FDA schedules separate meetings to review BioMarin, Sarepta Duchenne drugs

The agency has raised some eyebrows by scheduling panel meetings two months apart for drugs designed to address the same rare disease. 

By Nicole Gray • Oct. 15, 2015

23andMe nabs $115M in new financing and a $1.1B valuation

The consumer genetic testing firm comes surging back with a strong Series E.

By Nicole Gray • Oct. 15, 2015

Why Bernie Sanders' opposition to Califf's FDA nomination is misguided

Presidential candidate Bernie Sanders said he was proud to call pharma his number one enemy during the Democratic presidential debate last night. But that antipathy may have led him to a misleading argument against Dr. Califf.

By Nicole Gray • Oct. 14, 2015

FDA delays decision on Collegium's painkiller

Last month, an FDA panel recommended the long-acting opioid painkiller, Xtampza, for approval with on a 23-0 vote.

By Nicole Gray • Oct. 13, 2015

Good news on the horizon for Indian pharma as FDA ramps up approvals

Analysts expect the period between March 2015 and March 2016 to be much better in terms of earnings than the comparable period last year, thanks in large part to more FDA drug approvals. 

By Nicole Gray • Oct. 13, 2015

Controversy erupts over pediatric OxyContin guidance

Critics say the FDA's decision to expand the painkiller's use to children as young as 11 could fuel an addiction crisis.

By Nicole Gray • Oct. 13, 2015

Bristol-Myers' Opdivo nabs expanded lung cancer indication

It's now approved for treatment of both squamous and non-squamous non-small cell lung cancer (NSCLC) tumors in patients whose disease progressed during or after platinum-based chemotherapy.

By Nicole Gray • Oct. 12, 2015

Senators propose adding nurses, physician assistants to Open Payments database

A bipartisan duo of senators has introduced the bill as a way to "close the loop" and bolster overall transparency surrounding drug company payments. 

By Nicole Gray • Oct. 9, 2015

Pharma CEOs head to WH to hear Obama's TPP pitch; Clinton comes out against trade deal

President Obama certainly has his work cut out for him in selling execs like Pfizer CEO (and PhRMA chairman) Ken Frazier and others on the 12-nation trade agreement's biologics exclusivity compromise.

By Sy Mukherjee • Oct. 8, 2015

Pharma giants join forces to squash CA drug price cap initiative

J&J, Pfizer, Bristol-Myers Squibb, and Eisai are among the firms doling out millions to a PhRMA-backed effort to defeat the AIDS Healthcare Foundation-supported California Drug Price Relief Act. 

By Sy Mukherjee • Oct. 8, 2015

Pharma loves priority review vouchers—The FDA? Not so much

The goal of priority review vouchers is to encourage companies to focus on rare pediatric or tropical diseases. But not all voucher holders are doing that.

By Nicole Gray • Oct. 8, 2015

FDA halts Advaxis immuno-oncology trials after patient death

A woman with cervical cancer died during a clincal trial involving axalimogene, stoking fears that the drug was involved. The company says it wasn't.

By Nicole Gray • Oct. 8, 2015

FDA commish-in-waiting removes name from papers criticizing agency

Dr. Robert Califf has requested that his name be removed from papers he co-authored for the October issue of Clinical Trials that criticizes certain clinical trial oversight measures and recommends some controversial policy changes. 

By Nicole Gray • Oct. 8, 2015

Study: Merck hep C combo effective in kidney disease patients

Although Merck will most likely be third to market with its next-generation HCV drug, it's aiming to democratize treatment options even further.

By Nicole Gray • Oct. 7, 2015

Feds lose dietary supplement case against Bayer

The U.S. Department of Justice and the Federal Trade Commission had alleged that the company made false claims about Philip's Colon Health, an OTC product. 

By Nicole Gray • Oct. 6, 2015

Alkermes generic for blockbuster schizophrenia med Abilify bags FDA nod

The medication is administered every four to six weeks.

By Nicole Gray • Oct. 6, 2015

Bristol-Myers settles SEC charges over China bribery scandal for $14.2M

The illegal-yet-commonplace bribery practices of some global pharmaceuticals are coming under increasing scrutiny.

By Nicole Gray • Oct. 6, 2015

Spark inches closer to a pioneering US gene therapy approval

Recent results from a pivotal trial evaluating SPK-RPE65 therapy in patients with inherited night blindness were encouraging, sending the biotech's shares flying Monday. 

By Nicole Gray • Oct. 6, 2015

Indian foreign secretary: EU ban on generic drugs 'unwarranted'

Ever since the E.U. banned 700 generic drugs from India, free trade talks have fallen apart. 

By Nicole Gray • Oct. 6, 2015

TPP trade deal reached, BIO & PhRMA unhappy with drug patent compromise

The landmark trade liberalization deal, which involves 12 countries and covers 40% of the world economy, still has to be ratified by Congress and approved by lawmakers in the other countries. But biopharma did not win the 12-year biologics exclusivity it wanted.

By Nicole Gray , Sy Mukherjee • Oct. 5, 2015

Amicus delays regulatory submission for Fabry drug

When Amicus announced that it would delay submission of Galafold (migalastat), the stock fell by 53% and lost $760 million in market value. It's rebounded 11% in early trading Monday.

By Nicole Gray • Oct. 5, 2015

Merck's Keytruda wins lung cancer indication—but it's not as broad as Opdivo's

The immuno-oncologic is now approved for second-line treatment of non-small cell lung cancer tumors that express high levels of the PD-L1 protein.

By Nicole Gray • Oct. 5, 2015

Sarepta's new strategy for winning a landmark Duchenne drug approval

The FDA wanted larger trials and more data, so the company used data from patients in other trials to create a control arm—and to bolster its chances of approval for eteplirsen. 

By Nicole Gray • Oct. 2, 2015

EMA nominates Guido Rasi as executive director—again

Will the second time be the charm?

By Nicole Gray • Oct. 2, 2015

Bristol-Myers' Opdivo/Yervoy combo wins FDA approval, will cost $256,000

The price tag is already raising some eyebrows.

By Nicole Gray • Oct. 2, 2015