Biotech: Page 89
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Getty / Edited by BioPharma Dive
Bluebird stops studies of sickle cell gene therapy after new cancer cases
The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.
By Ben Fidler , Ned Pagliarulo • Updated Feb. 16, 2021 -
Permission granted by Centessa Pharmaceuticals
10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model
The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.
By Ned Pagliarulo • Feb. 16, 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 -
Danielle Ternes/BioPharma Dive
A gene therapy pipeline takes shape for a cluster of rare diseases
Lysosomal storage disorders, diseases of cellular metabolism gone wrong, are the focus of a fast-expanding lineup of experimental genetic medicines, a research boom that recalls biotech's roots.
By Ned Pagliarulo • Feb. 12, 2021 -
Courtesy of Galapagos
Gilead, Galapagos halt development of experimental drug, denting research alliance
Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.
By Kristin Jensen • Feb. 11, 2021 -
Getty / Edited by BioPharma Dive
A new startup gets Takeda's backing to take complex genetic medicines 'off the shelf'
Ensoma debuts with a lucrative alliance with the Japanese pharma and an unusual way to deliver genetic medicines into the body.
By Ben Fidler • Feb. 11, 2021 -
Getty / Edited by BioPharma Dive
AbbVie exploring how CRISPR gene editing can improve cell therapies
Using technology from Caribou Biosciences, AbbVie hopes to engineer "off-the-shelf" CAR-T cells that can better withstand attacks from the immune system.
By Jacob Bell • Feb. 10, 2021 -
Elizabeth Regan/BioPharma Dive
Small biotech gets big win on treatment for rare swelling disorder
An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.
By Jonathan Gardner • Feb. 9, 2021 -
Courtesy of Editas Medicine
Editas names new CEO in latest executive shakeup
James Mullen, chair of Editas' board and a former Biogen CEO, will replace Cynthia Collins in a critical year for the gene editing biotech.
By Ned Pagliarulo • Feb. 8, 2021 -
Jacob Bell/BioPharma Dive
PTC aims again for FDA review of Duchenne drug despite latest miss
The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.
By Jonathan Gardner • Feb. 5, 2021 -
Permission granted by Gilead Sciences
Gilead sales propped up by COVID-19 drug Veklury
Sales of the antiviral drug accounted for a quarter of the biotech's product revenue in the fourth quarter, disguising hits to its business elsewhere.
By Ned Pagliarulo • Feb. 5, 2021 -
With $588M IPO, Sana leads wave of new biotechs going public
Nine other drug developers are set to price initial public offerings this week, extending a record run of financing activity from last year. Sana's is one of the largest in recent history.
By Ben Fidler • Feb. 3, 2021 -
Permission granted by Biogen
Biogen laser-focused on Alzheimer's drug as rest of business falters
While the biotech prepares to launch aducanumab, its latest earnings report shows significant hits to top-selling drugs, plus another pipeline failure.
By Jacob Bell • Feb. 3, 2021 -
Jacob Bell/BioPharma Dive
Jazz Pharma to buy GW Pharma, maker of CBD-based epilepsy drug, for $7.2B
The deal gives Jazz, best known for its sleep disorder drugs, access to Epidiolex, the first prescription cannabidiol medicine approved by the FDA.
By Ned Pagliarulo • Feb. 3, 2021 -
Vertex comes to a crossroads
The biotech's cystic fibrosis business is booming. But with a pipeline of risky, disjointed assets, some on Wall Street aren't sure what Vertex's next move is, or why it hasn't been spending its massive amounts of cash.
By Jacob Bell • Feb. 2, 2021 -
Shifting strategy, Coherus buys rights to experimental cancer drug
The biosimilar maker will develop an immunotherapy rival to Merck's Keytruda via a deal with China's Junshi Biosciences.
By Jonathan Gardner • Feb. 1, 2021 -
Permission granted by Gilead Sciences
Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy
Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.
By Ned Pagliarulo • Feb. 1, 2021 -
Permission granted by Vetter Pharma
Sponsored by Vetter PharmaNavigating the challenges of proper fill and finish in clinical development
Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance.
By Claus Feussner, Ph.D., Senior Vice President Vetter Development Service, Vetter Pharma-Fertigung GmbH & Co. KG • Feb. 1, 2021 -
Jacob Bell/BioPharma Dive
FDA delays verdict for Biogen's closely watched Alzheimer's drug, raising investor optimism
Investors feared an outright rejection for aducanumab. But the FDA moving its approval deadline back three months is a signal to some that the agency wants to approve Biogen's drug.
By Jacob Bell • Jan. 29, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen study data bolster prospects of KRAS-blocking cancer drug
Results from a mid-stage study showed Amgen's drug, sotorasib, shrank tumors in over a third of lung cancer patients, affirming earlier findings.
By Ned Pagliarulo • Updated Jan. 29, 2021 -
FDA approves first-of-its-kind lupus drug
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.
By Jacob Bell • Jan. 25, 2021 -
Getty / Edited by BioPharma Dive
Beam, Verve stockpile cash as investors bank on gene editing progress
Beam expects to receive $260 million through a private stock placement, while Verve raised $94 million to support initial studies of its heart disease treatment.
By Ned Pagliarulo • Jan. 19, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Cancer-focused biotech turns its tools to building a 2nd-generation coronavirus vaccine
As worries about coronavirus mutations grow, Gritstone Oncology will work with the NIH to develop a shot capable of stimulating a broad immune response.
By Jonathan Gardner • Jan. 19, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US pushes for wider use of 'underutilized' COVID-19 antibody drugs as pandemic worsens
A $2.6 billion deal with Regeneron is part of a renewed effort by government officials to bolster uptake of the treatments, which haven't gained traction.
By Ben Fidler • Jan. 15, 2021 -
US to pay up to $2.6B for more doses of Regeneron's COVID-19 antibody drug
The deal expands an earlier agreement between Regeneron and the U.S., though many of the issues limiting the drug's use haven't been solved.
By Kristin Jensen • Jan. 13, 2021 -
Danielle Ternes/BioPharma Dive
JPM21: Gene editing for heart disease, a new date to watch in Alzheimer's research and Pfizer's deep pockets
Verve, a buzzy gene editing startup, unveiled its first drug candidate, which is designed to treat hereditary high cholesterol by changing a single letter in the DNA sequence of a key gene.
By Ned Pagliarulo • Jan. 12, 2021
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