FDA warns Indian drugmaker over open-air API production

Inspectors from the agency weren't thrilled to find birds and insects nearby equipment used for drug manufacturing.

By Ned Pagliarulo • March 22, 2018

FDA to study how drug promotion affects doctors' decisions

Drugmakers spend billions of dollars trying to get their products in front of prescribers, and the FDA wants to know how influential that practice has become.

By Jacob Bell • March 21, 2018

Seattle Genetics secures key label expansion for Adcetris

The antibody-drug conjugate is now approved together with chemo for frontline Hodgkin lymphoma, giving newly diagnosed patients another treatment option.

By Ned Pagliarulo • March 21, 2018

HHS makes case against hospitals' 340B suit in new filing

Big cuts by HHS to payments made from pharmas to hospitals have become the center of a major legal fight.

By David Lim • March 21, 2018

New FDA transparency push begins with J&J's Erleada

The prostate cancer drug is the first in a new program which will involve publishing the key clinical trial data supporting approval decisions.

By Jacob Bell • March 20, 2018

CSL Behring's Hizentra wins FDA nod for CIDP

The company is hoping the plasma derivative's subcutaneous administration will differentiate it enough to capture market share.

By Randi Hernandez • March 19, 2018

CMS finalizes coverage of DNA sequencing for cancer patients

The agency will also cover similar tests approved by the FDA.

By Jeff Byers • March 19, 2018

Trump to pitch national PDMP to fight opioid crisis

The president will visit New Hampshire to announce a slate of proposals, including calling for legislation to allow Medicaid to reimburse residential treatment at facilities with more than 16 beds.

By David Lim • March 19, 2018

Prescribed Reading: Neuro's comeback tour

Activity in the neuroscience space spiked higher, with a flurry of licensing deals highlighting BioPharma Dive's prediction the field is ready for a resurgence.

By Lisa LaMotta • March 16, 2018

Solid Biosciences reveals upgraded clinical hold for gene therapy

The newly public biotech lost more than 60% of its value after announcing an FDA hold for its DMD study. 

By Lisa LaMotta • March 15, 2018

Pharma pay to hospitals in 340B under fire at Senate panel

The hearing comes as drugmakers point fingers at hospitals and other players involved in the drug pricing system.

By David Lim • March 15, 2018

SEC charges against Theranos, Holmes dispel last shreds of unicorn myth

According to the SEC's complaint, both repeatedly misled investors about the state of the company's once widely touted blood-testing technology. 

By Ned Pagliarulo • March 15, 2018

MorphoSys readies filing after positive Phase 2 lymphoma data

Promising mid-stage data in a hard-to-treat patient population has prompted the biotech to seek FDA approval early and begin commercialization plans.

By Lisa LaMotta • March 14, 2018

Right to Try fails amid warning from regulators, patient groups

Backers of the bill like President Trump and the Koch brothers faced off against major patient groups and some regulators.

By David Lim • March 14, 2018

Advaxis drops after clinical hold due to patient death

The death led the FDA to halt enrollment and dosing in a trial testing Advaxis' drug with Imfinzi, but analysts suggest AstraZeneca's drug could be the culprit.

By Lisa LaMotta • March 13, 2018

Prescribed Reading: Bold comments from Gottlieb, PBMs get the spotlight

Against the backdrop of Cigna's planned deal to buy Express Scripts, the FDA chief sharply criticized bad behavior from players involved in drug pricing.

By Lisa LaMotta • March 9, 2018

FDA recognizes GMP inspections by 4 more EU states

The move expands the number of EU regulators the FDA says can reliably conduct inspections of drug manufacturing facilities to 12.

By Ned Pagliarulo • March 8, 2018

Gottlieb takes aim at payers, pharmas for blocking biosimilars

The FDA chief lambasted PBMs, insurers and branded drugmakers for allegedly blocking market entry of the copycat biologics.

By Lisa LaMotta , David Lim • March 8, 2018

TaiMed's HIV biologic secures FDA nod

The approval showcases how China-based manufacturers of biologic drugs are moving up value chains to produce novel drugs. 

By Randi Hernandez • March 7, 2018

23andMe's DTC cancer test tentatively OK'd by FDA

Take-home genetic tests have gained traction with consumers, but regulators are warning they're no substitute for screenings at the doctor's office.

By Jacob Bell • March 7, 2018

Opdivo gets more flexible dosing, gaining edge over competition

The big pharma has found a new way to differentiate its PD-1 inhibitor as its closest competitor makes up ground.

By Lisa LaMotta • March 6, 2018

What's 'BerkshAmazMorgan' really capable of?

The recent announcement by Berkshire Hathaway, Amazon and JPMorgan Chase has pharma wondering what will happen next. Here are our top 4 predictions for this new collaboration.

By Howard Deutsch • March 6, 2018

Numbers show drugmakers are keeping RTFs under wraps

A BioPharma Dive analysis of company and FDA data show plenty of companies are not disclosing Refusal to File letters from the FDA. 

By Lisa LaMotta • March 5, 2018

Senator questions big pharma buyback strategy

Minnesota Senator Tina Smith asked five top pharmaceutical companies whether the benefits from the recent tax cut would be used to help lower drug costs.

By Randi Hernandez • March 5, 2018

Biogen, AbbVie withdraw MS drug after safety signals

The two companies removed Zinbryta, a third-line MS treatment, from global markets after cases of encephalitis cropped up. 

By Randi Hernandez • March 2, 2018