Orthofix C-suite upended over offensive conduct

Today’s Big News

Sep 12, 2023

In warning letters, FDA tells 8 companies to stop selling illicit eye drugs


With Roctavian as a launching pad, BioMarin looks to up pace of new drug filings


Orthofix board gives CEO, other C-suite members the boot for ‘offensive conduct’


2seventy eliminates 40% of roles, seeks replacement for CEO Nick Leschly as cell therapy falters


With multiple launches underway, Jazz names Galá its next operations chief 


Abbott’s recall of nearly 200K neurostim systems given FDA Class I rating

 

Featured

In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.
11-14
Sep
Philadelphia, PA
 

Top Stories

With Roctavian as a launching pad, BioMarin looks to up pace of new drug filings

To build the "best pipeline in BioMarin history," the California biotech is looking to its already approved meds as a jumping off point. 

Orthofix board gives CEO, other C-suite members the boot for 'offensive conduct'

The spine and orthopedics company said that President and CEO Keith Valentine, Chief Financial Officer John Bostjancic and Chief Legal Officer Patrick Keran will be replaced, effective immediately.

2seventy eliminates 40% of roles, seeks replacement for CEO Nick Leschly as cell therapy falters

CEO Nick Leschly is leading a long list of 2seventy bio employees who are heading to the exit. With rival drugs putting its approved cell therapy under pressure, the bluebird bio spinout is eliminating 176 roles and advancing fewer R&D programs internally to stretch its cash runway out to 2026.

With multiple launches underway, Jazz names Renée Galá its next operations chief

As Jazz turns the page from its long-time growth driver Xyrem and leans on a trio of newer medicines for growth, its executive roster is undergoing some changes.

Abbott's recall of nearly 200K neurostim systems given FDA Class I rating

Though designed to be a help, the “MRI mode” feature on many of Abbott’s implanted neuromodulation systems may turn out to be something of a hindrance for some users.

Acelyrin fails late-phase clinical trial months after $540M IPO, sending stock hurtling downward

Acelyrin has given its investors a nasty shock. Months after raising $540 million in a rare biotech IPO, the company has reported the failure of its lead prospect in a phase 2b/3 inflammatory disease clinical trial, causing its share price to plummet by 58% in premarket trading.

Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or potentially earlier under certain circumstances. The Sprycel patents in question aren’t due to expire until Sept. 28, 2026.

Humacyte's regenerative tissues ace trial in vascular trauma repair

Humacyte unveiled results from a late-stage clinical trial showing that its Human Acellular Vessel approach could outperform synthetic grafts in long-term patency as well as in amputation and infection rates.

CureVac hand-picks mRNA flu vaccine for GSK-partnered program but keeps data tucked away

​​​​​​​CureVac has hand-picked the mRNA influenza vaccine that will advance into the phase 2 portion of a clinical trial, but the famously tight-lipped biotech is keeping the data to itself for now.

Novartis pulls Sandimmune batch after crystals formed in bottles, posing safety risks

A potentially dangerous crystal formation was found in a bottle of the drug, which is used to prevent organ rejections in transplant patients.

New test aims to spot signs of Parkinson’s disease within a teardrop

Axim Biotech announced that it has developed a rapid, point-of-care assay that could be used for the neurodegenerative condition, by searching for abnormal formations of a key brain protein.
 
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