New analysis boosts Harvoni as 'safest' next-gen hep C option

In a postmarketing-based analysis, Harvoni was found to have fewer side effects than Sovaldi and VieKira Pak.

By Nicole Gray • Dec. 10, 2015

New study: Chemical castration doubles risk of Alzheimer's disease

Approximately 500,000 men with prostate cancer in the U.S. are taking anti-androgen medication, also know as chemical-castration drugs.

By Nicole Gray • Dec. 9, 2015

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

Obama FDA nominee under the microscope as regulators review pivotal Xarelto trial he ran

It could potentially prove to be a hurdle to Dr. Robert Califf's confirmation as FDA commissioner. 

By Nicole Gray • Dec. 8, 2015

Laguna Pharma calls it quits after phase 3 CVD drug flop

It's been less than a year since Laguna, headed up by CEO Bob Baltera, raised $30 million in venture financing. 

By Nicole Gray • Dec. 8, 2015

ASH15: Early-stage Keytruda trial shows unprecedented response in advanced multiple myeloma

In a phase 1 trial, Keytruda-treated patients with advanced multiple myeloma had an overall response rate (ORR) of 76%. 

By Nicole Gray • Dec. 8, 2015

Lilly's next-gen insulin hopes hit a buzzsaw as firm ditches late-stage diabetes candidate

The peglispro program is being shut down over concerns about severe liver toxicities. 

By Nicole Gray • Dec. 7, 2015

Merck's Keytruda gets presidential lift as Jimmy Carter announces he's cancer-free

Speaking at a Sunday school class at Maranatha Baptist Church in Georgia, the former president said there were no longer signs of cancer in his brain.

By Nicole Gray • Dec. 7, 2015

ASH15: J&J/AbbVie's Imbruvica cuts CLL death risk; Bluebird/Celgene buoyed by NIH myeloma data

New clinical data shows promise in patients with the hardest-to-treat cases of multiple myeloma and chronic lymphocytic leukemia (CLL). 

By Nicole Gray • Dec. 7, 2015

ASH15: Bluebird tanks 35% on gene therapy data; Novartis preps 2017 filing for blood cancer CAR-T

Biopharma firms chasing next-generation blood disorder therapies presented some major data at the American Society of Hematology meeting over the weekend.

By Nicole Gray • Dec. 7, 2015

Inside the bold new fight for an HIV cure: An exclusive interview with amfAR CEO Kevin Robert Frost

Seven years ago, Frost faced calls for his resignation over his suggestion that an HIV cure was an attainable goal. This week, his group announced the establishment of a research institute which he compares to NASA and the Manhattan Project that is 100% focused on this precise mission.

By Nicole Gray • Dec. 4, 2015

UPDATE: FDA places complete hold on Zafgen obesity med trials after 2nd patient death

Zafgen shares have now plunged nearly 64% since Tuesday's closing price.

By Sy Mukherjee • Dec. 3, 2015

Could CRO revenues become a victim of the Pfizer-Allergan merger?

With a merged firm that will likely be looking to cut redundancies, companies such as Parexel, Icon, and Pharmaceutical Product Development could see declining revenues in the short term. 

By Nicole Gray • Nov. 30, 2015

UPDATE: BioMarin Duchenne drug appears destined for failure after brutal FDA meeting

FDA advisers didn't appear swayed by emotional testimony from patients and advocates during Tuesday's meeting.

By Nicole Gray • Nov. 25, 2015

Pricey hep C drugs found to be cost-effective in early disease and beyond

A new simulation proved early treatment of the disease can achieve significant, low-cost results, bolstering calls for earlier insurance coverage of treatments. 

By Nicole Gray • Nov. 24, 2015

Roche's immuno-oncology blockbuster hopeful shines in early melanoma trial

Atezolizumab is also already in late-stage development for bladder and lung cancers. 

By Nicole Gray • Nov. 24, 2015

How biopharma companies can thrive in the era of megamergers and shrinking budgets

We spoke with James Crowley at Accenture Life Sciences about what it takes to not only survive, but to shine, in a hyper-competitive market.

By Nicole Gray • Nov. 24, 2015

New data: Celldex brain cancer vaccine boosts long-term survival in advanced disease

The news sent shares of the company up 12% on Friday and up another 11% in early Monday trading.

By Nicole Gray • Nov. 23, 2015

Sandoz chases 2-for-2 record as US biosim pioneer as FDA agrees to review copycat Neulasta

The FDA has agreed to review Sandoz's (part of Novartis) biosimilar version of Amgen's Neulasta (pegfilgrastim). 

By Nicole Gray • Nov. 19, 2015

Innovation update: Advancing the standard of care in rheumatoid arthritis

This year’s ACR meeting highlighted new developments in rheumatoid arthritis (RA). We spoke to Dr. Terence Rooney, Medical Director of Lilly Bio-Medicines and Dr. Rory O’Connor, Senior Vice President and Head of Global Medical Affairs at Pfizer about JAK inhibition, innovation, and new treatment options for RA. 

By Nicole Gray • Nov. 19, 2015

Clovis Oncology's stock plummets on bad news about lung cancer drug

The prospects for its lead candidate lung cancer drug took a hit as the FDA requested more clinical data and a competiting drug won approval. 

By Nicole Gray • Nov. 18, 2015

Liver Meeting '15 wrapup: Battling more hep C genotypes, shortening treatment regimens

The face of hepatitis treatment has transformed in the past two years. But drug makers aren't through reaching for even greater heights.

By Sy Mukherjee • Nov. 18, 2015

Beyond trials: Real-world studies strengthen case for PrEP in HIV prevention

A clinical study in three STD infection clinics showed that pre-exposure prophylaxis (PrEP) works in real-world settings. 

By Nicole Gray • Nov. 17, 2015

Lucentis more effective than lasers for reversing diabetes-induced blindness in new study

The research shows that treatment with Lucentis (ranibizumab for injection) is more effective than laser therapy for proliferative diabetic retinopathy (PDR).

By Nicole Gray • Nov. 17, 2015

Liver Meeting '15: AASLD calls out payers on HCV med coverage; WHO's plan to wipe out hep C & B by 2030

On the second-to-last day of the annual Liver Meeting, the World Health Organization plotted an ambitious plan for eliminating viral hepatitis, and several pharma companies continued to present data on new, next-gen drug combos.

By Sy Mukherjee • Nov. 17, 2015

Liver Meeting 2015: Merck combo shines for IV drug abusers, Genfit preps phase 3 for pioneering NASH med

BioPharma Dive is at the American Association for the Study of Liver Diseases (AASLD) annual meeting in San Francisco. Here's what you need to know.

By Sy Mukherjee • Nov. 16, 2015