FDA rejects Mesoblast cell therapy (again)

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Today's Big News

Aug 4, 2023

Seagen, Merck put $1.6B ADC collab on the back burner citing 'emerging treatment landscape'


UPDATED: Amgen's tarlatamab BiTEs at small cell lung cancer in brief readout


2nd time unlucky for Mesoblast as FDA rejects cell therapy again, sinking shares


Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline 


New Vir CEO makes her mark, dropping small-molecule platform to 'judiciously' use $1.9B war chest


Aligos culls another hepatitis B asset, citing inconclusive efficacy data


Small biotech ends stealth mission to conduct gene edits without triggering immune system

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Featured

Seagen, Merck put $1.6B ADC collab on the back burner citing 'emerging treatment landscape'

Seagen is putting a phase 2 Merck-partnered antibody-drug conjugate on the shelf for now, nearly three years after signing on to a $1.6 billion partnership for the asset.
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Top Stories

UPDATED: Amgen's tarlatamab BiTEs at small cell lung cancer in brief readout

One of Amgen's top BiTE molecules continues to inch forward after the company posted a brief phase 2 readout Thursday. The trial update included no new data, but Amgen said tarlatamab posted better safety and efficacy data than it produced in phase 1.

2nd time unlucky for Mesoblast as FDA rejects cell therapy again, sinking shares

Mesoblast’s second attempt to win over regulators to its off-the-shelf cell therapy has had no more success than the first try, sinking the Australian biotech’s stock.

Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline

The company is tripling down on its Alzheimer’s franchise, rounding out its tau-focused pipeline with a gene therapy aimed at amyloid-beta plaques.

New Vir CEO makes her mark, dropping small-molecule platform to 'judiciously' use $1.9B war chest

Vir Biotechnology is narrowing its focus. Sitting on $1.9 billion, the infectious disease specialist has decided to stop work on its innate immunity small molecule platform as part of its efforts to “judiciously allocate” its capital.

Aligos culls another hepatitis B asset, citing inconclusive efficacy data

Strike another hepatitis B drug candidate from Aligos Therapeutics’ once-stacked pipeline. The biotech kept up the cadence of program pruning by deciding against committing more cash to an siRNA prospect after getting a look at early-phase data.

Small biotech ends stealth mission to conduct gene edits without triggering immune system

Gene editing biotech NeuBase Therapeutics is stopping program development and looking for a sale after its board of directors voted to close up shop and seek strategic alternatives.

Chutes & Ladders—Peter Marks has no immediate plans to leave the FDA

CBER chief Peter Marks doesn't have any plans to leave the FDA—yet. Anthony Fauci's replacement at NIAID has been founf. Jamie Rubin takes CFO role at Boundless after EQRx stint.

Fierce Pharma Asia—BMS, BeiGene strike settlement; Sumitomo, Otsuka suffer trial failures; AZ's CEO talks China

Bristol Myers Squibb and BeiGene decided to terminate their three-drug licensing deal. Sumitomo Pharma's Otsuka-partnered schizophrenia candidate ulotaront failed in two phase 3 trials. AstraZeneca CEO responded to a report about the company's plan to spin out its China business. And more. 

'The Top Line': How to support patients during a drug shortage, plus this week's headlines

This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines.

Novo Nordisk, Eli Lilly face injury lawsuit from user of popular GLP-1 medicines

A Louisiana woman is suing Novo Nordisk and Eli Lilly, alleging that her use of Ozempic and Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, says that she also has been hospitalized on "several" occasions and that the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs.

Generation Z says gun violence, racism, climate change affecting mental health

Society's biggest problems, like racism and gun violence, are wearing on the mental health of the country's youngest demographic.

Amgen's hyped Humira biosimilar fritters away its exclusivity advantage

When Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunology powerhouse. But Thursday, Amgen reported second-quarter sales of just $19 million for Amjevita, a 63% drop sequentially.
 
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'The Top Line': How to support patients during a drug shortage, plus this week's headlines

This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines.
 

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