FDA halts PTC's Huntington's trial

Today's Big News

Oct 19, 2022

Buy now, pay later: Jazz hands over $50M for Zymeworks' phase 3 HER2-directed bispecific

Advaxis spies merger with Ayala as route back to Nasdaq

FDA pauses PTC's phase 2 Huntington's trial despite green light from regulators abroad

Ambrx cuts 15% of staff and dumps lead HER2 asset after 'strategic review'

After matching Comirnaty, Providence plans phase 3 booster study for COVID-19 vaccine candidate

Experimental Ebola shots to be used in Uganda outbreak: reports

 

Featured

Buy now, pay later: Jazz hands over $50M for Zymeworks' phase 3 HER2-directed bispecific

Jazz Pharmaceuticals has thrown its hat into the HER2 ring. For $50 million, the company has secured the chance to pay a further $325 million to take Zymeworks’ HER2-directed bispecific antibody forward after the release of pivotal data.
 

Top Stories

Advaxis spies merger with Ayala as route back to Nasdaq

With $20 million on hand and the second part of a potentially registrational phase 2/3 study just getting underway, Ayala was facing a potential cash crunch. But Advaxis may have solved its problems—in return for the hope of a return to the Nasdaq.

Taking Bold, Growth-Focused Actions During a Time of Economic Volatility in the Biotech Market

Cullinan Oncology’s strategic approach to research and development, focusing on modality-agnostic target oncology, positions the company to thrive.

Revealing new insights from the Tumor Microenvironment with AI-powered digital pathology

TME research is recognized as one of the most promising areas in oncology drug development. AI-powered digital pathology reveals new insights previously hidden by laborious manual pathology methods.

FDA pauses PTC's phase 2 Huntington's trial despite green light from regulators abroad

The FDA has pumped the brakes on PTC Therapeutics’ Huntington's disease trial in the U.S. even as the studies kick into gear in other countries.

Ambrx cuts 15% of staff and dumps lead HER2 asset after 'strategic review'

Ambrx has been mulling major changes since August. Now it has confirmed what form these will take: narrowing its cancer pipeline to earlier-stage therapies and dumping its lead asset at the expense of 15% of its workforce.

After matching Comirnaty, Providence plans phase 3 booster study for COVID-19 vaccine candidate

Almost two years after phase 3 results on the leading COVID-19 vaccines started rolling in, Providence Therapeutics has posted midphase data on its mRNA candidate and outlined plans to move into a pivotal booster study.

Experimental Ebola shots to be used in Uganda outbreak: reports

Uganda is implementing another measure to combat the current Ebola outbreak, with plans to dole out investigational vaccines in about two weeks.

Gilead touts Veklury resilience against mutated coronavirus, plots phase 3 for new COVID oral antiviral

Gilead Sciences has new data showing COVID drug Veklury maintained efficacy despite changes in a coronavirus structure it targets, just as the company explores expedited ways to launch a pivotal trial for an investigational oral antiviral.

'Stickier than most have assumed': Abbott upends COVID forecasts yet again with $1.7B in test sales

President Joe Biden may have declared the COVID-19 pandemic “over” in the U.S., but that news doesn’t appear to have reached the makers of diagnostic tests for the virus.

Merck KGaA faces probe in France over whether it misled patients about drug reformulation

Merck KGaA’s problems in France over its thyroid drug Levothyrox aren’t going away. Seven months after France’s highest court confirmed an earlier civil court ruling that ordered the Germany-based company to compensate users who suffered problems from Levothyrox, the case has advanced at the judicial level. On Tuesday, a judge in Marseille opened a formal probe to determine if the company provided misleading information when switching the formulation of Levothyrox.

Elevance Health beats the Street with $1.6B in profit for Q3

The company released its quarterly earnings report on Wednesday morning. Profits were up 7.2% from the prior-year quarter, where Elevance Health posted $1.5 billion.

Grifols christens capacity-tripling albumin plant, pledging 200 new jobs in latest plasma push

Alongside the christening of a new manufacturing plant in Dublin Wednesday, Spanish plasma specialist Grifols has received a thumbs-up on its Rigel-partnered platelet disorder drug from a nearby cost watchdog in the U.K.
 
Fierce podcasts

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'Podnosis': The explosion of consumer-initiated lab testing, key issues and trends with Medicare Advantage

This week on "Podnosis," we talk about the explosion of consumer-initiated lab testing. Also under discussion is our special report on the key issues and trends with Medicare Advantage.
 

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