After shutting down cancer drug, Clovis now facing government investigations

Earlier this month, Clovis said it expected rociletinib to be rejected by the FDA, prompting the company to terminate clinical trials. 

By Ned Pagliarulo • May 12, 2016

NIH-funded malaria vaccine shows safety, efficacy in early trial

While GlaxoSmithKline already has a vaccine on the market, protection against malaria is still a huge unmet medical need.

By Nicole Gray • May 12, 2016

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Pfizer planning first triple-drug immuno-oncology study

Expected to begin sometime next year, the early-stage trial will combine the checkpoint inhibitor avelumab with two other drugs. 

By Nicole Gray • May 11, 2016

NewLink Genetics writes off pancreatic cancer immunotherapy after phase 3 failure

Patients treated with the vaccine had three months shorter overall survival times than those in the control group.

By Nicole Gray • May 10, 2016

Wave Life Sciences touts more effective Duchenne drug

Just last week, Pfizer and Wave agreed to a potentially $911 million deal for advancing development of several genetic therapies for metabolic diseases.

By Nicole Gray • May 10, 2016

ICER questions high prices of multiple myeloma meds

A number of new drugs have come onto the market recently, including Johnson & Johnson's Darzalex and Amgen's Kyprolis. 

By Nicole Gray • May 9, 2016

Clovis shuts down cancer drug, will reduce staff by 35%

Last month, an FDA panel had overwhelmingly voted against recommending approval for Clovis' rociletinib. 

By Nicole Gray • May 6, 2016

New Zealand pushes back on coverage for Merck's Keytruda

Adding to Merck's challenges in the country, the cost agency Pharmac has proposed funding for rival Bristol-Myers' Opdivo. 

By Nicole Gray • May 5, 2016

Bayer's Stivarga shows efficacy in liver cancer

The phase 3 data could help expand the drug's indication to include hepatocellular carcinoma. 

By Nicole Gray • May 5, 2016

Clinical trials and the growing importance of informatics

Dimitris Agrafiotis, PhD, Vice President and Chief Data Officer at Covance, discusses his insights on how the applied use of informatics will transform the pharmaceutical industry by improving clinical trial performance. 

May 3, 2016

As new drugs take hold, Lilly ramps up R&D spend

Lilly spent nearly a quarter of its revenue on R&D in 2015 - the third highest figure in the industry. 

By Ned Pagliarulo • April 28, 2016

Major study shows no increased suicide risk from smoking cessation drugs

Pfizer's Chantix and GlaxoSmithKline's Zyban have carried black-box warnings for neuropsychiatric side effects. 

By Nicole Gray • April 25, 2016

Despite efforts of advocates, FDA panel votes against Sarepta's Duchenne drug

Many in the patient community had pegged their hopes on Sarepta's eteplirsen, after two other drugs for the condition were turned down by the FDA.

By Ned Pagliarulo • April 25, 2016

Proton pump inhibitors linked to serious kidney diseases in study

The study compared PPIs like AstraZeneca's Nexium to drugs known as H2 blockers. 

By Nicole Gray • April 25, 2016

Inside the development of Venclexta, AbbVie's new leukemia drug

Venclexta should help bolster AbbVie's oncology portfolio as it works to offset the threat of generic competition to its best-seller Humira. 

By Ned Pagliarulo • April 22, 2016

Bluebird Bio gene therapy sees encouraging early results in treatment of rare brain disease

The MA-based biotech hopes to prove its therapy is more effective than allogeneic stem-cell transplants. 

By Ned Pagliarulo • April 21, 2016

Armed with genetic data, UK biotech revisits abandoned Roche cholesterol drug

Several other large pharma companies have dropped similar drugs after studies failed to prove any cardiovascular benefits. 

By Nicole Gray • April 20, 2016

NIH suspends work at two facilities, including T-cell research

One of the facilities, a National Cancer Institute lab, was manufacturing T-cell therapies in collaboration with Kite Pharma. 

By Ned Pagliarulo • April 19, 2016

Bristol-Myers' Opdivo shows promise in head, neck cancers

The new data extend a string of positive results for the immunotherapy.

By Ned Pagliarulo • April 19, 2016

With new studies, Boehringer and Lilly to pit diabetes drug against heart failure

Jardiance is the first diabetes treatment proven to reduce the risk of cardiovascular disease. 

By Ned Pagliarulo • April 19, 2016

AbbVie's experimental hep c combo proves highly effective across genotypes

The combination treatment would also offer improved convenience as a once-daily regimen, compared to the company's multipill Viekira Pak. 

By Nicole Gray • April 18, 2016

EASL 2016: Merck's 'no patient left behind' approach to hepatitis C

The company's hep c med Zepatier faces an uphill battle as it competes against Gilead's dominant treatments, leading Merck to look at typically untreated patient populations. 

By Nicole Gray • April 18, 2016

Bristol-Myers' Opdivo gets boost from long-term survival data

More than a third of patients with advanced melanoma who received Opdivo survived past five years. 

By Ned Pagliarulo • April 18, 2016

Review of NCI facilities halts patient enrollment in Kite T-cell studies

Separately, the biotech announced three patients in an early stage trial of one of its T-cell treatments had continued to show durable responses against solid tumors. 

By Ned Pagliarulo • April 17, 2016

Most cancer drug labels don't include patient experiences: study

As a comparison, researchers found nearly 25% of other drugs included patient-reported outcomes information. 

By Nicole Gray • April 15, 2016