FDA: Page 35
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Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA pushes back decision on Zogenix epilepsy drug
Shares sank on concerns about the future of the drug designed to treat Dravet syndrome, a rare form of epilepsy.
By Kristin Jensen • Feb. 27, 2020 -
Jacob Bell/BioPharma Dive
FDA monitoring impact of coronavirus outbreak on medical product supply
The agency postponed drug and device inspections in China that were scheduled for February, limiting its oversight of a key country in the medical supply chain.
By Nick Paul Taylor • Feb. 18, 2020 -
Jacob Bell/BioPharma Dive
Cancer concerns knock Eisai's weight loss drug from market
Eisai has agreed to remove Belviq after the FDA said a post-marketing study found a "range of cancer types" appeared to develop more frequently in patients taking the drug.
By Jacob Bell • Feb. 14, 2020 -
Biogen dips as Alzheimer's drugs from Lilly, Roche fail again
Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.
By Jacob Bell • Feb. 10, 2020 -
FDA approves Aimmune drug as first treatment for peanut allergy
Aimmune's next challenge will be securing insurance coverage as people allergic to peanuts still have to avoid exposure to the food.
By Jonathan Gardner • Jan. 31, 2020 -
FDA, expecting a gene therapy boom, firms up policies
In seven guidance documents, the agency gave drugmakers guidelines on manufacturing, testing and long-term follow-up for the one-time treatments.
By Ned Pagliarulo • Jan. 28, 2020 -
FDA decision nears on Aimmune's contested peanut allergy drug
Palforzia is one of two products under review by the FDA that are aimed at desensitizing people highly allergic to peanuts.
By Jonathan Gardner • Jan. 24, 2020 -
Epizyme drug granted approval by FDA for rare cancer
Five years after buying back rights from Eisai, Epizyme won approval for its first-ever drug.
By Ned Pagliarulo • Updated Jan. 24, 2020 -
Kendall Davis/BioPharma Dive
While expected, Intercept's approval delay adds to NASH uncertainty
An upcoming FDA advisory meeting will be a key test for Intercept's ambitions to become the first drugmaker with an approved therapy for the liver disease.
By Jacob Bell • Jan. 17, 2020 -
Nektar quickly drops opioid drug after FDA panel rejection
After a decade of research, the biotech said it will withdraw its application for oxycodegol and make no further investment in the drug.
By Kristin Jensen • Jan. 15, 2020 -
Ultragenyx boosted by trial data for 2nd gene therapy
One analyst called the results, which sparked a 30% jump in Ultragenyx's stock price, better than expected. The biotech is now preparing a Phase 3 trial.
By Jonathan Gardner • Jan. 10, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 trends to watch at the FDA in 2020
With Stephen Hahn confirmed as commissioner, the regulator is better positioned to more firmly address political pressures and a rising tide of complex medicines.
By Jonathan Gardner • Jan. 9, 2020 -
Sponsored by Remarque Systems
Risk-based quality management: Your key to safety and effectiveness
Why is the FDA and other regulators urging clinical trial sponsors to rethink the way they design and run clinical trials?
Jan. 9, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA approval decisions to watch in the 1st quarter
Aimmune's peanut allergy therapy and Esperion's cholesterol offering could be among the new drugs cleared in the first few months of the new decade.
By Jacob Bell • Jan. 2, 2020 -
AstraZeneca and Merck's Lynparza cleared by FDA for pancreatic cancer
The pill is the second targeted treatment approved for pancreatic cancer, although its use is limited to only a small share of patients.
By Jonathan Gardner • Dec. 30, 2019 -
Intra-Cellular approval keeps focus on FDA's neuroscience review process
Lumateperone, to be sold as Caplyta, had conflicting results in late-stage trials. Its approval suggests the FDA is using a "glass half full lens" to review neuroscience drugs, said one analyst.
By Jacob Bell • Dec. 23, 2019 -
FDA rejects GSK's HIV therapy in setback to two-drug strategy
The British drugmaker said the Complete Response Letter was unrelated to product safety, but the delay could hamper GSK's bid to challenge rival Gilead.
By Andrew Dunn • Dec. 23, 2019 -
Daiichi, AstraZeneca breast cancer drug joins bumper crop of early FDA approvals
AstraZeneca bet big on the Japanese pharma's HER2-targeting therapy, a gamble that paid off with a speedy approval for Enhertu.
By Jonathan Gardner • Updated Dec. 23, 2019 -
FDA approves Merck's Ebola vaccine, a historic first against deadly virus
The pharma giant has already given 275,000 doses of the vaccine to fight an outbreak in central Africa. Other drugmakers, including J&J and Regeneron, are also developing vaccines.
By Andrew Dunn • Dec. 20, 2019 -
Amarin secures long-sought FDA nod, boosting sales hopes for heart pill
The company will target as many as 80,000 doctors with a doubled salesforce for Vascepa, CEO John Thero said Monday in an interview.
By Andrew Dunn • Updated Dec. 16, 2019 -
Jacob Bell/BioPharma Dive
Biogen's Alzheimer's drug gets caught in Sarepta's spotlight
The unexpected approval of Sarepta's Vyondys 53 has some wondering how lenient the FDA might be in reviewing aducanumab. Others, however, see little impact.
By Jacob Bell • Dec. 13, 2019 -
Hahn confirmed as FDA head, to lead agency as drug review process is tested
Stephen Hahn, an oncologist and former MD Anderson executive, is set to confront several pressing issues, including the rigor of the FDA's approvals.
By David Lim , Andrew Dunn • Dec. 13, 2019 -
In stunning twist, FDA approves Sarepta's Duchenne drug it rejected
Following an August rejection of Vyondys 53, Sarepta appealed the FDA's decision through a formal dispute resolution process that led to the agency's about-face.
By Ned Pagliarulo , Jonathan Gardner • Dec. 12, 2019 -
New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda
One Wall Street analyst expects the FDA's OK will help Tecentriq outpace Bristol-Myers Squibb's Opdivo in 2020 in the non-small cell lung cancer market.
By Jonathan Gardner • Dec. 4, 2019 -
Trump FDA nominee Hahn advanced by Senate HELP Committee
Senators voted 18-5 to move Hahn's nomination to a full Senate vote. Sen. Patty Murray cited concerns over Hahn's position on e-cigarettes in voting no.
By David Lim • Dec. 3, 2019
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