In a first, FDA approves an 'interchangeable' biosimilar for diabetes

The Latest

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  Deep Dive

  Record numbers of biotechs are going public. Here's how they're performing.

  Rallybio, Icosavax and Nuvalent raised $429 million combined on Wednesday night. Six more biotechs could follow by the end of the week. 

  UPDATED: July 29, 2021 at 3:33 p.m.

  Biotech

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  Sponsored by ZS

  Trends shaping biopharma's role in the healthcare ecosystem

  Four trends are shaping the healthcare ecosystem. These present new opportunities for biopharma.

  Manufacturing

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  Bluebird preps for split by selling manufacturing plant to well-funded startup

  The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10.

  Manufacturing

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  An AstraZeneca spinout scores a buyout option from Arena

  The potential acquisition marks a fast turnaround for Aristea, one of several biotechs formed from programs AstraZeneca decided not to advance internally.  

  Pharma

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  Merck rebounds to win a milestone immunotherapy approval in early breast cancer

  The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease. 

  Pharma

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  Biogen, Ionis tout data from early study of RNA-based Alzheimer's drug

  The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease. 

  Clinical Trials

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  Regeneron, AstraZeneca team up on targeted drugs for obesity

  After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight. AstraZeneca aims to help the biotech make a drug based on its findings.  

  Pharma

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  Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues

  With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals.

  FDA

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  Denali drug for rare brain disease disappoints investors

  New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts. Company shares fell by 15% Monday morning.

  Clinical Trials

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  BioNTech, WHO hatch plan to bring mRNA vaccines to Africa

  Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent. 

  Manufacturing

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  Caribou raises $304M in one of gene editing's most lucrative IPOs

  The IPO is several times larger than what CRISPR Therapeutics, Intellia and Editas raised several years ago, and ranks well ahead of a more recent offering from gene editing startup Beam. 

  Biotech

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  Gene therapy for Fabry: early stages, promising results

  Three companies are testing their gene therapies in early clinical trials, with initial results due later this year. Others are in preclinical stages and aim to follow soon.

  Gene Therapy

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  A biotech's eye gene therapy faces longer odds as serious side effects pile up

  Five trial participants with diabetic macular edema who received Adverum Biotechnologies' treatment experienced side effects never before reported for an eye gene therapy.

  Gene Therapy

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  Biogen executives attack Aduhelm criticism, blaming 'extensive misinformation'

  The company responded forcefully to controversy roiling around the Alzheimer's drug's approval, defending its data and interactions with the FDA.

  Biotech

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  Seres, after earlier success, fails a key test for microbiome drugs

  A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.

  Biotech

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  Drug distributors, J&J agree to pay $26B in major opioid settlement with states

  The long-negotiated deal could resolve the vast majority of lawsuits against the companies for their alleged role in contributing to the opioid epidemic.

  Pharma

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  Bluebird, with little fanfare, is first to bring a second gene therapy to market

  The approval of Skysona for a genetic brain disease is a milestone for one of gene therapy's pioneering companies, but isn't expected to turn Bluebird's financial fortunes around.

  Gene Therapy

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  Deep Dive

  8 key clinical trials to watch for the rest of 2021

  The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19 and gene-targeted cancer therapy.

  Clinical Trials

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  J&J predicts faster coronavirus vaccine sales amid debate over boosters

  The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks.

  Pharma

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  Pfizer, BioNTech ink vaccine supply deal for Africa in step toward addressing criticism

  The companies aim to deliver 100 million doses per year to 55 African countries in an effort to shrink the wide gap between high- and lower-income countries in coronavirus vaccinations.

  Pharma

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  Ardelyx latest biotech surprised by unexpected FDA criticism of drug application

  The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.

  FDA

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  Amylyx, faced with longer FDA path for promising ALS drug, gets major cash infusion

  A $135 million investment will help the small biotech potentially prepare to launch the treatment in Canada and Europe as well as fund another trial requested by U.S. regulators.

  UPDATED: July 20, 2021 at 2:47 p.m.

  Biotech

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  BioNTech returns to cancer roots with deal for Gilead cell therapy factory

  The German biotech purchased Kite Pharma's Gaithersburg, Maryland-based site, along with related research on T cell receptor-based cancer treatments.

  Biotech

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  Q&A

  Biohaven CEO on migraine drug's fast launch, TikTok ads and battling big pharma

  Sales of Nurtec ODT during the second quarter were double what Wall Street expected. CEO Vlad Coric explained to BioPharma Dive how the biotech did it, despite being far smaller than its chief rival. 

  Marketing

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  Cytokinetics heart drug succeeds in mid-stage study, boosting shares

  Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb. 

  Biotech

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  Questions on new Alzheimer's drug benefit, price loom large at ICER meeting

  "Right now, and I think for a while, the access is going to be pretty limited," former CMS and FDA head Mark McClellan said at the meeting, which featured yet another rebuke by experts of Aduhelm.

  Drug Pricing

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