340B scrutinized in Senate, targeted by Trump

Lawmakers questioned the program's vague intent, lack of transparency and what they called an "inadequate" level of oversight.

By David Lim , Tony Abraham • May 15, 2018

Pharma breathes easy as Trump's drug pricing plan fizzles

While Trump vowed to bring drug prices down, pharma and biotech stocks jumped higher after his speech delivered few immediate actions. 

By David Lim • May 11, 2018

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

Prescribed Reading: ShiTake a go; Novartis in hot water

Takeda finally secured its takeover of Shire. Elsewhere, Novartis came under fire for payments it made to Trump's lawyer. 

By Lisa LaMotta • May 11, 2018

What to expect from Trump's Friday drug pricing speech

The president is expected to lay out his administration's latest slate of proposals aimed at lowering the cost of drugs.

By David Lim • May 10, 2018

Cosmo's cancer diagnostic hits FDA roadblock

A letter from the agency said "deficiencies" in Cosmo's application prevented it from continuing its review of Methylene Blue MMX. 

By Suzanne Elvidge • May 10, 2018

Lipocine's testosterone drug rejected again

The biotech confirmed receipt of an FDA complete response letter, but insisted the issues thwarting approval are not insurmountable.

By Jacob Bell • May 9, 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

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

Celgene's timeline for refiling ozanimod gets mixed reviews

Analysts were split on whether an early 2019 resubmission would drastically affect ozanimod's market opportunity.

By Jacob Bell • May 4, 2018

Prescribed Reading: Small deals mark tail end of Q1 earnings

First quarter earnings have largely wrapped up, with no major M&A announced. Several smaller deals, however, sparked investor interest. 

By Lisa LaMotta • May 3, 2018

Fremanezumab approval by mid-June unlikely, Teva says

Issues at Teva's contract manufacturer appear to have tripped up the migraine drug's application, although the generics giant still expects an OK by year-end.

By Ned Pagliarulo • May 3, 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

Brain Talk: Tackling a crisis while treating the patient

While the opioid crisis has brought to light the overuse and abuse of these drugs, there are still patients who suffer from pain and are responsibly using opioids as treatment.

April 23, 2018

As India, China drug industries mature, FDA scrutiny an overhang

Rising numbers of warning letters have put production quality in focus, just as both countries turn further toward novel drug R&D. 

By Ned Pagliarulo • April 23, 2018

Pfizer's Herceptin copy hits FDA roadblock

Regulators handed Pfizer a Complete Response Letter four months after approving Mylan's copycat version of the breast cancer drug. 

By Ned Pagliarulo • April 23, 2018

GW wins panel backing for Epidiolex, looks to FDA decision

Following an advisory committee's unanimous recommendation for Epidiolex, GW Pharma awaits a June decision on approval by the regulator. 

By Randi Hernandez • April 20, 2018

Prescribed Reading: Shire on the block; FDA flip-flops

There are potentially multiple suitors looking to take out Shire. Elsewhere, the FDA is making surprise reversals.

By Lisa LaMotta • 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

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

FDA staff positive on GW Pharma drug for seizures

Agency documents on the first whole-plant-based cannabis drug Epidiolex appear favorable for GW ahead of the Thursday advisory meeting. 

By Randi Hernandez • April 18, 2018

DEA seeks to more strictly manage opioid manufacturing

A proposed rule would allow the agency to consider drug misuse when setting the annual quotas that govern production of the painkillers. 

By Ned Pagliarulo • April 18, 2018

Amazon reportedly drops plan to distribute drugs to hospitals

The report is not entirely unexpected. Amazon previously canceled a wholesaler application in Maine and has told other state regulators it does not intend to sell drugs.

By David Lim • April 17, 2018

Alkermes up after FDA reversal on depression drug

The agency's about-face comes just two weeks after it issued a Refusal to File letter to the company.

By Lisa LaMotta • April 16, 2018