Medical Tidbits, European Commission Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma

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THOUSAND OAKS, Calif., Nov. 19, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the European Commission (EC) granted marketing authorization for Kyprolis® (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Kyprolis is the first irreversible proteasome inhibitor approved in the European Union (EU) for use in combination treatment of patients with relapsed multiple myeloma.1 read more

Pfizer and Allergan to Combine

NEW YORK & DUBLIN–(BUSINESS WIRE)–Nov. 23, 2015– Pfizer Inc. (NYSE:PFE) and Allergan plc (NYSE:AGN) today announced that their boards of directors have unanimously approved, and the companies have entered into, a definitive merger agreement under which Pfizer, a global innovative biopharmaceutical company, will combine with Allergan, a global pharmaceutical company and a leader in a new industry model – Growth Pharma, in a stock transaction currently valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion, based on the closing price of Pfizer common stock of $32.18 on November 20, 2015. The transaction represents more than a 30 percent premium based on Pfizer’s and Allergan’s unaffected share prices as of October 28, 2015. Allergan shareholders will receive 11.3 shares of the combined company for each of their Allergan shares, and Pfizer stockholders will receive one share of the combined company for each of their Pfizer shares. read more

European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 23, 2015– Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union (EU). read more

Poxel Presents New Data on Imeglimin and PXL770 at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Diseases in Los Angeles

LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative drugs to treat type 2 diabetes, today announced the presentation of data on its two lead pipeline programs at the World Congress on Insulin Resistance and Cardiovascular Diseases (WCIRDC), which was held last week in Los Angeles. On November 19th, the Company presented clinical data and in depth analysis demonstrating Imeglimin’s premium potential as a novel type 2 diabetes monotherapy improving insulin secretion and insulin sensitivity in diabetic patients from an 18-week phase 2 study. On November 20th, the Company presented exciting preclinical data for its next pipeline compound, PXL770, a direct adenosine monophosphate-activated protein kinase (AMPK) activator. The study showed that PXL770 improved glycemic control and produced an improved lipid profile in an established model of type 2 diabetes. read more

Samumed Completes Phase II Study for Its Potential Treatment of Androgenetic Alopecia: Safety Data Show No Serious Adverse Events in Any Treated Patient

SAN DIEGO–(BUSINESS WIRE)–Samumed, LLC, a leader in tissue regeneration, announced today the completion of a Phase II clinical trial for its potential treatment of androgenetic alopecia (AGA), commonly known as male pattern baldness. There were no serious adverse events (SAE) observed in either of the treatment groups, and the incidence of adverse events (AE) was similar between treatment and control groups. The company will report exploratory efficacy data, including change over time in non-vellus hair count and hair density, when they become available. read more

NaviGate Cardiac Structures Inc. (“NCSI”) Reports First Patient Treated for Mitral Regurgitation (“MR”)

LAKE FOREST, Calif.–(BUSINESS WIRE)–NaviGate Cardiac Structures Inc. (“NCSI”), an emerging medical device company developing valved stents for replacement of incompetent mitral heart valves, announced today that a First-In-Human implant of its catheter-guided, mitral-valved stent into a beating heart was performed successfully in a 53-year-old male patient presenting with severe 4+* MR. The interventional team was led by Dr. Cristián Baeza Prieto at San Borja Arriarán Hospital in Santiago, Chile, on October 26, 2015. The patient is thriving at four weeks post-procedure. read more

Generon Collaborating with Mayo Clinic to Initiate a Phase IIa Study with F-652, a First-in-Class Biologic, to Treat Patients with Alcoholic Hepatitis

SHANGHAI–(BUSINESS WIRE)–Generon Corporation, a leading biotech company in China, announced today that the US FDA has cleared a phase IIa IND entitled “An open-label, cohort dose escalating study to assess the safety and efficacy of F-652 in patients with alcoholic hepatitis”. The clinical study is a multi-center trial led by Dr. Vijay Shah, Chair, Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN. Generon had reached an agreement with Mayo Clinic to conduct the phase IIa clinical study earlier this year.The current phase IIa clinical program is a collaboration between Generon and an alcoholic hepatitis consortium funded by the US National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH). The alcoholic hepatitis consortium, “Translational Research and Evolving Alcoholic Hepatitis Treatment (TREAT)” is a joint effort of three institutions: Mayo Clinic, Rochester, MN; Indiana University Health, Indianapolis, IN; and Virginia Commonwealth University Medical Center, Richmond, VA.


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