First Neulasta biosimilar headed to US market

The FDA has approved Mylan and Biocon's copycat pegfilgrastim, putting even more pressure on the already weakening Amgen franchise.

By Jacob Bell • June 6, 2018

FDA puts illegal opioid websites on notice, issues warning letters

Commissioner Scott Gottlieb said the effort is one piece of a broader effort to crack down on opioids sold online and shipped by mail.

By David Lim • June 6, 2018

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

Dova reveals $9K to $13.5K Doptelet price, stock sags

After keeping quiet at approval, the company disclosed a steeper-than-expected price for the thrombocytopenia treatment. At least one analyst is worried it could hurt uptake.

By Suzanne Elvidge • June 1, 2018

PhRMA criticizes ICER in latest skirmish over valuing drugs

The drug lobby sponsored an analysis that found ICER's cost-effectiveness methods would force seniors to switch treatments if ever adopted in Medicare Part B.

By Ned Pagliarulo • May 31, 2018

Allergan to sell off women's health, anti-infective businesses

CEO Brent Saunders, who has been under pressure over Allergan's sliding share price, emphasized the move does not signal a "fire sale" at the pharma.

By Ned Pagliarulo • May 30, 2018

TherapeuticsMD garners FDA OK for Imvexxy

After a prior rejection, the women's health company gets the go-ahead for its estrogen capsule for pain during sex.

By Lisa LaMotta • May 30, 2018

Half of orphan drug sales to come from cancer, Evaluate finds

Global orphan drug sales will hit $262 billion by 2024, the firm estimates, with oncology treatments representing a larger slice of that pie.

By Jacob Bell • May 30, 2018

EU refines IP rules to boost biosimilars and generics

The European Commission is loosening an IP law to improve the competitiveness of EU drugmakers in the global generic and biosimilar market.

By Suzanne Elvidge • May 29, 2018

Senators call for list prices in DTC ads

Pfizer, Bristol-Myers and Novartis are just a few of the companies lawmakers asked to voluntarily disclose wholesale acquisition costs in ad campaigns.

By Jacob Bell • May 23, 2018

Trump pricing plan could lead to higher patient costs, Avalere suggests

The consultancy says parts of the administration's blueprint could end up costing cancer patients more out of pocket.

By Lisa LaMotta • May 23, 2018

Teva says CGRP drug could gain approval by mid-September

Manufacturing issues have delayed the Israeli company's migraine drug, putting it at a disadvantage to competitors.

By Jacob Bell • May 23, 2018

FDA approves first TPO agonist for chronic liver disease

Dova's Doptelet, available in June, will be the first oral option for liver disease patients with thrombocytopenia.

By Suzanne Elvidge • May 22, 2018

3 market-busting hurdles to NASH commercialization

With the first NASH drugs expected to win approval over the next two to three years, drugmakers will face several major barriers to market entry. 

By Lisa LaMotta • May 21, 2018

AstraZeneca finally gets US Lokelma approval

The third time is the charm for AstraZeneca and its hyperkalemia drug, which gained an FDA thumbs-up last week.

By Suzanne Elvidge • May 21, 2018

Amgen, Novartis' closely watched migraine drug approved

Aimovig heads to the U.S. market with a $6,900 annual price tag — which analysts say falls below expectations and bodes well for payer pickup.

By Jacob Bell • May 18, 2018

CMS weighing National Coverage Decision for CAR-T

The agency is considering whether there is enough evidence to support national Medicare coverage of the pricey cancer therapies.

By Lisa LaMotta • May 17, 2018

FDA clears new tool in fight against opioid epidemic

Regulators approved US WorldMeds' Lucemyra, the first non-opioid for easing the withdrawal process.

By Jacob Bell • May 17, 2018

To shame drugmakers, CMS publicizes price hikes

The agency updated an existing Medicare spending dashboard, singling out annual price increases for select drugs such as Sanofi's Lantus.

By Ned Pagliarulo • May 16, 2018

Oncology boom spurs DTC advertising, and with it controversy

As the debate for and against direct-to-consumer advertising rages on, cancer drugmakers look poised to pump massive amounts of money into the practice.

By Jacob Bell • May 16, 2018

Pfizer's Epogen biosimilar finally gets FDA go-ahead

On the third try, Retacrit becomes the first epoetin alfa copycat to secure U.S. approval.

By Suzanne Elvidge • May 16, 2018

FDA to call out branded drugmakers for blocking generics

The effort, which will be published online, seeks to highlight pharmaceutical companies abusing the system to stall generic competition.

By David Lim • May 15, 2018

Adcomm support removes one hurdle for Ionis, Akcea drug, but many remain

The committee voted 12-8 in favor of approving Waylivra. Yet even if the FDA follows suit, the drug would come to market weighed down by safety baggage.

By Jacob Bell • May 11, 2018

IPR protocol would change under new PTO proposal

If passed, the new rule would make standards for inter partes review and other legal actions more aligned with those used in federal courts.

By Jacob Bell • May 10, 2018

Ironwood confronts gout stigma in new Duzallo ads

Marketers had to take a different approach to reach gout patients, who often blame themselves for the disease. 

By Lisa LaMotta • May 9, 2018

Walmart to limit opioid prescriptions to 7-day supply

Federal regulators and state governments have also turned toward restrictions on dispensing as another tool to combat opioid abuse in the U.S.

By Ned Pagliarulo • May 9, 2018