Industry News

Additions/Deletions for Prescription and OTC Drug Product Lists

FDA News - Fri, 2017-02-17 14:36
The list has been updated through November 2016.
Categories: Industry News

Becton, Dickinson and Company initiates industry alliance to combat rising opioid crisis

Centerwatch - Fri, 2017-02-17 09:59

Becton, Dickinson and Company (BD), a global medical technology company, has announced a new alliance dedicated to help address the rising opioid crisis in acute care settings. Comprised of top health systems and industry leaders, the alliance is a new initiative stemming from the recently launched BD Institute for Medication Management Excellence. The industry alliance will expand […]

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Categories: Industry News

CRISPR, Intellia, Caribou and ERS Genomics provide update on CRISPR/Cas9 U.S. patent

Centerwatch - Fri, 2017-02-17 09:54

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics provided an update on the Patent Trial & Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) decision on the motions filed by the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively, UC), on one hand, and the Broad Institute, […]

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Categories: Industry News

ProTrials Research expands research capabilities to include data management services

Centerwatch - Fri, 2017-02-17 09:35

CRO ProTrials Research, announced the expansion of its suite of services to include data management. In response to the evolving needs of their clients, ProTrials has broadened their offering, adding both data management services and a variety of electronic data capture (EDC) platforms, which allow for a customized approach to meet individual client needs. “At […]

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Categories: Industry News

FDA expands approval of Spiriva Respimat inhalation spray for pediatric asthma

Centerwatch - Fri, 2017-02-17 08:44

Boehringer Ingelheim Pharmaceuticals has announced that the FDA approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms. The FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and the FDA also granted pediatric […]

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Categories: Industry News

Newly Added Guidance Documents

FDA News - Fri, 2017-02-17 08:20
Categories: Industry News

QuintilesIMS named to FORTUNE’s 2017 list of “World’s Most Admired Companies”

Centerwatch - Thu, 2017-02-16 11:02

QuintilesIMS has once again been named to FORTUNE magazine’s “World’s Most Admired Companies” list. The 2017 listing marks the third consecutive year the company has been recognized by FORTUNE as a most admired company. QuintilesIMS received the distinction in FORTUNE’s Healthcare: Pharmacy and Other Services category with high marks in quality of management, value as a long-term investment, effectiveness in […]

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Categories: Industry News

Luxcel Biosciences , Axiogenesis, BMG LABTECH to develop cell metabolism analysis platform

Centerwatch - Thu, 2017-02-16 11:00

Three European technology SME’s, together with two research institutions, Oxford University and Imperial College London, have been awarded €2.5 million funding from the European commission under the H2020 Fast Track to Innovation (FTI) pilot, to develop and launch a cell metabolism analysis platform that is predicted to be part of routine in vitro cell biology and drug development.  The […]

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Categories: Industry News

Integra LifeSciences to acquire the Codman Neurosurgery Business for $1.04B in Cash

Centerwatch - Thu, 2017-02-16 10:55

Integra LifeSciences, a global provider of medical technology, has made a binding offer to acquire the Johnson & Johnson Codman Neurosurgery business for a price of $1.045 billion in cash. Codman Neurosurgery offers a portfolio of devices focused on advanced hydrocephalus, neuro-critical care and operative neurosurgery. If the binding offer is accepted, upon closing, Integra […]

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Categories: Industry News

FDA approves Tirosint-SOL for hypothyroidism and TSH suppression

Centerwatch - Thu, 2017-02-16 10:50

IBSA announced that the FDA has approved Tirosint-SOL (levothyroxine sodium oral solution), a liquid form of levothyroxine for the following two conditions: hypothyroidism and TSH suppression in the management of some thyroid cancers. Levothyroxine, the synthetic form of the thyroid hormone thyroxine, is used in all cases of thyroid deficiency. It is on the list […]

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Categories: Industry News

Ardelyx announces successful phase III trial of tenapanor for hyperphosphatemia

Centerwatch - Thu, 2017-02-16 10:42

Ardelyx, a clinical-stage company focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases, has reported that the phase III clinical trial evaluating the efficacy and safety of tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis met its primary endpoint and was generally […]

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Categories: Industry News

Gilead releases Genvoya HIV-1 data

Centerwatch - Thu, 2017-02-16 10:36

Gilead Sciences announced 144-week data from two phase III studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg) for the treatment of HIV-1 infection in treatment-naïve adults. Through week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild (elvitegravir […]

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Categories: Industry News

PRA Health Sciences, Takeda expand partnership to Japan, form joint venture

Centerwatch - Thu, 2017-02-16 10:25

PRA Health Sciences and Takeda Pharmaceutical have agreed to a new partnership to expand their global relationship, initially disclosed in September 2016, to include Japan. Takeda and PRA will establish a joint venture, each holding 50% of the share respectively, to provide clinical trial delivery and pharmacovigilance services as a strategic partner of Takeda in […]

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Categories: Industry News

Clinerion and ASUS Life partner in Taiwan

Centerwatch - Thu, 2017-02-16 10:21

Clinerion and ASUS Life signed a strategic alliance. Clinerion and ASUS Life, together with the Show Chwan Healthcare System, will deliver innovative services for the efficient running of clinical trials, clinical patient recruitment, market access and real-world evidence in Taiwan. ASUS Life is a unique joint venture which combines the power and reliability of ASUS’ […]

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Categories: Industry News

BIO adds Gary Andres as senior executive vice president of Public Affairs

Centerwatch - Thu, 2017-02-16 09:00

The Biotechnology Innovation Organization (BIO) has announced that long-time Majority Staff Director of the House Energy and Commerce Committee Dr. Gary Andres will be joining BIO as senior executive vice president of Public Affairs. “I am delighted to have Gary join the BIO team. He brings a wealth of experiences and skills to this critical […]

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Categories: Industry News

Certara Vice President Piet van der Graaf appointed F1000Prime faculty member

Centerwatch - Thu, 2017-02-16 08:56

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that Professor Piet van der Graaf, PharmD, Ph.D., its vice president of quantitative systems pharmacology, has been appointed an F1000Prime faculty member. In this new role, Professor van der Graaf will contribute article reviews and […]

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Categories: Industry News

ERT named finalist for PACT Technology Company of the Year award

Centerwatch - Thu, 2017-02-16 08:40

ERT, a global data and technology company that minimizes risk and uncertainty in clinical trials, has been named a finalist for the Philadelphia Alliance for Capital and Technologies (PACT) Technology Company of the Year award. ERT is one of only three companies nominated to receive this recognition. Every year, the PACT Enterprise Awards Program recognizes […]

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Categories: Industry News

Boehringer Ingelheim, Weill Cornell Medicine partner on next generation COPD treatments

Centerwatch - Wed, 2017-02-15 13:03

Boehringer Ingelheim has announced a collaboration with Weill Cornell Medicine to identify new treatment approaches for chronic obstructive pulmonary disease (COPD) in order to develop novel treatments that could possibly halt or even reverse the progression of the disease process. The new, three-year collaboration combines Weill Cornell Medicine’s Department of Genetic Medicine’s unique understanding of […]

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Categories: Industry News

RCSI, Almac partner on target therapy-resistant cancer tumors

Centerwatch - Wed, 2017-02-15 13:01

RCSI (Royal College of Surgeons in Ireland) and Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, have announced a major research collaboration that aims to gain a new understanding of how to target tumor cells that are resistant to cancer therapies and cause cancer to spread […]

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Categories: Industry News

Incyte, Agenus amend collaboration agreement

Centerwatch - Wed, 2017-02-15 12:55

Incyte and Agenus have amended the License, Development and Commercialization Agreement that was originally entered into January 9, 2015. The amended agreement converts the ongoing GITR and OX40 antibody programs from co-funded development and profit-sharing arrangements to royalty-bearing programs, with Incyte now responsible for funding and conducting global development and commercialization. Should candidates from either […]

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Categories: Industry News
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