AZ’s Andexxa notches postmarket win

Today's Big News

Jun 5, 2023

J&J’s multiple myeloma combo produces déjà vu with 96% Carvykti-like response


AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval


FDA collects another 6,000 complaints—including 40 deaths—linked to Philips’ CPAP recall


'We're swimming against the tide': Why Lilly is trying new strokes to persevere against pain


Amgen extends retraining order in Horizon pursuit as court's scheduling comes into focus


ASCO: Illumina's oncology exec on the need to 'democratize genomic profiling in cancer'

 

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ASCO: J&J’s multiple myeloma combo produces déjà vu with 96% Carvykti-like response

Johnson & Johnson has seen response rates as high as 97% in multiple myeloma before but this time, it’s not for Carvykti. No, this time the healthcare giant’s pharmaceutical unit Janssen is shining the spotlight on a combo study for talquetamab and Tecvayli.
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Top Stories

AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval

The phase 4 study ended ahead of schedule after it quickly established the benefits of Andexxa. AZ now plans to seek full approvals for the drug.

FDA collects another 6,000 complaints—including 40 deaths—linked to Philips’ CPAP recall

The new additions bring the total number of complaints that the FDA has collected between April 2021—when Philips first began alerting customers to potential issues with some of its respiratory devices—and the end of March of this year to more than 105,000, with 385 reported deaths.

'We're swimming against the tide': Why Lilly is trying new strokes to persevere against pain

Easing pain may have been one of the original goals of medicine, but the zeitgeist has long since moved on to harder-to-treat conditions. That makes Eli Lilly’s efforts to reinvigorate the space all the more intriguing.

Amgen extends restraining order in Horizon pursuit as court's scheduling comes into focus

Amgen and Horizon extended a prior September restraining order to Halloween as they work through the FTC litigation. Up next, the parties are set for a court hearing on September 11.

ASCO: Illumina's oncology exec on the need to 'democratize genomic profiling in cancer'

“Our data show that an enormous and even alarming number of patients are not getting genomic profiling when they get diagnosed,” Kevin Keegan, general manager of Illumina's oncology business, said in an interview at ASCO.

Anxious for actionable data sooner than 2031, Biogen trims Denali-partnered Parkinson's program

Biogen and partner biotech Denali Therapeutics are trimming down a Parkinson’s disease clinical program that was not expected to complete until 2031 in hopes of getting some actionable data sooner.

Novo Nordisk offers €154M in negotiations to acquire diabetes devicemaker Biocorp

Barely two years into its partnership with Biocorp, the French maker of “smart” connected medical devices, Novo Nordisk is upping the ante.

ASCO: Johnson & Johnson's Balversa tops chemotherapy in bladder cancer trial

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.

ASCO: At long last, Servier finds a survival benefit in difficult brain cancer

Servier promised that interim data from a phase 3 study would “shift the treatment paradigm” for a type of brain cancer that has long been stagnant in clinical research in March. Now, we’ve got the goods.

ASCO: Merck bills Keytruda, used around surgery, as new standard in 'messy' early lung cancer realm

As doctors navigate the "messy" early-stage non-small cell lung cancer landscape with various immunotherapy approaches, Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used before and after surgery, as a new standard of care.

ASCO: C2i Genomics CEO, CTO aim to create a 'one-stop shop for precision oncology'

While many of the companies currently developing blood tests to help diagnose cancer or track the disease’s progression are churning out physical tests that can be sent out to labs and hospitals around the world, C2i Genomics is taking a different approach.

FDA rejects Clovis' long-shot bid for approval of Rubraca

Six months after filing for bankruptcy, Clovis was hoping for a last gasp win for fading cancer drug Rubraca. But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy.

Canadian biotech narrows trial population to lift solid tumor drug out of FDA hold

The FDA has signed off on an amended trial protocol for Theratechnologies’ solid tumors medicine, lifting its clinical hold and setting the Canadian biotech free to proceed.
 
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'The Top Line': Democratizing access to meds, plus the headlines

This week on "The Top Line," we discuss the need to democratize access to medications like emergency contraception, plus Elizabeth Holmes, the state of Alzheimer's research, and the rest of the week's headlines.

 

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