily autoinjector for UCB's ZILBRYSQ (zilucoplan), with complete dose delivery in 99.8% of 449 administrations, UCB said. Commercial availability is expected in Q1 2027.

The device is cleared for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. UCB (Euronext Brussels: UCB) describes ZILBRYSQ as the first and only macrocyclic peptide C5 inhibitor approved as a self-administered, once-daily subcutaneous autoinjector for gMG in the U.S.

Autoinjector adds a second self-administration route alongside the prefilled syringe

Before this approval, ZILBRYSQ was available only as a self-administered prefilled syringe (PFS). The autoinjector automatically delivers a pre-defined dose when activated against the skin. Patients or their care partners now have two portable options.

Eli Lilly to Report Q3 2026 Results on October 29

Image
Eli Lilly to Report Q3 2026 Results on October 29

Indianapolis – October 16, 2026 -- Eli Lilly and Company (NYSE: LLY) will publish its third-quarter 2026 financial results on October 16, 2026, and will discuss the numbers on a conference call the same day.

Lilly schedules a 10 a.m. Eastern call for investors and media

The conference call begins at 10 a.m. Eastern time. Lilly will use it to detail the company's financial performance for the quarter with the investment community and media.

Lilly opens the live webcast to the general public

Investors, media and the general public can follow the call through a live webcast. Lilly will post the access link on its investor relations website, and a replay will be available there after the call ends.

The announcement gives no financial figures, guidance or earnings metrics ahead of the October 29 release.

WuXi XDC Wins Best CDMO a Fourth Year at 2026 World ADC Awards

Shanghai – October 15, 2026 -- WuXi XDC (2268.HK) has won "Best CDMO" at the 2026 World ADC Awards for the fourth consecutive year and "Best CRO" for the second, making it the only contract research, development and manufacturing organization (CRDMO) to take both titles two years running.

WuXi XDC reports record 51 new iCMC projects in first half of 2026

According to the company's 2026 interim results, WuXi XDC had more than 810 global clients as of June 30, 2026. Fifteen of the top 20 pharmaceutical companies by revenue are among its partners. The company has helped clients submit more than 160 IND applications and now holds 328 iCMC projects. The 51 signed in the first half of 2026 are a record.

Headcount exceeds 3,600, and more than 50% of employees hold a master's degree or higher.

Clinical ink Targets 67% Obesity Drug Drop-Off With Behavioral Data

Image
Clinical ink Targets 67% Obesity Drug Drop-Off With Behavioral Data

Toronto – October 14, 2026 -- Real-world discontinuation of weight-loss medications can reach 67% within 12 months, while clinical trials show sustained weight reduction of 15–22% over 72 weeks, according to materials for an Xtalks webinar featuring Clinical ink executives on October 29.

Psychology, not only side effects, drives discontinuation of obesity therapy

Side effects, cost and access explain only part of the drop-off, the organizers state. Confidence, doubt and treatment identity are increasingly recognized as independent predictors of discontinuation. Motivations differ by patient, rooted in appearance, day-to-day function or long-term health risk.

Most patient support programs have no validated way to identify behavioral risk before it affects outcomes, creating a gap for pharma teams managing obesity portfolios.

Insmed to Present Three Late-Breaking TPIP Abstracts at CHEST 2026

Image
Insmed to Present Three Late-Breaking TPIP Abstracts at CHEST 2026

Bridgewater, N.J. – – October 14, 2026 -- Insmed (Nasdaq: INSM) will present four abstracts on its investigational inhaled therapy treprostinil palmitil inhalation powder (TPIP) at CHEST 2026 in Phoenix, three of them late-breaking, and two ARIKAYCE abstracts at IDWeek 2026 in Washington, D.C. CHEST runs Oct. 18–21 and IDWeek runs Oct. 21–24.

Chief Medical Officer Martina Flammer said the presentations span the company's respiratory portfolio of BRINSUPRI, TPIP and ARIKAYCE.

Carnyx's CNYX-005 Adds 1.5-2 Hours of Sleep in Aged Rat Study

Image
Carnyx's CNYX-005 Adds 1.5-2 Hours of Sleep in Aged Rat Study

Indianapolis – October 14, 2026 -- Carnyx Therapeutics Ltd. unveiled CNYX-005, an oral sleep candidate that increased total sleep time by roughly 1.5 to 2 hours in aged rats versus a control arm, as the preclinical-stage company moves toward clinical development.

The increase was driven primarily by more non-rapid eye movement (NREM) sleep. Researchers measured sleep architecture using continuous electroencephalography (EEG) monitoring.

Carnyx hires Chris Brearley, M.D., as Chief Medical Officer ahead of clinical entry

Brearley brings more than 30 years of experience in translational medicine, clinical pharmacology and early-stage drug development. His prior roles include senior positions at Pfizer, Amgen and Serono. He has designed and overseen first-in-human and early-stage clinical studies, the stage CNYX-005 now approaches.

Brearley said he aims to translate the findings into a rigorous clinical development program.

Cancer Drug Spend Hits $252B as FDA Clears RAS Pancreatic Therapy

Image
Cancer Drug Spend Hits $252B as FDA Clears RAS Pancreatic Therapy

San Diego – – October 14, 2026 -- Global spending on cancer medicines reached $252 billion in 2024 and is forecast to exceed $400 billion by 2028, according to the IQVIA Institute, with the United States accounting for roughly 46% of the total.

About 150 new active substances entered the U.S. oncology market between 2015 and 2024, and launch activity in 2020 to 2024 ran nearly 40% ahead of the prior five years.