Biotech: Page 74
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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 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 -
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 -
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 -
Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs
The ambitious cell therapy developer, which has already raised nearly $1 billion from investors, will test the IPO market just as the pace and performance of recent biotech offerings have slowed considerably.
By Ben Fidler • May 26, 2021 -
Sarah Silbiger via Getty Images
J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies
Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.
By Jonathan Gardner • May 24, 2021 -
A biotech backs off NASH after trial failure
NGM Biopharmaceuticals has decided not to pursue a late-stage NASH program after its drug aldafermin became the latest in a long line of medicines to fail to help patients with the common liver condition.
By Jacob Bell • May 24, 2021 -
Bluebird's next gene therapy gets backing from European regulator
The treatment for a progressive, often deadly brain disease could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world.
By Jacob Bell • May 21, 2021 -
In the midst of a 'strategic shift,' Voyager loses CEO and R&D head
The shake-ups come as the biotech prepares to invest more in its technology and also begin human testing for one of its most advanced gene therapies.
By Jacob Bell • May 20, 2021 -
Sean Gallup via Getty Images
Pfizer, BioNTech to send EU up to 1.8B coronavirus vaccine doses
The deal, which the companies and the bloc have been negotiating for weeks, will significantly expand on the current contract for 600 million shots.
By Kristin Jensen • May 20, 2021 -
Off-the-shelf CAR-T, a Tagrisso rival and the next breast cancer drugs
Study abstracts for drugs from Allogene, EQRx, Sanofi and Lilly drew early interest and helped set the stage for the meeting.
By Ben Fidler , Ned Pagliarulo • May 20, 2021 -
FDA delays a biotech's cancer cell therapy once again
Iovance, which now plans to submit its melanoma treatment to the FDA next year, separately disclosed that its CEO Maria Fardis will resign.
By Kristin Jensen • Updated May 19, 2021 -
Sarah Silbiger via Getty Images
FDA approval sets stage for a showdown between Alexion and Apellis
Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease.
By Jacob Bell • May 17, 2021 -
Permission granted by Biogen
Biogen gene therapy misses goal in eye disease study
The results are a setback for Biogen, which spent $800 million two years ago to acquire the treatment's developer, Nightstar Therapeutics.
By Ned Pagliarulo • May 14, 2021 -
Sarah Silbiger via Getty Images
Heron, on third attempt, secures FDA approval for non-opioid painkiller
The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020.
By Kristin Jensen • May 13, 2021 -
Third Rock launches biotech targeting 'notoriously difficult' DNA regulators
With $82 million in hand, Flare Therapeutics is looking to create precision cancer drugs by going after a type of protein called transcription factors.
By Jacob Bell • May 13, 2021 -
Permission granted by Biogen
Biogen licenses a stroke drug from Japanese drugmaker TMS
The drug, which Biogen had an option to license, is one of two in the biotech's pipeline for a condition that has had few new treatments developed.
By Kristin Jensen • May 12, 2021 -
Permission granted by Laronde
Moderna founder launches new biotech, looking to cure diseases through 'endless RNA'
Laronde comes equipped with $50 million from Flagship Pioneering and a goal to upend how diseases are treated with long-lasting RNA medicines.
By Jacob Bell • May 10, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.
By Jonathan Gardner • May 7, 2021 -
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
Two biotechs team up to bring CRISPR to 'natural killer' cell therapy
A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy.
By Ben Fidler • May 6, 2021
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