The Latest

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  Deep Dive

  Biotech M&A is picking back up. Here are the latest deals.

  Despite newly realized fears of an activist FTC, analysts expect dealmaking to continue this year with small buyouts like Ironwood’s acquisition of VectivBio as well as larger M&A.

  Updated May 22, 2023

  Deals

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  Illumina chair loses to Icahn pick as proxy battle ends

  The decision to replace board Chair John Thompson could change the company’s course as it decides whether to divest liquid biopsy company Grail.

  Updated May 25, 2023

  Biotech

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  BenevolentAI CFO resigns as company lays off staff, restructures

  The biotech, one of several AI drug discovery specialists to go public in recent years, is cutting up to 180 jobs and reorganizing its pipeline to conserve cash.

  Biotech

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  Apellis abandons ALS drug after study miss

  The trial failure is the second for an ALS medicine this week, adding to a lengthy list of study setbacks that have thinned the pipeline of experimental medicines for the disease in recent years.

  Clinical Trials

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  PTC lays off staff, fires CFO as neuromuscular drug study fails

  The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.

  Biotech

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  Annexon claims a silver lining in failed eye drug study

  The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.

  Clinical Trials

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  House lawmakers, PBM lobby spar over committee hearing

  At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.

  Marketing

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  Digital health funding holds steady in Q1 after year of decline

  The sector defied trends seen in the larger venture capital environment, where funding continues to fall. But investment is still at years-low levels.

  Biotech

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  Deep Dive

  After a record run, fewer biotechs are going public. Here’s how they’re performing.

  Though it’s early and the sample size is small, the majority of biotechs that have gone public in 2023 have held their value, a departure from each of the previous five years.

  Updated May 26, 2023

  Biotech

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  FDA approves new antibiotic for hospital-acquired pneumonia

  The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

  FDA

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  Obesity drugs

  Novo says oral version of obesity drug succeeds in large study

  The company plans to seek approvals of the drug, a more convenient form of the popular injectable medicine Wegovy, later this year.

  Clinical Trials

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  Blueprint wins key FDA approval for rare disease drug

  The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future. But the drug’s sales potential isn’t clear, and a top competitor is close behind.

  FDA

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  Concentra bids on Atea, seeking to acquire another struggling biotech

  The company behind the recent takeover of Jounce Therapeutics is looking to buy a second drug developer to potentially sell for parts.

  Biotech

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  ALS drug development

  Wave shelves ALS drug following trial setback

  A small study found patients on the experimental therapy fared no better than those receiving a placebo, dealing yet another blow to Wave’s research efforts.

  Clinical Trials

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  Ironwood to buy rare disease drugmaker in billion-dollar deal

  The acquisition would give Ironwood a drug in late-stage testing for a condition known as short bowel syndrome, further building out the company’s gastrointestinal-focused research.

  Deals

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  Future of Intercept’s NASH drug in doubt after FDA panel rejection

  The safety risks of obeticholic acid were too great for an advisory committee to recommend approval without clear proof of its benefits. But collecting that data may not be “economically feasible,” an executive said.

  Updated May 22, 2023

  FDA

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  Novartis buys rare disease gene therapy from Avrobio

  The pharma will pay nearly $90 million to acquire Avrobio’s treatment for cystinosis, an inherited condition caused by the toxic buildup of an amino acid.

  Biotech

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  FDA approves Krystal gene therapy for rare wound disorder

  Cleared to treat dystrophic epidermolysis bullosa, Vyjuvek is the sixth gene therapy for an inherited disease to gain clearance in the U.S.

  FDA

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  Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

  At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth.

  Updated May 19, 2023

  Pharma

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  Moderna reports ‘encouraging’ early data for one of its rare disease medicines

  Now known for its vaccine research, the biotech said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

  Biotech

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  Supreme Court sides with Sanofi, Regeneron in patent fight with Amgen

  The court’s ruling could open the door for challenges to older classes of antibody therapies, said one legal expert, who added that it will give competitors “solace.” 

  Updated May 18, 2023

  Pharma

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  RSV vaccines

  FDA advisers back maternal use of Pfizer RSV vaccine

  The panel voted 14-0 that Pfizer’s data showed its shot to be effective. The vaccine could be the first for protecting infants by maternal immunization.

  FDA

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  Mustang pares research, sells manufacturing plant to save money

  The biotech joins a score of other cell and gene therapy developers that, on the heels of a historic market downturn, have cut costs.

  Biotech

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  On heels of Amgen lawsuit, FTC broadens investigation of PBMs

  The regulator is probing the business practices of two more drug purchasing organizations, deepening an investigation that began last year.

  Pharma

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  Emerging biotech

  Siren emerges from stealth with plans to marry gene therapy to cancer immunotherapy

  Spun out of the lab of former UCSF researcher Nicole Paulk, the biotech is targeting brain and eye tumors with a new kind of treatment it has dubbed “immuno-gene therapy.”

  Biotech

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