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99 stories matching this filter · ← front page

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  • Walgreens Specialty Pharmacy highlights holistic support to boost oncology medication adherence
    Advances in oncology are moving care out of the clinic and into patients' homes, with treatments becoming more personalized. This shift means patients often manage complex drug schedules themselves…
    BioPharma Dive · 1mo agoPositive↗ source
  • Healthcare systems lag behind rapid expansion of GLP-1 therapies, raising care and trust challenges
    GLP-1 drugs have demonstrated that pharmacological treatment can effectively reduce obesity, and regulators have now approved them for additional uses such as cardiovascular risk reduction, metabol…
    BioPharma Dive · 1mo agoNeutral↗ source
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Compass eyes J&J’s Spravato playbook for upcoming psychedelic drug COMP360 launch
Compass executives told BioPharma Dive that, if the FDA approves their treatment, they plan to follow the commercial strategy Johnson & Johnson used for its ketamine spray Spravato. When Spravato…
BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • J&J and Contineum's oral M1 inhibitor fails second mid-stage depression trial
    Contineum Therapeutics and Johnson & Johnson reported that their oral M1 receptor inhibitor, known as PIPE-307 or JNJ-5120, did not meet its primary endpoints in a Phase II study for major depressi…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Experts urge FDA to require credentials for psychedelic therapy providers
    At a recent public hearing, mental health experts called on the FDA to adopt safety measures as it pushes to speed up psychedelic therapy development. The experts specifically recommended that pro…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Definium Therapeutics reports positive Phase 3 results for oral LSD anxiety drug DT120
    Definium Therapeutics announced Monday that its experimental oral LSD formulation, DT120, achieved positive outcomes in a Phase 3 trial targeting an anxiety disorder. The trial, the company's thir…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 1mo agoDealNeutral↗ source
  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Supernus and Indivior announce all-stock merger to create CNS-focused drugmaker
    Supernus Pharmaceuticals and Indivior Pharmaceuticals have signed an all‑stock merger agreement to combine their businesses. The new company will be dedicated to developing treatments for central…
    Endpoints · 2mo agoDealPositive↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 2mo agoPositive readoutNegative↗ source
  • Draig Therapeutics raises $65 million Series B to push depression drug targeting synapse repair
    Draig Therapeutics announced it has closed a $65 million Series B financing round that was oversubscribed. The capital will be used to advance its neuropsychiatry pipeline, with the lead program f…
    Endpoints · 3mo agoDealPositive↗ source
  • Virtual mental-health firms accelerate AI chatbot development using therapy session data
    People are turning to artificial intelligence for daily tasks, companionship and emotional support, prompting virtual mental‑health providers to explore AI solutions. Companies that were previousl…
    Endpoints · 3mo agoNeutral↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 3mo agoNeutral↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health announced it has closed a $50 million Series B financing round. The capital will be used to move two depression drug candidates into mid-stage clinical trials. The round was led…
    Endpoints · 4mo agoDealNeutral↗ source
  • Rapport Therapeutics says it is ready to launch its seizure drug independently
    In a recent interview, CEO Abe Ceesay explained that Rapport Therapeutics has assembled an investor syndicate and feels fully prepared to bring its seizure drug to market on its own. Founded in 20…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • FDA approves oral decitabine/cedazuridine plus venetoclax for older AML patients unable to tolerate intensive chemo
    The FDA has approved the oral combination of decitabine/cedazuridine (Inqovi) with venetoclax (Venclexta) for adults with newly diagnosed acute myeloid leukemia who are at least 75 years old or hav…
    onclive · 5mo agoApprovalPositive↗ source
  • FDA approves all-oral decitabine/cedazuridine plus venetoclax for older or unfit AML patients
    The FDA has granted approval for the combination of decitabine and cedazuridine (Inqovi) with venetoclax (Venclexta) to treat newly diagnosed acute myeloid leukemia in adults who are at least 75 ye…
    onclive · 5mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma
    The U.S. Food and Drug Administration has granted accelerated approval to sonrotoclax (brand name Beqalzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at l…
    onclive · 5mo agoApprovalPositive↗ source
  • Pirtobrutinib Extends Progression-Free Survival to 14 Months in BTK-Inhibitor-Pretreated CLL Patients
    The phase 3 CLL-321 trial enrolled patients whose disease had progressed after prior covalent BTK inhibitor therapy. Participants were randomly assigned to receive pirtobrutinib or the investigator…
    onclive · 5mo agoPositive readoutPositive↗ source
  • FDA expands pirtobrutinib use to second-line CLL after covalent BTKi failure, broadening treatment options
    The BRUIN CLL-321 phase 3 trial provided the data that led the FDA to approve pirtobrutinib for patients whose chronic lymphocytic leukemia has progressed after a covalent BTK inhibitor. This marks…
    onclive · 5mo agoApprovalPositive↗ source
  • MD Anderson expert highlights impact of WHO’s updated AML diagnostic criteria on patient care
    Dr Sanam Loghavi, an associate professor and medical director at MD Anderson Cancer Center, discussed the recently revised WHO diagnostic criteria for acute myeloid leukemia. She emphasized that a…
    onclive · 5mo agoPositive↗ source
  • Tirabrutinib and CAR T-cell therapy show promise for relapsed/refractory primary CNS lymphoma
    Experts highlighted emerging data on tirabrutinib and CAR T-cell therapy as potential new options for patients with relapsed or refractory primary central nervous system lymphoma. CAR T-cell thera…
    onclive · 5mo agoRegulatoryPositive↗ source