Sanofi, Insilico's $1.2B deal to heat up 'biotech winter'

Today's Big News

Nov 8, 2022

BioMarin's hemophilia gene therapy faces further delays over fresh FDA requests

Adaptimmune to lay off up to 30% of staff as allogeneic ambitions stunted by cell line change

ADC's accelerated review troubles signal FDA's tough new stance on confirmatory studies

Amid 'biotech winter,' Insilico turns up the heat with Sanofi deal worth $1.2B in biobucks

GSK hep B treatment’s efficacy slips 60% in full phase 2 readout, but phase 3 going ahead

Zenas zips up $118M to launch phase 3 for rare autoimmune disease candidate

Galecto posts GULLIVER-2 data to travel deeper into severe liver disease

 

Featured

BioMarin's hemophilia gene therapy faces further delays over fresh FDA requests

BioMarin’s hopes for bringing its hemophilia gene therapy to market remain just out of reach, with the FDA now requesting a look at its manufacturing site and long-term phase 3 data.
 

Top Stories

Adaptimmune to lay off up to 30% of staff as allogeneic ambitions stunted by cell line change

Adaptimmune is cutting staff and culling assets as it looks to prioritize a push for FDA approval of its lead asset. The cutbacks come as the company is delaying clinical readiness of its allogeneic program to swap out the cell lines.

ADC's accelerated review troubles signal FDA's tough new stance on confirmatory studies

ADC Therapeutics seems to have run headlong into the FDA’s new strict policy on accelerated reviews: Get your confirmatory study in line before filing, or wait.

Amid 'biotech winter,' Insilico turns up the heat with Sanofi deal worth $1.2B in biobucks

Insilico Medicine is radiating heat amid the biotech winter, kindling its fires with a Sanofi collab that could be worth up to $1.2 billion in biobucks—the AI drug discovery company’s largest deal to date.

GSK hep B treatment’s efficacy slips 60% in full phase 2 readout, but phase 3 going ahead

The efficacy of GSK's hepatitis B treatment may have dropped by over 60% between the interim and end-of-study analysis, but the Big Pharma is still hopeful the antisense oligonucleotide treatment will provide a functional cure for the infection.

Zenas zips up $118M to launch phase 3 for rare autoimmune disease candidate

Zenas BioPharma has raised a $118 million series B to zoom in on a pipeline of immune-based therapies and launch a phase 3 for its lead candidate that was licensed from Xencor less than a year ago.

Galecto posts GULLIVER-2 data to travel deeper into severe liver disease

Galecto is trying to build out the case for its severe liver disease candidate GB1211, presenting phase 1/2 data linking the small-molecule inhibitor of galectin-3 to reductions in several enzymes in post hoc analyses.

What a divided Congress could mean for healthcare in the next year

As Republicans appear poised to take control of at least one chamber of Congress, experts say GOP lawmakers could scrutinize implementation of the Inflation Reduction Act.

Eli Lilly lines up launch of diabetes platform that tracks blood sugar, insulin pen use

With FDA clearance secured for its Bluetooth-connected insulin dose-tracking technology, Eli Lilly is ready to pick up the tempo.

Moderna’s Spikevax carries higher risk of myocarditis than Pfizer's Comirnaty, study says

Nearly two years after the rollout of COVID-19 vaccines, risks such as myocarditis are still being assessed. Researchers found that the risk of myocarditis is greater after a second dose of Moderna's shot compared with Pfizer/BioNTech's competing vaccine.

Wrestling inflation, COVID-19 and the Ukraine conflict, Bayer stocks up to evade future manufacturing bottlenecks: CEO

Even though Bayer achieved gains across all three of its business sectors for the third quarter of 2022, the company has had to "contend with the current unfavorable business environment,” Bayer CEO Werner Baumann told investors on a conference call Tuesday.

Mayo Clinic spinout Anumana acquires NeuTrace to develop cardiac procedure AI

The goal is to link patient records with ECG data to provide personalized cardiovascular care.
 
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‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

This week on “The Top Line,” we dig into Philips’ revelation that it is laying off 4,000 workers and planning for even more restructuring.
 

Resources

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Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.
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The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.
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Softgel Formulation Enables Oral Delivery of Testosterone

Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy.
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Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities
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Catalent Pulmonary & Nasal Delivery Capabilities Sheet

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