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Transgene Expands Phase II Clinical Trial of Therapeutic Vaccine TG4001 in Combination With Avelumab Versus Avelumab Monotherapy in Patients With HPV16-positive Anogenital Cancers

Transgene Expands Phase II Clinical Trial of Therapeutic Vaccine TG4001 in Combination With Avelumab Versus Avelumab Monotherapy in Patients With HPV16-positive Anogenital Cancers - Trial will focus on patients without liver metastases, based on encouraging data in Phase Ib/II study - Trial targets indications where clinical outcomes can be improved versus standard therapeutic options and immune checkpoint inhibitors ("ICIs") - Continued clinical collaboration with Merck KGaA, Darmstadt, Ger...
Distrito Federal United States United Kingdom Lucie Larguier Christophe Le Tourneau Le Tourneau

Genentech's Actemra Becomes the First Biologic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition

Search jobs 04-Mar-2021 Genentech’s Actemra Becomes the First Biologic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition – Systemic sclerosis (SSc) is a rare disease that impacts up to 75,000 people in the United States – – Approximately 80% of SSc patients may be affected by interstitial lung disease (ILD), a...
United States South San Francisco Levi Garraway Karl Mahler Loren Kalm Shirley Dang

How One Woman Fought Treatment-Resistant Depression

How One Woman Fought Treatment-Resistant Depression March 3, 2021 FacebookTwitterEmail (BPT) - For years before her diagnosis, Nicole thought her daily routine was normal. Habits like sleeping for 18 hours a day, missing school and struggling to maintain friendships just seemed like hallmarks of an “angsty” personality, as many in her life had labeled her. “It wasn’t until my mom became worried about me and started taking me to doctors and psychiatrists that I began to realize I wasn’...
United States National Institute Of Mental Health National Pregnancy Registry For Antidepressants Janssen Pharmaceuticals Inc Agency For Healthcare Research Methods In Clinical Research

Merck Provides Update on KEYTRUDA® Indication in Metastatic Small Cell Lung Cancer in the US

Merck known as MSD outside the United States and Canada, today announced the company is voluntarily withdrawing the U.S. indication for KEYTRUDA for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal of this indication was done in consultation with the U.S. Food and Drug … Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announ...
United States Kristen Drake Courtney Ronaldo Peter Dannenbaum Patrick Ryan Roy Baynes

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Aimmune Presents New Clinical Data From Pooled Safety Analysis in Patients Treated With PALFORZIA for up to ~3.5 Years

Posted on 192 Aimmune Therapeutics, a Nestlé Health Science company developing and commercializing treatments for potentially life-threatening food allergies, today announced new clinical data from a pooled analysis of three controlled phase 3 (PALISADE 1, RAMSES, ARTEMIS 3, ARC008, ARC011) trials of PALFORZIA ® [Peanut ( Arachis hypogaea) Allergen Powder-dnfp]. These data will be presented at the American Academy of Allergy, Asthm...
United States Jodi Sievers Lauren Barbiero Stephen Tilles Thomas Casale University Of South Florida

HUMIRA® Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

ABBVie today announced that the U.S. Food and Drug Administration approved HUMIRA ® for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8. 1,2 “Ulcerative colitis can have a profound effect on children and for too … ABBVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration...
United States Leonard Feinstein Marla Dubinsky Brandee Pappalardo Access Economics Pty Center At Mount Sinai

Valneva Reports FY 2020 Results and Major Corporate Achievements

Press release content from Globe Newswire. The AP news staff was not involved in its creation. Valneva Reports FY 2020 Results and Major Corporate Achievements VALNEVAFebruary 25, 2021 GMT Excellent progress on clinical programs Unprecedented partnering deal signed with Pfizer for Lyme disease vaccine candidate VLA15, including $130 million upfront payment as part of over $300 million for upfront and milestone payments Positive initial Phase 2 results Acceleration of pediatric development ann...
United Kingdom United States New Zealand David Lawrence Biopharma Pharmakon Teresa Pinzolits
Source: apnews.com

Jazz Pharmaceuticals Completes Submission of Supplemental New Drug Application for Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia

(2) DUBLIN, Feb. 16, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the completion of the rolling submission for the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of adult patients with idiopathic hypersomnia. If approved, Xywav will be the first and only approved treatment in the U.S. for adults with i...
Robert Iannone Jacqueline Kirby Andrean Flynn Khan Trotti Diane Powell Jazz Pharmaceuticals Inc

Jazz Pharmaceuticals Completes Submission of Supplemental New Drug Application for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the completion of the rolling submission for the supplemental New Drug Application...
Robert Iannone Jacqueline Kirby Andrean Flynn Khan Trotti Diane Powell Jazz Pharmaceuticals Inc

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