PointCross Releases eDataValidator for SDTM, ADaM, SEND, and Define.XML Conformance to Prevailing FDA, CDISC, and PMDA Rules
Integrated QC dashboard and unlimited validation cycles for interim and final datasets creates industry’s most…
Year: 2022
FDA Approves QSYMIA® for the Treatment of Obesity in Adolescents Ages 12-17
CAMPBELL, Calif., July 20, 2022 (GLOBE NEWSWIRE) — VIVUS LLC today announced that the U.S….
Secure Transfusion Solutions Announces Company Name Change and Opening of its Third Trusting Heart Blood Center in Beaverton, Oregon
Formerly recognized as Secure Transfusion Services, the company will now be known as “Secure Transfusion…
Trusting Heart Blood Center Announces the Opening of its Third Platelet Donation Center in Beaverton, Oregon
BEAVERTON, Ore., July 20, 2022 (GLOBE NEWSWIRE) — Trusting Heart Blood Center (THBC) announces the…
Vaxart Publishes Clinical Data Suggesting its Oral COVID-19 Pill Vaccine Candidate Induces Long-Lasting Mucosal Immune Responses that are Highly Cross-Reactive
Vaccine-induced mucosal IgA antibody responses persisted for up to 1 year and had a higher…
Vericel to Report Second-Quarter 2022 Financial Results on August 3, 2022
CAMBRIDGE, Mass., July 20, 2022 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced…
AIM ImmunoTech reports additional patient data from Single-Center Named Patient Program evaluating Ampligen as maintenance therapy for advanced pancreatic cancer indicating additional progression-free and overall survival over previously published data
Professor C.H.J. van Eijck, MD, PhD Professor C.H.J. van Eijck, MD, PhD Ampligen® (rintatolimod) has…
Qu Biologics to Receive Additional Funding to Launch Clinical Trial for the Restoration of Innate Immune Function in the Elderly Following Health Canada Go-Ahead
BURNABY, British Columbia, July 20, 2022 (GLOBE NEWSWIRE) — Qu Biologics Inc., a private clinical…
Alvotech Initiates a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease, with combined sales…
Alvotech Initiates a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease, with combined sales…
Rhythm Pharmaceuticals Announces Early Access Authorization for Setmelanotide for Use in Patients with Bardet-Biedl Syndrome in France
— Reimbursed early access program allows for patients in France to receive setmelanotide for treatment…
Amarin to Report Second Quarter 2022 Financial Results and Host Conference Call on August 3, 2022
DUBLIN, Ireland and BRIDGEWATER, N.J., July 20, 2022 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN)…
Auron Therapeutics announces $48 million Series A financing to drive novel oncology pipeline leveraging a machine learning, multi-omics-based platform
Auron expands its leadership team with the appointments of David Millan, Ph.D., as Chief Scientific…
ProKidney Appoints Kerry Cooper, M.D., as Senior Vice President of Medical Affairs
Extensive Nephrology Medical Affairs Leadership and Clinical Practice Expertise Brought to ProKidney WINSTON-SALEM, NC, July…
SalioGen Therapeutics Strengthens its Leadership Team to Advance its Gene Coding™ Platform
CAMBRIDGE, Mass., July 20, 2022 (GLOBE NEWSWIRE) — SalioGen Therapeutics, a privately held biotechnology company…
Spectral Medical Provides Update on Tigris Clinical Trial
Provides positive case study on patient enrolled at University of Michigan 14 clinical sites actively…
Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome
FDA acknowledges that data from a randomized withdrawal period of Study C602 have the potential…
Rhythm Pharmaceuticals Announces Early Access Authorization for Setmelanotide for Use in Patients with Bardet-Biedl Syndrome in France
— Reimbursed early access program allows for patients in France to receive setmelanotide for treatment…
Aquestive Therapeutics to Report Second Quarter 2022 Financial Results and Recent Business Highlights on August 2 and Host Conference Call on August 3 at 8:00 a.m. ET
WARREN, N.J., July 20, 2022 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical…
Brickell Biotech Regains Compliance with Nasdaq Minimum Bid Price Requirement
BOULDER, Colo., July 20, 2022 (GLOBE NEWSWIRE) — Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a…