Food and Drug Administration

SHAREHOLDER ALERT: Robbins LLP Announces That FibroGen, Inc. (FGEN) is Being Sued for Misleading Shareholders

Thursday, April 15, 2021 - 7:11pm

FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease and cancer.

Key Points: 
  • FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease and cancer.
  • On February 11, 2020, FibroGen announced that the FDA had completed its filing review of its NDA for roxadustat.
  • FibroGen acknowledged that it could no longer conclude that roxadustat reduces the risk of cardiovascular events or hospitalization when compared to a currently approved anemia injection used as a control.
  • Shareholders pay no fees or expenses.\nContact us to learn more:\n'

Medable Secures Another $78 Million Funding to Fuel Digital Innovation for Patient-Centered Drug Development

Thursday, April 15, 2021 - 12:37pm

b'Medable Inc. today announced $78 million in new funding to fuel advances in the delivery of digital and decentralized clinical trials, accelerating the industry\xe2\x80\x99s shift to patient-centered drug development.

Key Points: 
  • b'Medable Inc. today announced $78 million in new funding to fuel advances in the delivery of digital and decentralized clinical trials, accelerating the industry\xe2\x80\x99s shift to patient-centered drug development.
  • Medable will use the funding to continue enabling broad adoption of digital trials and patient-centric strategies at global scale.
  • By minimizing the need for in-person site visits, Medable customers have achieved unprecedented results \xe2\x80\x93 including 3X faster enrollment and over 90 percent retention rates.
  • \xe2\x80\x9cMedable is committed to delivering the leading solutions to drug developers for this incredibly important change in how clinical research is conducted.

Merck to Discontinue Development of MK-7110 for COVID-19

Thursday, April 15, 2021 - 11:46am

As previously reported, Merck subsequently received feedback from the US Food and Drug Administration that additional data, beyond the study conducted by OncoImmune, would be needed to support a potential Emergency Use Authorization application.

Key Points: 
  • As previously reported, Merck subsequently received feedback from the US Food and Drug Administration that additional data, beyond the study conducted by OncoImmune, would be needed to support a potential Emergency Use Authorization application.
  • We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships.
  • These statements are based upon the current beliefs and expectations of the company\xe2\x80\x99s management and are subject to significant risks and uncertainties.
  • There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.

Asia Pacific Electronic Clinical Outcome Assessment Markets, 2019-2020 & 2021-2026 - ResearchAndMarkets.com

Wednesday, April 14, 2021 - 6:44pm

b'The "Asia Pacific Electronic Clinical Outcome Assessment Market By Delivery Mode, By End Use, By Country, Industry Analysis and Forecast, 2020 - 2026" report has been added to ResearchAndMarkets.com\'s offering.\nThe China market dominated the Asia Pacific Pharma & Biotech Companies Market by Country in 2019, thereby, achieving a market value of $17.1 Million by 2026.\nWith an aim to gather patient data in a clinical trial, an eCOA solution is utilized.

Key Points: 
  • b'The "Asia Pacific Electronic Clinical Outcome Assessment Market By Delivery Mode, By End Use, By Country, Industry Analysis and Forecast, 2020 - 2026" report has been added to ResearchAndMarkets.com\'s offering.\nThe China market dominated the Asia Pacific Pharma & Biotech Companies Market by Country in 2019, thereby, achieving a market value of $17.1 Million by 2026.\nWith an aim to gather patient data in a clinical trial, an eCOA solution is utilized.
  • The global electronic clinical outcome assessment (eCOA) solutions market is anticipated to witness consistent & high growth over the forecast years.
  • Hence, clinical outcome assessments (COAs) are constantly utilized to evaluate the treatments\' influence on several chronic diseases, and in some cases, these have a considerable role in the regulatory approval of drugs.
  • Although, the major restraints for the market growth are the huge cost of implementation & data privacy concerns.\nMarket Segments covered in the Report:\n'

Global Myelodysplastic Syndrome Clinical Trials Review, H2 2020 Edition - ResearchAndMarkets.com

Wednesday, April 14, 2021 - 4:02pm

b'he "Myelodysplastic Syndrome Global Clinical Trials Review, H2, 2020" clinical trials has been added to ResearchAndMarkets.com\'s offering.\n"Myelodysplastic Syndrome Global Clinical Trials Review, H2, 2020" provides an overview of Myelodysplastic Syndrome Clinical trials scenario.\nThis report provides top line data relating to the clinical trials on Myelodysplastic Syndrome.

Key Points: 
  • b'he "Myelodysplastic Syndrome Global Clinical Trials Review, H2, 2020" clinical trials has been added to ResearchAndMarkets.com\'s offering.\n"Myelodysplastic Syndrome Global Clinical Trials Review, H2, 2020" provides an overview of Myelodysplastic Syndrome Clinical trials scenario.\nThis report provides top line data relating to the clinical trials on Myelodysplastic Syndrome.
  • Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe.
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.
  • Report also provides prominent drugs for in-progress trials (based on number of ongoing trials).\nThe report enhances the decision making capabilities and helps to create an effective counter strategies to gain competitive advantage.\nReport provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status\nThe report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company\nThe report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment\nAids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials\nFacilitates clinical trial assessment of the indication on a global, regional and country level\n'

Greenwich LifeSciences Announces Update of GP2 Phase III Clinical Trial Design at the 2021 AACR Annual Meeting

Wednesday, April 14, 2021 - 11:00am

View the full release here: https://www.businesswire.com/news/home/20210414005362/en/\nPoster Presentation CT256 from 2021 AACR Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)\nThe AACR published the Phase III trial design abstract on April 9, 2021 and the poster on April 10, 2021.

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210414005362/en/\nPoster Presentation CT256 from 2021 AACR Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)\nThe AACR published the Phase III trial design abstract on April 9, 2021 and the poster on April 10, 2021.
  • The recently reported robust immune response data, which peaked after 6 months in the Phase IIb trial, will help to finalize the Phase III trial design, including the immune response monitoring strategy.
  • This immune response data could be reported before the interim analysis.\xe2\x80\x9d\nUpdated Phase III Clinical Trial Design: The Company and the Baylor College of Medicine presented the updated design of the planned Phase III clinical trial to breast cancer key opinion leaders.
  • Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.

Better Therapeutics Launches Real World Evidence Study of Prescription Digital Therapeutic for Type 2 Diabetes

Wednesday, April 14, 2021 - 1:01pm

BT-001 is an investigational, prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.\nThe open-label, non-randomized, controlled study will evaluate approximately 1,000 patients with type 2 diabetes in Steward Health Care engaged with BT-001 for one year.

Key Points: 
  • BT-001 is an investigational, prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.\nThe open-label, non-randomized, controlled study will evaluate approximately 1,000 patients with type 2 diabetes in Steward Health Care engaged with BT-001 for one year.
  • \xe2\x80\x9cWe believe our prescription digital therapeutic has the power to positively disrupt the current standard of care and help patients with behavior-driven conditions, translating to improved patient outcomes and significant healthcare savings.
  • BT-001 is concurrently being evaluated in a pivotal study as a prescribed treatment used under physician supervision for people with uncontrolled type 2 diabetes.
  • The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, heart disease and other conditions.

Establishment Labs to Announce First Quarter 2021 Financial Results on May 5

Wednesday, April 14, 2021 - 1:00pm

Motiva Implants\xc2\xae are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the Company\xe2\x80\x99s direct salesforce.

Key Points: 
  • Motiva Implants\xc2\xae are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the Company\xe2\x80\x99s direct salesforce.
  • In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant\xc2\xae clinical trial in the United States in April 2018.
  • In addition to Motiva Implants\xc2\xae, Establishment Labs\xe2\x80\x99 product and technologies portfolio includes the Divina\xc2\xae 3D Simulation System and other products and services.
  • Please visit our website for additional information at www.establishmentlabs.com .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210414005103/en/\n'

Cybin Advances IND-Enabling Studies of Two Psychedelic Molecules, CYB003 and CYB004 for Investigational New Drug Applications

Tuesday, April 13, 2021 - 12:15pm

Labcorp Drug Development will serve as the pre-clinical research organization for Cybin.\n\xe2\x80\x9cStarting the IND-enabling trials for CYB003 and CYB004 is an exciting and important step forward for Cybin as we progress the study of these molecules.

Key Points: 
  • Labcorp Drug Development will serve as the pre-clinical research organization for Cybin.\n\xe2\x80\x9cStarting the IND-enabling trials for CYB003 and CYB004 is an exciting and important step forward for Cybin as we progress the study of these molecules.
  • Our scientific team is eager to produce a robust submission to the FDA that will advance our path forward to clinical trials.
  • The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products.
  • Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials.

 FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

Monday, April 12, 2021 - 6:20pm

After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider may determine whether self-injection with Xolair prefilled syringe by the patient or a caregiver is appropriate.

Key Points: 
  • After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider may determine whether self-injection with Xolair prefilled syringe by the patient or a caregiver is appropriate.
  • For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision.
  • Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR.
  • Patients should call their doctor for medical advice about side effects.\nPatients may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch .