FDA warns popular Lilly, AZ, J&J, Boehringer diabetes meds could cause ketoacidosis

The agency's warning is directed at the widely used, newer class of diabetes drugs known as SGLT2 inhibitors.

By Nicole Gray • May 18, 2015

US class action against India's Ranbaxy cites dishonesty, manipulation of FDA rules

The Indian pharma giant, recently purchased by Sun Pharma, is being accused of large-scale deception on its generic drug applications. 

By Nicole Gray • May 15, 2015

Industry, advocate pressure helps revive key 21st Century Cures exclusivity incentives

The newest draft of 21st Century Cures reinstates orphan drug exclusivity measures that were nixed in the previous one. Can stakeholder lobbying resurrect even more of them?

By Sy Mukherjee • May 14, 2015

Analysts answer: How long will it take the first Copaxone generics to gain market share?

We spoke with two DRG analysts about how the first generic substitutable version of Copaxone will change treatment of multiple sclerosis over the next five to 10 years.

By Nicole Gray • May 13, 2015

Challenges ahead for Vertex's controversial Kalydeco combo despite FDA panel nod

Price tag and efficacy will remain significant hurdles for payers.

By Nicole Gray • May 13, 2015

7 drugs get SMC backing

The Scottish Medicines Consortium agreed to provide coverage for Takeda's Entyvio, along with two blood cancer drugs, but it also rejected a handful of others.

By Nicole Gray • May 12, 2015

What the Tories' election victory means for the NHS and UK pharma

The ruling Conservative party won a majority of seats last week and has promised more funding for the NHS.

By Nicole Gray • May 11, 2015

FDA staff raises red flags over new Vertex cystic fibrosis med's cost

Agency staff is questioning whether Orkambi is worth the price.

By Nicole Gray • May 11, 2015

Liberia declared Ebola-free

But experts warn that Sierra Leone and Guinea are still at risk.

By Nicole Gray • May 11, 2015

AbbVie, Roche nab FDA breakthrough designation for top leukemia prospect

It's particularly promising news for AbbVie, since the experimental treatment could be paired with Imbruvica.

By Nicole Gray • May 8, 2015

Mark your calendars: FDA will hold public meeting on off-label use this summer

A coalition of pharma companies is advocating for looser rules around off-label advertising. 

By Nicole Gray • May 8, 2015

Congress calls for gender equity in clinical trials

Proposed legislation also aims to ensure that drugs approved through an expedited approval pathway are safe and effective for women.

By Nicole Gray • May 7, 2015

7 questions you might have about biosimilarity, answered

We interviewed FDA and pharma vet David Rosen, who has been tracking the emergence of biosimilars in the U.S., for a Q&A on the evolving role of the products. 

By Nicole Gray • May 6, 2015

Study: FDA bends over backwards to accommodate orphan drug developers

The authors note that only eight of the 27 orphan drugs approved between July 2010 and June 2014 were held to "conventional" standards.

By Nicole Gray • May 5, 2015

Amgen successfully defends melanoma hopeful T-Vec, gets positive FDA feedback

But panel members still expressed frustrations to the biotech.

By Nicole Gray • May 4, 2015

21st Century Cures changes would loosen Sunshine Act's CME disclosure rules

There are concerns that current Sunshine Act interpretations of continuing medical education are compromising programming.

By Nicole Gray • May 4, 2015

FDA approves Glaxo's asthma drug Breo Ellipta for adults

But the company's hopes of securing an indication for teens seem to have been dashed for now.

By Nicole Gray • May 1, 2015

FDA approves Kythera's double-chin injection

Kybella has been approved for use in improving the appearance of submental fat—double-chin—in adults. 

By Nicole Gray • April 30, 2015

4 big changes you need to know about the latest draft of 21st Century Cures

Big new money for the NIH, a big win for the industry when it comes to economic information-sharing, and a significant provision seemingly gets nixed in the latest draft of the FDA reform bill.

By Sy Mukherjee • April 30, 2015

Can the new FDA guidance on biosimilarity expedite development and approval?

New biosimilars guidance from the FDA may decrease existing barriers to entry for companies trying to break into the biosimilar market. Two analysts explain why.  

By Nicole Gray • April 30, 2015

Game on: FDA approves first generics of blockbuster antipsychotic Abilify

It will be be available in multiple strengths and dosages. 

By Nicole Gray • April 29, 2015

FDA officially reject's Merck's Bridion—again

This is the 3rd agency rejection of the drug.

By Nicole Gray • April 29, 2015

Controversy ahead: HHS inspector general encourages more Part D drug rebates

A new report finds that Medicaid rebates exceeded Part D rebates in 2012.

By Nicole Gray • April 29, 2015

3 key lessons industry leaders have learned from the latest Ebola crisis

Leaders from Merck, GlaxoSmithKline, J&J, Novavax, the FDA, and the NIH shared their thoughts on what we've learned about preparing for infectious epidemics like Ebola.

By Sy Mukherjee • April 28, 2015

Good news for Lilly: Cyramza nabs yet another FDA approval

And it's a big one.

By Nicole Gray • April 28, 2015