Clinical Trials: Page 77
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Gilenya beats Copaxone head-to-head at higher dose, study finds
The multiple sclerosis drugs are top-sellers for their respective makers, Novartis and Teva. Yet a Phase 3b trial showed an efficacy edge for Gilenya.
By Andrew Dunn • Oct. 11, 2018 -
As clock ticks, EMA launches 3rd phase of Brexit plan
The agency has started to scale back non-urgent activities as its move to Amsterdam draws closer.
By Suzanne Elvidge • Oct. 11, 2018 -
Explore the Trendline➔
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
5-year data shows earlier Ocrevus treatment slows MS progression
Ocrevus is a key drug for Roche's efforts to grow through biosimilar competition to the Swiss pharma's top-selling biologics.
By Suzanne Elvidge • Oct. 11, 2018 -
FDA clears Vertex, CRISPR to test gene-editing therapy in sickle cell patients
With a clinical hold dating back to May resolved, the companies said they plan to start a Phase 1/2 study of CTX001 in the U.S. by year's end.
By Jacob Bell • Oct. 10, 2018 -
Elizabeth Regan/BioPharma Dive
Roche, Ionis focusing on eye disease through new deal
On the heels of their Huntington's disease collaboration, the companies are teaming up again — this time on a therapy targeting the immune system.
By Jacob Bell • Oct. 10, 2018 -
Arbutus' clinical challenges trigger stock slide
Shares in the biotech dropped by more than half this week on news of several hurdles in the clinic for its hepatitis B research.
By Suzanne Elvidge • Oct. 10, 2018 -
J&J's top-seller Stelara looks set to expand into ulcerative colitis
New data show Stelara led to higher rates of clinical remission and response than placebo. An approval would further expand the biologic's market.
By Andrew Dunn • Oct. 9, 2018 -
Sarepta builds out gene therapy manufacturing with latest CDMO deal
The biotech is thinking ahead, inking partnerships in recent months with Paragon Bioservices and Brammer Bio to support its gene therapy pipeline.
By Suzanne Elvidge • Oct. 9, 2018 -
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Celgene showcases Otezla's potential in scalp psoriasis
Patients receiving treatment achieved significant improvements in moderate-to-severe scalp psoriasis compared to placebo, according to fresh Phase 3 data.
By Suzanne Elvidge • Oct. 9, 2018 -
Loxo, Blueprint drive forward with RET-targeting cancer therapies
No selective inhibitors of the oncogene are currently approved in the U.S. — something both biotechs hope to change with their respective therapies.
By Ned Pagliarulo • Oct. 8, 2018 -
Merck gets a shot in the arm with expanded label for Gardasil
The HPV vaccine is now also approved for adults aged 27 through 45 years old, widening the addressable market for Merck.
By Suzanne Elvidge • Oct. 8, 2018 -
Lilly sweetens its position in diabetes with positive 'twincretin' data
Researchers found LY3298176, which targets both GLP-1 and GIP, significantly outperformed placebo on measures of glucose control and weight loss.
By Suzanne Elvidge • Oct. 5, 2018 -
Roche's flu drug strongly beat placebo. But could one data miss be critical?
Baloxavir marboxil fell short of showing a statistical edge over Roche's older Tamiflu in the overall study population, although it did so in a subgroup.
By Andrew Dunn • Oct. 4, 2018 -
Elizabeth Regan/BioPharma Dive
Sarepta gene therapy for DMD takes another step forward
Updated results, including data from a fourth boy with Duchenne muscular dystrophy, help to firm up the prospects for the biotech's gene therapy.
By Ned Pagliarulo • Oct. 4, 2018 -
Gilead's Biktarvy matches GSK's Triumeq in Phase 3 study
Biktarvy is a key drug for Gilead in its battle with GSK for HIV market share. New Phase 3 data could help Gilead make its case.
By Suzanne Elvidge • Oct. 4, 2018 -
Roche drug shows benefit in spinal muscular atrophy
Yet attention remains focused on a gene therapy in development by Novartis, which could reshape treatment of the genetic neuromuscular disorder.
By Ned Pagliarulo • Oct. 3, 2018 -
Jacob Bell/BioPharma Dive
Seattle Genetics' Adcetris tops chemo in Phase 3 lymphoma trial
An unexpected hit on overall survival could be a boost for the biotech and partner Takeda as they seek to expand the market for Adcetris.
By Suzanne Elvidge • Oct. 2, 2018 -
10 biotechs set to shake up the industry's top ranks
Analysts at Cowen picked 10 midsized biotechs that might be next to catch the market's eye as pipeline setbacks and missed financial targets have frustrated investors of larger drugmakers.
By Ned Pagliarulo , Andrew Dunn • Oct. 1, 2018 -
Alnylam puts its chips on speedy OK for rare disease drug
An early look at late-stage data showed the RNAi drug givosiran significantly cut levels of a key disease biomarker. But will that be enough for the FDA?
By Ned Pagliarulo • Sept. 28, 2018 -
Aldeyra has positive dry eye data — for now
Though its lead candidate beat vehicle in a Phase 2 study, Aldeyra's presentation of the results raised questions about the trial readout.
By Jacob Bell • Sept. 26, 2018 -
Takeda's dream of a first-line ALK inhibitor supported by late-stage data
Pfizer, Roche and Novartis all have first-line drugs for ALK-positive lung cancer, putting pressure on Takeda to keep up in the increasingly competitive market.
By Jacob Bell • Sept. 25, 2018 -
AstraZeneca's Imfinzi shows its strength in Stage 3 lung cancer
Results released at World Lung spell out the cancer immunotherapy's survival benefit, bolstering AstraZeneca's place in the earlier, locally advanced setting.
By Ned Pagliarulo • Sept. 25, 2018 -
Tecentriq sets the bar in small-cell lung cancer
Roche owns the first successful Phase 3 study of an immunotherapy in the less-common lung cancer type. But others are closing in.
By Ned Pagliarulo • Sept. 25, 2018 -
AstraZeneca heart study delivers mixed results for diabetes drug
The pharma hopes the results will help Farxiga compete with Eli Lilly and Boehringer Ingelheim's rival Jardiance, which has carved out a leading position on the strength of its heart claims.
By Andrew Dunn • Sept. 24, 2018 -
Vascepa's big heart benefit pumps up Amarin's value by $2B
Amarin's CEO called it "the single most significant advance in preventative cardiovascular drug therapy since the advent of statin therapy."
By Andrew Dunn • Sept. 24, 2018
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