The Latest
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Kendall Davis/BioPharma Dive
Deep Dive10 clinical trials to watch in the first half of 2022
Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.
Updated Jan. 6, 2022 -
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Sponsored by Iowa Economic Development AuthorityIowa's institutions on the leading edge of next-gen vaccines and therapies
Learn more about Iowa's efforts in the ongoing fight against pandemics and other threats to human and animal health.
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Jonathan Gardner / BioPharma Dive
Atara sells cell therapy plant to Fujifilm for $100M
The site, which specializes in manufacturing off-the-shelf immunotherapies, was once a key asset for Atara. New owner Fujifilm will still supply the biotech under a long-term agreement.
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Permission granted by Cortexyme
Cortexyme to shift focus after FDA places hold on experimental Alzheimer's drug
While a recent trial of Cortexyme's drug had failed, the biotech was planning to move ahead with another study. Now the company is cutting costs and prioritizing an earlier-stage therapy.
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Carl Court via Getty Images
Moderna follows Pfizer in beginning trial of omicron vaccine
The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant. New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine.
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Sarah Silbiger via Getty Images
A biotech wins the first FDA drug approval in a rare type of eye cancer
U.K.-based Immunocore's treatment, known as Kimmtrak, is also the first T cell receptor drug to have reached market in the U.S. so far.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A, while far from recent heights, is picking back up. Here are the latest deals.
UCB's buyout of Zogenix, the first major biotech acquisition of 2022, carries a premium and total value that would rank among the top 10 deals of last year, during which M&A trailed off sharply.
Updated Jan. 19, 2022 -
Sarah Silbiger via Getty Images
Incyte withdraws cancer drug from FDA review after discussions with regulator
The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals.
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Meletios Verras via Getty Images
Gene editing startup Metagenomi raises $175M to advance research pipeline
The biotech raised the Series B round during "probably one of the worst biotech markets" emerging drugmakers have faced in some time, a Metagenomi executive told BioPharma Dive.
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Jens Schlueter via Getty Images
With new trial, Pfizer and BioNTech will test whether an omicron vaccine is needed
The trial, which will enroll nearly 1,500 people, could help determine whether a variant-specific shot is more effective than an additional booster of Pfizer's original vaccine.
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Elizabeth Regan / Industry Dive
Sierra Oncology records success in late-stage study of bone cancer drug
The biotech said it plans to soon submit the drug, which it acquired for cheap from Gilead three years ago, to the Food and Drug Administration for approval.
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Adeline Kon/BioPharma Dive
Deep DiveRecord numbers of biotechs are going public. Here's how they're performing.
Bausch & Lomb, the 169-year-old eye drug developer and subsidiary of the former Valeant Pharmaceuticals, filed for what could be one of the sector’s largest IPOs.
Updated Jan. 24, 2022 -
Jacob Bell / BioPharma Dive
Merck drug for chronic cough rejected by FDA
According to the drugmaker, the FDA asked in a complete response letter for more information related to how the drug's efficacy was measured.
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Permission granted by Gilead Sciences
US turns to Gilead's COVID-19 drug to help counter omicron
With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.
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Danielle Ternes/BioPharma Dive
5 questions facing gene therapy in 2022
As record levels of money pour into gene therapy research, biotechs are under increased pressure to address issues related to safety, delivery and overlapping pipelines.
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National Institute on Aging, NIH
Roche sees cause for optimism with failed Huntington's disease drug. Others aren't so sure.
After halting a Phase 3 trial of the drug last year, Roche went digging for more data. What it found led to plans for another trial, but the pharma's hypothesis may rest on shaky ground.
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Alnylam Pharmaceuticals
Alnylam, awaiting key study data, builds case for its next rare disease drug
New results show the effects of its next drug for transthyretin amyloidosis appear to hold up for a year and a half. But it's unclear whether treatment will help those with heart problems, a much larger market opportunity.
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Brian Tucker / BioPharma Dive
5 questions facing biotech M&A in 2022
Analysts expect that deal engines are ready to start firing again following the recent quiet period. Still, uncertainty remains about how biopharma acquisitions could play out in the coming months.
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Top Merck executive to depart company for CEO role at ingredients maker
Frank Clyburn, a Merck veteran and head of the company's human health division, will leave next month to run IFF, following the exit of other top leaders at the drugmaker.
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Cancer biotech Zymeworks to lay off more than 100 staff in restructuring
The biotech's newly minted CEO said the 25% workforce reduction should help make Zymeworks more financially stable as it focuses on developing experimental cancer drugs and forging new deals.
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5 questions facing the FDA in 2022
If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.
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Courtesy of Merck & Co.
Generic manufacturers sign pact to supply Merck COVID pill to lower-income countries
The licenses will help make molnupiravir available to people in more than 100 countries, giving public health authorities a needed tool despite the drug's limited effectiveness.
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Courtesy of GlaxoSmithKline
GSK loses R&D chief Barron to high-powered startup amid investor pressure
Hal Barron, a key figure in GSK's efforts to revitalize its drug research, will step down as its top scientist at a time when the company is feeling heat from investors to deliver faster growth.
Updated Jan. 19, 2022 -
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UCB to buy Zogenix for nearly $2B in 'first step' for M&A in 2022
The acquisition will give the Belgian pharma access to an epilepsy drug that won U.S. approval in June 2020 but that Zogenix has struggled to sell.
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Courtesy of EQRx
EQRx builds case for cancer drug it hopes can disrupt market
Study results show EQRx's drug, which it means to position as a lower-cost alternative to widely used cancer immunotherapies, extended the lives of lung cancer patients. But it's unclear whether that will be enough to sway the FDA.
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Sarah Silbiger via Getty Images
Bluebird faces longer wait for FDA verdict on experimental gene therapies
The FDA has extended by three months its review of Bluebird's treatments for beta thalassemia and a rare brain disorder, the latest delay in the company's lengthy road to market in the U.S.
