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      Deals:

      Novo Nordisk announced it will work with the biotech Septerna to develop oral GLP-1 obesity drugs in a deal worth up to $2.2 billion, including $200 million upfront. 

      GSK is paying $1.2 billion upfront to Boston Pharmaceuticals for an experimental drug to treat MASH. 

      Eli Lilly plans to expand Purdue University collaboration with up to a $250 million investment

      Azafaros received $146 million for late-stage trials in three metabolic disorders.

      Datavant is set to acquire real-world data specialist Aetion and double its life sciences team.

      Publicis Production announced an exclusive partnership with Copli to bring the latter company’s AI-driven MLR review technology into its creative and content supply chain.

      AbbVie and ADARx Pharmaceuticals announced a collaboration and license option agreement to develop next-gen siRNA therapies across multiple therapeutic areas.

      LENZ Therapeutics and Lotus Pharmaceutical announced an exclusive license and commercialization agreement for LNZ100 in the Republic of Korea and southeast Asia.

      DirectRx Pharmacy partnered with University of Michigan Ross School of Business for a consulting studio project aimed at improving health outcomes.

      Recipharm and ProductLife Group announced a strategic partnership to accelerate development projects.

      FDA:

      The FDA plans to rapidly roll out a generative AI model to assist scientific reviews across the agency by the end of June. 

      The agency announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market.

      The FDA approved AbbVie’s Emrelis (telisotuzumab vedotin-tllv) for adults with previously treated advanced non-small cell lung cancer with high c-Met protein overexpression.

      The agency approved Merck’s Welireg (belzutifan) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

      The FDA granted accelerated approval to Verastem’s combination treatment for ovarian cancer.

      The agency granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.

      Thermosome received an Orphan Drug Designation for lead compound THE001.

      The agency approved a product from Teal Health that serves as the U.S.’s first at-home alternative to the pap smear.

      Biohaven announced the FDA would be delaying the PDUFA date for its neurodegenerative disease therapy troriluzole.

      The FDA issued a Request for Information to begin the nutrient review process required by law for infant formula.

      GC Biopharma received FDA approval for its U.S. Plasma Collection Center in Calexico, California.

      Funding rounds:

      Chicago-born biotech startup Pathos AI secured a $365 million Series D funding round.

      Angelini Ventures invested in a $39 million Series A extension round for Therini Bio.

      Remedy Plan Therapeutics raised $18 million in financing. 

      Chronic care startup Omada Health filed to go public.

      Former Theranos CEO Elizabeth Holmes’ romantic partner – the father of her children – has raised millions of dollars to start up Haemanthus, a new blood-testing company.

      Layoffs:

      Vor Bio to wind down and shed most of its staff.

      NGM Bio is axing 75% of its staff.

      Leap Therapeutics is halving its headcount.

      Atara Biotherapeutics is letting go of 30% of its remaining employees

      Allogene is laying off 28% of its workforce.

      Insitro cut 22% of its workforce – about 60 people.

      Kyverna Therapeutics is cutting 16% of its staff.

      10x Genomics is shedding 8% of its global workforce.

      Biotech investment firm RA Capital laid off staff at its internal startup incubator.

      Industry news:

      Sanofi said it would commit at least $20 billion in investments in the U.S. through 2030.

      Roche announced a $550 million investment to expand its North American headquarters in Indianapolis, establishing it as a U.S. manufacturing hub for continuous glucose monitoring systems.

      Merck KGaA dropped a surcharge on life sciences sector orders within China following the U.S.-China agreement to pause sky-high tariffs on each other.

      However, Merck KGaA continued its U.S. tariff surcharge but at a ‘decreased’ rate.

      Republicans on the House Energy and Commerce Committee advanced legislation containing cuts to Medicaid and healthcare provisions.

      Lilly said new data published in the New England Journal of Medicine on Zepbound show the GIP/GLP-1 dual agonist is a better weight loss drug than Novo’s Wegovy. 

      Corvus Pharmaceuticals reported new Phase 1 data in atopic dermatitis that sent its stock price skyrocketing.

      Johnson & Johnson’s Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis

      AbelsonTaylor Group, a 2024 MM+M Agency 100 honoree, set up a program called UNITE to provide pro bono campaign-development services to healthcare startups and small businesses. The deadline to submit is June 6.

      Illumina estimates about $85 million in costs this year related to tariffs on its DNA sequencing products

      Illumina also said the Securities and Exchange Commission closed its investigation into the company’s $8 billion purchase of Grail and doesn’t intend to pursue enforcement action.

      A jury awarded Regeneron $135.6 million dollars of compensatory damages and $271.2 million dollars in punitive damages in a case involving Amgen.

      Citing “regulatory and market developments,” Galapagos NV said its board had “decided to re-evaluate” the split.

      Lucid Group launched the Lucid Group US – a strategic unification of its U.S. agencies, Lighthouse and DiD.

      RemeGen announced that a Phase 3 combination study of the HER2-targeted antibody-drug conjugate disitamab vedotin delivered positive results in a pivotal study among Chinese patients with newly diagnosed bladder cancer.

      Spectrum Science, a 2024 MM+M Agency 100 honoree, announced the formalization of Spectrum Science Media, an omnichannel, performance media planning, buying and optimization service.

      Genentech is expected to add 420 jobs in North Carolina.

      iTeos and GSK are ending the development of an anti-TIGIT antibody, after interim results from a Phase 2 lung cancer trial did not show clinically meaningful improvements.

      ODAIA launched an early access program for pharma companies interested in using and providing feedback on healthcare professional engagement solutions.

      J&J MedTech launched the MemoryGel Enhance Breast Implants – the largest breast implants on the market for reconstruction.

      Walgreens is expanding the number of retail stores served by its micro-fulfillment centers, which use robots to fill thousands of prescriptions for patients who take medications to manage or treat diabetes, high blood pressure and other conditions.

      Cytokinetics said a Phase 3 trial testing its investigational therapy aficamten against a commonly used beta blocker in patients with obstructive hypertrophic cardiomyopathy met its primary endpoint.

      Panalgo, a Norstella company, launched two solutions: LinQNotes and Ella AI.

      See last week’s edition of Rx Rundown.