Biotech: Page 86
-
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 -
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 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 -
Sarah Silbiger via Getty Images
Pharma erupts as Biden administration backs waiver of vaccine patent rights
The major shift in policy did not result in concrete action from the U.S., however, sparking ongoing criticism of unequal vaccine access.
By Jonathan Gardner , Ned Pagliarulo • May 6, 2021 -
Getty / Edited by BioPharma Dive
CSL closes deal for UniQure gene therapy in hopeful sign for M&A
Completion of the buyout eases concerns the arrangement might be held up by the FTC, which has signaled it will step up scrutiny of life sciences deals.
By Kristin Jensen • May 6, 2021 -
Permission granted by Eric Kelsic / Dyno Therapeutics
Dyno, in demand for its gene therapy work, raises $100M for fast expansion
After inking three pharma deals within a year of launching, the Harvard spinout has the backing of Andreessen Horowitz and several other top investors.
By Jonathan Gardner • May 6, 2021 -
Permission granted by Eikon Therapeutics
Roger Perlmutter, former Merck research chief, resurfaces to lead a small biotech
Months after leaving his post as Merck's top scientist, Perlmutter has become CEO of Eikon Therapeutics, which plans to use Nobel Prize-winning microscope technology to discover new drugs.
By Ben Fidler • May 5, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Adagio, flush with cash, launches large study of next-gen COVID-19 antibody
The privately held biotech believes its drug might treat or prevent infections from existing variants and future coronavirus strains, which could make it a competitor to marketed therapies from Regeneron and Eli Lilly.
By Kristin Jensen • May 5, 2021 -
Permission granted by Esker Therapeutics
Esker, a new biotech startup, launches with plans to make targeted immune drugs
Led by a former MyoKardia executive, Esker Therapeutics is developing a drug that could eventually compete with one of Bristol Myers Squibb's most closely watched candidates.
By Jonathan Gardner • May 5, 2021 -
Sage braces for make-or-break depression data
The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results.
By Jacob Bell • May 4, 2021 -
Courtesy of Sarepta
Sarepta's second-gen Duchenne drug shows signs of topping its first
An experimental Duchenne drug developed with a newer technology may be more potent than Sarepta's marketed treatment Exondys 51. But early data also brought new safety concerns.
By Jonathan Gardner • May 3, 2021 -
Roivant valued at $7B in blank-check merger, bucking SPAC slowdown
Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million.
By Ben Fidler • May 3, 2021 -
Jacob Bell/BioPharma Dive
Avrobio changes course after FDA closes path for speedy gene therapy approval
The FDA recently converted its clearance for a standard Fabry treatment to a full approval, complicating Avrobio's plans to seek an accelerated OK for its rare disease therapy.
By Ned Pagliarulo • May 3, 2021 -
A serious side effect puts a biotech's eye gene therapy in limbo
Adverum Biotechnologies has unmasked a Phase 2 study in which a trial participant suffered severe inflammation and vision loss — a finding that could threaten the program’s future in multiple eye diseases.
By Ben Fidler • April 29, 2021 -
Maddie Meyer via Getty Images
Moderna plans to triple coronavirus vaccine production next year
The biotech aims to double capacity at plants in Switzerland and Spain, and by 50% at U.S. sites. The total number, however, will depend on the mix of primary and booster doses.
By Jonathan Gardner • April 29, 2021 -
Wall Street fears Amgen's tough first quarter is just the start
Product sales fell by 5% in the first quarter, keeping the pressure high for Amgen to deliver on expectations for its KRAS cancer drug Lumakras.
By Jacob Bell • April 28, 2021 -
Permission granted by Biogen
Under pressure, Biogen will allow some patients early access to experimental ALS drug
Biogen plans to start a compassionate use program in July that would let a small group of patients with rapidly progressing disease access its drug.
By Jacob Bell • April 27, 2021 -
Vertex moves pain drug into mid-stage testing
VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain.
By Jacob Bell • April 26, 2021 -
Coronavirus vaccine makers Oxford, Novavax follow up with a promising malaria shot
A vaccine co-developed by the U.K. academic center and the Maryland biotech could be the first to meet the WHO's efficacy target for a malaria vaccine.
By Ben Fidler • April 23, 2021
Previous
