NICE approves coverage of Genzyme's Lemtrada for MS

In a reversal from last year, NICE has approved coverage of Genzyme's Lemtrada (alemtuzumab) for the treatment of multiple sclerosis. After receiving additional cost-effectiveness data as requested, the company decided that the treatment is worth covering. 

By Nicole Gray • May 28, 2014

GlaxoSmithKline focus of UK fraud inquiry

News of this investigation comes shortly after initiation of an investigation of the company in China for alleged illegal activities related to bribing doctors.

By Nicole Gray • May 28, 2014

Explore the Trendline➔

Commercialization

New drugs for obesity are becoming blockbusters, while Trump administration pressure is reshaping pharma marketing strategies ahead of looming patent cliffs.

By BioPharma Dive staff

The end of an era: E-cigarette manufacturers face regulatory oversight

New regulations introduced by FDA in April promise to be a game-changer for this rapidly growing industry.

By Nicole Gray • May 28, 2014

Top analyst ranks 22 pharma firms based on R&D prowess

Bristol-Myers Squibb tops the list, compiled by analyst Richard Evans.

By Nicole Gray • May 27, 2014

FDA approves Vectibix for colorectal cancer

The drug will be used in combination therapy for treatment of a specific type of the cancer.

By Nicole Gray • May 27, 2014

CMHP says no to Avastin for brain cancer

Although Avastin (bevacizumab) is widely used on the U.S. to treat various types of cancer, including glioblastoma, European advisors have recommended that EMA not approve it for treatment of glioblastoma.

By Nicole Gray • May 27, 2014

AstraZeneca rethinks its drug R&D process

The cost of drug development is much higher than often cited, which means that research and development failure is even more costly. What factors influence success, and how are companies, like AstraZeneca attempting to improve research and development productivity?

By Nicole Gray • May 27, 2014

Inhibikase receives orphan drug designation for PML treatment

Imatanib is used to treat various cancers, and has been tested extensively by Inhibikase Therapeutics for the treatment of PML, a potentially fatal side effect associated with immunomodulatory therapy for patients with autoimmune diseases. It represents the only treament option for PML and has been granted orphan drug designation by FDA. 

By Nicole Gray • May 23, 2014

Takeda's Entyvio approved by FDA for inflammatory bowel disease

Although FDA approved the drug for second-line treatment of IBD (moderate-to-severe ulcerative colitis and Crohn's disease), the drug's targeted action in the gastrointestinal tract may make it appealing to patients who experience extreme side effects with certain first-line treatments such as TNF blockers.

By Nicole Gray • May 22, 2014

Insurers push back against cost of new Hep C treatment

Gilead's Sovaldi is a breakthrough for treating HCV, but payers are rebelling against the high price tag. 

By Nicole Gray • May 22, 2014

FDA grants orphan drug status to AbbVie's Humira

AbbVie's Humira has been granted orphan drug status for the treatment of uveitis. It is currently a $2.6 billion drug used to treat various inflammatory conditions.

By Nicole Gray • May 21, 2014

Novartis will market Fovista for wet AMD outside of the U.S.

The company is partnering with Ophthotech Corp. in a deal worth $1 billion.

By Nicole Gray • May 21, 2014

Sanofi kicks off a meningitis awareness campaign as Menactra sales fall

Sanofi has launched an awareness campaign featuring Olympic swim champion, Dana Torres. The goal of the campaign is to raise awareness among mothers and adolescents about the dangers of meningococcal meningitis, and the need to have not only one, but two, shots of Menactra as a preventive measure against the deadly virus. 

By Nicole Gray • May 19, 2014

Teva delays introduction of generic copaxone while promoting new formulation

As it faces patent expiration of Copaxone, Teva has launched a new, more convenient formulation and increased its patient support program.

By Nicole Gray • May 19, 2014

Biogen Idec pledges 1 billion units of clotting factor to developing countries

The pledge for patients in the developing world comes as the company moves into the hemophilia market with recombinant clotting factor therapies for the treatment of hemophilia A and B. 

By Nicole Gray • May 16, 2014