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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 -
Fizkes/Shutterstock.com
Sponsored by OM1A 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 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineCommercialization
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 -
Deep Dive // Patent thickets
Two decades and $200 billion: AbbVie’s Humira monopoly nears its end
The first biosimilar copy of Humira is set to arrive in the U.S. next week, testing both AbbVie and the market potential for knockoff biologic drugs.
By Jonathan Gardner • Updated Jan. 27, 2023 -
Permission granted by Akili Interactive
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 -
Permission granted by DarioHealth
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 -
Getty Images
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 -
Retrieved from FTC.
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 -
Permission granted by Biogen
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 -
Permission granted by Biogen
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 -
Permission granted by Biogen
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 -
Permission granted by Novartis
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 -
Permission granted by Biogen
New Alzheimer's drugs
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 -
Permission granted by Biogen
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 -
Getty Images
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 Parduhn • 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 -
Stockbakery/Shutterstock.com
Sponsored by Veeva CrossixAudience targeting in a changing digital landscape
How will your digital advertising strategy evolve in a future without cookies?
Dec. 6, 2021 -
Permission granted by Biogen
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 -
Permission for use granted by IQVIA
Sponsored by IQVIAIQVIA 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 -
Permission granted by IQVIA
Sponsored by IQVIAPatients, 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 -
Jon Cherry via Getty Images
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
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