Loxo Oncology Announces Larotrectinib Clinical Update in Patients with TRK Fusion Cancers at the European Society …

Loxo Oncology Announces Larotrectinib Clinical Update in Patients with TRK Fusion Cancers at the European Society …

– Median Duration of Response Not Reached With One Year of Additional Follow-up – – 67 Newly Reported TRK Fusion Patients Exhibit 81% ORR – STAMFORD, Conn., Oct. 21, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, and Bayer AG, Germany, […]

Companion Animal Speciality Drugs Market by Product Types, Application and Growth Forecast

Companion Animal Speciality Drugs Market by Product Types, Application and Growth Forecast

United StatesCompanion Animal Speciality Drugs Market research report will help you take informed decisions, understand opportunities, plan effective business strategies, plan new projects, analyse drivers and restraints and give you a vision on the industry forecast. Companion Animal Speciality Drugs Market report would come in handy to understand your competitors and give you an insight about […]

Probiotics and Antibiotics Join Forces to Eradicate Drug-Resistant Bacteria

Probiotics and Antibiotics Join Forces to Eradicate Drug-Resistant Bacteria

Antimicrobial resistance (AMR) happens when micro-organisms such as bacteria, fungi, viruses, and parasites undergo a metamorphosis when they are exposed to antimicrobial drugs such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics. When micro-organisms have developed antimicrobial resistance they are referred to as superbugs.  Consequently, the medicines that once were effective in the treatment of infections […]

Recon: Vertex Touts Positive Preliminary Results for Three Drug CF Combo; AbbVie CFO to Retire

Recon: Vertex Touts Positive Preliminary Results for Three Drug CF Combo; AbbVie CFO to Retire

Posted 19 October 2018 | By Michael Mezher  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump’s Drug Price Bust (WSJ) Orphan Drugs in the United States (IQVIA) (PharmaLetter-$) Abbvie CFO Chase to Retire Next Year (Reuters) (Fierce) Vertex Three-drug combination improves life for […]

Selinexor Granted Priority Review by FDA for Heavily Treated Multiple Myeloma

Selinexor Granted Priority Review by FDA for Heavily Treated Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted priority review to Karyopharm Therapeutics’ application requesting accelerated approval of its investigational therapy selinexor as a treatment for multiple myeloma patients who have failed five prior myeloma therapies. A final decision is expected by April 6, 2019. “As a potential new therapy with a novel mechanism and compelling […]

Scientists receive $5.1 million grant to develop stem cell-based therapy for blinding retinal conditions

Scientists receive $5.1 million grant to develop stem cell-based therapy for blinding retinal conditions

Scientists at the UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the Stein Eye Institute have been awarded a $5.1 million grant from the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions. The award by the California Institute for Regenerative […]

New Drug Application for HIV drugs dolutegravir and lamivudine

New Drug Application for HIV drugs dolutegravir and lamivudine

ViiV Healthcare has announced it has submitted a New Drug Application for HIV two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) to the FDA.  The submission is based on the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL. The results of these […]

FDA Advisory Committee Recommends Approval of Shire's Prucalopride (SHP555) for Chronic Idiopathic Constipation

FDA Advisory Committee Recommends Approval of Shire's Prucalopride (SHP555) for Chronic Idiopathic Constipation

Intended for U.S. Audience FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation If FDA grants approval, prucalopride will be the only readily available 5-HT4 receptor agonist1 in the U.S. for chronic idiopathic constipation in adults; FDA is anticipated to make a final decision by the end of December Cambridge, Mass. […]

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