Oncology

Ensysce Biosciences CEO Lynn Kirkpatrick oversees the development of novel medicines to reduce or eliminate prescription drug abuse. The La Jolla, California-based company’s oxycodone prodrug candidate PF614 is now in a Phase 2 clinical trial. It is designed to offer similar pain relief as prescription opioids with a limited risk of drug abuse and addiction.…

Dr. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, says her entry into the pharmaceutical industry was serendipitous. “I always wanted to be a doctor, and during medical school, I was fascinated by the science behind how cancer happens and what we can do to better treat it,” she said. After following this…

Brentford, UK–headquartered GSK (LSE/NYSE:GSK) reported long-term data from the phase 3 PRIMA study indicating that the PARP inhibitor Zejula (niraparib) promoted a sustained and clinically meaningful progression-free survival (PFS) benefit in ovarian cancer patients. The survival benefit was evident across biomarker subgroups, including BRCAm, HRd and HRp. Patients in the HRd subgroup had a 48%…

The risk of cancer deaths has fallen steadily in recent years. Before the pandemic, the risk of death from cancer fell roughly 2% annually from 2015 to 2019. In the 1990s, the risk of cancer death fell approximately 1% each year, according to the American Cancer Society. In addition to improved screening and diagnosis, cancer…

Cancer diagnoses and screenings dramatically dropped during the peak of the COVID-19 pandemic. Recent data from tens of thousands of patients suggest that the U.S. is likely to see at least two years of increased cancer diagnosis rates and poorer outcomes, according to Jeff Elton, CEO of ConcertAI. EHR data reflect a pronounced drop in pan…

FDA has approved the selective fibroblast growth factor receptor (FGFR) inhibitor Pemazyre (pemigatinib) to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.  The drug, developed by Incyte (Nasdaq:INCY), first won approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.  The latest indication, MLNs with FGFR1 rearrangement, covers an…

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.…