Nicole Watkins

FDA Issues Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit

Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. “This action today shows our agency’s dedication to working around the clock to …

Read More »

Pfizer and EMD Serono Terminate Phase 3 Study of Avelumab Plus CRT for Treatment of Head and Neck Cancer

ROCKLAND, Mass. and NEW YORK, March 13, 2020 /PRNewswire/ — EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy …

Read More »

FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Kidney Disease

INGELHEIM, Germany, and INDIANAPOLIS, Ind.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of empagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. The …

Read More »

FDA Grants Fast Track Designation to Balstilimab and Zalifrelimab for Treatment of Advanced Cervical Cancer

LEXINGTON, Mass., March 12, 2020 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination …

Read More »

Thermo Fisher Scientific Signs Agreement with Janssen to Co-Develop Companion Diagnostic for Cancer

CARLSBAD, Calif., March 12, 2020 /PRNewswire/ — Thermo Fisher Scientific announced today it has signed an agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to co-develop a companion diagnostic (CDx) in oncology. The CDx will support clinical trial enrollment globally. Under the agreement, …

Read More »

Preclinical Data Show Tumor Treating Fields Induces Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with Anti-PD-1 Therapy

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) announced today that preclinical data on Tumor Treating Fields in combination with anti-PD-1 therapy were published in the peer-reviewed journal, Cancer Immunology, Immunotherapy. The published study suggests that Tumor Treating Fields therapy can induce anticancer immune response and provide the first evidence for the immunostimulatory effects of …

Read More »

Phase 3 Study of Cerdiranib and Lynparza Fails to Meet Primary Endpoint in Platinum-Resistant Ovarian Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced high-level results from the Phase 3 GY004 trial, led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI), that examined primarily the efficacy and safety of investigational medicine cediranib …

Read More »

Engage Therapeutics Announces Phase 2b Study of Staccato Alprazolam for Seizure Cessation Meets Primary Endpoint

SUMMIT, N.J., March 12, 2020 (GLOBE NEWSWIRE) — Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing an orally inhaled therapy designed to terminate an active epileptic seizure, today announced that its Phase 2b StATES study of Staccato® alprazolam met its primary endpoint which was proportion of responders achieving cessation of seizure …

Read More »

FDA Grants Accelerated Approval for Opdivo Plus Yervoy for Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.1,2 Approval for this indication has been granted under …

Read More »

Forty Seven and Rocket Pharmaceuticals Announce Research Collaboration for Fanconi Anemia

MENLO PARK, Calif. and NEW YORK, March 11, 2020 (GLOBE NEWSWIRE) — Forty Seven, Inc. (Nasdaq: FTSV) and Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT) announced today that they have entered into a research collaboration to pursue clinical proof-of-concept for Forty Seven’s novel antibody-based conditioning regimen, FSI-174 (anti-cKIT antibody) plus magrolimab (anti-CD47 …

Read More »