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  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 4d agoNeutral↗ source
  • GLP-1 drugs push employers to rethink worker health-care costs
    GLP-1 medications are prompting many employers to reexamine how they fund employee health care. Rising prescription use and associated costs are forcing companies to consider new benefit designs an…
    STAT · 6d agoNegative↗ source
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Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
BioSpace · 9d agoApprovalPositive↗ source
  • U.S. Employers Plan to Drop GLP-1 Drug Coverage, Survey Shows 14% Will Cut Benefits by 2027
    About 14% of U.S. employers have already decided or intend to stop covering GLP-1 medicines by 2027, according to a Reuters‑cited Business Group on Health survey. The shift reflects growing concern…
    STAT · 11d agoNegative↗ source
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 18d agoPositive readoutPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 18d agoNeutral↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 19d agoRegulatoryPositive↗ source
  • Enveda reports promising Phase 1 data for oral drug that mimics exercise to preserve muscle during weight loss
    Enveda, a biotech based in Boulder, Colorado, announced Phase 1 results for its oral candidate ENV-308, a chemically engineered version of the metabolite lactate phenylalanine (lac-phe). The metabo…
    STAT · 19d agoPositive readoutPositive↗ source
  • Medicare’s new $50 GLP‑1 weight‑loss drug program may create barriers for patients, warns experts
    Medicare has launched a program that caps out‑of‑pocket costs for GLP‑1 weight‑loss medicines such as Wegovy, Zepbound and Foundayo at $50 a month for eligible beneficiaries. The initiative is inte…
    STAT · 26d agoRegulatoryNegative↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Biologics surge drives CMOs and CDMOs to boost sterile fill-finish and prefilled syringe capacity
    Biologics, biosimilars and GLP-1 therapies are increasing demand for sterile injectable products, prompting contract manufacturers to expand capacity. CMOs and CDMOs are adding fill-finish, lyophi…
    BioSpace · 1mo agoPositive↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Podcast explores father's quest for ultra‑rare disease therapy, telehealth GLP‑1 prescribing probe and fugitive posing as biotech exec
    The latest episode of STAT’s "The Readout Loud" podcast examines three distinct stories that intersect with the biotech world. Hosts Allison DeAngelis and Elaine Chen sit down with colleagues Jason…
    STAT · 1mo agoNeutral↗ source
  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 1mo agoDealPositive↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 1mo agoDealNeutral↗ source
  • Novo Nordisk sues Eli Lilly, alleging deceptive ads that misrepresent GLP-1 drug efficacy
    Novo Nordisk filed a lawsuit in federal court in New Jersey accusing Eli Lilly of running a deceptive advertising campaign. The complaint says Lilly’s ads compare the highest doses of its weight‑l…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Former staff allege LifeMD prioritized GLP-1 prescription volume over patient safety
    Novo Nordisk lists telehealth firm LifeMD on its website as a provider that offers legitimate medicine sourcing and patient support for individuals seeking GLP-1 drugs such as Ozempic and Wegovy.…
    STAT · 1mo agoNegative↗ source
  • HHS vaccine committee receives new charter amid broader health policy updates
    The U.S. Health and Human Services vaccine advisory panel has been granted a new charter, a change that was noted quietly in a recent health newsletter. The same briefing highlighted other policy…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
    Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology. The announcement coincided…
    STAT · 1mo agoApprovalPositive↗ source
  • Mwyngil Therapeutics launches obesity program that avoids GLP-1 pathway
    Mwyngil Therapeutics, a newly formed biotech startup, is pursuing obesity treatments that do not target the GLP-1 receptor, a pathway that has dominated recent weight-loss drug development. CEO Lu…
    STAT · 1mo agoNeutral↗ source
  • Europe to Speed Review of RevMed Drug as Concerns Rise Over Kailera GLP-1 Pill and FDA Clears Vera Therapy
    European regulators said they will move more quickly to assess RevMed's investigational drug, aiming to shorten the evaluation timeline. Separate reports highlighted that recent data from Kailera'…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Secret shopper study examines GLP-1 prescribing practices on telehealth platforms
    STAT Health Tech newsletter reports a secret shopper study that evaluated how telehealth sites prescribe GLP-1 drugs. The study involved researchers posing as patients to assess prescribing behavi…
    STAT · 2mo agoNeutral↗ source
  • Study finds many telehealth sites prescribe GLP-1 weight-loss drugs with minimal clinical oversight
    A secret-shopper investigation examined 49 direct-to-consumer telehealth platforms that offer GLP-1 medicines such as semaglutide and tirzepatide for weight loss. Researchers posing as patients fo…
    STAT · 2mo agoRegulatoryNegative↗ source
  • STAT+: More signs that GLP-1s may help with peripheral artery disease
    Anthropic will begin developing drugs, BridgeBio pockets a billion, and more biotech news from The Readout
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Investors increase stakes in Bain-backed biotech startup as FDA gene‑therapy chief departs
    Investors are putting more money into a biotech startup backed by private‑equity firm Bain Capital, according to the STAT+ newsletter. Vijay Kumar is leaving his role as acting director of the FDA…
    STAT · 2mo agoDealNeutral↗ source