5 drugs to watch as biotechs report Q2

Wall Street is keeping a close eye on new launches from Amgen, Gilead and Vertex as biotechs work to turn around an up-and-down 2018.

By Jacob Bell • July 16, 2018

More insurers using outcomes-based deals with drug, device companies

Cardiovascular, infectious diseases and oncology are the top three therapeutic areas where the contracts are used, according to an Avalere survey.

By Meg Bryant • July 13, 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 downgraded as high price tag threatens to slow new drug's pickup

The biotech believes Doptelet could tap into a multibillion dollar market, but some analysts question whether that could happen anytime soon.

By Jacob Bell • July 11, 2018

Medtronic, UnitedHealthcare say value-based pact cut diabetes costs

The biggest U.S. payer and largest medical device company saw encouraging results in the program's first year.

By Susan Kelly • July 11, 2018

Pfizer price hikes on pause after Trump pressure

In doing so, the pharma appeared to issue a warning of its own, suggesting prices could rise in 2019 unless Trump's pricing blueprint takes effect.

By Ned Pagliarulo • July 11, 2018

Vertex spars with UK's May over Orkambi pricing

After the NHS rejected an offer on pricing of the biotech's cystic fibrosis drugs, the company hinted its future in the country could be in jeopardy.

By Suzanne Elvidge • July 9, 2018

Prior authorization limits would be 'reasonable' for CGRP drugs, ICER says

While Amgen won some credit for pricing its new migraine drug lower than expected, payers could still act as a gatekeeper for access to CGRP inhibitors. 

By Ned Pagliarulo • July 5, 2018

Digital health funding sets new H1 record with $3.4B raised

The sustained growth reflects the sector's maturation and a healthy venture ecosystem, a new Rock Health report says. Despite bullish investment levels, however, exits have been slow. 

By Meg Bryant • July 3, 2018

FDA calls Pfizer Estring marketing misleading

The agency's Office of Prescription Drug Promotion took the pharma to task for not mentioning the product's risks.

By Suzanne Elvidge • July 3, 2018

CMS to states: Medicaid must cover accelerated approval drugs

The agency explained that any treatment cleared through the accelerated approval pathway and defined as a "covered outpatient drug" must be covered.

By David Lim • June 28, 2018

Gottlieb calls out Perrigo for missed postmarket study deadline

The FDA chief took to Twitter to remind drugmakers of their responsibilities to conduct required follow-up studies. 

By Ned Pagliarulo • June 27, 2018

Achaogen gets a yes and a no for antibiotic Zemdri

The FDA granted approval for urinary tract infections but not for blood infections, spurring a 20% stock slump.

By Suzanne Elvidge • June 27, 2018

DIA18: How much are PRVs even worth?

Evidence has shown the value of these regulatory fast passes has diminished in recent years, and may trend further downward as the market matures.

By Jacob Bell • June 27, 2018

DIA18: Value-based contracts pose more questions than answers

Drugmakers and payers are still figuring out what data are needed to support a new wave of pricing agreements and how to collect that information earlier.

By Jacob Bell • June 26, 2018

Connecting in context: Leveraging geo-location campaigns to drive ROI

Mobile campaigns continue to dominate the advertising space, but with good reason. Geo-location technology is providing new and effective ways of reaching target audiences.  

By Catherine Dold • June 25, 2018

CVS, facing Amazon threat, offers at-home prescription delivery

The pharmacy giant said it will become the first national drugstore to deliver prescriptions directly to consumers.

By Rebecca Pifer Parduhn • June 20, 2018

Purdue Pharma lays off 350, cutting remainder of sales force

The layoffs mark an end to the Oxycontin maker's direct marketing of its prescription medicines to doctors.

By Ned Pagliarulo • June 20, 2018

Gottlieb lays out FDA plans to speed generic reviews, spur label updates

The agency is set to launch a new review tool aimed at reducing the number of cycles of application review.

By David Lim • June 19, 2018

How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass

In submitting ALXN1210, the rare disease biotech used one of its priority review vouchers to hasten an approval decision from regulators.

By Jacob Bell • June 19, 2018

Nonprofit pharma picks up coveted PRV

Securing approval for its river blindness drug also hands Medicines Development for Global Health a coveted regulatory fast pass.

By Suzanne Elvidge • June 15, 2018

GSK touts two-drug HIV therapy, intends to file this year

Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market. 

By Jacob Bell • June 14, 2018

Biosimilars could still pack revenue-busting punch, analyst suggests

Uptake of the few copycat biologics launched in the U.S. has been slow. Yet a Leerink analyst expects a typical biosimilar will erode 20% of branded drug sales in the first year post-launch. 

By Ned Pagliarulo • June 13, 2018

Big pharma shows no signs of 'massive' drug price cuts

The nation's largest drugmakers have yet to voluntarily bring down prices on their drugs as President Trump claimed they would — and recent exchanges with lawmakers signal such reductions may not be coming.

By Jacob Bell • June 13, 2018

FDA permits more expansive communication between drugmakers, payers

New guidance sets out the agency's thinking on what information companies can share with insurers about their products, including for unapproved uses.

By Ned Pagliarulo • June 13, 2018

FDA mulls new incentives to stem antimicrobial resistance

The agency is working to smooth approval pathways for new products, while proposing changes to reimbursement to account for limited use.

By Suzanne Elvidge • June 13, 2018