Metzger emphasized that early companion diagnostic decisions are critical and at the same time challenging to adapt to an ongoing drug development program

Although the medical need has never been greater – only two new antibiotics gained approval between 2008 and 2010, while resistance continues to spread inexorably – regulatory uncertainties, particularly in the U.S., had become a major obstacle to new drug development

According to the Pharmaceutical Research and Manufacturers of America (PhRMA), last year biopharmaceutical research companies had approximately 460 medicines targeting rare diseases either in clinical trials or awaiting FDA review. (See BioWorld Insight, Oct 15, 2012.) Interest in drug development targeting orphan disease indications continues to heat up

But is early stage discovery and drug development most efficiently handled by pharmas and academic institutions, which are positioned more for late-stage development and scientific exploration, respectively...Atul Saran, senior vice president of corporate development and ventures at MedImmune, part of London-based AstraZeneca plc, who spoke on a Monday panel on biotech partnering with academia, said the pharma/academia model doesn't threaten the role of biotechs in drug development

Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461 , a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (p

CHICAGO – Improved technologies for molecular imaging agents and wider use of biomarkers may be moving the drug development industry away from the blockbuster model – and toward a niche market strategy where smaller patient populations are treated by more effective, targeted drugs – but that doesn't mean treating disease, particularly cancer, will get any less complex

CHICAGO – Big pharmas and biotechs have been flirting with the concept of open innovation – collaborative sharing of data to speed up the drug development process – for years

drug development deal in inflammatory skin

Cerecor has been busy with other business and drug development activities

Although the medical need has never been greater – only two new antibiotics gained approval between 2008 and 2010, while resistance continues to spread inexorably – regulatory uncertainties, particularly in the U.S., had become a major obstacle to new drug development

The news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned

And the prevention route is not altogether foreign to oncology drug development, since tamoxifen, the selective estrogen receptor modulator, has been granted FDA clearance not only for the treatment of breast cancer, but also to reduce the risk of the disease

Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461, a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (p

MedDay raised $10.5 million to progress three drug development programs including multiple sclerosis

Synergy Pharmaceuticals Inc., of New York, will boost its development of plecanatide, a candidate for gastrointestinal disorders, with an offering of $90 million of common stock. Plecanatide has the potential to treat disorders like chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C). If underwriters exercise an overallotment option in full, the size of the offering would be $103.5 million in aggregate value. Credit Suisse, Citigroup and Canaccord

MedDay raised €8 million (US$10.5 million) to take forward three drug development programs, two of which already have yielded promising data in small-scale human trials, in progressive forms of multiple sclerosis (MS) and in treatment-resistant forms of psychotic illness...For Sofinnova, it represents the fund's first drug development deal in France in about six years

MedDay raised €8 million (US$10.5 million) to take forward three drug development programs, two of which already have yielded promising data in small-scale human trials, in progressive forms of multiple sclerosis (MS) and in treatment-resistant forms of psychotic illness...For Sofinnova, it represents the fund's first drug development deal in France in about six years

Isis recently received a $7.5 million milestone payment from GSK related to the start of a Phase II/III study of ISIS-TTRRx, an antisense drug in development for transthyretin amyloidosis

The trilogy of a mechanism of action, a clinical improvement and a biosignature registered in the lab and at the bedside provides us and our partners as much comfort as anyone derives from first-in-class drug development programs," Miller said.