Biotech: Page 84
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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 -
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 -
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 -
Permission granted by Biogen
As review of its Alzheimer's drug wraps up, Biogen prepares for an uncertain launch
On an earnings call Thursday, executives shed more light on how they intend to address some of the challenges that would come with selling a controversial drug like aducanumab.
By Jacob Bell • April 22, 2021 -
With money pouring into biotech, Versant raises another $950M
Versant's announcement comes as biotechs continue to rake in record levels of cash, supporting a wave of new drug company startups.
By Jacob Bell • April 21, 2021 -
The next 2 months in biotech and pharma will be busy. Here's what to watch.
New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • April 20, 2021 -
Getty / Edited by BioPharma Dive
Bluebird to withdraw gene therapy from Germany after dispute over price
The biotech will cut staff, primarily in Europe, after negotiations with German health authorities resulted in a price lower than Bluebird had sought.
By Ned Pagliarulo • April 20, 2021 -
Vertex bets another $900M on CRISPR treatment for blood diseases
Vertex and CRISPR Therapeutics are tweaking their partnership so that the larger biotech will cover 60% of the costs — and receive 60% of the future profits — related to a gene editing therapy for sickle cell disease and beta thalassemia.
By Jacob Bell • April 20, 2021 -
Positive data in hand, TG Therapeutics readies MS drug for FDA review
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.
By Jonathan Gardner • April 19, 2021 -
Permission granted by Adagio Therapeutics
A startup raises $336M to make a better antibody drug for COVID-19
Adagio Therapeutics, a well-financed spinout of antibody developer Adimab, could challenge Regeneron and Eli Lilly if its drug candidate proves protective in clinical tests.
By Ben Fidler • April 19, 2021 -
Permission granted by Relay Therapeutics
Relay buys AI startup to aid unorthodox drug discovery quest
The $85 million acquisition is an unusual and early step for a company like Relay, which went public last July and only just began clinical testing of its lead drugs last year.
By Ned Pagliarulo • April 16, 2021 -
Jacob Bell/BioPharma Dive
FDA faces backlash after seeking more data on an experimental ALS therapy
The ALS Association demanded the FDA "move with the urgency" other agencies have in reviewing a drug from Amylyx Pharmaceuticals.
By Jacob Bell • April 14, 2021 -
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Moderna watches for 'waning immunity' as new data show durable vaccine protection
Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade.
By Ben Fidler • April 14, 2021 -
Permission granted by Gilead Sciences
Gilead stops Veklury study, citing enrollment challenges, changing treatment
The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients.
By Jacob Bell • April 13, 2021 -
Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar
Just two months after launching, Jaguar Gene Therapy has raised another $139 million for a preclinical pipeline aimed at gene-linked autism and diabetes.
By Ned Pagliarulo • Updated April 13, 2021 -
Jacob Bell/BioPharma Dive
Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application
While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response.
By Jacob Bell • April 9, 2021 -
Biogen adds a late-stage prospect to its growing biosimilar business
A deal with Bio-Thera Solutions hands Biogen rights to a late-stage copycat of Actemra, Roche's blockbuster treatment for inflammatory diseases.
By Jacob Bell • April 8, 2021 -
Permission granted by Tessera Therapeutics
Bluebird executive joins Flagship startup Tessera as CMO
David Davidson is leaving Bluebird bio after nearly a decade as the gene therapy developer's top doctor. His new home, Tessera, just raised $230 million to advance its "gene writing" research.
By Ned Pagliarulo • April 7, 2021 -
FibroGen admits misleading safety data for anemia drug, dimming prospects
In a surprise announcement, the company said data used to tout the safety of the anemia pill roxadustat included "post hoc changes" that executives only became aware of during regulatory review.
By Ben Fidler • April 7, 2021 -
New data push a biotech's muscle disease drug closer to a key test
An experimental medicine from Scholar Rock could complement a gene therapy from Novartis and other treatments for the disease, though its benefit needs to be proven in further study.
By Jacob Bell • April 6, 2021 -
Ionis cuts jobs at a former spinout and inks new deal with Sobi
Some seven months after acquiring the rest of Akcea Therapeutics, Ionis is laying off most of the subsidiary's staff and turning to Sobi to sell its drugs.
By Ben Fidler • April 6, 2021
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