Merck's Keytruda wins lung cancer indication—but it's not as broad as Opdivo's

The immuno-oncologic is now approved for second-line treatment of non-small cell lung cancer tumors that express high levels of the PD-L1 protein.

By Nicole Gray • Oct. 5, 2015

Sarepta's new strategy for winning a landmark Duchenne drug approval

The FDA wanted larger trials and more data, so the company used data from patients in other trials to create a control arm—and to bolster its chances of approval for eteplirsen. 

By Nicole Gray • Oct. 2, 2015

EMA nominates Guido Rasi as executive director—again

Will the second time be the charm?

By Nicole Gray • Oct. 2, 2015

Bristol-Myers' Opdivo/Yervoy combo wins FDA approval, will cost $256,000

The price tag is already raising some eyebrows.

By Nicole Gray • Oct. 2, 2015

Chasing a ghost: Why is FDA guidance on biosim interchangeability taking so long?

We spoke with Dave Fox, former associate chief counsel for drugs at the FDA and a partner in Hogan Lovell’s Life Sciences practice in Washington, D.C., to gain insight into the evolution of the biosimilars industry in the U.S.

By Nicole Gray • Oct. 2, 2015

WHO pushes for far more aggressive worldwide use of HIV meds

The agency says that anyone with an HIV diagnosis should start anti-retroviral therapy (ART) immediately.

By Nicole Gray • Oct. 1, 2015

10 top trends driving the biopharma industry today

From pricing controversies to the continued deluge of M&As, to put-up-or-shut-up moments for hotly anticipated drug candidates, here are 10 of the most important industry trends that biopharma professionals need to understand.

By Sy Mukherjee • Oct. 1, 2015

Clovis set for showdown with AZ as it wins fast-track for lung cancer drug

The biotech is taking on a pharma giant with more than 20 times its market cap.

By Nicole Gray • Oct. 1, 2015

Global standoff looms between US, developing nations over WTO waiver extension

A waiver which exempts UN-classified least-developed countries (LDCs) from patent laws expires on January 1, 2016.

By Nicole Gray • Oct. 1, 2015

Sanofi hopes to broaden diabetes portfolio as FDA accepts lixisenatide submission

The investigational therapy is in the same class as Novo's Victoza and Lilly's Trulicity.

By Nicole Gray • Sept. 30, 2015

Lilly settles Sanofi dispute, plans 2016 launch for biosim Lantus

Eli Lilly will launch Basaglar, a biosimilar version of Sanofi's Lantus SoloSTAR, in December 2016.

By Nicole Gray • Sept. 29, 2015

House Dems demand Valeant CEO testify on price hikes with Shkreli, stock plunges

Democrats on the House Oversight Committee want Chairman Rep. Jason Chaffetz (R-UT) to issue a subpoena to Valeant demanding documents related to February price increases for Isuprel and Nitropress. And they want CEO Michael Pearson to testify alongside biopharma's current PR nightmare: Martin Shkreli.

By Nicole Gray • Sept. 29, 2015

FDA approves Bayer's autoinjector for MS drug

BETACONNECT is the first and only autoinjector for Betaseron (interferon beta-1b), which is used to treat relapsing-remitting multiple sclerosis (RRMS).

By Nicole Gray • Sept. 28, 2015

FDA revokes Sun Pharma's approval for epilepsy drug after compliance concerns

Manufacturing problems at India-based plants continue to haunt the country's biopharma industry.

By Nicole Gray • Sept. 28, 2015

The diabetes king? Novo finally gets its Tresiba long-acting insulin approval

Tresiba (insulin degludec injection) is the first new FDA-approved basal insulin molecule in 10 years and may enshrine Novo as the top diabetes-focused biopharma firm in the world.

By Nicole Gray • Sept. 28, 2015

FDA warns Pathway Genomics cancer blood test 'may harm the public health'

The startup has developed a blood test that it touts as a faster, less-expensive way to detect cancer. 

By Nicole Gray • Sept. 25, 2015

After bad news on Breo, Glaxo's monthly asthma drug wins an EU rec

Nucala (mepolizumab) is an injectable IL-5 monoclonal antibody designed to treat severe asthma in patients who are non-responsive to high-dose inhaled corticosteroids.

By Nicole Gray • Sept. 25, 2015

Amgen-Allergan's Avastin biosimilar shows promise in lung cancer trials

If the results hold, this could be a huge deal for U.S. biosimilars—and a major test for their savings prowess.

By Nicole Gray • Sept. 24, 2015

FDA approves Taiho Oncology's pill for metastatic colorectal cancer

Lonsurf is a 2-in-1 combo therapy that combines trifluridine with tipiracil hydrochloride.  

By Nicole Gray • Sept. 24, 2015

India's Serum Institute chases fast-track approval for dengue treatment as cases spike

New Delhi is facing the worst outbreak of dengue fever in five years.

By Nicole Gray • Sept. 23, 2015

Clinton calls out Turing & Shkreli on wild price hike, releases pharma cost cap plan

When the Democratic presidential front-runner tweeted her plans to release a drug price-control plan on Monday, the Nasdaq Biotech Index dropped nearly 5%. 

By Nicole Gray • Sept. 22, 2015

Bristol-Myers' immuno-oncology star Opdivo nabs kidney cancer priority review

The drug is currently approved for the treatment of advanced melanoma and advanced squamous non-small cell lung cancer (NSCLC). 

By Nicole Gray • Sept. 22, 2015

Shire's once-daily extended-release ADHD drug now approved in Europe

It can be used to treat attention-deficit hyperactivity disorder (ADHD) in patients aged six to 17. 

By Nicole Gray • Sept. 22, 2015

2nd time's the charm for Allergan, Richter antipsychotic drug

Cariprazine was rejected by the FDA in 2013, but won approval this time around based on new phase 3 data. 

By Nicole Gray • Sept. 21, 2015

Obama's FDA chief nominee received more than $200K in industry fees

Dr. Robert Califf has close ties to the biopharma industry.

By Nicole Gray • Sept. 21, 2015