Another congressional hearing on drug prices yielded a familiar clanking about importation, direct Medicare negotiation and transparency, transparency, transparency.

DUBLIN – The EMA aims, as best it can, to maintain a business-as-usual stance in the run-up to Brexit and the agency's associated departure from London. But its "Brexit Preparedness Business Continuity Plan," which it published late on Monday, sets out in stark terms the extent to which it may be forced to depart from that agenda given the massive disruption to its day-to-day operations brought on by the U.K.'s decision to exit the European Union.

Immune Design Corp. said the FDA blessed its plans to initiate a pivotal phase III of CMB-305, its prime-boost vaccine approach against NY-ESO-1-expressing tumors, in individuals with locally advanced unresectable or metastatic synovial sarcoma, a subtype of soft tissue sarcoma.

SAN FRANCISCO – Bispecific antibodies, expected as a class to carve out a multibillion-dollar niche in the decade ahead, continue to face multiple challenges between now and then. However, with significant clinical investment, the approach is gaining momentum, company executives said at the BIO Investor Forum in San Francisco on Monday.

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from industry on two related draft guidances for reporting adverse events for biologics and for adopting an EU guideline on good pharmacovigilance practices.

HONG KONG – Generon Corp. (Shanghai) Ltd. has reached an agreement with the FDA under a special protocol assessment (SPA) regarding the second pivotal global phase III study design of its chemotherapy-induced neutropenia (CIN) treatment.

Syndax Pharmaceuticals Inc., of Waltham, Mass., said it agreed to sell about 2 million shares of common stock to Biotechnology Value Fund LP and certain of its affiliates in a registered direct offering for gross proceeds of about $25 million based on the offering price of $12.37 per share, representing the closing price of the company's shares on Oct. 13.

Amgen Inc., of Thousand Oaks, Calif., and Boston Children's Hospital entered a neuroscience research collaboration to identify pain targets based on human genetic analyses.

Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, said it started a phase I trial of epilepsy candidate XEN-1101, an orally administered Kv7 potassium channel opener that has the potential to treat both adult as well as rare pediatric genetic forms of epilepsy.

Privately held Hemoshear Therapeutics LLC signaled its intention to compete both with small peers and big biopharma in the race to develop therapies for liver diseases, especially nonalcoholic steatohepatitis (NASH), by luring Takeda Pharmaceutical Co. Ltd. to a funded three-year discovery and development pact.