Biotech


  • Image attribution tooltip
    Seth Babin/BioPharma Dive
    Deep Dive

    Heart attacks struck Sek Kathiresan's family. He's devoted his life to stopping them.

    After several family members had early heart attacks, Kathiresan vowed to understand why they happen. His research journey has changed medical practice and led to a new biotech startup, Verve Therapeutics, that seeks to prevent them.

    By Nov. 29, 2021
  • Image attribution tooltip
    libre de droit via Getty Images

    Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy

    The regulator will decide whether to approve Bluebird's treatment by next May, but its evaluation begins more than a year later than the biotech first hoped.

    By Nov. 22, 2021
  • Explore the Trendline
    Image attribution tooltip
    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
    Trendline

    Inside the race to bring coronavirus vaccines to the world

    More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

    By BioPharma Dive staff
  • Image attribution tooltip
    Permission granted by Gilead Sciences

    Gilead pays up to retain rights to Arcus cancer drugs

    The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.

    By Nov. 18, 2021
  • Image attribution tooltip
    Permission granted by Chroma Medicine

    A startup emerges with $125M and plans to edit the epigenome

    Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.

    By Nov. 17, 2021
  • Image attribution tooltip
    Courtesy of Roche

    Roche cuts ties with Atea after COVID-19 pill's trial failure

    The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own.

    By Kristin Jensen • Nov. 17, 2021
  • Image attribution tooltip
    Permission granted by Biogen

    European drugs regulator signals rejection likely for Biogen's Aduhelm

    A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month.

    By , Nov. 17, 2021
  • Image attribution tooltip
    Permission granted by Biogen

    Al Sandrock, Biogen's top scientist and Aduhelm defender, to retire in surprise exit

    Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech. 

    By Nov. 16, 2021
  • Image attribution tooltip

    Permission granted by IQVIA

    Sponsored by IQVIA

    Establishing an integrated evidence plan for medical affairs and beyond

    Over the life of a biopharmaceutical product, there are many situations when data from randomized controlled trials (RCTs) may not be sufficient to address stakeholder questions of value, safety and effectiveness.

    Nov. 15, 2021
  • Image attribution tooltip
    Permission granted by Cortexyme

    Cortexyme plans path forward for Alzheimer's drug that failed study

    Detailed trial results presented last week are "interesting," one Alzheimer's expert said, but there are still "many challenges and uncertainties" with Cortexyme's unorthodox approach to treating the disease.

    By Nov. 12, 2021
  • Image attribution tooltip
    Maddie Meyer via Getty Images

    Moderna, escalating dispute with NIH, claims government had no role in key vaccine patent

    The biotech claimed its NIH partners were involved only after a key discovery was made "by Moderna scientists using Moderna technology." The dispute could end up in court.

    By , Nov. 11, 2021
  • Image attribution tooltip
    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    Detailed Roche study results muddy another Alzheimer's hypothesis

    Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.

    By Nov. 11, 2021
  • FibroGen cuts jobs as it weighs anemia drug's future in US

    The company, which had its treatment rejected by the FDA in August, eliminated 30 jobs and 70 open positions. An upcoming meeting with the agency looms as a key event.

    By Kristin Jensen • Nov. 10, 2021
  • Image attribution tooltip
    Permission granted by Biohaven Pharmaceuticals

    Pfizer buys into Biohaven's fast-selling migraine medicine

    The pharmaceutical giant will pay Biohaven $500 million for ex-U.S. rights to rimegepant — a sizable licensing deal, though not the buyout that some of the biotech's investors appeared to be hoping for.

    By Nov. 9, 2021
  • Image attribution tooltip
    Courtesy of Alltrna

    Moderna founder unveils new drug company focused on a different kind of RNA

    Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules.

    By Nov. 9, 2021
  • Image attribution tooltip
    National Cancer Institute, NIH

    Mirati gives first look at KRAS drug combination in lung cancer

    Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.

    By Updated Nov. 8, 2021
  • Image attribution tooltip
    Courtesy of Sanofi

    Eye-focused gene therapy startup gets $60M cash infusion from Sanofi

    Shortly after postponing a $135 million IPO, Gyroscope has found another way to back a treatment for a disease that's become a top target of multiple drugmakers.  

    By Nov. 8, 2021
  • Image attribution tooltip
    Artur Plawgo via Getty Images

    Beam gets green light to begin first clinical test of base editing

    Alongside the milestone, the gene editing biotech also announced John Maraganore, who will soon step down as Alnylam's CEO, will join its board.

    By Nov. 8, 2021
  • Image attribution tooltip
    Getty / Edited by BioPharma Dive

    Cystic fibrosis group partners with Moderna founder to find better, potentially curative treatments

    With an initial investment of $20 million, the collaboration will use technologies from various Flagship-backed companies to discover and develop new therapies for the disease.

    By Nov. 3, 2021
  • Image attribution tooltip
    Maddie Meyer via Getty Images

    Moderna, teaming with a startup, wades further into gene editing

    The biotech has identified gene editing as a natural fit for the technology it uses to deliver its vaccines and drugs. A deal with Metagenomi, a startup backed by Bayer, will further those ambitions.

    By Nov. 2, 2021
  • Image attribution tooltip
    Jacob Bell / BioPharma Dive

    Amylyx asks FDA to approve ALS drug, while also preparing late-stage study

    The biotech has officially filed for review of its closely watched ALS treatment, an outcome that seemed unlikely just a few months ago.  

    By Updated Nov. 2, 2021
  • Image attribution tooltip
    Carl Court via Getty Images

    Moderna faces delay in plans to bring coronavirus vaccine to US teenagers, young kids

    The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S. 

    By Nov. 1, 2021
  • Image attribution tooltip
    Permission granted by Gilead Sciences

    Despite strong quarter, some wonder how long Gilead can rely on coronavirus drug

    While other drugs in Gilead’s arsenal fell short, third quarter revenue from Veklury tripled what analysts had expected, reaching nearly $2 billion.

    By Oct. 29, 2021
  • Image attribution tooltip
    Alnylam

    John Maraganore, pioneering RNAi executive, to step down as Alnylam CEO

    Alnylam shares fell 15% on the news, which surprised Wall Street analysts and ends Maraganore's 19-year run overseeing the company's journey from startup to a biotech worth nearly $20 billion.  

    By Oct. 28, 2021
  • Image attribution tooltip
    Permission granted by Cortexyme

    Cortexyme drug fails in Alzheimer's trial, but company sees validation of unorthodox approach

    Cortexyme shares lost more than three-fourths of their value after the the biotech's therapy, which is designed to work differently than drugs like Aduhelm, missed both primary goals in a late-stage study.

    By Oct. 26, 2021
  • Image attribution tooltip
    Sergio Flores via Getty Images

    Moderna vaccine safe and spurs immune response in kids, company says

    The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.

    By Oct. 25, 2021