Bristol-Myers' Opdivo wins EU nod in lymphoma

The checkpoint inhibitor has now secured six approvals in Europe across four different forms of cancer. 

By Suzanne Elvidge • Nov. 23, 2016

Spectrum's Qapzola turned down by FDA

Following the failure of two earlier trials, Spectrum is stepping up to another study to try to prove efficacy.

By Suzanne Elvidge • Nov. 21, 2016

Ex-FDA official settles insider trading charges

Gordon Johnston will pay the SEC roughly $127,000 to settle charges he illegally passed on non-public information about generic drug approvals to a hedge fund. 

By Ned Pagliarulo • Nov. 16, 2016

FDA issues warning to Supernus for 'misleading' marketing

The agency took aim at a recent video for Oxtellar RX, a product responsible for a quarter of the company's revenue.

By Jacob Bell • Nov. 16, 2016

Boxed warning added to label of Bayer's Essure

The FDA decided to require the warning in February, but solicited comments from the industry and other stakeholders on its approach. 

By Ned Pagliarulo • Nov. 16, 2016

The increasing threat of antimicrobial resistance

How the overuse of antibiotics has taken its toll on society and what drug developers are doing about it. 

By Suzanne Elvidge • Nov. 16, 2016

Teva focusing on restructuring, compliance in wake of probe

CEO Erez Vigodman says a 'culture of compliance' now underpins every business decision.

By Judy Packer-Tursman • Nov. 16, 2016

Lilly touts Jardiance heart benefit ahead of FDA decision

Seeking a competitive edge, Eli Lilly presented new findings weeks before the FDA decides on labeling.

By Judy Packer-Tursman • Nov. 15, 2016

Costs for many Medicare drugs continue steady rise

The undiscounted cost of 11 drugs more than doubled last year, led by Valeant's treatment for high blood sugar, Glumetza. 

By Ned Pagliarulo • Nov. 15, 2016

Dynavax drops on FDA rejection of hep B vaccine

While Dynavax still sees a path to approval for Heplisav-B, the California biopharma is now hunting for a partner to help it advance the program further. 

By Ned Pagliarulo • Nov. 14, 2016

Prescribed Reading: Trump wasn't the only news in pharma

Bristol-Myers made portfolio changes, Europe welcomed several biosimilars to market, the FDA talked off-label promotion and multiple drugs were hit with holds. 

By Lisa LaMotta • Nov. 11, 2016

CHMP decision round-up; PTC wins reprieve

European regulators also recommended approval for new drugs from Gilead and Sanofi, as well for three biosimilars.

By Ned Pagliarulo • Nov. 11, 2016

Gilead's Vemlidy approved for hep B in US, EU

The big biotech is banking on the drug to keep antiviral sales flowing, but critics accuse the company for delaying roll-out of better medicines in favor of profits.

By Jacob Bell • Nov. 11, 2016

Mylan reveals probes as EpiPen fine fuels Q3 loss

The drugmaker's EpiPen troubles continued as the $465 million fine paid to the Department of Justice hit company earnings hard. 

By Judy Packer-Tursman • Nov. 11, 2016

Valeant hit with another FDA warning letter

An M&A-heavy strategy appears to have led to gaps in integrating newly acquired products into Valeant's quality management systems, the FDA report suggested. 

By Ned Pagliarulo • Nov. 10, 2016

RedHill full steam ahead on stomach-illness drug

The Israeli biopharma received positive feedback during a pre-Phase 3 meeting with the FDA, and has a confirmatory study scheduled for the first half of 2017.

By Jacob Bell • Nov. 10, 2016

Arrowhead spanked with clinical hold in hep B

It's a setback for ARC-520, which is forecast to reach as much as $4.5 billion in annual sales by 2020 if approved.

By Judy Packer-Tursman • Nov. 10, 2016

FDA invites pharma input in off-label debate

A two-day industry meeting continues Thursday, aiming to gather input on the FDA's regulatory approach to off-label drug promotion. 

By Ned Pagliarulo • Nov. 9, 2016

FDA asks how best to tweet Rx risks (in exactly twice this much space)

If a drug's benefits are promoted on social media, is posting a link to its risks enough to strike a balance?

By Judy Packer-Tursman • Nov. 9, 2016

Armed with positive data, Biogen accelerates launch prep for SMA drug

Infrastructure and logistics must be adjusted to prepare for greater patient demand, the firm said at a conference

By Judy Packer-Tursman • Nov. 8, 2016

Cempra drug narrowly wins support of FDA panel

Members of the committee raised concerns about safety risks seen in testing of the bacterial pneumonia drug but were convinced by strong efficacy data. 

By Jacob Bell • Nov. 7, 2016

DOJ may file charges soon in sweeping generic-pricing probe

Reports indicate more than a dozen drugmakers and 24-odd drugs are being investigated, with charges coming shortly. 

By Judy Packer-Tursman • Nov. 7, 2016

Prescribed Reading: ASH abstracts hit biotech hard

Companies refocus their M&A strategies, while abstracts from the upcoming ASH meeting disappoint investors and new discoveries could help treat a rare disease. 

By Lisa LaMotta • Nov. 4, 2016

Prop 61: What does it mean for drug prices?

California has a controversial initiative on the ballot today that pharma has spent millions to defeat. 

By Jacob Bell • Nov. 4, 2016

Cempra stock plummets after FDA raises safety concerns

Briefing documents issued ahead of an advisory panel meeting Friday flagged safety concerns with Cempra's lead product, a drug for pneumonia. 

By Jacob Bell • Nov. 3, 2016