FDA grants speedy review to Sarepta’s Duchenne gene therapy

The Latest

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  Deep Dive

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

  Thirty-nine biotech companies have been bought so far this year in deals worth above $50 million, representing a combined value of nearly $43 billion.

  Updated Nov. 14, 2022

  Deals

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  Sponsored by Cardinal Health

  Navigate the complexities of cell and gene therapies

  See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.

  Gene Therapy

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  Spectrum to lay off R&D staff after FDA drug rejection

  The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib.

  Biotech

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  Sanders poised to lead Senate health committee

  The longtime pharma critic is set to become chair of the HELP Committee, a post that holds significant power in directing congressional efforts on healthcare issues.

  Drug Pricing

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  Novartis, research group to advance new kind of malaria drug into late-stage test

  The Swiss pharma and the Medicines for Malaria Venture plan to start a Phase 3 trial of a non-artemisinin combination treatment next year.

  Pharma

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  Biotech ObsEva sells drug rights to forestall funding crunch

  In an effort to extend its cash runway and keep its stock listing, ObsEva is offloading rights to an experimental preterm labor drug in a deal with Xoma.

  Biotech

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  Deep Dive

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

  Just 20 drugmakers have priced an initial public offering this year, less than one-fifth last year’s total of 104, according to BioPharma Dive data.

  Updated Nov. 18, 2022

  Biotech

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  Novo Nordisk to boost drug manufacturing in Denmark

  The Danish drugmaker has invested heavily in expanding its production capacity for oral and injectable drugs. A new $744 million project is the latest investment.

  Manufacturing

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  Teva taps Sandoz veteran to take over CEO post from Schultz

  Richard Francis will take over for the retiring Kåre Schultz on Jan. 1. He’ll face major challenges at Teva, including opioid settlements, biosimilar launches and reducing the company’s debt.

  Pharma

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  Merck to buy blood cancer biotech Imago for $1.35B

  The deal is Merck’s second notable acquisition in the past year and a half, part of a strategy to diversify its pipeline beyond top-selling immunotherapy Keytruda.

  Pharma

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  Merck KGaA outlines plan to rev up drug R&D

  The German company aims to, on average, launch a new medicine or major treatment indication every 18 months in a bid to boost its pharma business.

  Pharma

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  Deep Dive

  Health tech companies weigh funding options amid weak IPO market

  Healthcare technology companies are delaying initial share sales and searching for new sources of cash. Experts don’t expect a quick recovery.

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  Cancer drugmaker Plexxikon gets new life as Opna Bio

  Eight months after Daiichi Sankyo shuttered the San Francisco Bay Area subsidiary, Plexxikon’s former CEO is resuscitating its drug research under a new name.

  Biotech

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  Replay reveals second gene therapy spinout, debuting new biotech Telaria

  Telaria is the second spinout in Replay’s “hub-and-spoke” model, and will focus on developing a gene therapy for recessive dystrophic epidermolysis bullosa.

  Biotech

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  First-of-its-kind Type 1 diabetes drug wins FDA approval

  Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen. 

  FDA

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  FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar

  Eli Lilly’s long-acting copycat drug, first approved in late 2021, now has a designation that will allow pharmacists to swap it for Sanofi’s Lantus.

  FDA

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  Former Rubius CEO to lead buzzy Flagship startup

  Pablo Cagnoni was appointed CEO at the RNA drug startup Laronde days after departing Rubius, a once high-flying biotech that’s now laid off nearly all its employees and is seeking a sale. 

  Biotech

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  CRISPR gene editing

  Editas to seek partner for CRISPR medicine after lackluster study results

  While the biotech will not develop the gene editing therapy further on its own, CEO Gilmore O’Neill claimed the data are still a meaningful demonstration of what CRISPR can accomplish. 

  Clinical Trials

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  FDA panel votes in favor of Ardelyx’s once-rejected kidney disease drug

  The recommendation represents a surprising turnaround for Ardelyx’s drug, which the FDA put before an advisory committee only after the biotech appealed its rejection last year.

  FDA

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  Regeneron teams up with CytomX to develop dual-targeting cancer drugs

  Regeneron will pay CytomX $30 million to try to create bispecific antibody drugs that are safer and have a wider reach than existing treatments.  

  Pharma

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  Pfizer, BioNTech start study testing next COVID-19 vaccine

  The new candidate is meant to provide broader immunity over a longer period of time and is part of the companies’ strategy to stay ahead of a shifting coronavirus threat.

  Pharma

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  Biotechs reveal layoffs, research revamps in third quarter earnings

  Tricida, Harpoon, Freeline and three other small drug developers last week announced plans to cut staff or to reprioritize their drug development.

  Biotech

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  Divided Congress after midterms will allow HHS to execute on policy priorities, Becerra says

  The agency is focused on implementing drug price negotiation in Medicare and surprise billing regulations, according to the secretary.

  Drug Pricing

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  Freeline cuts back as it continues search for gene therapy partner

  The U.K. biotech will sell its German unit and lay off staff to save cash as it focuses on therapies for Gaucher and Fabry diseases.

  Biotech

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  Q&A // Emerging biotech

  Eli Lilly’s Julie Gilmore on finding up-and-coming companies and backing small biotechs

  Only a small fraction of the companies Lilly evaluates get into its incubator, according to Gilmore. Here’s how the big pharma selects them.

  Pharma

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  After $250M Roche buyout, a startup plans a second strike with fresh funding

  Backed by the same investors and team as an immunotherapy biotech Roche bought in September, Bonum Therapeutics plans to develop “conditionally” active cancer medicines.

  Biotech

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