Cancer

ZL-1310, a DLL3-targeting ADC, has shown a 74% objective response rate in extensive-stage small cell lung cancer after platinum-based chemotherapy, making it a new contender in this setting.

Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.

Big pharma executives at ARM’s Cell and Gene Meeting on the Mesa shared some of the practical challenges of bringing one-time treatments to market in hemophilia, cancer and beyond.

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

Schrödinger has for years discovered drug candidates for other companies and derisked them, testing them in silico using its computational models. Now, it is exploring its own ability to develop drugs in the clinic, starting with low-risk bets. Will the company’s approach succeed where others have failed?

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Start-ups pitched a diverse deck of innovative technologies to three judges and an audience of potential investors, strategics and physicians at the Octane Medical Innovation Forum in Irvine, CA. Highlights include neuromodulation company Sinaptica Therapeutics, which won the competition for both “People’s Choice” and “Judge’s Choice.”

The sponsors of medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

China gets more complicated as multinational drug makers venture deep into it. Even with a local savvy business partner, Merck is learning to navigate through fast-shifting market dynamics amid policy changes, consumer perceptions of foreign brands, and competition from local firms as it takes stock of its market access, pricing and life cycle management strategies.