Warning: getimagesize(https://magazine.pharmamkt.net/wp-content/uploads/2020/09/logo-group.jpg): failed to open stream: HTTP request failed! HTTP/1.1 404 Not Found in /home/luciamun/public_html/magazine/wp-content/plugins/td-cloud-library/shortcodes/header/tdb_header_logo.php on line 792

The largest community of pharma leaders

Regulatory Affairs

Asana BioSciences to Present Positive Results from Phase 2b Study of Oral JAK/SYK Inhibitor Gusacitinib in Patients with Chronic Hand Eczema in the Late-Breaking...

LAWRENCEVILLE, N.J.--(BUSINESS WIRE)--Asana BioSciences’ Oral Gusacitinib (ASN002) demonstrates rapid and significant...

Xeris Pharmaceuticals Granted Fast Track Designation by the FDA for Its Novel Concentrated Diazepam Formulation (XP-0863) For Injection

CHICAGO--(BUSINESS WIRE)--Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging...

Aptinyx Announces Proposed Public Offering of Common Stock

EVANSTON, Ill.--(BUSINESS WIRE)--Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing...

After Meeting with FDA, Guided Therapeutics to Start Study in Support of its Application for FDA Approval

PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)-- #FDA--After Meeting with FDA, Guided Therapeutics to...

AppliedVR Receives FDA Breakthrough Device Designation to Treat Pain with Digital Therapeutic

LOS ANGELES--(BUSINESS WIRE)-- #chronicpain--AppliedVR, a pioneer advancing the next generation of...

Venatorx Pharmaceuticals to Present Data on Cefepime-Taniborbactam at IDWeek 2020

MALVERN, Pa.--(BUSINESS WIRE)-- #FightingSuperbugs--Venatorx Pharmaceuticals has two data presentation featuring cefepime-taniborbactam...

Cyclo Therapeutics Phase 3 Pivotal Program Can Begin Enrollment Per US FDA

GAINESVILLE, Fla.--(BUSINESS WIRE)--Cyclo Therapeutics, Inc. (OTCQB: CTDH), a clinical stage biotechnology...

オクタファルマ、NUWIQ®の添付文書に未治療患者での免疫原性のデータを含める更新をFDAが承認と発表

スイス・ラッヘン--(BUSINESS WIRE)--(ビジネスワイヤ) -- オクタファルマは、米国食品医薬品局(FDA)が当社のヒト細胞株由来組み換え型第VIII因子(FVIII)製剤NUWIQ®に対する添付文書の更新を承認したと発表しました。NUWIQ ®は、血友病A患者における出血の予防と治療を目的に承認されています。更新された添付文書には、未治療患者(PUPs)でのNuProtect試験から得た免疫原性のデータが含まれます。 FVIIIインヒビターの発現は、重度血友病Aの未治療患者(PUPs)で最も重篤な治療合併症です。外因性外来FVIIIに対するインヒビターの発現は、治療の効果を低減し、患者の長期的な関節の健康と生活の質に悪影響を与える場合があります。従ってインヒビター発現のリスクを最小限に抑えることは、未治療患者に対する治療判断で考慮すべき重要事項です。 更新されたNUWIQ®の添付文書には、真の未治療患者で単一のFVIII製剤を検討した前向き試験として最大の規模を持つNuProtect試験から得たデータが含まれます。患者は予防またはオンデマンド療法としてNUWIQ®の Source...

Mycovia Pharmaceuticals, Inc. Announces Last Patient Completes Final Visit in their Global Phase 3 “VIOLET Studies” for Oteseconazole (VT-1161) for the Treatment of Recurrent...

DURHAM, N.C.--(BUSINESS WIRE)--Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated...

Subscribe to this newsletter




 
2020 Call for Writers

Are you looking to inspire others in the pharma industry through your writing? You’re invited to submit your articles to become a Featured Writer for The Pharmaceutical Marketing Group website.