Sanofi wins OK in Europe for blood disorder drug

European regulators have given the nod to Cablivi, the first approval specifically for a rare blood clotting disorder known as aTTP.

By Suzanne Elvidge • Sept. 4, 2018

EC approves GSK's Nucala for kids with severe asthma

Children as young as 6 across Europe can now use the respiratory drug.

By Suzanne Elvidge • Aug. 31, 2018

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Merck's virology business needs a boost. It may not get that from 2 new HIV drugs

While company executives see Delstrigo and Pifeltro as continuing Merck's legacy in HIV, Wall Street isn't so sure the drugs can outclass market heavyweights.

By Jacob Bell • Aug. 31, 2018

Alnylam's Onpattro cleared in Europe as ICER sets pricing battle

Regulators OK'd the first RNA interference therapy in Europe, but a new report finds the list price between 967% and 1,821% above value thresholds.

By Andrew Dunn • Aug. 30, 2018

Despite new approval, Bayer continues to face hemophilia headwinds

A terminated distribution partnership and stiffening market competition are threats to the German drugmaker's hemophilia business.

By Jacob Bell • Aug. 30, 2018

FDA warns of link between some diabetes drugs and serious infection

SGLT2 inhibitors, a kind of Type 2 diabetes medication, have been connected with a rare and sometimes life-threatening genital infection.

By Suzanne Elvidge • Aug. 30, 2018

In a summer of C-suite departures, a week of commercial hires

Vertex, Bristol-Myers and Gilead brought new blood onto commercial leadership teams, underscoring some of the market pressures each faces.

By Jacob Bell • Aug. 29, 2018

Pfizer calls out pharma peers for 'scare tactics' on biosimilars

Frustrated by slow uptake of its biosimilars, Pfizer is petitioning the FDA to set ground rules for what biologic makers can say about copycat rivals.

By Ned Pagliarulo • Updated Aug. 29, 2018

UK's NICE judges Yescarta too pricey, dealing blow to Gilead

Cost and reimbursement issues will be a key test for Gilead as it seeks to sell its CAR-T treatment in Europe.

By Ned Pagliarulo • Updated Aug. 29, 2018

Harvard Pilgrim offers rare peek at 6 years of drug costs

Prescription drugs accounted for 25% of total healthcare spending by the New England insurer in 2016, driven higher by specialty medicines like Humira.

By Suzanne Elvidge • Aug. 28, 2018

FDA ups the ante for copycats, antibiotics, orphan drugs. But is it working?

Regulators are using incentives to spur development of much-needed drugs. The results so far have been mixed.

By Jacob Bell • Aug. 27, 2018

Cigna, Express Scripts shareholders greenlight deal

About 90% of Cigna votes were cast in favor of the acquisition, yet the $67 billion deal is still subject to a number of regulatory approvals.

By Tony Abraham • Updated Aug. 27, 2018

Lawmakers push to require price disclosure in DTC drug ads

An amendment providing HHS with funding for implementing the idea passed the Senate last week, providing some legislative backing for the Trump administration's plans. 

By Ned Pagliarulo • Aug. 24, 2018

Approval in hand, Shire's next step is to deliver on high hopes for lanadelumab

Some have deemed the drug, now branded as Takhzyro, best-in-class for treating hereditary angioedema. But Shire's had setbacks in this space before.

By Jacob Bell • Aug. 24, 2018

Insurers, PBMs nudge FDA to finalize interchangeability guidance

A lack of final guidance from the FDA could be reducing patient access to biologics, according to a letter from payers, trade bodies and patient groups.

By Suzanne Elvidge • Aug. 24, 2018

Pfizer inks marketing deal for Exact's Cologuard

Exact said about 401,000 tests were performed during the first six months of 2018, leading to revenue of $193 million. The CEO now expects $700 million in sales for next year.

By Andrew Dunn • Aug. 22, 2018

FDA extends EpiPen expiration date to ease shortages

Current shortages stemming from ongoing manufacturing delays could put children at risk as the school year approaches.

By Suzanne Elvidge • Aug. 22, 2018

Drug combos may prove more costly than generic components, study finds

Research published in JAMA suggests paying for branded drug combos rather than buying the component generics separately may have cost the government program nearly $1 billion in 2016. 

By Suzanne Elvidge • Aug. 22, 2018

HHS touts drug pricing 'wins,' but true tests still to come

The Trump administration has extracted some concessions from a handful of pharma companies, but January will test whether freezes on price hikes last. 

By Ned Pagliarulo • Aug. 21, 2018

EpiPen class action lawsuit against Mylan, Pfizer to continue, judge rules

Multidistrict litigation alleges the companies engaged in "an illegal scheme to monopolize the market" for epinephrine auto-injectors.

By Jacob Bell • Aug. 21, 2018

Walmart, Anthem partner on Medicare program

Tie-ups between healthcare firms and retailers have ticked up, with Walmart now planning to offer discounts on OTC drugs for some Anthem customers.

By Daphne Howland • Aug. 20, 2018

Aimovig launch bolsters hopes for blockbuster sales

Though several recent blockbusters-to-be have disappointed, Leerink analyst Geoffrey Proges believes Aimovig's start augurs well for anti-CGRP drugs.

By Ned Pagliarulo • Aug. 20, 2018

Eisai-Merck partnership picks up first-line Lenvima approval

While Keytruda combo trials remain in progress, the companies secured an important OK for the kinase inhibitor in hepatocellular carcinoma.

By Suzanne Elvidge • Aug. 20, 2018

Opdivo gets speedy approval in 3rd-line small cell lung cancer

Though Bristol-Myers' drug is breaking into a less competitive market, it may soon run into trouble there from the likes of Tecentriq and Keytruda.

By Jacob Bell • Aug. 17, 2018

Teva granted FDA approval for first EpiPen generic

It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.

By David Lim • Aug. 16, 2018