Bayer pads blockbuster case for Nubeqa with phase 3 win in metastatic prostate cancer BeyondSpring lurches down as FDA rejects plinabulin, raising questions about lung cancer prospects FDA clears Insightec’s MRI-guided sound wave technology to treat prostate cancer Providers slam House for not delaying nearly 10% Medicare payment cuts in must-pass spending deal Improving CAR-T cell therapies for cancer by targeting a protein 'brake' Novartis' Sandoz yanks one lot of deep vein thrombosis injectable after exposure to heat during shipping Healthcare Dealmakers—Athenahealth sells for $17B; Tenet drops $1.2B on ASCs Little European biotech Sotio nabs a super $316M funding round for its superagonist work Boston Scientific launches trial of modular, leadless pacemaker-defibrillator system Witty: Why UnitedHealth's innovation strategy starts with breaking down silos Biogen's Spinraza, Fosun-Kite's Yescarta and a controversial Alzheimer's drug: All you need to know about China's new state coverage Hear, hear: Sound Life Sciences wins FDA OK for app that uses sonar to measure breathing Gene therapy startup bursts forth from incubation at J&J and F-Prime, graduating with $80M and a Novartis veteran at the helm Featured Story | By Fraiser Kansteiner A combination of Bayer’s androgen receptor inhibitor Nubeqa plus standard of care trumped standard care alone at prolonging the lives of men with metastatic hormone-sensitive prostate cancer. read more |
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Top Stories By Nick Paul Taylor The BeyondSpring roller coaster has plunged downward again. While BeyondSpring wowed investors with its phase 3 lung cancer data in August, the FDA found less to like in another indication, rejecting the drug on the grounds that the single registrational trial was too flimsy to show the drug’s benefit. read more By Andrea Park The prostate cancer-focused technology’s FDA clearance comes just a month after Insightec racked up yet another regulatory approval for its Exablate Neuro system. read more By Robert King Provider groups slammed the House for not delaying nearly 10% in Medicare payment cuts in a must-pass spending bill, as concerns mount the cuts could go through next month. read more By Angus Liu CAR-T cells to treat cancer have precious little time to proliferate in the body, which often limits their anti-tumor efficacy. A team at the Curie Institute pinpointed the protein SOCS1 as an inhibitor of CAR-T expansion and survival and suggested it could be targeted to improve T-cell therapies. read more By Fraiser Kansteiner Sandoz is recalling one lot of enoxaparin sodium injection single dose syringes after part of the batch was exposed to high temperatures during shipping. The balmy conditions may have “significantly impacted” the drug’s effectiveness, Sandoz said. read more By Dave Muoio Best Buy wraps up a $400 million remote monitoring purchase and more merger and acquisition news from the month of September. read more By Ben Adams In one of the biggest funding rounds for a European biotech ever, Czech Republic cancer company Sotio Biotech has grabbed a huge 280 million euro ($316 million) raise. read more By Conor Hale The study is testing two separate devices that aim to work together to keep the heart from beating too fast or too slow and communicate wirelessly and require no electric leads to be threaded into the heart muscle. The study’s first two patients underwent the procedure at the Cleveland Clinic. read more By Paige Minemyer Even as the healthcare system drives toward innovation, it remains too "fragmented" to achieve sustained and substantial improvements, said UnitedHealth Group CEO Andrew Witty. read more By Angus Liu Sixty-seven novel therapies entered China’s national reimbursement drug list for the first time and offered an average 61.7% discount through negotiations with the government. Here we summarize some of the most important movements from the likes of Biogen, Fosun-Kite, Eli Lilly, AstraZeneca and more. read more By Andrea Park In studies submitted to the FDA for authorization, Sound's software was used to monitor patients with chronic respiratory pulmonary disease, asthma, congestive heart failure, anxiety and more. read more By Nick Paul Taylor AviadoBio has come flying out the traps surrounded by A-list names. Incubated at F-Prime Capital and Johnson & Johnson’s JJDC, AviadoBio exited stealth with $80 million from backers such as New Enterprise Associates and a C-suite led by Novartis veteran Lisa Deschamps. read more | 