Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA staffers raise doubts over key Vertex combo

As an FDA review nears for Vertex's Kalydeco-lumacaftor tandem--approval of which could help Kalydeco reach 10 times the number of cystic fibrosis patients it currently does--the agency's staffers have some concerns.

Pfizer settles lawsuits tying sex and gambling addictions to dopamine meds

Pfizer is settling class-action litigation brought by patients who claimed the drugmaker did not adequately warn them of possible side effects of drugs they were taking to treat their Parkinson's disease or restless leg syndrome.

Novartis grabs Zykadia approval in Europe, setting the stage for showdown

Novartis' Zykadia picked up some steam in its head-to-head rivalry with Pfizer's Xalkori, snagging EU approval and setting the stage for a showdown as the companies compete for top dog.

Homeland Security: Hospira infusion pump vulnerable to cyberattack from low-skilled hacker

The Department of Homeland Security warned that due to a cybersecurity flaw, a low-skilled remote hacker could alter the configurations of Hospira's LifeCare PCA Infusion System.

Amarin sues FDA over 'free speech' issue the agency says it is ready to hash out

Irish drugmaker Amarin, which reported another quarterly loss today, has sued the FDA for curtailing its free speech, namely being able to discuss off-label uses of its omega-3 capsule Vascepa that might spur some sales.

FibroGen gets $15M from AZ as it advances roxadustat candidate toward China nod

AstraZeneca paid a $15 million milestone payment to U.S.-based FibroGen as it works on moving to file for China FDA approval for roxadustat, an anemia candidate in clinical trials, as early as next year.

China looks to guidelines for drugs prescribed to children

China has formed a committee to come up with a guide for ensuring the safety of drugs that are prescribed for children, seeking to assess how and why medicines are used and gather data for further study.

Free speech or simply marketing? The FDA is taking that argument public

The FDA is taking its off-label marketing debate public. After an onslaught of lawsuits and citizen petitions against drug-marketing restrictions--all citing the First Amendment--the agency will hold a public meeting this summer to talk about off-label promos and free speech,  Reuters  reports.  

AbbVie gets a 'breakthrough' for one of its top cancer drugs

A couple of months ago, AbbVie pointed to its late-stage cancer drug venetoclax (ABT-199) as a prime reason it was willing to pay a dizzying $21 billion in order to acquire Imbruvica-maker Pharmacyclics. Matching the blood cancer blockbuster with its experimental therapy would help amp up its market reach, said AbbVie. And the FDA has now boosted that argument with its breakthrough therapy designation for venetoclax, possibly opening the door to a swifter approval path.

FDA makes strides in inspection effort but challenges persist

In a report to Congress this week, the Office of Inspector General said that the number of inspections of generic drugmakers, preapproval and so-called surveillance inspections, were up to 243 in 2013 from 149 in 2011, a 63% jump. The vast majority of those were combined inspections for both preapproval applications and to check on general GMP conditions.