Theorem Clinical Research

Clinical Intelligence

Amgen initiates trial of Talimogene Laherparepvec and Merck's Keytruda

Thursday, December 11, 2014 01:46 PM

Amgen has initiated a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck's FDA approved, anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.

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Quest Diagnostics

Neurocrine Biosciences expands clinical pipeline

Thursday, December 11, 2014 01:12 PM

Neurocrine Biosciences has announced that NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist, has entered clinical trials for the treatment of classic congenital adrenal hyperplasia (CAH) a disease that affects approximately 20,000-30,000 people in the U.S. The company has successfully completed a pilot clinical trial in adults with classic CAH and is initiating an open-label, single ascending dose trial in approximately 15 adolescent females with classic CAH, the 1401 Study.

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FDA expands Gardasil 9 approval

Thursday, December 11, 2014 01:07 PM

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.

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FDA approves Blincyto (Blinatumomab) for leukemia

Thursday, December 4, 2014 02:20 PM

The FDA has granted approval of Amgen’s Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval.

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FDA issues final rule on changes to pregnancy and lactation labeling information

Thursday, December 4, 2014 02:03 PM

The FDA has published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

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First MS patients in the U.S. receive Genzyme’s Lemtrada following FDA approval

Thursday, December 4, 2014 01:43 PM

Genzyme, a Sanofi company, has announced that the first U.S. patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its Nov. 14 FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

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The CenterWatch Monthly, December 2014

Monday, December 1, 2014 01:45 PM

Growing adoption of feasibility review committees

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CytRx announces partial clinical hold affecting aldoxorubicin clinical trials

Monday, November 24, 2014 02:58 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has received notice from the FDA that its clinical trials for aldoxorubicin have been placed on partial clinical hold. All currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols, but no new patients can be enrolled until the clinical hold is lifted.

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HedgePath Pharmaceuticals files IND application

Monday, November 24, 2014 02:23 PM

HedgePath Pharmaceuticals, a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, has filed an IND application with the FDA.

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FDA approves hydrocodone product with abuse-deterrent properties

Monday, November 24, 2014 02:08 PM

The FDA has approved Purdue Pharma’s Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids—Evaluation and Labeling.

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AiCure
CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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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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