Medical Tidbits, Celebrating The Companies Bringing Innovations to Market

The Productive Innovation Index started with (as usual at IDEA) a small question – are pharmaceutical companies more different than they are similar? The industry is often described as if it were monolithic, with critics and fans all presenting problems or prescribing solutions that they believe will affect every company equally. We went on to ask the necessary next question: if two companies had the same asset at the early stages of development, would one make more of it than the other? The answer, to everyone, was ‘of course.’ As Matt Ridley says in The Evolution Of Everything, “Given that every football match starts with the same number of players, roughly the same size of pitch, the same sort of ball and the same rules, is it not astounding that every game is unique?” And so we found, as soon as we started looking at the scores – excellence in developing and launching innovative medicines is not equally shared among the major pharma companies. Some, it seems, are systematically excellent. read more

Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). XELJANZ XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors.

“Pfizer continues to be an innovator in inflammation and immunology. The introduction of the first and only once-daily oral JAK inhibitor for RA, XELJANZ XR, builds upon Pfizer’s tradition of developing patient-centered therapies,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. read more

Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

A New Topical Acne Treatment with Proven Efficacy and Tolerability in Once-Daily Dosing PRNewswire/ — Allergan plc (NYSE:AGN), a leading global pharmaceutical company, today announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) to market ACZONE® (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older.[1] ACZONE® Gel, 7.5% delivers proven efficacy to treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone in just once-a-day application. read more

Mitsubishi Tanabe Pharma Corporation Signs Licensing Agreement with A. Menarini Asia-Pacific for Spedra (Avanafil) in 10 Countries in Asia-Pacific

SINGAPORE–(BUSINESS WIRE)–Mitsubishi Tanabe Pharma Corporation (TSE: 4508), and Singapore-based A. Menarini Asia-Pacific Holdings Pte Ltd (“Menarini AP”) have entered into a licensing agreement to commercialize and promote SPEDRA™ (avanafil). Menarini AP will receive exclusive licensing rights from Mitsubishi Tanabe Pharma Corporation to market Avanafil in China, Hong Kong, Macao, Taiwan, Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam.  read more

Lilly Receives Positive CHMP Opinion for Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis

PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy. Ixekizumab is designed to specifically target IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis.1

This is the first regulatory step toward approval for ixekizumab in Europe. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the EU. The Commission usually makes a decision on marketing authorization within two to three months of the CHMP issuing its recommendation. read more

European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV

Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents – read more

Sobi and Biogen Receive Positive Opinion from CHMP for Alprolix® (rFIXFc) for the Treatment of Hemophilia B

STOCKHOLM & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) and Biogen (NASDAQ: BIIB) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted for Alprolix® (rFIXFc), a recombinant factor IX Fc fusion protein therapy for the treatment of hemophilia B. If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals.

Cook Medical has expanded its original July 2015 recall for the Beacon Tip Catheter

Cook Medical has expanded its original July 2015 recall for the Beacon Tip Catheter to include additional product lots. The recall now affects 408,011 total catheters distributed in the US.

Cook Medical started the original recall after it received complaints that the catheter tip may split or separate, and could potentially enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.

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