To investors, Eisai and partner Biogen's recent phase 3 Alzheimer's data on anti-amyloid candidate BAN2401 aren't good enough. China's latest vaccine scandal drew much criticism, and it could offer a chance for foreign vaccine makers. Bristol-Myers Squibb tapped Tsinghua University to discover novel targets in cancer and autoimmune diseases. And more.
Eisai and partner Biogen recently showed in a late-stage Alzheimer’s trial that their amyloid-fighting antibody significantly slowed cognitive decline and amyloid accumulation in the brain, but many were not impressed. “[T]he studies were not large enough to definitely demonstrate cognitive efficacy and the BAN2401 study did not meet its primary endpoint,” the Alzheimer's Association said in a statement.
China’s latest vaccine scandal exploded on social media. Citizens raged about Changchun Changsheng Life Sciences’ manufacturing misconduct and expressed an even broader distrust in locally made vaccines. Drug and stock regulators and the central government have launched probes, and the company’s chairwoman was detained. This could offer an opportunity for foreign vaccine makers to expand their meager share in China.
Bristol-Myers Squibb has inked a deal with China’s Tsinghua University to discover drugs that hit novel cancer and autoimmune disease targets. For BMS, the pact strengthens its ties to an important but hard-to-navigate market, and for Tsinghua, the deal further validates its credentials as an immunology institute.
Takeda’s Alunbrig beat Pfizer and Merck KGaA’s Xalkori at fending off ALK-positive non-small cell lung cancer growth in previously untreated patients, an interview phase 3 readout showed. The data could put Alunbrig to the first-line setting, where Xalkori, Novartis’ Zykadia and Roche’s Alecensa already sit.
About a month after Bristol-Myers Squibb’s Opdivo became the first immuno-oncology therapy approved in China, Merck has also won its own approval for rival Keytruda in advanced melanoma, spreading the heated PD-1/L1 battle to a key emerging market. China’s drug regulator accelerated Keytruda’s review, allowing for simultaneous clinical validation for the first time.
Samsung BioLogics has won FDA approval for its first finished product at the second of three plants it built in rapid succession. The plant, already approved by the FDA to make drug substances, is now licensed to manufacture a monoclonal antibody. The CDMO unit also reported earnings this week.
South Korea biotech Peptron has developed an extended-release formulation of exenatide—the main GLP-1 receptor agonist in AstraZeneca’s diabetes meds Byetta and Bydureon. In a recent study in a rat model of Parkinson’s, the drug helped rats challenged with a brain lesion increase dopaminergic neurons, which is a hallmark in Parkinson’s relieve.