UCB’s psoriasis hopeful hits another FDA delay

Today’s Big News

Sep 20, 2023

Neuralink begins recruiting people with quadriplegia for brain-computer interface trial 


Genentech sees more potential in peptides, signs $1B biobucks deal with PeptiDream 


UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay 


CDMOs SK pharmteco, Oxford Biomedica make cell and gene therapy manufacturing M&A plays 


Merck KGaA doubles up on AI partners, tapping BenevolentAI and Exscientia for drug discovery push

 

Featured

Neuralink begins recruiting people with quadriplegia for brain-computer interface trial

Neuralink is looking for volunteers who have quadriplegia caused by a spinal cord injury or ALS, according to a company blog post.
 

Top Stories

Genentech sees more potential in peptides, signs $1B biobucks deal with PeptiDream

PeptiDream is clearly doing something right. Big Pharmas have been queueing round the block to collaborate on the Japanese biotech’s peptide discovery platform, and, now, long-term partner Genentech is back with $40 million in upfront cash for a fresh licensing agreement.

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.

CDMOs SK pharmteco, Oxford Biomedica make cell and gene therapy manufacturing M&A plays

Two CDMOs have revealed acquisitions that will bolster their production capabilities and increase their global footprint. Korea's SK pharmteco has taken a controlling stake in the Pennsylvania-based Center for Breakthrough Medicines for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Merieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million).

Merck KGaA doubles up on AI partners, tapping BenevolentAI and Exscientia for drug discovery push

Merck KGaA is spreading its bets on an artificial-intelligence-enabled future for drug discovery, inking similar three-target deals with BenevolentAI and Exscientia. The deals are collectively worth more than $30 million upfront and $1 billion in potential milestones.

CMR Surgical sews up $165M in funding as it continues its global robot rollout

According to the company, its Versius system counts more than 140 installations in international hospitals, which to date have been used to conduct more than 15,000 keyhole surgeries.

For Biocon Biologics' CEO, the Humira biosimilar clash isn't only about market share

The biosimilar fracas targeting AbbVie’s megablockbuster Humira is taking shape. But to Biocon Biologics CEO Shreehas Tambe, the battle doesn’t solely revolve around market share. And the company won’t get distracted from its long-term strategy, he said.

Taysha ends work on gene therapy after Astellas walks away, FDA requests randomized trial

Astellas has turned down the chance to option an asset from Taysha Gene Therapies. And with Taysha identifying study design feasibility challenges after talking with the FDA, the biotech has stopped internal development of the candidate and added it to a large pile of dropped and deprioritized programs.

Ypsomed inks deal to manufacture GLP-1 autoinjectors for Novo Nordisk

Joining Novo Nordisk's GLP-1 assembly line is Ypsomed, which has signed on to produce “large quantities of autoinjectors” for the Danish drugmaker.

ARS Pharmaceuticals hit with surprise FDA rejection for epinephrine nasal spray Neffy, vows to appeal

Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.

Ex-Nkarta exec Nadir Mahmood rises to first CEO role at UCSF spinout Rezo

Nadir Mahmood is taking his first CEO gig leading Rezo Therapeutics, which spun out of UCSF and is chaired by longtime biotech exec George Scangos.
 
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