Biotech
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Sponsored by Millipore-Sigma®Incorporating automation and digitalization into the industrial microbiology workflow
A closer look at the impact of automated and digitalized technologies on the industrial microbiology workflow.
By Brad Grobler, Director of Strategic Initiatives, Biomonitoring Solutions at MilliporeSigma • June 21, 2021 -
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Trial failure dashes Biogen hopes for next Alzheimer's drug
Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research.
By Jonathan Gardner • June 17, 2021 -
Explore the Trendline➔
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
TrendlineInside 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 -
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FDA approves Blueprint cancer drug for use in rare blood disease
The agency's decision makes available a new treatment option for patients with advanced systemic mastocytosis, boosting the biotech in the process.
By Kristin Jensen • June 17, 2021 -
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Gene editing biotech Verve to raise $267M in large IPO
Capitalizing on investor interest in gene editing, the high-profile startup has secured one of the richest biotech initial public offerings priced this year.
By Ned Pagliarulo • June 17, 2021 -
Courtesy of CureVac
CureVac vaccine disappoints in key study amid 'unprecedented' spread of variants
The German biotech’s shot appeared less effective than other mRNA vaccines at preventing COVID-19. But it's unclear whether differences between the shots, or exposure to more elusive variants in testing, are the cause.
By Ben Fidler • UPDATED: June 17, 2021 at 11:37 a.m. -
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Biogen gene therapy deal has yet to bear fruit
Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.
By Jacob Bell • June 15, 2021 -
Chip Somodevilla via Getty Images
Former FDA chief Hahn joins venture firm that launched Moderna
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
By Jonathan Gardner • June 15, 2021 -
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Sage antidepressant succeeds in key study, but data raise questions
Zuranolone, a drug that's crucial for Sage's future and the focus of a multi-billion dollar bet by Biogen, could be headed for a regulatory review. But new trial results are more mixed than the overall outcome suggests.
By Ben Fidler , Ned Pagliarulo • UPDATED: June 15, 2021 at 10:39 a.m. -
Brian Tucker / BioPharma Dive
Moderna founder raises another $2B to fuel new startups
Flagship Pioneering reopened one of its funds in April, quickly raising fresh cash for new biotech investments.
By Jacob Bell • June 14, 2021 -
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Blood disease treatment from CRISPR, Vertex shows promise in more patients
The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.
By Ned Pagliarulo • June 11, 2021 -
Ryan McKnight, Vertex Pharmaceuticals Inc.
Vertex stops work on second rare disease drug after study results disappoint
The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.
By Jacob Bell • UPDATED: June 11, 2021 at 10:28 a.m. -
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
Beigene expands into cancer cell therapy with Shoreline pact
The fast-growing biotech will work with Shoreline to develop cancer treatments using natural killer cells, an emerging alternative to T-cell based therapies.
By Ned Pagliarulo • June 09, 2021 -
Permission granted by Biogen
Deep DiveA first-of-its-kind Alzheimer's drug raises heavy questions around who will and won't get it
Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face.
By Jacob Bell • June 08, 2021 -
Permission granted by Biogen
The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.
Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.
By Ned Pagliarulo • UPDATED: June 9, 2021 at 10:33 a.m. -
Permission granted by Biogen
Deep DiveIn historic move, FDA approves a closely watched and controversial Alzheimer's drug
With the decision, the agency cleared the way for what many predict will become a lucrative and sought-after option — though fierce debate continues over whether Biogen's aducanumab actually benefits patients' daily lives.
By Jacob Bell • UPDATED: June 7, 2021 at 3:30 p.m. -
Sarah Silbiger via Getty Images
Bluebird cleared by FDA to resume studies of sickle cell gene therapy
An investigation by the company determined the treatment was "very unlikely" to be the cause of a case of leukemia reported in one of the trials.
By Ned Pagliarulo • June 07, 2021 -
Orchard abandons promising gene therapy for rare immune disorder
The U.K. biotech deprioritized the therapy last year, despite positive results in clinical testing that were recently published in a top medical journal.
By Kristin Jensen • June 03, 2021 -
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Biotech venture capital still booming as venBio raises another $550M
VenBio has previously invested in a range of treatment areas and technologies, including cell and gene editing companies like Precision Bio and Artiva.
By Jacob Bell • June 03, 2021 -
Bayer AG
Bayer buys a biotech and its offshoot in bet on radiopharmaceuticals
The German pharma will add an experimental prostate cancer medicine to its pipeline through the deal, which reflects growing industry interest in the field.
By Ned Pagliarulo • June 03, 2021 -
Elizabeth Regan / Industry Dive
MorphoSys to buy Constellation in $1.7B deal, aided by unusual funding
Royalty Pharma will effectively fund MorphoSys' acquisition of the cancer biotech through a separate agreement to buy MorphoSys' shares of royalties on several marketed and experimental medicines.
By Ned Pagliarulo • June 02, 2021 -
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Alkermes prepares for uncertain launch as FDA finally clears schizophrenia drug
Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.
By Jacob Bell • June 01, 2021 -
Amgen Inc.
Amgen pays $400M for an eczema drug, putting faith in an old partner
A deal with Kyowa Kirin gives Amgen rights to an experimental treatment aimed at an autoimmune target that has drawn interest from multiple drugmakers.
By Kristin Jensen • June 01, 2021 -
Permission granted by Parexel
Sponsored by Parexel Biotech4 insights on decentralized trials for biotechs
Here are four things we have learned about DCTs that biotech companies can consider when designing a decentralized or hybrid trial.
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National Cancer Institute, NIH
In first, FDA approves KRAS-blocking cancer drug from Amgen
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.
By Ned Pagliarulo • UPDATED: May 29, 2021 at 12:35 p.m. -
Courtesy of EQRx
EQRx readies a lower-cost alternative to pricey cancer immunotherapies
The biotech and its partner CStone disclosed Phase 3 results in lung cancer that support approval plans for a drug similar to treatments like Merck's Keytruda, but would be priced at a fraction of the cost.
By Ben Fidler • May 28, 2021
