Sunitinib

Graybug Vision Reports Analysis of Data from the Six-Month Extension Study of the ALTISSIMO Phase 2b Trial in Wet AMD

Retrieved on: 
Tuesday, September 28, 2021

The second phase of ALTISSIMO was a six-month extended observation phase, or Extension Study, in which patients were monitored without additional treatment to determine the duration of effect measured from their last treatment during the Core Study.

Key Points: 
  • The second phase of ALTISSIMO was a six-month extended observation phase, or Extension Study, in which patients were monitored without additional treatment to determine the duration of effect measured from their last treatment during the Core Study.
  • Participation in the Extension Study was voluntary, but only patients who completed all study visits, and did not require supportive therapy at their Month 12 visit during the Core Study, were eligible.
  • This is the longest duration ever achieved with an intravitreal injection in a randomized, masked, and controlled clinical trial in wet AMD.
  • As in the Core Study, GB-102 1mg continued to be well-tolerated and maintained a favorable safety profile during the Extension Study.

Graybug Vision to Participate in the Cantor Virtual Global Healthcare Conference

Retrieved on: 
Tuesday, September 21, 2021

BALTIMORE, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 11:20 a.m.

Key Points: 
  • BALTIMORE, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 11:20 a.m.
  • Dr. Guerard will provide a corporate update, including a full analysis of the 18-month data from the ALTISSIMO Phase 2b trial of GB-102 1mg.
  • Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve.
  • Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Baltimore, Maryland.

Biotech CEO Pioneers a Paradigm-Shifting Drug Development Model

Retrieved on: 
Tuesday, September 21, 2021

NEW YORK, Sept. 21, 2021 /PRNewswire/ -- Unnecessary Expense: An Antidote for the Billion-Dollar Drug Problem by TRACON Pharmaceuticals President and CEO, Dr. Charles Theuer, is now available.

Key Points: 
  • NEW YORK, Sept. 21, 2021 /PRNewswire/ -- Unnecessary Expense: An Antidote for the Billion-Dollar Drug Problem by TRACON Pharmaceuticals President and CEO, Dr. Charles Theuer, is now available.
  • Driven by runaway drug development expenses, the average cost of $2 billion gets offloaded onto patients and third-party payers at premium rates, perpetuating the affordability issues many healthcare consumers struggle with today.
  • Theuer's alternative approach to the outsourcing behaviors of Big Pharma is TRACON's streamlined model of aligned drug development, which harnesses global innovation to benefit patients and allow drug innovators to stay incentivized and involved as they navigate clinical trials and FDA approvals.
  • Dr. Theuer's previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, and gastrointestinal cancer epidemiology.

HUTCHMED and AstraZeneca Initiate SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China

Retrieved on: 
Wednesday, September 8, 2021

The Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression.

Key Points: 
  • The Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression.
  • The study will evaluate the efficacy and safety of TAGRISSO in combination with ORPATHYS comparing to TAGRISSO alone, a standard-of-care treatment option for these patients.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib.
  • Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China.

Graybug Vision Announces Financial Results for the Three and Six Months Ended June 30, 2021, and Recent Corporate Developments

Retrieved on: 
Wednesday, August 11, 2021

In June 2021, the last patient exited the extension period, with 60% of GB-102 1 mg patients requiring no supportive therapy during the six-month extension period.

Key Points: 
  • In June 2021, the last patient exited the extension period, with 60% of GB-102 1 mg patients requiring no supportive therapy during the six-month extension period.
  • Present 12-month ALTISSIMO Phase 2b clinical trial data at the American Academy of Ophthalmology (AAO) meeting, November 12-15, 2021.
  • As of June 30, 2021, the companys cash and cash equivalents, and short-term and long-term investments totaled $78.2 million.
  • Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve.

Gastric Cancer Drugs Global Market Report 2021 Featuring Eli Lilly and Co, Novartis, Merck KGaA, Otsuka Pharmaceutical, and F. Hoffmann-La Roche - ResearchAndMarkets.com

Retrieved on: 
Monday, August 9, 2021

The "Gastric Cancer Drugs Global Market Report 2021: COVID-19 Impact and Recovery to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Gastric Cancer Drugs Global Market Report 2021: COVID-19 Impact and Recovery to 2030" report has been added to ResearchAndMarkets.com's offering.
  • Major players in the gastric cancer drugs market are Eli Lilly and company, Novartis, Merck KGaA, Otsuka Pharmaceutical, and F. Hoffmann-La Roche.
  • The gastric cancer drugs market consists of sales of drugs for gastric cancer.
  • Increase in number of cases in gastric cancer will drive the market for gastric cancer drugs.

Graybug Vision to Participate in the 2021 Wedbush PacGrow Healthcare Virtual Conference

Retrieved on: 
Wednesday, August 4, 2021

REDWOOD CITY, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a panel discussion titled Goldeneye at the Wedbush PacGrow Healthcare Conference on Wednesday, August 11, 2021 at 9:45 a.m.

Key Points: 
  • REDWOOD CITY, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a panel discussion titled Goldeneye at the Wedbush PacGrow Healthcare Conference on Wednesday, August 11, 2021 at 9:45 a.m.
  • A live webcast of the panel will be available in the Investors and Media section of the companys website at https://investors.graybug.vision/news-events/events-presentations .
  • Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve.
  • Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California.

LianBio Appoints Pascal Qian as General Manager of China

Retrieved on: 
Monday, August 2, 2021

LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, today announced that it has appointed Pascal Qian to the position of China General Manager.

Key Points: 
  • LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, today announced that it has appointed Pascal Qian to the position of China General Manager.
  • Mr. Qian has extensive experience launching products in China, including Verzenio, Tyvyt, Elunate, Afinitor, Votrient, Sutent, Vfend and Singulair.
  • He has also led new product development initiatives in China for multiple globally developed drugs, including crizotinib, axitinib and palbociclib.
  • Mr. Qian most recently served as the Vice President, Head of Oncology Business Unit, at Lilly China.

Eisai: New Data on LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Versus Sunitinib

Retrieved on: 
Tuesday, June 8, 2021

"The additional data showed an improvement of specific health-related quality of life measures for patients who received LENVIMA plus KEYTRUDA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients."

Key Points: 
  • "The additional data showed an improvement of specific health-related quality of life measures for patients who received LENVIMA plus KEYTRUDA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients."
  • In an analysis of a secondary endpoint of HRQoL scores in the CLEAR/KEYNOTE-581 trial, LENVIMA plus KEYTRUDA and LENVIMA plus everolimus were evaluated to determine the impact on HRQoL compared to sunitinib in patients with advanced RCC.
  • LENVIMA plus KEYTRUDA demonstrated a similar TTD in 14 out of 18 HRQoL and disease-related symptom scores, and a delay in TTD for physical functioning, dyspnea, appetite loss, and EQ-5D visual analog scale compared to sunitinib.
  • LENVIMA plus KEYTRUDA demonstrated a delay in TUDD in 16 out of 18 HRQoL and disease-related symptom scores and a similar TUDD for cognitive functioning and financial difficulties compared to sunitinib.

Exelixis Announces Consistent Efficacy Benefits Across Subgroups of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-line Treatment for Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, June 4, 2021

CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.

Key Points: 
  • CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.
  • The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.