Here are the latest stories being discussed in biopharma today:
Organon Makes Major Acquisition for Women’s Health in Europe
Merck subsidiary Organon is expanding its European portfolio with the addition of two Eli Lilly migraine treatments. Targeting maladies that disproportionately affect women’s health, Organon has agreed to pay an initial $50 million for the commercial rights in Europe, plus additional sales-based milestones. The company has already established a solid CNS team to handle the increase. Lilly’s Emgality and Reyvow medications are considered ideal purchases as migraines are three times more common among women than men. Emgality garnered $651 million in sales for Eli Lilly in 2022.
Arcutis Wins FDA Seal for New Foam Skin Treatment
Arcutis Biotherapeutics has earned FDA approval for a new foam treatment for seborrheic dermatitis for individuals aged nine and up. The topical treatment, known as Zoryve (roflumilast), is a phosphodiesterase-4 inhibitor and will be commercially available from January 2024. The foam will cost the same as its cream formulation, which is already FDA-approved and costs $858 per tube. This marks the first new treatment mechanism for seborrheic dermatitis in over twenty years, which affects around 12% of the adult population and 42% of infants.
FDA Gives Green Light to Opioid Safety Labeling Changes
The FDA has finalized safety labeling changes for opioid-based medications. With these adjustments, the administration aims to provide better information on the risks of opioid addiction, abuse, and misuse. These measures may result in potentially fatal overdoses and other serious harm. Specific label changes will provide clearer instructions regarding the initially intended use of opioid analgesics in outpatient settings. Providers are required to balance the benefits and risks when considering opioid treatment for their patients.
Atara Biotherapeutics to Lay Off Workers by Year’s End
Biotechnology company Atara Biotherapeutics plans to terminate 73 of its California-based employees by the end of this year. The layoffs come amid a company-wide restructuring effort aimed at improving efficiency and reducing costs. The employees affected by the layoffs will be compensated, receiving severance packages as well as outplacement services. This move is part of the company’s broader efforts to focus its resources on its T-cell Immunotherapy platform and strategic priorities.
FDA Expands Authorization for Akili’s Video Game for ADHD
The US Food and Drug Administration has broadened the authorization for Akili’s video game designed for ADHD (Attention Deficit Hyperactivity Disorder) patients. The video game treatment, called EndeavorRx, was initially cleared by FDA last year for use in children aged 8-12 with primarily inattentive or combined-type ADHD. The expanded authorization now includes children aged between 8-12 years who have demonstrated inattention issues.
Sanofi and Boehringer Commit $80M for VC’s Rare Disease Study
In an exclusive commitment, Sanofi and Boehringer have agreed to devote $80 million towards a study for a new platform for rare diseases. Led by a veteran venture capitalist who is also battling his own rare disease, the funds will be used to launch a venture aimed at understanding and combating the challenges of rare diseases. More details on this pioneering venture are expected to be released soon.
Illumina to Divest from Grail After Anti-trust Concerns
Genomics company Illumina intends to divest its stake in Grail, a move coming two years after an $8 billion deal was impeded by antitrust issues. The parting comes as Grail continues to focus on early cancer detection through its Galleri blood test. Further information about Illumina’s divestment plan from Grail is yet to be revealed.
