Commercial

Disruptive Innovation – The Impact: Perspectives from Senior Pharma Executives

May 25, 2018

Disruptive Innovation in the Life Science Industry At a panel session hosted by ICON early in 2018, senior executives from leading pharma companies shared their views on ‘Disruptive Innovation’. The session was chaired by Nuala Murphy (President, Clinical Research Services, ICON) and guest panellists Francesca Wuttke (Managing Director, MSD Global Health Innovation Fund), Dr. William H. Carson (President and CEO of Otsuka […]

BioMarin Receives Standard Approval for Palynziq™ (pegvaliase-pqpz) Injection for Treatment of Adults with Phenylketonuria (PKU), a Rare Genetic Disease

May 25, 2018

SAN RAFAEL, Calif., May 24, 2018 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that BioMarin received standard approval from the U.S. Food and Drug Administration (FDA) for Palynziq™ (pegvaliase-pqpz) Injection to reduce blood phenylalanine (Phe) concentrations in adult patients with phenylketonuria (PKU), who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing […]

Myriad Announces Seven New Payer Coverage Decisions for Prolaris®

May 24, 2018

SALT LAKE CITY, May 23, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a worldwide leader in personalized medicine, today announced seven new commercial coverage decisions for Prolaris®, the company’s market leading prognostic test for patients with prostate cancer. The payers include a top-25 commercial insurer in the United States and in aggregate the payers […]

Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

May 24, 2018

Holzkirchen, Germany, May 24, 2018 – Sandoz, a Novartis division and the global leader in biosimilars, today announced that the European Commission (EC) has approved Zessly® (infliximab) for use in Europe. Zessly is approved for use in all indications of the reference medicine*** including rheumatoid arthritis, adult Crohn’s disease, pediatric Crohn’s disease, adult ulcerative colitis, […]

Better Late Than Never: AstraZeneca Finally Pushes Potassium Drug Lokelma To The FDA Finish Line

May 24, 2018

AstraZeneca can finally try to reap some returns from its $2.7 billion buyout of ZS Pharma. After back-to-back rejections over manufacturing problems, its potential blockbuster hyperkalemia drug Lokelma, formerly known as ZS-9, has finally been approved by the FDA. Lokelma won the approval based on data from five clinical trials that showed the drug could […]

Exelixis’ Partner Ipsen Announces European Commission Approval of CABOMETYX® (Cabozantinib) for Previously Untreated Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma

May 23, 2018

SOUTH SAN FRANCISCO–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq:EXEL) today announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC) in the European Union.   “The expanded marketing authorization of CABOMETYX […]

Innovus Pharma Announces the Launch of its Product Vesele® in Canada

May 23, 2018

SAN DIEGO–(BUSINESS WIRE)–Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, today announced the launch of its product Vesele®, approved by Health Canada for the increase […]

FDA Approves US WorldMeds’ LUCEMYRA™ (lofexidine) After Priority Review for the Management of Opioid Withdrawal Symptoms

May 23, 2018

LOUISVILLE, Ky., May 16, 2018 /PRNewswire/ — US WorldMeds today announced that the US Food and Drug Administration (FDA) approved LUCEMYRA (lofexidine) for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. The FDA reviewed LUCEMYRA under Priority Review, which is granted to submissions for medications that would provide significant improvements in […]

Granules Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Granules India Limited Received US FDA Approval for Generic Methylergonovine Tablets

May 23, 2018

HYDERABAD, India, May 17, 2018 /PRNewswire/ —   Granules India Ltd., today announced that the U.S. FDA has approved its Abbreviated New Drug Applications (ANDA) for Methylergonovine 0.2 mg Tablets. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited. The approved ANDA is the bioequivalent to the reference […]

Amneal Announces FDA Approval and Launch of Generic Welchol® (Colesevelam HCl) Tablets, 625 mg

May 23, 2018

BRIDGEWATER, N.J., May 17, 2018 /PRNewswire/ — Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol® (colesevelam HCI) tablets, 625 mg. Amneal has immediately initiated commercialization activities for this first-to-market […]

LOKELMA™ approved in the US for the treatment of adults with hyperkalemia

May 23, 2018

May 18, 2018—AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood (greater than 5.0 mEq/L). The risk of hyperkalemia increases significantly for […]

ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV

May 23, 2018

London, 21 May 2018 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted marketing authorisation for Juluca (dolutegravir 50mg/rilpivirine 25mg) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically […]

FDA Approves Prolia® (Denosumab) For Glucocorticoid-Induced Osteoporosis

May 23, 2018

THOUSAND OAKS, Calif., May 21, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, […]

Breckenridge Announces Approval for 40mg Duloxetine Delayed-release Capsules additional strength.

May 23, 2018

BOCA RATON, Fla., May 21, 2018 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announced today the supplemental approval for the 40mg strength of Duloxetine Delayed-Release Capsules. The U.S. Food and Drug Administration granted final approval for the Supplemental Abbreviated New Drug Application (sANDA), which is being manufactured and supplied by its vertically integrated parent company, Esteve Pharmaceuticals, […]

Depression Drugs Market to be Worth US$ 5000 Mn by 2026 | TMR

May 23, 2018

ALBANY, New York, May 22, 2018 /PRNewswire/ — Transparency Market Research (TMR) has published a new report titled, “Depression Drugs Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018-2026”. According to the report, the global depression drugs market was valued at US$ 6,500 Mn in 2017 and is anticipated to decline at […]

Glenmark Pharmaceuticals Receives ANDA Approval for Colesevelam Hydrochloride Tablets, 625 mg

May 23, 2018

MUMBAI, May 22, 2018 /PRNewswire/ —   Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride Tablets, 625 mg, the generic version of Welchol®1 Tablets, 625 mg, of Daiichi Sankyo Inc. The company has already commenced supplies of the product to […]

A Study Analyzing Observational Data Shows Real-World Effectiveness of Prevnar® 13 in Adults Age 65+

May 23, 2018

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that results from a study analyzing real-world effectiveness data found that Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) reduced the risk of hospitalization from vaccine-type pneumococcal community-acquired pneumonia (CAP) by 73% (95% CI: 12.8−91.5%) in adults aged 65 and older.1 Importantly, Prevnar 13 (PCV13) worked […]

Sun Pharma Announces USFDA Approval of YONSA® (abiraterone acetate) To Treat Metastatic Castration-Resistant Prostate Cancer In Combination With Methylprednisolone YONSA® was shown in clinical studies to be an effective form of abiraterone acetate, and can be taken with or without food, in combination with methylprednisolone

May 23, 2018

MUMBAI & PRINCETON, N.J. & KING OF PRUSSIA, Pa.–(BUSINESS WIRE)–Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and […]

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