Theorem Clinical Research

Bristol-Myers Squibb

FDA expands approved use of Opdivo to treat lung cancer

Thursday, March 5, 2015 01:42 PM

The FDA has expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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Quest Diagnostics

Bristol-Myers Squibb, Bavarian Nordic ink agreement for PROSTVAC

Wednesday, March 4, 2015 01:06 PM

Bristol-Myers Squibb has signed an exclusive option to license and commercialize PROSTVAC, Bavarian Nordic's investigational phase III prostate-specific antigen (PSA)-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

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Bristol-Myers Squibb to acquire Flexus Biosciences

Monday, February 23, 2015 01:02 PM

Bristol-Myers Squibb has signed a definitive agreement to acquire all of the outstanding capital stock of Flexus Biosciences, a San Carlos, Calif.-based, privately held biotech focused on the discovery and development of novel anti-cancer therapeutics. The transaction has a potential total consideration of $1.25 billion, including $800 million upfront and development milestones that, upon achievement, could total up to $450 million. The transaction has been approved by the boards of directors of both companies and by the stockholders of Flexus.

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Rigel, Bristol-Myers Squibb ink R&D collaboration

Monday, February 23, 2015 01:01 PM

Rigel Pharmaceuticals and Bristol-Myers Squibb have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. T

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FDA approves record 41 new drugs in 2014, over 40% for rare diseases

Friday, January 16, 2015 02:52 PM

Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.

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Eli Lilly inks agreements with Merck, Bristol-Myers Squibb

Wednesday, January 14, 2015 12:21 PM

Eli Lilly has formed two separate collaboration agreements. The first agreement with Merck is an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials. The second, with Bristol-Myers Squibb, is a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of BMS' immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299).

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Ono Pharmaceutical, Bristol-Myers Squibb, Kyowa Hakko Kirin partner

Thursday, December 11, 2014 11:56 AM

Bristol-Myers Squibb and Japan-based companies Ono Pharmaceutical and Kyowa Hakko Kirin have entered into a clinical trial collaboration agreement to conduct a phase I combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody. The study, which will be conducted in Japan, will focus on evaluating the safety, tolerability and anti-tumor activity of combining Opdivo and mogamulizumab as a potential treatment option for patients with advanced or metastatic solid tumors.

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Otsuka to acquire Avanir for $3.5 billion

Tuesday, December 2, 2014 11:32 AM

Tokyo-based Otsuka Pharmaceutical will acquire Avanir Pharmaceuticals of Aliso Viejo, Calif., for $17 per share in cash, for a total value of approximately $3.5 billion.

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Global oncologists share insights into cancer immunology

Monday, November 24, 2014 08:00 AM

Cancer immunotherapy has become one of the hottest fields of clinical research in decades.

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Lexicon expands management

Thursday, November 6, 2014 03:13 PM

Lexicon Pharmaceuticals has announced management additions directed toward the completion of phase III development and commercial preparations for telotristat etiprate in carcinoid syndrome and preparation for phase III initiation and commercial readiness for sotagliflozin (LX4211) in type 1 diabetes.

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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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