FDA staff backs Amgen biosim of AbbVie's Humira

An independent advisory panel is set to review Amgen's application early next week. 

By Ned Pagliarulo • July 8, 2016

Pfizer pledges to disclose risks of opioid addiction

In an agreement with the city of Chicago, the drug giant committed to strict standards for marketing and promoting the addictive painkillers. 

By Ned Pagliarulo • July 6, 2016

Explore the Trendline➔

Commercialization

New drugs for obesity are becoming blockbusters, while Trump administration pressure is reshaping pharma marketing strategies ahead of looming patent cliffs.

By BioPharma Dive staff

Federal appeals court reaffirms biosimilar launch rules

The Supreme Court is considering whether to hear a related case on when biosimilar drugmakers must notify brand name companies of their intent to sell copy biologics.

By Ned Pagliarulo • July 5, 2016

Insys stages recovery as FDA approves liquid THC drug

Syndros, Insys' second-approved drug, is still awaiting DEA scheduling however. 

By Edwin Lopez • July 5, 2016

UK cost agency knocks back Bristol-Myers' Opdivo in kidney cancer

In draft guidance, the watchdog raised concerns over the cancer immunotherapy's long term benefit in treating renal cell carcinoma. 

By Ned Pagliarulo • July 5, 2016

Gilead reveals new wave of price hikes for six drugs

Among the six were the HIV drugs Complera and Stribild, along with the blood cancer drug Zydelig. 

By Edwin Lopez • July 5, 2016

Pfizer's PCSK9 drug notches two Phase 3 wins

Bococizumab would be the third PCSK9 drug to hit U.S. markets, but Pfizer hopes to distinguish it with stronger clinical data. 

By Nicole Gray • June 30, 2016

Major trade group slams 'misleading' analysis of drug prices

In an op-ed Wednesday, the president of BIO pushed back on a recent Bloomberg report on rising drug prices, calling it "conjecture." 

By Ned Pagliarulo • June 30, 2016

In narrow vote, FDA panel supports heart benefit claim for Lilly diabetes drug

Allowing Boehringer and Lilly to claim Jardiance cuts the risk of cardiac death is expected to significantly boost the drug's market potential. 

By Ned Pagliarulo • June 29, 2016

What does it take to succeed as a New York biotech startup?

Although biotech has been slow to take off in New York, venture activity in the city may be accelerating. BioPharma Dive spoke with the CEO of Rgenix about why he plans to stay.  

By Nicole Gray • June 29, 2016

Harvard Pilgrim inks pay-for-performance deals with Novartis, Eli Lilly

Outcomes-based pricing has become more common as insurers seek to limit rising prescription drug costs. 

By Ned Pagliarulo • June 28, 2016

Gilead wins FDA nod for pan-genotypic Hep C drug

In an unusual move, Gilead priced Epclusa below the cost of existing drugs Harvoni and Sovaldi, at just under $75,000 for a 12-week course of treatment. 

By Ned Pagliarulo • June 28, 2016

Teva seals deal to market copy of AstraZeneca diabetes drug

Under settlement terms, the Israeli drugmaker will be able to sell generic versions of AstraZeneca's Byetta next year. 

By Ned Pagliarulo • June 24, 2016

Opko wins approval for kidney drug after manufacturing snag

The FDA had turned down Opko's original application due to manufacturing issues at third-party contractor Catalent. 

By Nicole Gray • June 23, 2016

Russian biosims company accuses Roche of undercutting its business

Filing suit in a New York federal court, Biocad claimed Roche tried to block it from entering the U.S. market with biosimilar versions of three Roche cancer drugs.

By Nicole Gray • June 23, 2016

AstraZeneca writes off $80 million after US authorities say nasal flu vaccine ineffective

An advisory panel at the Centers for Disease Control and Prevention recommended against using AstraZeneca's FluMist nasal spray for the upcoming flu season. 

By Ned Pagliarulo • June 23, 2016

Doctors who ate on pharma's dime prescribed drugs more often, study finds

Higher rates of prescribing were seen even though the average meal cost less than $20. 

By Nicole Gray • June 22, 2016

Supreme Court asks for DOJ input on biosimilar case, delaying decision

Novartis' generics unit Sandoz is locked in a legal battle with Amgen over when biosimilars companies can launch copies of branded drugs. 

By Nicole Gray • June 22, 2016

Could label update for diabetes med Jardiance boost drug class?

A new forecast predicts the so-called SGLT-2 diabetes drugs, headlined by Jardiance, could become the third best-selling class of drugs by 2022. 

By Nicole Gray • June 22, 2016

Austin biotech Savara adds two lung drugs in deal for Serendex

Savara raised $20 million in March to advance its lead drug, an inhaled antibiotic, into Phase 3 testing. 

By Nicole Gray • June 22, 2016

Philips ad for lung device wins top honors at Cannes

Several big pharma companies, such as Pfizer and Teva, also took awards for their ads at the international marketing competition. 

By Nicole Gray • June 21, 2016

Clinton racks up donations from pharma industry

Although individual donations from pharma made up a small share of Clinton's overall fundraising, her total far exceeded amounts raised by Donald Trump or Bernie Sanders. 

By Nicole Gray • June 20, 2016

NIH turns down request to override cancer drug patent

Consumer groups had argued the $129,000 price tag for Xtandi limits patient access, justifying intervention by the government under a little-used law.

By Ned Pagliarulo • June 20, 2016

Doubling down on biosimilars, Novartis plans five launches by 2020

The Swiss giant aims to introduce biosimilar copies of blockbuster biologic drugs, such as AbbVie's Humira and Roche's Rituxan, by the end of the decade. 

By Ned Pagliarulo • June 20, 2016

Why Novartis' new heart med could reverse slow start

BioPharma Dive spoke to Clyde Yancy, Chief of Cardiology at Northwestern University, about the new clinical practice guidelines recommending Entresto.

By Nicole Gray • June 17, 2016