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Shire, Roche slug it out in hemophilia drug battle

Roche’s bid to take a chunk of the hemophilia drug market dominated by Shire took another blow with the Irish company winning a preliminary injunction.

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FDA panel to focus on safety of Novartis gene therapy drug

The U.S. Food and Drug Administration will ask a panel of advisors to focus on the safety of Novartis AG’s experimental gene therapy drug when it meets to review the product.

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FDA lifts hold on Concert Pharma’s hair loss study

The U.S. FDA lifted a clinical hold on a trial testing Concert Pharmaceuticals Inc.’s therapy for alopecia areata, a type of hair loss.

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Production Problems Lead Pacira to Cut Jobs in San Diego

Pacira Pharmaceuticals will discontinue manufacturing of its DepoCyt product due to “persistent technical issues.” In addition to shuttering the drug production, Pacira will also terminate employees associated with manufacturing of the drug.

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U.S. FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Sprycel in Children with Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.

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Cost-Cutting Continues as AstraZeneca Unloads U.S. HQ in $50 Million Deal

Pharma giant AstraZeneca sold its U.S. headquarters in Delaware for $50 million after it sat on the market for nearly a year, the News Journal of Wilmington reported.

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FDA approves new treatment for sickle cell disease

FDA approved Endari oral powder for patients 5 years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

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Georgia public health official to head U.S. CDC

The Trump administration named Georgia public health Commissioner Dr. Brenda Fitzgerald to lead the U.S. Centers for Disease Control and Prevention in Atlanta.

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UK Supreme Court rules in favor of Lilly’s patents

The UK Supreme Court ruled that generic drugmaker Actavis’ versions of the cancer drug Alimta directly infringe on certain Eli Lilly patents in Europe.

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IDMP & the Emperor’s new clothes

The fact that the European Medicines Agency again pushed back the deadline for ISO IDMP (Identification of Medicinal Products) compliance has not stopped the life sciences technology and services industry from promoting IDMP software and solutions.

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Alnylam and Sanofi Genzyme Initiate ATLAS Phase 3 Program with Investigational RNAi Therapeutic Fitusiran in Patients with Hemophilia A and B with or without Inhibitors

lnylam Pharmaceuticals Inc., the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced the initiation of the ATLAS Phase 3 clinical program for fitusiran.

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Capricor Falls as Johnson & Johnson Bails on Stem Cell Heart Med

Johnson & Johnson’s Janssen Biotech opted out of its licensing deal with Los Angeles-based Capricor Therapeutics for CAP-1002 (allogeneic cardiosphere-derived cells).

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Alexion is Under Investigation by the HHS Office of Inspector General

Shares of Connecticut-based Alexion Pharmaceuticals took a hit, falling about 5 percent after reports revealed the company is under investigation from the U.S. Department of Health and Human Services’ Office of the Inspector General.

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WHO warns of imminent spread of untreatable superbug gonorrhoea

At least three people worldwide are infected with totally untreatable “superbug” strains of gonorrhoea which they are likely to be spreading to others through sex, the World Health Organization (WHO) said.

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Intouch Solutions Promotes Peter Weissberg to Vice President of Market Access

Intouch Solutions announces the promotion of Peter Weissberg to vice president of market access.

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Robot wars: knee surgery marks new battleground for companies

The world’s top medical technology companies are turning to robots to help with complex knee surgery, promising quicker procedures and better results in operations that often leave patients dissatisfied.

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Fishawack Boosts Healthcare Marketing Capabilities as Carling Communications Joins the Group

The Fishawack Group of Companies – one of the largest independent medical communications organizations – acquired the Carling Group of Companies based in San Diego, including Carling Communications and MCME Global. Carling Communications is the first agency in the Fishawack Group to be focused entirely on healthcare marketing, while MCME Global specializes in medical education.

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Lilly and Purdue University Announce Strategic Research Collaboration

Eli Lilly and Company and Purdue University announced a strategic collaboration to conduct life science research. The five-year agreement, where Lilly will provide up to $52 million, marks Purdue’s largest strategic collaboration with a single company.

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Japan’s Konica Minolta Takes Out SoCal Diagnostics Firm Ambry Genetics in $1 Billion Deal

Tokyo-based Konica Minolta is buying Viejo, Calif.-based Ambry Genetics in a deal totaling $1 billion.

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Patient Deaths Prompt the FDA to Suspend Three of Merck & Co.’s Keytruda Trials

FDA placed a clinical hold on three trials studying Merck’s PD-1 inhibitor Keytruda in combination with products developed by Celgene following Merck’s initial reporting of several patient deaths.

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