British agency, doctors spar over aggressive statin guidance

In a letter, the physicians question the draft guidance, which could add millions of people to the number taking the cholesterol treatment.

By Nicole Gray • June 12, 2014

Dendreon faces large debt payment as CEO departs

For the company, the combination of low Provenge sales and high debt has been challenging, leading to speculation about its future.

By Nicole Gray • June 11, 2014

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

MS advocates fight back against NICE access policies

Once again, the British agency has rejected a multiple sclerosis drug, citing a high cost-to-utility ratio. MS advocates are fighting back.

By Nicole Gray • June 11, 2014

Edison Pharma gets another orphan drug designation for vatiquinone

Same molecule, different indication, additional orphan drug designation: That is the strategy that Edison Pharma is pursuing. 

By Nicole Gray • June 10, 2014

Teva wins expanded indication for Parkinson's drug

The approval of Azilect for one more treatment combination is a positive step forward for the company's position in the Parkinson's disease category.

By Nicole Gray • June 10, 2014

Momenta Pharma receives orphan drug status for novel pancreatic cancer drug

The advent of a new possible treatment option for pancreatic cancer has the potential to shift the standard of care and increase the extremely low five-year survival rate for patients.

By Nicole Gray • June 10, 2014

Merck bets big on hepatitis C market with Idenix purchase

The products being developed by the two firms are different types of drugs, with different mechanisms of action, but they all are oral and interferon-free.

By Nicole Gray • June 10, 2014

Pfenex uses R&D prowess to develop AMD alternative to Lucentis

The company has brought its AMD candidate into clinical trials in just two years---and based on its high-throughput screening technology, there are many more candidate-concepts ready to be hatched.

By Nicole Gray • June 9, 2014

Survey finds lack of science and tech talent in UK

U,K.-based Hays recruits for the pharmaceutical industry and cites a lack of well-qualified talent, especially statisticians and scientists.

By Nicole Gray • June 9, 2014

Pradaxa faces challenges in U.S., moves forward in EU with approval

Boehringer Ingelheim is developing a strategy to reverse excess bleeding in Pradaxa-treated patients . The company continues to pursue regulatory milestones. 

By Nicole Gray • June 9, 2014

AstraZeneca ties its future to a promising drug pipeline

The firm predicts a nearly $20 billion increase in revenues by 2023, as it continues to develop small-molecule and biologics-based therapies for the treatment of various cancers.

By Nicole Gray • June 8, 2014

FDA approves Biogen Idea's Eloctate for Hemophilia A

Patients with hemophilia are benefiting from the availability of better treatment options -- including Eloctate --  that require fewer injections than previous treatments.

By Nicole Gray • June 7, 2014

GW Pharma's orphan drug gains fast-track status

The drug, Epidiolex, is used to treat Dravet syndrome, a rare form of childhood epilepsy.

By Nicole Gray • June 6, 2014

Larger trial helps make the case for adjuvant chemo in bladder cancer patients

Getting reliable trial data from large-scale trials has been difficult for researchers studying bladder cancer. A new European trial is offering a breakthrough.

By Nicole Gray • June 6, 2014

Major advisory panel redefines multiple sclerosis

For almost 20 years, researchers and clinicians have relied on an understanding of multiple sclerosis outlined in 1996. Using a treasure trove of new data and technology, the International Advisory Committee on Clinical Trials is refining that paradigm. 

By Nicole Gray • June 5, 2014

Zytiga shows benefit in men with non-metastatic prostate cancer

Men with non-metastatic cancer may benefit from treatments for more aggressive cancer, based on a series of studies. The latest from JNJ highlights Zytiga's efficacy in reducing PSA levels significantly. 

By Nicole Gray • June 5, 2014

As oral hepatitis C market grows, will AbbVie use a radical pricing strategy?

AbbVie is waiting for approvals from US and EU regulators for its new triple-drug, fixed-dose, oral hepatitis C drug. It's not as easy to take as Gilead's Sovaldi, but experts predict that AbbVie's pricing may be easier to swallow.

By Nicole Gray • June 5, 2014

Frontage Labs to expand key facilities

The company will expand manufacturing, research and office-based facilities. Its role helping pharmaceutical companies advance research and development efforts is in high demand---and growing.

By Nicole Gray • June 5, 2014

BMS and Indian CRO extend drug discovery contract

Eight years of collaboration between the two companies has produced six drug candidates. 

By Nicole Gray • June 5, 2014

Eli Lilly opens clinical data to medical researchers

The company joins a growing number of peers that are making their clinical trial data available to researchers via secured, Web-based portals.

By Nicole Gray • June 5, 2014

Bayer, Orion partnering to develop prostate cancer drug

Bayer is trying to build a strong portfolio in this therapeutic area--and is off to a good start with Xofigo, which was approved last year. 

By Nicole Gray • June 5, 2014

UK companies want quicker EMA approval for certain drugs

Pharma companies in the United Kingdom like the European Medicines Association's plan to bring certain drugs to market more quickly. There's already a queue and admission of a larger workload for regulating agencies.

By Nicole Gray • June 4, 2014

Companies partner to develop immunology-based cancer therapies

GlaxoSmithKline's collaboration with Adaptimmune is part of a larger trend in which large companies partner with companies specializing in treatments that leverage immune function to treat cancer. 

By Nicole Gray • June 4, 2014

Boehringer's Giotrif improves overall survival in clinical trials

Once again, research has shown that the molecular make-up of a cancer -- in this case, lung cancer -- influences outcomes.

By Nicole Gray • June 4, 2014

GSK's combo breast cancer treatent fails in phase III

Although the trial in women with HER2-positive  breast cancer just failed, the data confirmed strong results for 4-year DFS for women treated with trastuzumab alone. 

By Nicole Gray • June 2, 2014