FDA Grants Breakthrough Therapy Designation to Lenvima-Keytruda Combo for Advanced Endometrial Carcinoma

FDA Grants Breakthrough Therapy Designation to Lenvima-Keytruda Combo for Advanced Endometrial Carcinoma

The U.S. Food and Drug Administration granted breakthrough therapy designation to an investigational combination of Eisai ’s Lenvima (lenvatinib) and Merck ‘s Keytruda (pembrolizumab) for the treatment of patients with a subset of advanced endometrial carcinoma . Specifically, the FDA’s decision covers patients with advanced and/or metastatic non-microsatellite instability […] Click here to view original[…]

Pfizer Oncology loses its CMO to Allergan as cancer exec Charles Hugh-Jones makes a career leap

Pfizer Oncology loses its CMO to Allergan as cancer exec Charles Hugh-Jones makes a career leap

Allergan $AGN has recruited top cancer executive Charles Hugh-Jones, the guy who’s been leading Pfizer Oncology as CMO, to serve as the pharma giant’s new senior vice president and chief medical officer. The move comes just 16 months after Hugh-Jones joined Pfizer’s oncology arm. Before that, he was a […] Click here to view original[…]

Almac and Elasmogen receive £2m grant for oncology research

Almac and Elasmogen receive £2m grant for oncology research

(Image:Getty/kkoslov) The biopharmaceutical company Almac Discovery ​ – part of the contract development and manufacturing organization (CDMO) Almac Group –and Elasmogen, a University of Aberdeen spin-out firm, have been awarded a grant from Innovate UK ​. The companies applied for the grant to support development of a technology platform […] Click here to view original[…]

Biopharma Firms: Make FDA Draft Guidance on Including Adolescents in Adult Oncology Trials Global

Biopharma Firms: Make FDA Draft Guidance on Including Adolescents in Adult Oncology Trials Global

AstraZeneca, Gilead, GlaxoSmithKline and lobbying groups PhRMA and BIO are calling for further global harmonization of a US Food and Drug Administration (FDA) draft guidance on including adolescents in adult oncology clinical trials. Industry group BIO said that because the draft, released in June , “signals the first time […] Click here to view original[…]

Clovis Oncology Announces First Patient Enrolled in the Phase 3 ATHENA Trial

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today the randomization of the first patient in the Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca ® (rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO ® (nivolumab), for the treatment of advanced ovarian cancer. […] Click here to view original[…]

Adjuvant mFOLFIRINOX Extends Survival in Pancreatic Cancer

CHICAGO—A randomized, multicenter, phase III trial showed that patients with surgically resected pancreatic cancer lived a median of 20 months longer when treated with modified FOLFIRINOX in the adjuvant setting compared to single agent gemcitabine ( Abstract LBA4001 ). The study findings were presented at the 2018 ASCO Annual […] Click here to view original[…]

Janssen and Immune Bioscience team up for oncology antibodies

Janssen and Immune Bioscience team up for oncology antibodies

Immune Biosolutions has announced a research collaboration and license agreement with Janssen that will focus on the discovery and development of therapeutic antibodies in oncology. The collaboration will utilise Immune Bioscience’s Nebula antibody discovery platform to advance oncology targets that historically have been a challenge for therapeutic development. “The […] Click here to view original[…]

Regeneron expands immuno-oncology push with Bluebird pact

Regeneron expands immuno-oncology push with Bluebird pact

Dive Brief: Regeneron is broadening its research bets in immuno-oncology, announcing Monday a partnership with Bluebird bio that will pair the New York biotech’s antibody prowess with Bluebird’s cell therapy and gene transfer expertise. The two companies will focus on developing cancer therapies that leverage a type of cellular […] Click here to view original[…]