Novartis says Kymriah receives second FDA approval

Novartis says Kymriah receives second FDA approval

(Reuters) – Swiss drugmaker Novartis said on Tuesday it received a second approval from the U.S. Food and Drug Administration (FDA) for a second form of the blood cancer drug Kymriah. FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd […]

Recon: Regeneron and Express Scripts Reach Deal on Cholesterol Drug

Recon: Regeneron and Express Scripts Reach Deal on Cholesterol Drug

Posted 01 May 2018 | By Zachary Brennan  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Regeneron And Express Scripts Reach A Deal On Embattled Cholesterol Drug (Forbes) (CNBC) (Endpoints) (Press) Bristol-Myers dumps late-stage IDO studies in wake of Incyte’s pivotal implosion in yet another setback (Endpoints) […]

FDA, FTC take action against companies misleading kids with e-liquids that resemble children's juice boxes, candies …

FDA, FTC take action against companies misleading kids with e-liquids that resemble children's juice boxes, candies …

As part of ongoing efforts to protect youth from the dangers of nicotine and tobacco products, today the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued 13 warning letters to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food […]

FDA grants orphan drug designation to elamipretide for LHON

FDA grants orphan drug designation to elamipretide for LHON

The FDA granted Orphan Drug Designation to elamipretide, for the treatment of Leber’s hereditary optic neuropathy… Stealth BioTherapeutics (Stealth), has announced that the US Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the investigational drug candidate, elamipretide, for the treatment of Leber’s hereditary optic neuropathy (LHON).   LHON is an […]

Key Stock Catalysts in the FDA Drug Application Process

Key Stock Catalysts in the FDA Drug Application Process

Pharmaceutical and biotech companies in the US must follow a standard process to advance a new drug candidate through nonclinical and clinical studies. Drug development in the US follows a standard process through which pharmaceutical and biotech companies advance a new drug candidate through nonclinical and clinical studies. Once the company’s clinical data proves the […]

Vertex Pharmaceuticals Takes a Detour Around the FDA's Roadblock

Vertex Pharmaceuticals Takes a Detour Around the FDA's Roadblock

Vertex Pharmaceuticals (NASDAQ:VRTX) started the year on a high note with the approval of its new cystic fibrosis drug, Symdeko. It posted solid first-quarter results, although the company announced it had to adjust its plans slightly for the next-generation triple combination cystic fibrosis drugs after the Food and Drug Administration (FDA) put up a roadblock. […]

Nonprofit gets second crack at suit to amend FDA drug-trial consent forms

Nonprofit gets second crack at suit to amend FDA drug-trial consent forms

A California-based nonprofit suffered a setback on Friday in its lawsuit against the U.S. Food and Drug Administration over the warnings given to people who participate in clinical drug trials. Judge James Boasberg in U.S. District Court for the District of Columbia agreed with the FDA that the Center for Responsible Science (CRS) had failed […]

FDA Clears New Drug Application For Pluristem's PLX-R18; What's Next?

FDA Clears New Drug Application For Pluristem's PLX-R18; What's Next?

Pluristem Therapeutics Inc. (NASDAQ: PSTI), which develops placenta-based cell therapy products, announced Monday that the FDA cleared an investigational new drug application for PLX-R18 cell therapy to treat acute radiation syndrome. Pluristem shares were rallying 7.26 percent Monday afternoon to $1.33.  An IND App Primer  An IND application is the first step in FDA’s drug […]