Small companies may be key to big advances in malaria treatment

Malaria remains a major killer worldwide, and treatments quickly become ineffective because of resistance. On an industry level, smaller firms are taking on that challenge.

By Nicole Gray • June 13, 2014

Protein Sciences boosts influenza vaccine availability, distribution

In response to healthcare professionals who want access to Flublok ahead of the 2014-15 flu season, the company will make its recombinant vaccine available as early as September. 

By Nicole Gray • June 13, 2014

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

X-Chem, Pfizer team up on orphan drug development

The collaboration pairs two companies that are powerful in different ways.

By Nicole Gray • June 13, 2014

Critics slam European Medicines Agency on transparency issues

BMJ, the Cochrane Collaboration and the AllTrials campaign are among several groups that have accused the EMA of trampling on the rights of researchers and the public.

By Nicole Gray • June 13, 2014

Lilly's Cyramza fails in phase III liver cancer trials, but sees a way forward

Although the drug failed to show statistical results for survival advantage in patients with advanced liver cancer, there were some meaningful results.

By Nicole Gray • June 13, 2014

AstraZeneca breathes new life into its respiratory portfolio

The company has acquired rights to a drug developed by Synairgen and is reporting positive phase II results on its psoriatric arthritis drug.

By Nicole Gray • June 13, 2014

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

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

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

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