New statins being developed to reduce side effects

The fact that using statins to significantly decrease the risk of CVD can increase the risk of diabetes is counterintuitive, but it is real.

By Nicole Gray • June 12, 2014

FDA delays review date for Orexigen's obesity drug

With almost 10,000 study subjects, Orexigen is responding to the federal agency's request for rigorous evidence to support their resubmitted NDA.

By Nicole Gray • June 12, 2014

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Researchers uncover protein that drives resistance to cancer treatment

A drug that has been approved for the treatment of myelogenous leukemia may help block resistance in Tarceva-treated lung cancer patients and extend lifespan.

By Nicole Gray • June 12, 2014

New Italian law allowing reimbursement for off-label prescribing causes concern

Opponents are concerned the law raises significant safety issues.

By Nicole Gray • June 12, 2014

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In a letter, the physicians question the draft guidance, which could add millions of people to the number taking the cholesterol treatment.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

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

Pharma leaders at Biovision discuss high costs of innovation

Executives from Sanofi and Johnson & Johnson discussed the underlying reasons that the cost of drug development, and by extension drug prices, seem high.

By Nicole Gray • June 10, 2014

GelStat gets medical marijuana foothold with Mastix Medica acquisition

The acquisition will bolster Gelstat's weight-loss chewing gum product line and allow the company to move into the high CBD/low THC market.

By Nicole Gray • June 10, 2014

South-Korea based Cho-A Pharma partners with Manchester United

Given the soccer team's fan base throughout Korea and Vietnam, this partnership represents a path to increase interest in Cho-A Pharm's nutritional and OTC products. 

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

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

GSK to pay $105 million to settle suit over illegal marketing claims

As part of the settlement, the company has pledged to take a series of steps designed to prevent future violations.

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

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