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

Why several FDA reviewers recommended not approving female libido med Addyi

One reviewer was concerned that the combination of Addyi (flibanserin 100 mg) and alcohol was tested mainly in men.

By Nicole Gray • Sept. 17, 2015

AbbVie, Janssen chase first-line approval of Imbruvica for CLL

The medication is currently indicated as a second-line treatment. 

By Nicole Gray • Sept. 16, 2015

UPDATE: Obama nominates Robert Califf as next FDA commissioner

If confirmed, the former Duke University School of Medicine Vice Chancellor and professor of medicine will lead the agency during a critical period of change and regulatory overhauls. 

By Sy Mukherjee • Sept. 16, 2015

10th Indian pharma plant this year makes FDA's do-not-import list

Once again, the problem at hand is production quality. 

By Nicole Gray • Sept. 15, 2015