Number of violation letters issued by FDA hits all-time low

Over the last two years, the FDA's Office of Prescription Drug Promotion (OPDP) issued only 20 letters. 

By Nicole Gray • Jan. 7, 2016

Biotech startup Vtesse granted FDA breakthrough designation for orphan NPC drug

Vtesse has been working on a potentially first-of-its-kind treatment for Niemann-Pick Type C1 Disease, a genetic disease affecting one in 100,000 to 150,000 children. 

By Ned Pagliarulo • Jan. 6, 2016

ACCME vs. PharmedOut: How credible is CME in the age of Addyi?

Dr. Adriane Fugh-Berman, director of PharmedOut, has argued that most CME is commercially driven. 

By Nicole Gray • Jan. 6, 2016

Gilead grabs priority review for pangenotype hep C combo; Hep B med shown to be safe

The combo, which includes the megablockbuster Sovaldi, won priority review just as the biotech announced its experimental hep B drug was proven as effective and safer than its current med. 

By Ned Pagliarulo • Jan. 6, 2016

Rat study finds link between neural tube defects and low PCSK9 levels

If the results hold, they could raise concerns about taking PCSK9 inhibitors during pregnancy. 

By Nicole Gray • Jan. 5, 2016

New UK program gave 500 melanoma patients early access to Merck's Keytruda

Keytruda had been accepted into the UK's new Early Access to Medicines Scheme back in March of 2015. 

By Nicole Gray • Jan. 4, 2016

FDA oncology chief Pazdur scrutinized over cancer drug approvals after wife's death

After facing criticism for a slow process, drug approval times have declined by one month at the FDA over the past three years—a period concurrent with Mary Pazdur's battle with cancer and eventual death. 

By Nicole Gray • Jan. 4, 2016

The year ahead: 11 execs & experts predict what's in store for biopharma in 2016

With a record-setting year behind us, we can only imagine what’s ahead for the industry in the coming months. Fortunately, industry execs and experts from Sanofi, Boehringer, Bain, amfAR, Novocure, and others shared some of their own predictions with BioPharma Dive.

By Nicole Gray • Jan. 4, 2016

FDA approves 2015's 45th new drug, AstraZeneca's gout med

Zurampic (lesurinad) is indicated for treatment of hyperuricemia, often associated with gout.

By Nicole Gray • Dec. 23, 2015

11 biopharma execs & experts look back on 2015: A record year for record-breaking

We spoke with bigwigs from Sanofi, the Biosimilars Council, Novocure, Accenture, Bain, amfAR, Boehringer Ingelheim, and more on what they considered the most significant events that drove biopharma this past year.

By Nicole Gray • Dec. 22, 2015

Sun Pharma's Halol plant gets FDA warning, shares slump 7%

The FDA is not satisfied with Sun's current efforts to fix quality-related issues found during inspections. 

By Nicole Gray • Dec. 21, 2015

Fortune reporter offers apology for previous glowing coverage of Theranos

In June 2014, Roger Parloff wrote a cover story for Fortune extolling Theranos and its CEO, Elizabeth Holmes. Now, he's detailed how he felt the company misled him. 

By Nicole Gray • Dec. 18, 2015

Chinese FDA's crackdown on poor-quality drugs shows no signs of easing up

The Chinese Food and Drug Administration announced it would strengthen regulation of clinical trials for new drug development. 

By Nicole Gray • Dec. 18, 2015

Narcan is just the beginning: Unleashing the power of opioid antagonism

We spoke with Roger Crystal, CEO of Lightlake Therapeutics, about new ways to use old drugs to address opioid overdose and other addiction-related disorders.  

By Nicole Gray • Dec. 18, 2015

Lilly gets its Lantus copycat Basaglar approved by FDA—but not as a biosimilar

Although the agency approved Basaglar in part due to its similarity to Sanofi's existing insulin superstar, it deemed the therapy a "follow-on biologic" in the U.S.

By Ned Pagliarulo • Dec. 17, 2015

Advaxis soars as FDA releases patient death-related clinical hold on its drugs

Shares have flown more than 55% since Tuesday afternoon.

By Nicole Gray • Dec. 17, 2015

Ted Cruz proposes controversial plan to expedite drug approvals through 'reciprocity'

The RESULT plan would essentially allow Congress to overrule FDA decisions. 

By Nicole Gray • Dec. 16, 2015

Mylan to Strides: Help us cover the tab for your noncompliant plants

There were signs of problems at several Bangalore-based facilities before Mylan acquired Strides Arcolabs in late 2014. 

By Nicole Gray • Dec. 16, 2015

Valeant, in the hot seat, beefs up its legal and crisis management muscle

The pharma giant has typically not lobbied Capitol Hill aggressively, making this move a change in strategy. 

By Nicole Gray • Dec. 14, 2015

FDA approves first-of-its-kind chemo overdose antidote, Vistogard

It's a first-in-class oral therapy marketed by Wellstat Therapeutics. 

By Nicole Gray • Dec. 14, 2015

New study: Too many factories, too few inspectors for India's pharma industry

A review by Assocham/RNCOS found that there are roughly 1,500 qualified inspectors for 10,000 Indian manufacturing facilities. 

By Nicole Gray • Dec. 11, 2015

FDA AdComm recommends Teva asthma drug for adults—but not teens

In a rebuke, the committee unanimously voted not to recommend approving the drug for children between the ages of 12 and 17. 

By Nicole Gray • Dec. 11, 2015

A lead researcher and a Boehringer SVP on the drumbeat of innovation in oral anticoagulants

We spoke with the two experts to better understand how innovation can thrive even when things seem to be headed south. 

By Nicole Gray • Dec. 11, 2015

Clinton plan would pump brakes on Pfizer-Allergan deal, other major inversion mergers

The presidential contender's proposal would require inversion deals to set a 50% foreign company ownership threshold before a U.S. firm can shift its tax base, among other measures.

By Ned Pagliarulo • Dec. 10, 2015

Sanofi scores landmark approval for world's 1st Dengue vaccine in Mexico

Dengvaxia will likely be approved in other regulatory markets, too. The big question for Sanofi is, what's an appropriate price point?

By Nicole Gray • Dec. 10, 2015