FTC deadlocks on vote to launch study into PBM practices

The antitrust agency won't study pharmacy benefit managers' pricing and contract practices as proposed, after a 2-2 vote by commissioners Thursday.

By Samantha Liss • Feb. 17, 2022

Seagen shares sink as sales outlook of cancer drug disappoints

The biotech is predicting sales of Tukysa, its new breast cancer drug, will remain flat or fall in 2022 as competition increases from AstraZeneca's rival medicine Enhertu.

By Jacob Bell • Feb. 10, 2022

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

Amgen expects rising sales through 2030, but Wall Street still has doubts

Facing falling sales of top-seller Enbrel, the biotech tried to shore up confidence in its ability to grow new products, like the cancer drug Lumakras.

By Kristin Jensen • Feb. 9, 2022

Biogen buys into fast-advancing Roche cancer drug

The biotech will pay $30 million to opt into rights for mosunetuzumab, a bispecific antibody that Roche has developed for non-Hodgkin's lymphoma.

By Ned Pagliarulo • Feb. 1, 2022

Medicare faces blowback over plan to limit coverage of Biogen's Alzheimer's drug

Biogen, along with allies in industry, plans to pressure Medicare to water down its policy, which limits coverage of Aduhelm and drugs like it to clinical trials.

By Jonathan Gardner , Jacob Bell • Jan. 14, 2022

Medicare proposes to limit coverage of Biogen Alzheimer's drug

The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.

By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.

By Jonathan Gardner • Dec. 22, 2021

After intense pushback, Biogen to cut price of Alzheimer's drug

Effective Jan. 1, the average list price for Aduhelm will drop about 50% to just over $28,000 a year. It's a move the company hopes will appease insurers and lower out-of-pocket costs for patients.

By Jacob Bell • Dec. 20, 2021

European regulators say no to Aduhelm, but Biogen is pushing back

The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks."

By Jacob Bell • Dec. 17, 2021

J&J's coronavirus vaccine faces new US limits

Days after the FDA strengthened safety warnings for J&J's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred."

By Jonathan Gardner • Updated Dec. 17, 2021

Humana, Centene sue drugmakers, alleging anticompetitive practices on HIV drugs

The insurers filed suit against Gilead, J&J, Bristol Myers Squibb and Teva, claiming the drugmakers conspired to protect lucrative HIV drugs from competition.

By Rebecca Pifer • Dec. 14, 2021

AbbVie's blockbuster weighed down by safety concerns for a similar Pfizer drug

Like Pfizer's Xeljanz, the label for AbbVie's Rinvoq has been updated to warn about risks of death and major cardiovascular events like stroke.

By Jacob Bell • Dec. 6, 2021

Audience targeting in a changing digital landscape

How will your digital advertising strategy evolve in a future without cookies?

Dec. 6, 2021

Anticipating Aduhelm's costs, Medicare plans big jump in premiums

While CMS is still weighing whether to authorize wide coverage of Biogen's pricey Alzheimer's drug, administrators are planning to build reserves in case costs skyrocket.

By Jonathan Gardner • Nov. 15, 2021

IQVIA Omnichannel Navigator: A platform for informing smarter marketing decisions

This year, the pharmaceutical industry will spend more on its promotional activities than any year before. It’s estimated that the total U.S. promotional spend for 2021 will be around $30 billion.

By Kathryn Grimshaw • Nov. 8, 2021

Patients, payers, policy and pressure: Trends to watch in 2021

It has become increasingly difficult to forecast and achieve net sales goals. Pressures were building long before 2020, and the COVID-19 pandemic has only accelerated and amplified the challenges.

Nov. 1, 2021

CDC panel backs COVID-19 boosters for Moderna, J&J vaccine recipients

Advisers' recommendations followed the FDA's clearance of additional doses for certain people vaccinated with Moderna's and J&J's shots, while also endorsing a mix-and-match approach.

By Jonathan Gardner , Shoshana Dubnow • Updated Oct. 22, 2021

Biogen's Alzheimer's drug is struggling, and a turnaround might not be coming soon

Sales of Aduhelm during the third quarter totaled only $300,000, falling well below expectations amid controversy over its approval and physician reluctance to prescribe it.

By Jacob Bell • Oct. 20, 2021

Sage, Biogen detail plans to get their newer depression drug approved

Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.

By Jacob Bell • Oct. 19, 2021

Boehringer wins 'interchangeable' status for Humira copy, strengthening competitive threat

The interchangeable approval could help to boost adoption of Boehringer's biosimilar when it launches in mid-2023, a date set via settlement with AbbVie.

By Ned Pagliarulo • Oct. 18, 2021

Lilly drug cleared by FDA for wider use in breast cancer

Verzenio now has an expanded approval for treatment of a common form of early cancer, although the label granted by FDA places some limits on use.

By Kristin Jensen • Oct. 13, 2021

Biohaven migraine drug sales again top Wall Street forecasts

The neuroscience-focused biotech continues to win market share in a battle with some of the industry's largest companies.

By Kristin Jensen • Oct. 6, 2021

Lilly, Novartis, other pharmas could face fines for violating 340B law

The U.S. health department asked its inspector general to review the refusals of six drugmakers to offer discounts to safety net hospitals through community pharmacy partnerships.

By Rebecca Pifer • Sept. 24, 2021

CDC recommends Pfizer booster shots for many, overruling advisers on broad use

While agency advisers voted against recommending a third Pfizer vaccine dose for frontline workers, they were overruled by CDC Director Rochelle Walensky, who officially endorsed use in that group.

By Shoshana Dubnow , Ned Pagliarulo • Updated Sept. 24, 2021

Takeda wins FDA approval for targeted lung cancer drug

Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally. 

By Kristin Jensen • Sept. 16, 2021