For the second time in just over six months, there’s a newcomer in a next-generation class of breast cancer-fighters. Thursday, U.S. regulators greenlighted Eli Lilly’s Verzenio, better known as abemaciclib. The drug will join a pair of HR-postive, HER2-negative meds in Pfizer’s Ibrance and Novartis’ Kisqali, the latter of which won its own FDA approval […]
KCzobor@Premierendpoint.com
(201) 232-6182
NewLink inks deal with AstraZeneca to test Imfinzi combo
September 28, 2017
Dive Brief: NewLink Genetics Corp. has hooked up with AstraZeneca plc to study the safety and efficacy of combining its small molecule IDO pathway inhibitor, indoximod, with the British pharma’s anti-PD-L1 antibody Imfinzi in metastatic pancreatic cancer. Through a three-arm, mid-stage study, the companies will assess the combo treatment plus standard of care chemotherapy compared […]
SAN DIEGO, Sept. 27, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today presented an overview of the comprehensive immune monitoring data from the Phase 2 Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) at the 2nd World Congress on Electroporation and Pulsed […]
Amgen targets China in cancer biosimilar development deal with Simcere
September 27, 2017
Even as it battles against knockoffs of its own biologic drugs, Amgen is steadily growing its own biosimilar portfolio of copies of some of the bestselling cancer and inflammation drugs. Now, with a co-development deal with Simcere, Amgen is taking that effort to China, a country relying heavily on copycat drugs. The exclusive agreement includes […]
Another Alzheimer’s failure: Axovant’s drug flops in late-stage trial
September 26, 2017
Yet another once-promising treatment for Alzheimer’s disease has come up short in the final stage of development, this time adding Wall Street drama to the familiar disappointment that has plagued the drug industry for decades. A pill called intepirdine, developed by the biotech startup Axovant Sciences, failed to blunt the symptoms of Alzheimer’s in a […]
Bristol-Myers’ I-O star Opdivo steps up to challenge Bayer’s Stivarga in liver cancer
September 25, 2017
Bristol Myers Squibb’s Opdivo has won another approval—and the right to take on Bayer in liver cancer. Friday, the FDA cleared the immuno-oncology standout in patients with the most common type of liver cancer who’ve already been treated with Bayer’s Nexavar. The accelerated approval came on the back of positive overall response and duration of […]
FDA rejects Janssen’s Plivensia
September 25, 2017
Johnson & Johnson has been left “disappointed” after the FDA rejected its rheumatoid arthritis drug Plivensia (sirukumab). Efficacy is not the issue – but in a complete response letter to Janssen Biotech, the US regulator said that it needs additional clinical data to further evaluate its safety in the treatment of moderately to severely active […]
AbbVie pairs up another ADC cancer drug with Bristol-Myers Squibb’s Opdivo
September 22, 2017
AbbVie has joined forces with Bristol-Myers Squibb once again to test an experimental cancer drug with BMS’ checkpoint inhibitor Opdivo in the hope of coming up with a new treatment cocktail. Their latest collaboration will see PD-1 inhibitor Opdivo (nivolumab) paired with AbbVie’s antibody-drug conjugate (ADC) ABBV-399 in a phase 1b trial in non-small cell […]
European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma
September 21, 2017
DARMSTADT, Germany and NEW YORK, USA, September 21, 2017 /PRNewswire/ — First approved immunotherapy for rare and aggressive skin cancer in the European Union, with initial launches planned in Germany and the UK Builds on Bavencio’s previous accelerated approvals in the US and recent approval in Switzerland Approval based on data from Javelin Merkel 200 study including durable tumor response rate and duration of response Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: […]
3 Ways AI Is Changing Medicine
September 21, 2017
Recent developments in artificial intelligence (AI) are turning science fiction into science fact — and deep learning is at the heart of these advances. These AI systems have the ability to sift through scores of data, recognize patterns, and detect differences that might be imperceptible to humans. Some applications are already achieving remarkable results. One […]