Adcomm support removes one hurdle for Ionis, Akcea drug, but many remain

The committee voted 12-8 in favor of approving Waylivra. Yet even if the FDA follows suit, the drug would come to market weighed down by safety baggage.

By Jacob Bell • May 11, 2018

IPR protocol would change under new PTO proposal

If passed, the new rule would make standards for inter partes review and other legal actions more aligned with those used in federal courts.

By Jacob Bell • May 10, 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

Ironwood confronts gout stigma in new Duzallo ads

Marketers had to take a different approach to reach gout patients, who often blame themselves for the disease. 

By Lisa LaMotta • May 9, 2018

Walmart to limit opioid prescriptions to 7-day supply

Federal regulators and state governments have also turned toward restrictions on dispensing as another tool to combat opioid abuse in the U.S.

By Ned Pagliarulo • May 9, 2018

China's global investment push opens doors for domestic biotechs

The sweeping Belt and Road project launched five years ago could give homegrown Chinese biotechs a leg up investing in emerging markets. 

By Wang Fangqing • May 8, 2018

Outlook for Ionis, Akcea drug marred by safety concerns

With a looming advisory panel meeting, it appears volanesorsen's affect on blood platelet levels will be top of mind for regulators.

By Jacob Bell • May 8, 2018

AbbVie's elagolix could put pressure on budgets, ICER estimates

ICER's draft report did, however, find the experimental endometriosis drug would meet cost-effectiveness thresholds using an estimated price.

By Suzanne Elvidge • May 8, 2018

ICER: Vertex's CF drugs too expensive

A new report concluded the list prices of Kalydeco, Orkambi and Symdeko would have to come down 71% to 77% to meet cost-effectiveness thresholds.

By Jacob Bell • May 7, 2018

FDA approves Andexxa in major boost to Portola

Shares in Portola jumped on the news, reflecting investor relief the FDA did not require additional clinical study before okaying the reversal agent.

By Ned Pagliarulo • May 4, 2018

New approval sets up CAR-T showdown for Gilead, Novartis

Both Yescarta and Kymriah now carry an indication for diffuse large B cell lymphoma, spurring interest as to which will come out on top in that market.

By Jacob Bell • May 2, 2018

Regeneron, Sanofi drop PCSK9 price in deal with Express Scripts

In return, the major PBM will exclusively list Praluent on its national preferred formulary beginning in July.

By Ned Pagliarulo • May 2, 2018

Allergan defends ubrogepant's marketability

While data supports the efficacy of Allergan's CGRP drug, some safety signals could limit its ability to compete in the marketplace.

By Jacob Bell • April 27, 2018

A metabolite will make or break Celgene's ozanimod

Analysts speculate this metabolite, and lack of information about it, were the probable cause of a Refuse to File letter issued for ozanimod earlier this year.

By Jacob Bell • April 26, 2018

Supreme Court upholds constitutionality of IPR

The decision is sure to have lasting effects for the pharmaceutical industry, which sees the patent-challenging process as both a help and a hindrance.

By Jacob Bell • April 25, 2018

Biogen to increase stake in biosimilar developer Samsung Bioepis

Anticipating faster sales of the copycat biologics, Biogen plans to exercise a soon-to-expire option to increase its ownership of the Korean drugmaker.

By Ned Pagliarulo • April 25, 2018

GSK new drug success eclipsed by currency, Advair slump

In a positive sign for GSK, however, sales of the British drugmaker's important new shingles vaccine widely beat market expectations.

By Ned Pagliarulo • April 25, 2018

Lilly's JAK woes set the stage for AbbVie, Gilead to jump ahead

An adcomm's iffy stance on baricitinib could mean one less thing to worry about for rivals looking to break into the fairly open JAK inhibitor market.

By Jacob Bell • April 24, 2018

Lilly's baricitinib wins FDA panel nod, but still dogged by safety issues

Lilly entered the Food and Drug Administration committee meeting on Monday with a fuzzy outlook for its potentially billion-dollar arthritis drug. It left in much the same fashion.

By Jacob Bell • April 23, 2018

Out-of-pocket drug costs still murky, report underscores

A recent look by Iqvia at patient drug costs suggests they have, on average, fallen. Whether that's partially because of discounts and rebates remains unclear.

By Jacob Bell • April 20, 2018

Tagrisso wins first-line lung cancer approval, boosting AstraZeneca

Securing the FDA OK is a key step in AstraZeneca's plan to turn Tagrisso into a multi-billion dollar drug franchise.

By Suzanne Elvidge • April 20, 2018

Lilly's baricitinib to face tough questions at AdComm

FDA staff reviewers raised doubts about the safety of the once-rejected rheumatoid arthritis drug ahead of an advisory committee meeting Monday.

By Lisa LaMotta • April 19, 2018

Cosentyx jitters weigh on Novartis

Worries over a slowdown in the immunology drug's sales and a sharp decline in the Swiss pharma's U.S. generics business overshadowed otherwise strong quarterly growth.

By Ned Pagliarulo • April 19, 2018

Pushing 'value,' Harvard Pilgrim tests outcomes deals

An agreement with AstraZeneca for the pharma's lung drug Symbicort is the ninth value-based contract publicly announced by the regional insurer.

By Ned Pagliarulo • April 18, 2018

Rigel secures FDA approval for rare disease drug

News of the OK helped shares in the biotech recover from the effect of a clinical setback earlier this month. 

By Randi Hernandez • April 18, 2018

In win for generics makers, court knocks back Maryland price gouging law

Wording was a key concern for the court of appeals, as the law's text would have allowed it to unconstitutionally regulate interstate commerce.

By Jacob Bell • April 18, 2018