Biotech: Page 70
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Incyte eczema drug wins FDA OK, but with safety warning
A topical cream formulation of the drug in Incyte's top-selling product could help the company expand. The black box warning, though, might limit use.
By Kristin Jensen • Sept. 22, 2021 -
Permission granted by Vertex Pharmaceuticals
Deep Dive'This is the time to double down': Top Vertex executives defend research plan as pressure builds
A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.
By Ben Fidler • Sept. 22, 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 -
ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
By Ned Pagliarulo • Updated Sept. 21, 2021 -
Martin Vleck/Shutterstock.com
Sponsored by NuvoloCalibrate and connect your equipment in the cloud
Calibration is too important to do on spreadsheets or paper. See how you can improve your calibration activities with a cloud-based solution.
Sept. 20, 2021 -
Permission granted by Biogen
Biogen says experimental pain drug helps neuropathy patients in mid-stage trial
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.
By Jonathan Gardner • Sept. 17, 2021 -
Theravance to lay off 75% of employees alongside larger restructuring
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.
By Jacob Bell • Sept. 15, 2021 -
After talks with FDA, a biotech prepares to submit its closely watched ALS drug
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will soon ask for approval of AMX0035 — a change of plans from earlier this year.
By Jacob Bell • Sept. 15, 2021 -
Courtesy of CureVac
CureVac scales back mRNA manufacturing for coronavirus vaccine
The German biotech, which announced disappointing results for its shot in June, said the move was done in response to reduced demand.
By Shoshana Dubnow • Updated Sept. 15, 2021 -
Biotech funder Lightstone raises another $375M for life sciences investing
The venture firm, which previously invested in LocanaBio, Catamaran Bio and Tizona Therapeutics, said its third fund surpassed its target.
By Jacob Bell • Sept. 14, 2021 -
Getty / Edited by BioPharma Dive
Fourth trial volunteer dies in Astellas gene therapy study
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used.
By Ned Pagliarulo • Sept. 14, 2021 -
Permission granted by Biogen
Biogen offered a window into what's holding up Aduhelm. Investors didn't like what they saw.
At Morgan Stanley’s healthcare conference last week, executives detailed how the launch of their Alzheimer’s drug has been slower than expected, due in large part to lingering questions about trial data and insurance coverage.
By Jacob Bell • Sept. 9, 2021 -
Courtesy of Apellis Pharmaceuticals
Apellis eye drug succeeds in one key study, but falls short in its twin
Highly anticipated study results showed divergent outcomes for the biotech's therapy in treating a form of vision loss known as geographic atrophy. Even so, Apellis plans to soon ask for FDA approval.
By Ned Pagliarulo • Updated Sept. 10, 2021 -
Mario Tama via Getty Images
Jennifer Doudna-founded CRISPR biotech raises new cash to broaden drug development work
Originally formed as a diagnostics developer by Doudna and three other cofounders, Mammoth Biosciences has accelerated plans to make gene editing medicines.
By Shoshana Dubnow • Updated Sept. 10, 2021 -
Courtesy of National Resilience; Business Wire
Moderna expands mRNA vaccine supply in deal with new biotech producer
The company has previously said it could make up to 3 billion vaccine doses in 2022, depending on how booster shots are authorized.
By Shoshana Dubnow • Sept. 8, 2021 -
Permission granted by Apple Tree Partners
Venture capital pours more money into RNA medicines with the launch of Replicate
The company, which focuses on self-replicating RNA, comes equipped with $40 million from Apple Tree Partners and a stamp of approval from the former research head at Biogen.
By Jacob Bell • Sept. 8, 2021 -
Roche bets big on off-the-shelf cancer cell therapy with Adaptimmune deal
Long a bystander in the race to develop so-called allogeneic treatments, the cancer drugmaking giant has joined the fray with a wide-ranging alliance that could be worth up to $3 billion.
By Jonathan Gardner • Sept. 7, 2021 -
Courtesy of BioMarin Pharmaceutical
FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.
By Ben Fidler • Sept. 7, 2021 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Hint of benefit in Alzheimer's drug study fuel stock surge for Swiss biotech
A once-failed drug being developed by AC Immune and Roche appeared to slow cognitive decline in a small trial. But other study goals were missed, muddying the seemingly positive result.
By Ned Pagliarulo • Aug. 31, 2021 -
Courtesy of Galapagos
Galapagos CEO to retire, though successor yet to be announced
Onno van de Stolpe co-founded Galapagos in 1999. Under his watch, the Belgian biotech secured its first approved drug and a landmark deal with Gilead, though it has since hit a series of setbacks.
By Jacob Bell • Aug. 31, 2021 -
Permission granted by Laronde
Moderna founder's next big play in RNA raises $440M
Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus.
By Jacob Bell • Aug. 30, 2021 -
Elizabeth Regan/BioPharma Dive
BioMarin wins European approval to sell drug for dwarfism
The drugmaker is setting the price for Voxzogo high, at an annual price of around $300,000 per patient, although the company expects to make "material discounts" in the coming years.
By Ned Pagliarulo • Aug. 27, 2021 -
Courtesy of Gilead Sciences
Gilead wins reversal of $1.2B penalty in CAR-T patent case
A federal appeals court overturned an earlier verdict that had ruled Gilead's Kite Pharma unit infringed on a patent held by Bristol Myers Squibb.
By Ned Pagliarulo • Updated Aug. 26, 2021 -
Courtesy of Regeneron Pharmaceuticals
New data bolster Regeneron's plan to defend top-selling eye drug
Early results show a higher dose of the company's flagship drug Eylea appears as safe as the marketed version, a step forward in the company's plan to fight off emerging competition in the years ahead.
By Kristin Jensen • Aug. 25, 2021 -
Vertex, looking to broaden its gene editing abilities, asks a young biotech for help
A freshly inked agreement gives Vertex the right to use tools from Arbor Biotechnology to develop "ex vivo" cell therapies for diseases like Type 1 diabetes and sickle cell, among others.
By Jacob Bell • Aug. 24, 2021 -
Mario Tama via Getty Images
With new results, J&J's $1B gamble on a targeted inflammation drug faces long odds
Theravance, which agreed to co-develop a next-generation JAK inhibitor with J&J three years ago, said the experimental drug failed a mid-stage study in ulcerative colitis, leaving its future in doubt.
By Jonathan Gardner • Aug. 24, 2021
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