Medtronic names new robotics CMO

Today’s Big News

Sep 13, 2024

Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus


Zenas, MBX and Bicara all head to Nasdaq in hot day for biotech IPOs


Medtronic appoints new chief medical officer for digital surgery and robotics


Senators target online drug ad influencers in draft legislation, proposing new powers for FDA


ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value from new cancer meds


Biolexis enters oral GLP-1 horse race with preclinical study showing small molecule reduced weight of obese mice


In wake of Q2 revenue drop, Charles River cuts 3% of workforce


Tonix questions efficacy of oral migraine drugs in awareness campaign

 

Featured

Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.
 

Top Stories

Zenas, MBX and Bicara all head to Nasdaq in hot day for biotech IPOs

It’s a busy Friday for biotech IPOs, with Zenas BioPharma, MBX and Bicara Therapeutics all going public.

Medtronic appoints new chief medical officer for digital surgery and robotics

James Porter serves as medical director of robotic surgery at the Providence Swedish health system in Seattle.

Senators target online drug ad influencers in draft legislation, proposing new powers for FDA

Two senators want to empower the FDA to send warning letters to influencers and telehealth companies that publish deceptive drug ads online and require drugmakers to report payments to social media stars.

ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value from new cancer meds

Using the ESMO Magnitude of Clinical Benefit Scale, a group of Harvard researchers has scored companies according to the value of the cancer drugs they have brought to the market. Among the standout drugmakers in the analysis were Novartis, Daiichi Sankyo and AstraZeneca.

Biolexis enters oral GLP-1 horse race with preclinical study showing small molecule reduced weight of obese mice

Another contender has emerged in the race to develop oral GLP-1 drugs for weight loss. Biolexis Therapeutics’ small molecule BLX-7006 reduced the weight of obese mice by 15% over a 28-day span.

In wake of Q2 revenue drop, Charles River cuts 3% of workforce

In the wake of a second quarter that saw revenues decline by 3.2%, contract research organization Charles River Laboratories is laying off 3% of its workforce, a spokesperson confirmed to Fierce Biotech in an emailed statement.

Tonix questions efficacy of oral migraine drugs in awareness campaign

Tonix Pharmaceuticals is trying to start a conversation about a potential shortcoming of oral migraine drugs, kicking off a national campaign to raise awareness of a condition that can affect absorption.

Chutes & Ladders—Cue Biopharma queues up J&J vet as CBO

After 25 years at Johnson & Johnson and 30 in the industry, Lucinda Warren is moving on to new pastures at Cue Biopharma as its first chief business officer.

After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug

The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.

FDA pushed to be more open, collaborative to accelerate rare disease R&D

The FDA should be more open and collaborative to unleash a surge in approvals of rare disease drugs, according to a report by the National Academies of Sciences, Engineering, and Medicine.

ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop

AstraZeneca is detailing Truqap's pivotal trial flop in triple-negative breast cancer, a result that could raise additional doubts around the first-in-class AKT inhibitor. From AZ's perspective, a company executive argued the failure was probably a one-off.

Eli Lilly sells Life Sciences Studio lab to Arctoris, moving automation platform from San Diego to Oxford

Four years after launching a remote-controlled robotic laboratory in San Diego, Eli Lilly is shipping the operation overseas. The Big Pharma is selling a majority of the Life Sciences Studio laboratory to Arctoris, a contract research organization with headquarters in Oxford, England and Boston.
 
Fierce podcasts

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A look at flu vaccine manufacturing and supply

In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines.

 

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Epilepsy Clinical Trials

Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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