Here's a roundup of top developments in the biotech space over the last 24 hours:

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FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants

The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the vaccine composition to create a two-component (bivalent) booster vaccine.

Genmab Plans To File US Application For Epcoritamab In Blood Cancer Setting

FDA Extends Decision Date For Provention Bio's Lead Product Candidate 

Teplizumab is under review for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk individuals.

The company was also informed that if no major deficiencies are identified during the review period, the FDA plans to communicate proposed labeling and, if necessary, any post-marketing requirements or commitment requests by Oct. 17.

Akebia Terminates Vadadustat Agreement With Otsuka

As part of the termination, Otsuka has agreed to pay Akebia a settlement fee of $55 million.

Akebia is to assume responsibility for regulatory review processes previously led by Otsuka.

Shares are up 37.4% at 49 cents during the premarket session.

Oxford Biomedica Inks 3-Year Deal To Make AstraZeneca's COVID-19 Vaccine

Under the expanded deal, AstraZeneca will have access to Oxford Biomedica's Oxbox manufacturing facility to produce its shot on an as-needed basis beyond 2022.

Oxford Biomedica expects to recognize aggregate revenues of approximately 30 million pounds ($36 million) from AstraZeneca in the current financial year.

FDA Rejects NRx Pharma's Emergency Use Request For Aviptadil For COVID-19

NRx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis.

We will evaluate the options for Zyesami in COVID-19 respiratory failure and other lung disorders once we receive the full data set from the National Institutes of Health," said Robert Besthof, interim CEO.

Shares are slipping 4.83% to 57 cents during the premarket session.

Endo Posts Disappointing Data From Frozen Shoulder Trial

While participants receiving up to three doses of CCH showed some improvement in the change from baseline in the shoulder pathology composite score, the difference compared to those study participants receiving placebo was not statistically significant.

Shares are down 7.67% at 43 cents during the premarket session.

Nektar Names New Chief Finance Executive

Thomsen has served as SVP, finance and chief accounting officer of Nektar since 2008.

Gil Labrucherie, the company's current chief operating officer and chief financial officer, will be departing to pursue another opportunity at a private biotechnology company.

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