Pfizer nails down 4th nod from FDA in 5 weeks

Today's Big News

Jun 28, 2023

On conference circuit, biotechs lobby for their identity as new IRA drug pricing reforms take hold


AbbVie, Genmab's Epkinly shows promise in follicular lymphoma. Will FDA get on board?


Pfizer’s approval streak continues with FDA blessing for growth hormone treatment Ngenla


Masimo proxy battle ends with election of 2 board members from activist investor Politan


Bayer's Parkinson's cell therapy passes early clinical safety test, clearing path to phase 2

 

Featured

On conference circuit, biotechs lobby for their identity as new IRA drug pricing reforms take hold

The Inflation Reduction Act's drug pricing reforms have sent shock waves through the drug development world, with executives arguing the legislation stands to stymie the development of innovative new medicines.
18-19
Jul
July 18-19, 2023 | Jersey City, NJ
 

Top Stories

AbbVie, Genmab's Epkinly shows promise in follicular lymphoma. Will FDA get on board?

Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear.

Pfizer's approval streak continues with FDA blessing for growth hormone treatment Ngenla

Pfizer is on an FDA heater. With a blessing Wednesday for once-weekly growth hormone deficiency (GHD) drug Ngenla, the New York pharma giant has racked up four approvals from the agency over the last five weeks.

Masimo proxy battle ends with election of 2 board members from activist investor Politan

After several weeks of back-and-forth, the proxy battle activist investor Politan Capital Management waged against Masimo has drawn to a close.

Bayer's Parkinson's cell therapy passes early clinical safety test, clearing path to phase 2

Bayer has early evidence that its Parkinson’s disease cell therapy is safe. Now, with a phase 2 clinical trial on course to open enrollment next year, the German drugmaker is set to start showing whether the candidate can undo damage and restore motor function.

Blueprint keeps co-founder Alexis Borisy as director—without majority support from shareholders

Alexis Borisy, the serial biotech entrepreneur and self-dubbed “man of many hats,” may have to reduce two of his many duties.

ADA: Tandem strategy chief on the software, hardware updates that'll get late diabetes tech adopters off 'the sidelines'

Tandem Diabetes Care’s insulin pumps already make up more than a third of those used by people with Type 1 diabetes in the U.S., according to Elizabeth Gasser, an executive VP at Tandem and its chief strategy officer—but the company wants an even bigger piece of the pie.

Foghorn sinks plans for eye tumor drug after glimpsing phase 1 data

Foghorn Therapeutics isn’t having much luck with FHD-286. Only weeks after the FDA released a trial of the drug in two blood cancers from a clinical hold, the biotech has abandoned plans for the candidate in an eye tumor after taking a look at phase 1 data.

Activist investor NexPoint threatens to block Paratek's $462M sale

Paratek Pharmaceuticals' annual meeting is set for July 6, but fireworks are already exploding over the company’s attempt to sell out to investment firms Novo Holdings and Gurnet Point. Activist investor NexPoint Asset Management—which holds 12% of Paratek’s common stock—is trying to detonate the deal.

With approval supplement on deck, Reata dives into launch of its first commercial product Skyclarys

After an FDA thumbs up on Reata's approval supplement for Skyclarys, analysts feel confident the newly commercial-stage company can meet—or potentially even exceed—a $45.9 million sales target for 2023.  
 
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'The Top Line': The most expensive drugs in the US, plus this week's headlines

This week on "The Top Line," we discuss the most expensive drugs in the U.S., plus Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines.
 

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