Marketing

Moderna vaccine sales surpass expectations as company looks to fall boosters

The trajectory of COVID-19 vaccine sales is now harder to predict amid questions about the rollout of additional doses and whether purchasing in the U.S. might shift from the federal government to private payers.

By Ned Pagliarulo • May 4, 2022

Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Bristol Myers paid $13 billion to acquire the drug's maker, MyoKardia, and expects it to become a blockbuster. But a tricky dosing regimen, as well as safety concerns, could challenge the pharmaceutical giant's lofty forecast. 

By Jonathan Gardner • April 28, 2022

Biogen pulls European application for Aduhelm in another setback for the Alzheimer's drug

In a letter to regulators, Biogen said it chose to withdraw its approval filing after discussions with the EMA, which previously found the data supporting Aduhelm to be lacking.

By Jacob Bell , Ned Pagliarulo • April 22, 2022

DOJ cracks down on 'largest and most wide-ranging' COVID-19 fraud

Defendants, including doctors, medical business executives and fake vaccination card manufacturers, caused nearly $150 million in false billings to federal programs, the DOJ said. 

By Rebecca Pifer • April 21, 2022

Inflation is forcing prioritization of healthcare spending — are you ready?

Inflation means your customers' money doesn't travel as far as it did a few weeks ago.

April 18, 2022

Can digital therapeutics be profitable?

Licensing deals with pharmaceutical companies were an early strategy for digital health companies, but not all of them have lasted.

By Elise Reuter • April 11, 2022

The power of alerts

As medical affairs continues to invest in systems and data, it can quickly become overwhelming to keep up with it all.

April 11, 2022

Medicare finalizes policy limiting coverage of Biogen Alzheimer's drug

Biogen said it is considering its options following CMS' decision, which restricts reimbursement of Aduhelm to patients enrolled in a randomized clinical trial. 

By Jonathan Gardner • Updated April 7, 2022

A new approach for post-marketing safety studies

The large quantity of digitized healthcare data in the U.S. presents an enormous opportunity to shift dramatically how post-marketing safety studies can and should be conducted.

By Stefan Weiss, MD, MHSc, MBA, Managing Director of Dermatology, OM1 • April 4, 2022

Two decades and $200 billion: AbbVie's Humira monopoly nears its end

Biosimilar copies of Humira will arrive in the U.S. beginning early next year, testing both AbbVie and the market potential for knockoff biologic drugs.

By Jonathan Gardner • March 17, 2022

Akili, with plans to go public, prepares to ramp up marketing of video game treatment

"We've proven that foundation and now it's time to run and scale," said CEO Eddie Martucci. The company is going public through a $1 billion SPAC, rather than a traditional IPO.

By Elise Reuter • March 10, 2022

AbbVie holds off another Humira challenger with Alvotech deal

A settlement will allow the Iceland-based drugmaker to launch its Humira copycat, currently under FDA review, in the U.S. beginning next July.

By Ned Pagliarulo • March 9, 2022

Novo sees fast growth ahead of obesity drugs despite production hurdles

The Danish drugmaker aims to triple sales of its weight loss treatments Wegovy and Saxenda by 2025. But first, Novo needs to resolve manufacturing constraints that have slowed the former drug's launch. 

By Ned Pagliarulo • March 4, 2022

Sanofi partners with digital health company DarioHealth

The deal with DarioHealth is one of several digital health investments by the French pharma company in recent years, although not all have panned out.

By Elise Reuter • March 2, 2022

Moderna sued for allegedly infringing patents tied to COVID-19 vaccine

Arbutus and partner Genevant claim Moderna's coronavirus shot uses delivery technology covered by six patents they hold, an allegation Moderna denies. 

By Ned Pagliarulo • Feb. 28, 2022

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

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