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

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

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

Bayer CEO lays out departure plans

Even pharmaceutical executives grapple with work-life balance....Marijn Dekkers is planning to leave his chief executive officer position at Bayer by December 2016. 

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

Valeant and Pershing Square initiate hostile takeover of Allergan

After increasing the offer by about 20%, the next move is to go straight to the shareholders.

By Nicole Gray • June 2, 2014

ASCO takes long look at clinically meaningful outcomes for patients

Increasingly, payers and clinicians are focusing on CMOS to drive decision-making about patient care. 

By Nicole Gray • June 2, 2014

At ASCO conference, doctors mull new models for payment

Thought leaders at the American Society of Clinical Oncology conference are proposing methods to replace fee-for-service payments---a model they consider unsustainable. 

By Nicole Gray • June 2, 2014

Professor calls for more stringent guidelines to reduce adverse cardiovascular events

An editorial by Dr. Robert Blankenfield in the Journal of Cardiovascular Pharmacology and Theraputics cites evidence from large-scale trials in order to make the case. 

By Nicole Gray • June 2, 2014

Bayer and ar-GEN-X to collaborate on drug discovery

Development of antibody-based therapeutics is highly valued and has contributed significantly to treatment for cancer and autoimmune dieases. By collaborating, Bayer and ar-GEN-X are planning to advance those goals.

By Nicole Gray • June 2, 2014

ASCO looking at value, price to create cancer scorecard

With ASCO's annual meeting taking place in Chicago, the issue of the price of cancer drugs is front and center. The society's decision to factor cost into a new algorithm has been well received by payers and clinicians.

By Nicole Gray • June 2, 2014

Generic celecoxib approved in the US

Despite the black box warning on Celebrex (celecoxib), many patients find relief from arthritis and orthopedic pain with the drug. Recent FDA approval of generic celecoxib will now make that therapeutic relief less costly. 

By Nicole Gray • June 2, 2014

Innovative antidepressant developments depend on unlocking new targets

For the last 50 years, the treatment of depression with drugs has hinged mainly on targeting serotonin, dopamine or norepinephrine. There is still an unmet need for more treatment options, and the development pipeline does not seem promising for now. 

By Nicole Gray • May 30, 2014

Months after launch, Hepatitis C drug pricing debate remains

Everyone is discussing the price tag for Gilead's new hepatitis C treatment, while the company counters that using Sovaldi to cure hepatitis C will offset long-term disease-related costs.

By Nicole Gray • May 30, 2014

Novo Nordisk ready to venture into Germany with Tresiba for diabetes

Many pharma companies have found it difficult to eitehr launch into or stay in the German market because of tough pricing policies. After choosing not to launch Tresiba in Germany after EU approval, Novo Nordisk is rethinking their position and moving into the German market--which happens to be the largest pharma market in the EU.

By Nicole Gray • May 30, 2014

FDA allows first test into market to determine cause of kidney disease

Antibody-based testing will make it possible to determine whether a specific type of chronic kidney disease is autoimmune in nature. The implications have the potential to keep many patients off of the kidney transplant waiting list.

By Nicole Gray • May 30, 2014

Essentialis receives orphan drug designation for Prader-Willi syndrome treatment

Researchers are recruiting subjects for a clinical trial that may confirm a breakthrough treatment for this orphan disease.

By Nicole Gray • May 30, 2014

FDA accepts NDA from Mallinckrodt for combo pain medication

The NDA has been issued for Xartemis, a new oxycodone/acetaminophen formulation for the treatment of moderate to moderately severe pain. 

By Nicole Gray • May 29, 2014

FDA approves Aloxi for treatment of chemotherapy-related nausea/vomiting in children

FDA has approved Esai's Aloxi for the treatment of CINV in children, including infants as young as one month old. This is the first time a treatment for CINV has been approved for children six months and under. The majority of cases of cancer in children occur in those one year and under.

By Nicole Gray • May 29, 2014

Pfizer expands OTC portfolio with launch of OTC Nexium 24HR

The launch marks the fourth therapeutic area in which the company has an OTC presence. Pfizer acquired rights to Nexium from AstraZeneca in 2012.

By Nicole Gray • May 29, 2014

BMS dives into the immunooncology fray with CytomX collaboration

Other companies, including Merck, AstraZeneca and Pfizer are also heavily involved in immunooncology. Data highlights from this research will be reported at ASCO.

By Nicole Gray • May 28, 2014