Oncology

The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer. Enhertu, a HER2-directed antibody drug conjugate, is now the first approved therapy for patients with the HER2-low breast cancer subtype. The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for…

Amgen (Nasdaq:AMGN) announced that it would purchase the San Carlos, California–based ChemoCentryx (Nasdaq:CCXI) for $52 per share in cash, which equates to a total of approximately $3.7 billion. The centerpiece of the proposed acquisition is Tavneos (avacopan), which scored FDA approval last year for the adjunctive treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The disease…

Clinical-stage biopharma Olema Oncology’s (Nasdaq:OLMA) lead product candidate is OP-1250, an orally-available small molecule that recently won FDA Fast Track Designation for the treatment of ER+/HER2– metastatic breast cancer. OP-1250 is a complete estrogen receptor antagonist with combined activity as a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). The drug…

Merck (NYSE:MRK) has announced that it will stop the Phase 3 LYNK-003 trial focused on Lynparza (olaparib) with or without bevacizumab for patients with unresectable or metastatic colorectal cancer. Two experimental arms in the trial, one focused on Lynparza as monotherapy or in combination with the immunotherapy drug bevacizumab, will be suspended. The primary endpoint…

Amazon (Nasdaq:AMZN) and the Fred Hutchinson Cancer Research Center are working together on a Phase 1 FDA-approved clinical study that will investigate a personalized neo-antigen peptide vaccine for melanoma and certain types of breast cancer. According to a listing on clinicaltrials.gov, the study aims to recruit 20 participants. Amazon will offer scientific and machine learning capabilities…

The biotech CytoDyn (OTCQB:CYDY) installed Cyrus Arman as president starting on July 9, 2022. Arman will assume the CEO role and join the company’s board within six months.  Before joining CytoDyn, Arman was the chief business officer at Nimble Therapeutics (Madison, Wisconsin), assuming that role on ​​September 08, 2021.  “Early in the process, Dr. Arman…

Cancer treatment has been a critical point for clinical diagnostics. Over the years, various treatment approaches- from naked nucleic acid-based therapy, targeting microRNAs, oncolytic virotherapy, and suicide-gene-based therapy to CRISPR/Cas-9-based therapy. More recently, drug-based therapy has also emerged as a promising area for cancer therapeutics. Regarding drug administration, a major buzz has been created around…

Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it has accepted the company’s Biologics License Application (BLA) and granted priority review for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody developed by the company’s Genentech subsidiary. In February, Biogen (Nasdaq:BIIB) said it would pay $30 million to exercise an option to participate in the development and…

AstraZeneca (LON:AZN) has announced it has entered an agreement to acquire TeneoTwo and its Phase 1 clinical-stage CD19/CD3 T-cell engager TNB-486. The company will pay $100 million on deal closing to acquire all outstanding equity of TeneoTwo. In addition, AstraZeneca will pay an additional $805 million in milestone payments and another $360 million in potential…

Novartis (NYSE:NVS) has announced that chemotherapy plus tislelizumab, a humanized monoclonal antibody directed against PD-1, improved overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the Phase 3 RATIONALE 306 study. The survival benefits were seen in patients regardless of PD-L1 status. The…

Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL). In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic…

Oncopeptides AB (Nasdaq Stockholm:ONCO) has won a unanimous positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Pepaxti (melphalan flufenamide) in the EU. The European Commission will make a final decision on the drug candidate in the next 60 days. An approval would make the drug available…

The concept of “locality” differentiates a business or company and conveys its value. Phrases like “shop local,” “locally sourced” or “local place” demonstrate the importance of something that doesn’t require significant time, travel or expense, offers convenience and is trustworthy. Locality breeds familiarity and comfort, particularly in healthcare, where it can heavily influence decisions. Patients…

Oncology has benefited from a wave of advances in recent decades. From 1991 to 2018, the age-adjusted overall cancer death rate dropped 31%, according to an analysis from American Association for Cancer Research (AACR). That death rate dropped 2.4% between 2017 and 2018, marking the most significant annual reduction. The reasons for such improvements are multifaceted,…

Sanofi (Nasdaq:SNY) has agreed to sell Regeneron (Nasdaq:REGN) exclusive international rights of Libtayo (cemiplimab) for $900 million. Sanofi will also receive an 11% royalty on global sales of the drug. Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Sanofi could also receive $100 million if the drug hits regulatory milestones…

Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC. Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.…

The biotech CytoDyn (OTCQB:CYDY) has resolved a legal dispute with Dr. Richard Pestell, the company’s former medical officer who had been “fired with cause” in July 2019. Today, CytoDyn announced that it had reached a “non-cash settlement” with Dr. Pestell, agreeing to release 8.3 million shares of its stock held in escrow. In August 2019, the…

On the heels of announcing a restructuring plan that reduces its workforce by 30%, Black Diamond Therapeutics (Nasdaq:BDTX) has announced that its discovery engine was featured in the peer-reviewed Cancer Research journal. The journal is published by American Association for Cancer Research (AACR). A paper highlighted in the journal explained how the company’s Mutation-Allostery-Pharmacology (MAP) discovery…

AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC). The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.…

The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study. The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the…

The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA. Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY). The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. Of the five breakthrough therapy designations for the drug,…

Precision oncology firm Black Diamond Therapeutics (Nasdaq:BDTX) has announced a restructuring plan to free up cash to prioritize the development of BDTX-1535 and BDTX-4933. The company plans on trimming nearly one-third of its workforce. BDTX shares ticked up about 1% to $2.75 after announcing the news yesterday but fell 4% today to $2.64. According to…

Black Diamond Therapeutics (Nasdaq: BDTX) has announced that it has dosed the first patient in the Phase 1 study focused on BDTX-1535. BDTX-1535 is a MasterKey inhibitor of epidermal growth factor receptor (EGFR) to potentially treat non-small cell lung cancer (NSCLC) and glioblastoma (GBM). Cambridge, Massachusetts–based Black Diamond believes BDTX-1535 holds significant potential for EGFR-mutant…

The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S. Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical…

The cell and gene therapy company Mustang Bio (Nasdaq:MBIO) will initiate a Phase 1 clinical trial combining CAR T cells and oncolytic virus as a potential therapy for recurrent glioblastoma. The prognosis for glioblastoma is generally poor with approximately 40% survival in the first year following diagnosis, according to the American Association of Neurological Surgeons. The…