Biotech: Page 82
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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 -
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 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging biotech
New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.
By BioPharma Dive staff -
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 -
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 -
Brian Tucker / BioPharma Dive/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 -
Getty / Edited by BioPharma Dive
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 -
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 -
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 9, 2021 -
Permission granted by Biogen
Deep Dive // New Alzheimer's drugsA 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 8, 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 -
Permission granted by Biogen
Deep Dive // New Alzheimer's drugsIn historic move, FDA approves a closely watched and controversial Alzheimer's drug
The decision cleared the way for what many predicted would become a lucrative treatment. But a high price and controversy over whether Biogen's Aduhelm benefits patients weighed heavily on the drug's launch.
By Jacob Bell • Updated June 7, 2021 -
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 7, 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 3, 2021 -
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 3, 2021 -
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 3, 2021 -
Elizabeth Regan/BioPharma 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 2, 2021 -
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 1, 2021 -
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 1, 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.
June 1, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
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 -
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 -
Permission granted by Centessa Pharmaceuticals
Centessa raises $330M in third largest biotech IPO this year
The public offering follows just three months after Centessa, created from the merger of 10 Medicxi-backed drug startups, launched with $250 million in venture funding.
By Ned Pagliarulo • May 28, 2021 -
Getty / Edited by BioPharma Dive
UniQure moves Huntington's gene therapy to next phase of key trial
Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.
By Jonathan Gardner • May 27, 2021 -
Getty Images: Edited by BioPharma Dive
FDA restricts use of Intercept drug due to liver injury risk
An investigation linked the drug to severe injuries in about two dozen patients, leading the agency to add a new contraindication to the label.
By Kristin Jensen • May 27, 2021 -
'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA
The FDA's decision to approve aducanumb could have far-reaching consequences for patients, Biogen and Alzheimer's research. Here's how the drug's review came about.
By Ned Pagliarulo • May 27, 2021
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