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After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases.

With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very important for cancer.”

While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term.

During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.

In December 2024, Teva also secured FDA approval for the other liraglutide brand Victoza, indicated for type 2 diabetes.

Health Secretary Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Sept. 4, following the ouster of CDC Director Susan Monarez and tapping of HHS Deputy Secretary Jim O’Neill as her interim replacement.

Nipocalimab, approved as Imaavy for generalized myasthenia gravis earlier this year, failed to show significantly added benefit when used with an anti-TNFα therapy in patients with rheumatoid arthritis.

In another blow to Prothena’s neurodegenerative disease portfolio, anti-amyloid candidate PRX012 has run into the same problem that larger peers Biogen and Eli Lilly have battled: high rates of swelling in the brain.

Sometimes, job interviews stand out for all the wrong reasons, including odd settings, off-topic topics and questionable decorum. BioSpace collected several stories that highlight biopharma professionals’ strangest experiences as they pursued employment.

Exelixis is looking at the possibility of relocating some of the eliminated Pennsylvania roles to its headquarters in Alameda, California, according to a company spokesperson.

The American Academy of Pediatrics called the decision to limit children’s access to COVID-19 vaccines “deeply troubling.”

Novo Nordisk has brought on other cardiometabolic collaborators this year, including United Laboratories International and Deep Apple Therapeutics.

• New patent application covers treatment-emergent immune signature related to ‘turning cold tumors hot’ and the activation of targeted cytotoxic cellular immune responses • Company to host conference call later in April 2026 to review new biomarker signature • Biomarker signature meets pharmacodynamic/response criteria established by FDA’s Biomarkers, EndpointS and other Tools (BEST) program for use as a surrogate clinical endpoint of 1-year event free survival and 2-year overall survival in OST-HER2’s Phase 2b trial in the prevention of delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma to support a BLA submission under FDA’s Accelerated Approval Program

Anticipated peptide reclassification could expand the addressable market for PharmaTher’s PharmaPatch™ product strategy and PatchPrint™ manufacturing platform, strengthening its position in next-generation peptide delivery

Proven Med Tech Leader with an Established Track Record of Commercial Success and Optimizing Shareholder Value Leading to over $3.4 Billion in Successful Exits

Model Medicines’ antiviral intellectual property portfolio encompasses 15 patent families covering novel compositions of matter, multi-scaffold Markush chemistry, formulations, and broad-spectrum methods of use across RNA and DNA viruses

· New XSeed Labs team at Servier’s Paris-Saclay campus brings together AI and immunology expertise to advance next-generation biologics.