Allergan and Gedeon Richter’s drug cariprazine to treat severe bipolar depression in adults met the main goal of a late-stage study.
US FDA Accepts Regulatory Submission for Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer
AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Athersys Inc. and Mesoblast Ltd. are beginning final-stage trials in hundreds of patients that they – along with loyal investors – say could change the course of devastating stroke and heart failure.
Regeneron Pharmaceuticals Inc. and ISA Pharmaceuticals B.V. announced a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16-induced cancer, in combination with the PD-1 antibody cemiplimab (REGN2810).
Roche’s patent dispute with London-listed Shire over the Swiss drugmaker’s new hemophilia drug Hemlibra escalated, with Shire filing a new motion in a U.S. court that Roche says aims to stop some patients from getting its medicine.
Jnana Therapeutics launched with a $50 million Series A financing. Seed funders Polaris Partners and Avalon Ventures were joined in the round by Versant Ventures, AbbVie Ventures and Pfizer R&D Innovate.
Merck & Co.’s Keytruda came up short in a pivotal study as a second-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Novo Nordisk came closer to winning European approval for the company’s diabetes drug Ozempic, the Danish drugmaker’s largest growth prospect, when a European Medicines Agency experts’ panel issued a positive recommendation.
The U.S. Food and Drug Administration allowed Alnylam Pharmaceuticals Inc. to restart clinical trials on a drug to treat patients with a rare bleeding disorder.
Aclaris Therapeutics Inc.’s drug to treat a common type of skin growth called seborrheic keratoses received FDA clearance.
The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.
Merck KGaA is reviving plans to bring an oral multiple sclerosis (MS) treatment to the U.S. market, hoping for blockbuster sales despite regulatory concerns about side effects having frustrated the German company’s ambitions almost seven years ago.
Belgium-based reMYND’s pre-clinical diabetes therapy ReS39 will get a significant boost after the company entered a licensing agreement with noted European diabetes company Novo Nordisk.
Teva Pharmaceutical announced a comprehensive restructuring plan that includes the elimination of 25 percent of the company’s global workforce.
Pristine operating theaters and state-of-the-art medical equipment are featured in a new Dubai hospital that opened – exclusively for camels.
Jeremy Perrott, McCann Health Global Chief Creative Officer, created the film that is meant to be a wake-up call that delivers a shocking moment of truth, like a stinging slap across the face. The visual style of filming the teenage boy’s first-person point of view, delivers an immersive and immediate experience that shines a light on the danger of what can happen if parents do not take steps to create a prescription drug safe home.
In today’s world of healthcare advertising and marketing, should agencies do less telling and more listening? The answer is yes, according to new data on how well healthcare marketers think their agencies listen.
The U.S. Food and Drug Administration approved Pfizer Inc.’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade.
2017 has shaped up to be a bumper year for drug approvals, with U.S. officials clearing twice as many novel medicines as in 2016, yet returns on research investment at leading pharmaceutical companies are down.
Revance Therapeutics Inc. will wait to seek partnerships with bigger drugmakers until the company is closer to regulatory approval for its Botox rival treatment, Chief Executive Dan Browne told Reuters in an interview.