Clinical Trials: Page 105
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Regulus hits further setbacks as clinical hold upheld
Stock dropped by 20% after hours on Friday following an FDA request for more data on the microRNA-targeting drug RG-101.
By Suzanne Elvidge • Jan. 30, 2017 -
Prescribed Reading: J&J closes $30B deal, FDA talks regen med
J&J finally closes the deal with Actelion, despite poor data for Opsumit, while the FDA creates a new designation and Biogen looks to woo payers with data.
By Lisa LaMotta • Jan. 27, 2017 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Pfizer set to move C. diff vaccine into Phase 3
An interim analysis of data from a Phase 2 study showed positive immunogenic effects from treatment with the experimental vaccine.
By Judy Packer-Tursman • Jan. 27, 2017 -
Vertex touts CF drugs, but sees promise in pain
The Boston-based company anticipates sales growth for its cystic fibrosis drug Orkambi in Europe this year, but some analysts see movement there as slow-going.
By Judy Packer-Tursman • Jan. 26, 2017 -
Novartis aims to gain ground on I/O leaders
Merck, Roche and Bristol-Myers have seized the lead in immuno-oncology, but Novartis hopes to build a broad portfolio of second-generation immunotherapies that can close the gap.
By Ned Pagliarulo • Jan. 25, 2017 -
FDA
FDA report stresses importance of Phase 3 testing
Several rumored candidates for FDA chief under President Trump have previously criticized the FDA approval process as being too slow.
By Judy Packer-Tursman • Jan. 25, 2017 -
Deep Dive
Lilly turns to pain after solanezumab failure
With a new focus on pain and migraine medications, Eli Lilly hopes to reinvigorate its neuroscience pipeline and portfolio.
By Jacob Bell • Jan. 25, 2017 -
Why biosimilars could be market disruptors
The biologic copies are just now entering the U.S. market and could mean a shift in several major therapeutic indications.
By Suzanne Elvidge • Jan. 23, 2017 -
Marinus up on small ganaxolone hope
The Pennsylvania biotech reported positive data in a small number of patients, giving hope to investors.
By Lisa LaMotta • Jan. 23, 2017 -
Actelion misses goal in study, but takeover talks likely unaffected
Pharma giant J&J is in exclusive discussions with Actelion about a potential acquisition of the Swiss biotech and its portfolio of drugs for pulmonary hypertension.
By Ned Pagliarulo • Jan. 23, 2017 -
FDA gives go-ahead to Synergy's constipation drug
Facing a crowded market, the company’s CEO asserts that Synergy has “the right strategic vision and the right launch plan” for Trulance.
By Judy Packer-Tursman • Jan. 22, 2017 -
Prescribed Reading: A new era in pharma
Trump is in, Califf is out, Bristol-Myers foregoes any possible lead in lung cancer and the FDA made its mark.
By Lisa LaMotta • Jan. 20, 2017 -
Neurocrine's Tourette drug misses mark in mid-stage trial
The company remains optimistic about the treatment's potential, pursuing other indications for it including tardive dyskinesia.
By Jacob Bell • Jan. 19, 2017 -
AstraZeneca angles for more competitive position in I/O
Shifting the timeline and endpoints of the MYSTIC study could strengthen AstraZeneca's position in lung cancer.
By Suzanne Elvidge • Jan. 18, 2017 -
Trial failure deals harsh blow to Alcobra
The company, which focuses on cognitive disorder treatments, said its only candidate missed the primary endpoint of a Phase 3 study testing the drug in patients with ADHD.
By Jacob Bell • Jan. 17, 2017 -
Biogen upbeat about new Spinraza data
Positive results for the company's newly approved spinal muscular atrophy drug could support its sky high price tag.
By Suzanne Elvidge • Jan. 17, 2017 -
Allergan moves toward NDA after uterine fibroid drug's success
The Irish biopharma expects to submit the drug, which is already marketed in Canada and Europe, for U.S. approval in the latter half of 2017.
By Jacob Bell • Jan. 17, 2017 -
Tesaro plans speedy response to CRL for nausea drug
The drugmaker disclosed last week the FDA had requested more details on manufacturing practices, an area where an increasing number of applications have fallen short.
By Suzanne Elvidge • Jan. 13, 2017 -
Kite confident as CAR-T readout nears
The next two months will be crucial for Kite, which hopes to secure the first approval for a CAR-T therapy in the U.S.
By Ned Pagliarulo • Jan. 12, 2017 -
NCI launches new cancer drug formulary to speed combo trials
As pharma dollars pour into oncology, interest in the potential for combination therapies has grown dramatically.
By Ned Pagliarulo • Jan. 11, 2017 -
Sponsored by DrugDev
SCOPE 2017: Calling out Clinical Technology - Booth #400
As technology improves industries around us, drug development has gone the opposite direction with less efficient operations.
Jan. 10, 2017 -
Prescribed Reading: Quiet before the storm
M&A was slow in 2016 and 2017 is off to a slow start. But the JP Morgan conference in San Francisco next week could put dealmaking back in full swing.
By Lisa LaMotta • Jan. 6, 2017 -
Halozyme unveils mid-stage data for pancreatic cancer drug
The cancer-focused biotech said its drug has an edge in progression-free-survival, though some remain skeptical.
By Jacob Bell • Jan. 5, 2017 -
Ocular boasts more positive data for Dextenza
The company intends to release safety data and submit the post-surgery eye inflammation drug for approval in early 2017.
By Jacob Bell • Jan. 5, 2017 -
Inotek shares freefall after glaucoma drug failure
The Lexington, MA-based company's shares were 71% lower on Tuesday than when the markets closed on Dec. 30.
By Jacob Bell • Jan. 4, 2017
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