Principia Biopharma Inc. (PRNB) Granted PRN1008 Receives Orphan-Drug Designation from FDA for Treatment of …

Principia Biopharma Inc. (PRNB) Granted PRN1008 Receives Orphan-Drug Designation from FDA for Treatment of …

Get inside Wall Street with StreetInsider Premium. Claim your 2-week free trial here. Principia Biopharma Inc. (NASDAQ: PRNB) today announced that PRN1008, an oral, reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with immune thrombocytopenic purpura (ITP). Principia […]

FDA grants Orphan-Drug designation to Principia Biopharma's PRN1008

FDA grants Orphan-Drug designation to Principia Biopharma's PRN1008

The FDA has granted orphan-drug designation to Principia Biopharma’s (NASDAQ:PRNB) PRN1008, an oral, reversible covalent Bruton’s Tyrosine Kinase inhibitor, for the treatment of patients with immune thrombocytopenic purpura (ITP). Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved. Source link

FDA advisers back Shire constipation drug

FDA advisers back Shire constipation drug

Shire’s constipation drug prucalopride is moving closer to market – advisers to the FDA have just unanimously backed it as a treatment for chronic idiopathic constipation (CIC) in adults. As is the case with all FDA committees, the recommendation by the Gastrointestinal Drugs Advisory Committee is not binding. But the regulator will take the vote […]

Norepinephrine Reuptake Inhibitor AXS-12 Gets FDA Orphan Drug Designation for Narcolepsy

Norepinephrine Reuptake Inhibitor AXS-12 Gets FDA Orphan Drug Designation for Narcolepsy

Clinical-stage biopharmaceutical company Axsome Therapeutics Inc has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for AXS-12 for the treatment of narcolepsy.AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor. Axsome announced that it plans to initiate a phase 2 trial of AXS-12 for the treatment of the […]

Eisai Downplayed Drug's 'Homicidal' Side Effects, FDA Says

Eisai Downplayed Drug's 'Homicidal' Side Effects, FDA Says

By Jeff Overley Law360 (October 18, 2018, 7:55 PM EDT) — An Eisai Inc. sales representative downplayed the potential for epilepsy drug Fycompa to make patients think about killing people and promoted the product for off-label uses, the U.S. Food and Drug… To view the full article, register now. Source link

FDA snubs Novartis bid to repurpose inflammation drug for heart attacks

FDA snubs Novartis bid to repurpose inflammation drug for heart attacks

ZURICH (Reuters) – The U.S. Food and Drug Administration has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors, the Swiss drugmaker said on Thursday. FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss […]

FDA Panel OKs Stronger Opioid Despite Concerns

FDA Panel OKs Stronger Opioid Despite Concerns

By Pauline Anderson Oct. 18, 2018 — An FDA panel this week gave preliminary approval to a new kind of opioid for pain that is five to 10 times more potent than fentanyl. The drug advisory committee voted 10-3 to approve the drug, […]

FDA announces steps to modernise drug development and improve efficiency

FDA announces steps to modernise drug development and improve efficiency

US FDA commissioner has announced steps to modernise the drug development process to improve efficiency and promote innovation… The US FDA Commissioner Dr Scott Gottlieb has put out a statement for the modernisation of drug development, to improve the efficiency of the process and to promote the innovation of targeted therapies. He wrote how by […]

Axsome Therapeutics Receives FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy

Axsome Therapeutics Receives FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy

NEW YORK, Oct. 17, 2018 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, received on Tuesday, October 16, Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AXS-12 for the treatment of narcolepsy. Narcolepsy is a serious, […]