Merck, GSK and Pew Comment on Draft Guidance on LPAD Approval Pathway

Merck, GSK and Pew Comment on Draft Guidance on LPAD Approval Pathway

Merck, GlaxoSmithKline, BIO and Pew Charitable Trusts weighed in on recent draft guidance on the establishment of a limited population pathway for antibacterial and antifungal drugs (LPAD pathway). The draft is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway, which was created under […]

3 scientists share $500000 prize for work on cancer therapy

3 scientists share $500000 prize for work on cancer therapy

ALBANY, N.Y. — Tumors once considered untreatable have disappeared and people previously given months to live are surviving for decades thanks to new therapies emerging from the work of three scientists chosen to receive a $500,000 medical prize. The recipients of the annual Albany Medical Center Prize in Medicine and Biomedical Research, announced Wednesday, are […]

3 Hurdles Ahead of Alnylam and Its Revolutionary New Drug

3 Hurdles Ahead of Alnylam and Its Revolutionary New Drug

Taking a medical breakthrough from concept through commercial success is like ascending a mountain that grows taller and more treacherous with every setback. It’s taken Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) 16 years to launch its first drug, so challenges have had plenty of time to take up positions along this company’s path to a successful first launch. Alnylam’s […]

Endo Lifts Temporary Stay of FDA Litigation Following the Launch of a Bulk-Compounded Vasopressin Product by a …

DUBLIN, Aug. 15, 2018 /PRNewswire/ — Endo International plc (NASDAQ: ENDP) today announced that it is lifting a temporary stay of its litigation against the U.S. Food and Drug Administration (FDA).  The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by the Company’s subsidiaries, Par Sterile Products, LLC and […]

Endo International (ENDP) Reports Lift of Temporary Stay of FDA Litigation Following Launch of Bulk-Compounded …

Endo International (ENDP) Reports Lift of Temporary Stay of FDA Litigation Following Launch of Bulk-Compounded …

Get inside Wall Street with StreetInsider Premium. Claim your 2-week free trial here. Endo International plc (NASDAQ: ENDP) today announced that it is lifting a temporary stay of its litigation against the U.S. Food and Drug Administration (FDA). The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by […]

Amicus Therapeutics Has Room To Fall Ahead

Amicus Therapeutics Has Room To Fall Ahead

On Friday, the United States Food and Drug Administration (FDA) approved Amicus Therapeutics’ (FOLD) New Drug Application (NDA) surrounding GalafoldTM (migalastat) 123 mg capsules, marking the first New Drug Approval in the fabry disease space in around 15 years. Although the news seemed positive, concerns surrounding pricing and competition led to declines as the market […]

Recon: Biogen's Spinraza Too Costly for Britain; China Invalidates Patent on Gilead Hepatitis C Drug

Recon: Biogen's Spinraza Too Costly for Britain; China Invalidates Patent on Gilead Hepatitis C Drug

Posted 14 August 2018 | By Ana Mulero  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US New York sues OxyContin maker Purdue Pharma over opioids (Reuters) Tech Giants Pledge to Ease Patient, Provider Access to Health Data (WSJ) (The Hill) Flagship Pioneering’s Sigilon gets a new […]

Pharmaceutical Drugs Global Market Opportunities And Strategies To 2021

Pharmaceutical Drugs Global Market Opportunities And Strategies To 2021

NEW YORK, August 14, 2018 /PRNewswire/ — Pharmaceutical Drugs Global Market Opportunities And Strategies By the Drugs For Treatment: Musculoskeletal Disorders Drugs, Cardiovascular Drugs, Oncology Drugs, Anti-Infective Drugs, Metabolic Disorder Drugs, Central Nervous System Drugs, Genito-Urinary Drugs, Respiratory Diseases Drugs, Gastrointestinal Drugs, Hematology Drugs, Dermatology Drugs, Ophthalmology Drugs; With Forecast Until 2021 Read the full […]

Why a Parkinson's Drug Should Be Pulled From the Market

Why a Parkinson's Drug Should Be Pulled From the Market

By Jonathan Block Published: August 14, 2018 Last updated: August 13, 2018   The FDA should be vigilant of new drugs approved, but especially so for those that are approved under an expedited or accelerated approval pathway. Unfortunately, this is not the case for Nuplazid (pimavanserin), a Parkinson’s disease drug […]

Local firm's heart drug approved in US

Local firm's heart drug approved in US

Medicure Inc., the Winnipeg pharmaceutical company that focuses on developing and commercializing cardiovascular drugs especially for the U.S. market, has received regulatory approval for a new generic heart drug. Medicure received approval from the U.S. Food and Drug Administration (FDA) for a generic drug that is determined by the FDA to be therapeutically equivalent to […]

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