Center for Drug Evaluation and Research

After a successful Pre-IND meeting with FDA, Respira Technologies, Inc. announces plans to submit an Investigative New Drug Application (IND) to FDA in 2022 as the world's first truly inhalable prescription smoking cessation therapy

Tuesday, November 30, 2021 - 12:00pm

As a result, quitting "cold turkey" remains the #1 method of cessation for smokers trying to quit smoking.

Key Points: 
  • As a result, quitting "cold turkey" remains the #1 method of cessation for smokers trying to quit smoking.
  • Respira's combination device the RespiRxTM is the first truly patient-focused and ultra-portable handheld Vibrating Mesh Nebulizer (VMN) for local and systemic treatments.
  • The device is a handheld, portable with a pre-filled disposable drug-product containing cartridge that operates in any direction being held.
  • Respira has patents granted and multiple in review for its device design and drug product formulations.

FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

Monday, November 29, 2021 - 3:55pm

SILVER SPRING, Md., Nov. 29, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions.

Key Points: 
  • SILVER SPRING, Md., Nov. 29, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions.
  • Cytalux is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery.
  • "By supplementing current methods of detecting ovarian cancer during surgery, Cytalux offers health care professionals an additional imaging approach for patients with ovarian cancer."
  • Currently, surgeons rely on preoperative imaging, visual inspection of tumors under normal light or examination by touch to identify cancer lesions.

CNL Launches Program to Accelerate the Development of Targeted Radiopharmaceuticals in Canada

Thursday, November 25, 2021 - 8:00pm

The new program is designed to accelerate the development of targeted radiopharmaceuticals in Canada through collaborative research projects related to health sciences, radiobiology and medical isotope development, by providing access to the world-class laboratories and research capabilities at the Chalk River Laboratories campus.

Key Points: 
  • The new program is designed to accelerate the development of targeted radiopharmaceuticals in Canada through collaborative research projects related to health sciences, radiobiology and medical isotope development, by providing access to the world-class laboratories and research capabilities at the Chalk River Laboratories campus.
  • Launched in 2019, the CNRI program was originally established by CNL to advance the deployment of small modular reactor (SMRs) and advanced reactor designs.
  • For the programs first intake, research proposals must align with topics that include targeted delivery systems, toxicology and pre-clinical evaluation.
  • CNL will complete a final evaluation of the proposed project plans before making the final selection and approval of successful applicants.

FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs

Tuesday, November 23, 2021 - 10:00pm

"Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern.

Key Points: 
  • "Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern.
  • Today's approval helps meet a significant unmet medical need by providing a treatment option for this patient population."
  • CMV is a type of herpes virus that commonly causes infection in patients after a stem cell or organ transplant.
  • CMV infection can lead to CMV disease and have a major negative impact on transplant recipients, including loss of the transplanted organ and death.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Monday, November 22, 2021 - 1:40am

"AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.

Key Points: 
  • "AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
  • This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML."
  • The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Monday, November 22, 2021 - 12:10pm

AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.

Key Points: 
  • AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
  • This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML.
  • The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia.

FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism

Friday, November 19, 2021 - 3:27pm

"With this action, children with short stature due to achondroplasia have a treatment option that targets the underlying cause of their short stature."

Key Points: 
  • "With this action, children with short stature due to achondroplasia have a treatment option that targets the underlying cause of their short stature."
  • People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth.
  • Voxzogo works by binding to a specific receptor called natriuretic peptide receptor-B that reduces the growth regulation gene's activity and stimulates bone growth.
  • Researchers measured the participants' annualized growth velocity, or rate of height growth, at the end of the year.

Brii Bio Receives the BioCentury-BayHelix R&D Achievement of the Year Award at the 2021 BioCentury China Healthcare Summit

Wednesday, November 17, 2021 - 9:03am

The recognition is for the R&D achievements of Brii Bio's investigational monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 ("combination BRII-196/BRII-198"), for the treatment of COVID-19.

Key Points: 
  • The recognition is for the R&D achievements of Brii Bio's investigational monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 ("combination BRII-196/BRII-198"), for the treatment of COVID-19.
  • In parallel, the company has submitted the Phase 3 interim data to China Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA).
  • The BioCentury-Bayhelix China Healthcare Awards celebrate outstanding individuals and companies for their achievement and contribution to the local healthcare ecosystem.
  • R&D Achievement of the Year recognizes one company for a scientific discovery in China with direct impact to drug R&D or a significant achievement in pharmaceutical development milestones.

FDA Approves Treatment for Rare Blood Disease

Friday, November 12, 2021 - 9:55pm

SILVER SPRING, Md., Nov. 12, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.

Key Points: 
  • SILVER SPRING, Md., Nov. 12, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.
  • The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.
  • "This action highlights the FDA's commitment to helping make new treatments available to patients with rare diseases."
  • Treatment for polycythemia vera includes phlebotomies (a procedure that removes excess blood cells though a needle in a vein) as well as medicines to reduce the number of blood cells; Besremi is one of these medicines.

PhaseBio Reports Third-Quarter 2021 Financial Results and Recent Business Highlights

Wednesday, November 10, 2021 - 9:00pm

PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today provided an update on corporate activities and reported third-quarter 2021 financial results.

Key Points: 
  • PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today provided an update on corporate activities and reported third-quarter 2021 financial results.
  • Details about the upcoming presentation were set forth in PhaseBios press release on October 6, 2021 .
  • PhaseBio is commencing preparation of the BLA and, subject to favorable results being observed, is targeting a BLA submission to the FDA in mid-2022.
  • Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.