Mylan, Biocon's biosims back on track in EU after manufacturing snag

In August, Biocon had withdrawn two applications for approval of proposed biosimilars after the EMA said it would need to reinspect a drug facility.

By Suzanne Elvidge • Dec. 7, 2017

Lilly's Taltz gains new indication, improving position versus Cosentyx

Both drugs are now approved to treat psoriatic arthritis, which could help Taltz make up some of the ground Novartis' drug gained by being quicker to market.

By Jacob Bell • Dec. 6, 2017

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

Biogen inks outcomes-based contract for MS meds

A deal with Prime Therapeutics will link the cost of several of the biotech's multiple sclerosis drugs to patient adherence and clinical value. 

By Ned Pagliarulo • Dec. 6, 2017

FDA clears Amgen's Repatha for heart protection

Amgen can now market the PCSK9 inhibitor as an effective treatment to reduce heart attack and stroke, a potential edge to win over reluctant payers.

By Suzanne Elvidge • Dec. 6, 2017

Spark CEO Marrazzo hints at million dollar price tag

As potential approval of the first gene therapy for a rare form of blindness approaches, the problem of pricing still lacks an easy solution.

By Lisa LaMotta • Dec. 4, 2017

Mylan wins first US approval of Herceptin biosimilar

Earlier this year, the generics maker reached a settlement with Roche to market the biosimilar, although launch timing in the U.S. remains unclear.

By Ned Pagliarulo • Dec. 4, 2017

J&J jumps in on Actelion spinout's hypertension drug

Through a collaboration deal, Idorsia is handing over rights to aprocitentan in exchange for a $230 million milestone payment.

By Jacob Bell • Dec. 4, 2017

Most Impressive Drug Launch: Roche's Ocrevus

The first drug to win approval for primary progressive multiple sclerosis, Ocrevus' strong launch has already put the drug on a blockbuster trajectory. 

By Ned Pagliarulo • Dec. 4, 2017

Disruption of the Year: Long-Acting Hemophilia Drugs

Longer-acting treatments and gene therapies are likely to steal away hundreds of millions of dollars worth of revenue from established products in the coming years.

By Jacob Bell • Dec. 4, 2017

Senate passes tax bill that repeals individual mandate

Lawmakers will now attempt to work out the differences between the Senate bill and a similar tax bill the House passed last month that preserves the mandate.

By David Lim • Dec. 2, 2017

PhRMA, Express Scripts go head to head on drug pricing

The industry group and the PBM are both being blamed for the high price of drugs, but a complex pricing system only muddies the waters more. 

By Lisa LaMotta • Nov. 30, 2017

Sanofi to propose limits on use of dengue vaccine after safety signal

Recently analyzed clinical data showed the shot could intensify subsequent cases of the disease for individuals who had not previously been infected.

By Ned Pagliarulo • Nov. 30, 2017

FDA's generics goals may spell trouble for branded drug-device combos

With an eye to drug pricing, agency head Scott Gottlieb said the FDA is taking "taking new steps" to finalize guidance for generic drug-device combos.

By Jacob Bell • Nov. 29, 2017

FDA knocks generic maker for misbranding sleep aid

The warning letter to Magna Pharmaceuticals is only the third such notice issued this year by the FDA office in charge of regulating prescription drug promotion.

By Ned Pagliarulo • Nov. 29, 2017

Viagra comes out from behind the counter in the UK

The U.K. is the first country to permit Pfizer's Viagra to be sold in pharmacies without a prescription, a move aimed at curtailing the online black market.

By Suzanne Elvidge • Nov. 29, 2017

Biopharma in charts: New drugs and the search for growth

Threatened by competition to top-selling medicines, drugmakers across the industry are turning to new products. BioPharma Dive takes a look at how the efforts of seven biopharmas have fared. 

By Ned Pagliarulo • Nov. 28, 2017

How Anthem's new PBM will impact pharma

David Henka, CEO of RxTE Health, sat down with BioPharma Dive to discuss the implications of a new pharmacy benefit manager entering the marketplace. 

By Jacob Bell • Nov. 28, 2017

J&J eyes broader market for blood cancer med Darzalex

New study results could support approval of Darzalex in combination with three other drugs as a first-line treatment for certain patients with multiple myeloma.

By Ned Pagliarulo • Nov. 22, 2017

Concordia faces fine for bad pricing behavior

A U.K. regulator accused the drugmaker of price gouging, citing a near-6,000% increase in the price of a generic thyroid drug over 10 years.

By Suzanne Elvidge • Nov. 22, 2017

GSK boosted by US approval of two-drug HIV pill

Combining Tivicay with J&J's Edurant, the new regimen offers patients a less burdensome treatment option than current combos of three or more drugs. 

By Ned Pagliarulo • Nov. 22, 2017

Optum gets caught up in Express Scripts, Anthem legal fight

The latest legal challenge pulls Optum into an ongoing battle that adds turmoil to a rapidly changing and consolidating space.   

By Les Masterson • Nov. 21, 2017

Novo Nordisk: Obesity should be considered a chronic disease

Shifting dynamics in the diabetes market are pushing the Danish drugmaker to pursue other therapeutic areas. 

By Lisa LaMotta • Nov. 21, 2017

FDA pushes for more abuse-deterrent opioid generics

Under new Commissioner Gottlieb, the FDA has been looking to increase competition across markets by ushering more drugs through the system more efficiently. 

By Jacob Bell • Nov. 21, 2017

Roche's emicizumab wins US approval, threatening shake-up for hemophilia market

Hemlibra, as the drug will be marketed, is OK'd for routine prophylaxis in patients who have hemophilia A with factor VIII inhibitors.

By Jacob Bell • Nov. 16, 2017

Novartis sets Cosentyx hopes higher

Already a blockbuster, Cosentyx has been one of Novartis' fastest launches. Even so, the Swiss pharma believes more growth is in the cards.

By Ned Pagliarulo • Nov. 15, 2017