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Biden pledges faster U.S. approval for cancer drug cocktails

U.S. Vice President Joe Biden said on Tuesday that the United States would speed up the approval of promising new drug combinations in his government’s newly announced drive to cure cancer “once and for all”. Biden, who lost his 46-year-old son Beau to brain cancer last year, set out his plans at a World Economic […]

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Spero Therapeutics Hires Former Biomedical Advanced Research and Development Authority (BARDA) Anti-Infectives Program Chief

Melissa Stundick Joins Leadership Team as Head of Strategic Alliances CAMBRIDGE, Mass., Jan. 19, 2016 /PRNewswire-USNewswire/ — Spero Therapeutics, a biopharmaceutical company founded to develop novel therapies for the treatment of bacterial infections, announced the appointment of Melissa Stundick, Ph.D., to the newly created leadership position of Head of Strategic Alliances. In her new post, Dr. […]

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Michigan Mayor Calls for More Aid

The mayor of Flint, Mich., said Monday that federal aid the city is set to receive is just the tip of the iceberg of what will be needed to recover from lead contamination in its drinking water. President Barack Obama on Saturday declared a federal emergency in Michigan, freeing as much as $5 million in […]

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UK Junior Doctors Suspend Second Strike After Talks Progress

Britain’s junior doctors said on Tuesday they would suspend a threatened 48-hour strike planned for next week after making progress in conciliation talks with the government over pay and conditions for working anti-social hours. The junior doctors, or doctors in training who represent just over half of all doctors in the National Health Service (NHS), […]

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Acorda Bulks Up Parkinson’s Pipeline with $363 Million Takeover of Biotie

January 19, 2016By Mark Terry, BioSpace.com Breaking News Staff   Ardley, N.Y.-based Acorda Therapeutics, Inc. (ACOR) announced today that it plans to acquire Turku, Finland-based Biotie Therapies Corp. (BITI) for approximately $363 million. Acorda focuses on central nervous system disorders, such as multiple sclerosis (MS), spasticity related to MS, spinal cord injury (SCI), brain trauma […]

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J&J to Cut 3,000 Jobs in Medical Devices Division

Johnson & Johnson said on Tuesday it would cut about 3,000 jobs within its medical devices unit over the next two years, or about 4 to 6 percent of the struggling division’s global workforce, to generate annual cost savings of up to $1 billion and focus on more innovative products. The job cuts relate to […]

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Two Indian states halt sales of Roche’s Avastin drug

Two Indian states have put sales of Swiss drugmaker Roche’s blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat.   Avastin is a cancer drug but is often used by doctors to treat vision […]

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Ad Watchdog Calls Out Broadcast Networks for Airing Deceptive Ads

MADISON, Conn., Jan. 19, 2016 /PRNewswire-USNewswire/ — Consumer advocacy organization, truthinadvertising.org (TINA.org), has put major broadcast networks on notice regarding deceptive advertising. The ad watchdog alerted ABC, NBC, Turner Broadcasting (CNN & HLN), Fox Broadcasting, and The Weather Channel, to the airing of deceptive ads for Prevagen, an alleged brain supplement purported to be clinically proven […]

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EMD Serono Takes on Exclusive Promotion of Rebif® (interferon beta-1a) in the US

ROCKLAND, Mass., Jan. 19, 2016 /PRNewswire/ — EMD Serono, the biopharma business of Merck KGaA, Darmstadt, Germany today announced its continued commitment to serving the multiple sclerosis (MS) patient, medical and advocacy communities after taking on the sole rights to Rebif® (interferon beta-1a) in the United States as of January 1. Rebif, the number one prescribed […]

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Survey Says: 2015 U.S. Trends in Aggregate Spend, Disclosure and Transparency

What are key trends in the transparency compliance landscape?

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Penn Dental Medicine, CHOP Team Show HIV/AIDS Drugs Interfere with Brain’s ‘Insulation’

PHILADELPHIA, Jan. 18 2016 /PRNewswire/ — Antiretroviral therapies (ART) have enabled people with HIV/AIDS to live much longer lives, essentially transforming the disease into a chronic condition. Yet concerns for these patients remain. Up to half of people with HIV on these drug regimens have some sort of cognitive impairment, such as memory loss or problems […]

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iCo Therapeutics Terminates Employees in Radical Restructuring Move

VANCOUVER – iCo Therapeutics Inc. has undertaken a radical strategic reorganization that includes the termination of all employees in order to preserve cash resources while attempting to continue developing its experimental Oral Amphotericin B for the treatment of infectious diseases.   The reorganization comes about a year after the Phase II failure of iCo-007 injectable […]

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French drug trial volunteer dies: hospital

A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week. In total, 90 people took part in the trial of the […]

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Samsung Bioepis’ Enbrel drug copy gets EU approval

Samsung Bioepis Co Ltd said on Sunday it had received European Commission approval for its copy of the blockbuster biotech arthritis drug Enbrel. The drug, known scientifically as etanercept, will be sold in Europe by U.S. biotechnology group Biogen and rolled out gradually across all 28 European Union member states as well as Norway, Iceland […]

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Eleven Bio’s eye drug fails another late-stage study

Eleven Biotherapeutics Inc said its lead eye drug failed in a late-stage trial in treating patients with severe allergic conjunctivitis, sending its shares down 36 percent in after-market trading. The drug, codenamed EBI-005, failed to show statistically significant difference in treating ocular itching, compared with the vehicle arm, the company said on Friday. Eleven Bio […]

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Lessons from Latham & Watkins’ Representation of Pacira

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn?

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JANUARY 17th IS “DITCH YOUR NEW YEAR’S RESOLUTIONS DAY” — AVOID THE DITCH WITH STICK MOBILE APP

GSW has unveiled a new, free mobile app designed to help users “stick” to their New Year’s resolutions once and for all.

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Novartis receives two new FDA approvals for Cosentyx® (secukinumab) to treat patients with ankylosing spondylitis and psoriatic arthritis

EAST HANOVER, N.J., Jan. 15, 2016 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for two new indications – the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect […]

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Major drugmakers push back in U.S. price debate

With a backlash brewing over the price of medicines in the United States, drugmakers are pushing back with a new message: Most people don’t pay retail.    Top executives from Eli Lilly and Co (LLY.N), Merck & Co (MRK.N) and Biogen Inc (BIIB.O) said in interviews with Reuters this week that the media focus on retail, […]

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U.S. patent office rules against Amgen Humira challenge

U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira, a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine. In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that the […]

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