FDA: Page 71
-
Seres rekindles once-failed microbiome study
Under the FDA’s direction, the microbiome pioneer hopes its redesigned trial for a therapeutic treating C. diff. qualifies as a pivotal study.
By Judy Packer-Tursman • March 17, 2017 -
FDA hands AstraZeneca's ZS-9 another setback
The agency issued a complete response letter to AstraZeneca for its hyperkalemia drug, giving it a second rejection.
By Jacob Bell • March 17, 2017 -
FDA warns of Viberzi pancreatitis risk
Allergan's irritable bowel syndrome drug gets slapped with a safety warning.
By Suzanne Elvidge • March 17, 2017 -
Trump budget to cost pharma industry
The budget proposed by the Trump administration cuts funding to HHS and NIH, while increasing fees for companies to the FDA.
By Lisa LaMotta • March 16, 2017 -
FDA advisory panel votes against Endo's opioid painkiller
After the panel concluded the risks associated with Opana ER outweigh its benefits, the FDA will now have to decide what reforms to take for the prescription opioid.
By Jacob Bell • March 15, 2017 -
CBO: 24 million more uninsured by 2026 under AHCA
The score of the ACA replacement bill from the Congressional Budget Office was worse for the GOP than many expected, but Republicans responded by saying the report was flawed.
By Shannon Muchmore • March 14, 2017 -
Novartis locks up Kisqali approval, eyes Pfizer's lead
With approval of its CDK 4/6 inhibitor, Novartis hopes to catch Pfizer's Ibrance in a soon-to-be hotly contested field.
By Ned Pagliarulo • March 13, 2017 -
Deep Dive
Investors have high expectations for cannabinoids
The pipeline is moving forward for cannabis-mimicking pharmaceuticals as investors' interest grows and new clinical data spark approval hopes.
By Jacob Bell • March 13, 2017 -
FDA puts partial hold on Karyopharm's cancer drug
The pharma stresses that the FDA’s hold, while halting new patient enrollment until it’s lifted, is due to errors on written materials, not safety problems.
By Judy Packer-Tursman • March 12, 2017 -
FDA
Trump taps Scott Gottlieb to head FDA
The former FDA deputy commissioner, widely seen as a more traditional pick than other unorthodox names put forward, will likely push for deregulation and speedier review of drugs and devices.
By Ned Pagliarulo • March 10, 2017 -
Prescribed Reading: More backlash to drug pricing
Negotiating Medicare prices is now on the table, lawmakers are not happy with Marathon, and PTC is pushing back at the FDA.
By Lisa LaMotta • March 10, 2017 -
FDA
Radius shares slide after FDA delays decision on bone drug
In a surprise, the regulator extended its review of Radius' osteoporosis drug by three months, with a target action date now set for the end of June.
By Ned Pagliarulo • March 10, 2017 -
Nicox resubmits eye drug to FDA after manufacturing setback
Issues with an API contractor tripped up Nicox's new drug application for Zerviate last year. With that now resolved, Nicox hopes to win secure approval.
By Ned Pagliarulo • March 9, 2017 -
Trump 'enthusiastic' about drug price negotiation, lawmakers say
Two Democratic congressmen met with President Donald Trump yesterday to discuss a draft bill that would allow the government to directly negotiate prices with drugmakers.
By Ned Pagliarulo • March 9, 2017 -
GOP ACA bill has massive Medicaid changes, no CBO score
The bill still faces significant opposition, not only with Democrats but also Republicans who feel the tax credits are too generous, as well as some GOP governors who dislike the changes to Medicaid.
By Ana Mulero , Shannon Muchmore • March 8, 2017 -
Serenity wins FDA nod on frequent nighttime urination treatment
The company secured approval for its nocturnal nasal spray, but gets a boxed warning as well.
By Judy Packer-Tursman • March 8, 2017 -
FDA lifts trial holds for Seattle Genetics' cancer med
The agency is allowing two early-stage trials testing the treatment in patients with AML to continue, but the company is not continuing a Phase 1/2 study.
By Jacob Bell • March 7, 2017 -
PTC files DMD drug in spite of earlier rejection
The company employed a rarely used tactic to force the FDA to review Translarna for approval.
By Jacob Bell • March 6, 2017 -
Prescribed Reading: Icahn stokes M&A flames
The billionaire activist investor makes a new biotech hire; the CAR-T space heats up; and the FDA cooperates with EMA to improve manufacturing.
By Lisa LaMotta • March 3, 2017 -
FDA touts own role in women's heart health
The agency highlighted its efforts to curb heart disease in women, an oft-overlooked area of healthcare.
By Judy Packer-Tursman • March 3, 2017 -
FDA gives go-ahead to Lexicon's rare disease drug
The company plans to price Xermelo, a drug for carcinoid syndrome diarrhea, similarly to Novartis' leading treatment for the condition.
By Jacob Bell • March 1, 2017 -
La Jolla surges on Phase 3 results for shock patients
The San Diego-based company says its synthetic formulation of a blood-pressure regulator offers a new level of treatment for shock patients who fail first- and second-line therapies in the ICU.
By Judy Packer-Tursman • Feb. 27, 2017 -
Why drug pricing seems so complicated
Experts say pharma companies need to get better at incorporating clinical value into pricing and communicating this value.
By Judy Packer-Tursman • Feb. 27, 2017 -
Prescribed Reading: Bristol M&A steals the show
Debate about the future of Bristol-Myers dominated news coverage this week, while several cancer drugs failed in late-stage trials.
By Lisa LaMotta • Feb. 24, 2017 -
Resverlogix gets FDA input, redesigns kidney trial
This is the Canadian biotech’s third announcement over the past month on studies related to the potential of its lead candidate, apabetalone.
By Judy Packer-Tursman • Feb. 24, 2017
Previous
