FDA knocks back Novartis' Advair copy

Rejection of the generic will give GSK some breathing room as it prepares to absorb the financial hit of losing patent protection for the blockbuster asthma drug.

By Ned Pagliarulo • Feb. 8, 2018

Drug distributors join group to mitigate opioid crisis

A newly formed coalition, called Allied Against Opioid Abuse, includes distributors, care providers and pharmacists who seek to stem opioid abuse.

By Kate Patrick Macri • Feb. 7, 2018

New York latest to sue opioid manufacturer Insys

The New York lawsuit is the latest in a spate against the drug company: North Carolina, New Jersey and Illinois have all engaged in legal action against Insys.

By David Lim • Feb. 5, 2018

Prescribed Reading: Tax changes disappoint, ho-hum earnings

Recent earnings reports shine a light on investor expectations for the tax code changes and M&A in 2018.

By Lisa LaMotta • Feb. 2, 2018

Celltrion biosimilars plant hit with FDA warning letter

The South Korean drugmaker doesn't expect the warning to impact its ability to supply Pfizer with Inflectra, the companies' Remicade copy.

By Ned Pagliarulo • Feb. 1, 2018

India's Semler sues FDA for $50M over suspicious spreadsheet

Semler is taking on the FDA over actions the CRO says were spearheaded by a disgruntled employee.

By Suzanne Elvidge • Feb. 1, 2018

FDA adds black box warning to Intercept's Ocaliva

Shares in the New York biotech rose on relief the FDA's caution did not broadly limit use of the drug in patients with mild or moderate liver disease. 

By Ned Pagliarulo • Feb. 1, 2018

How Amazon, JPM and Berkshire could disrupt healthcare (or not)

"News of three corporate giants forming an independent healthcare company proves every business is a healthcare business," said David Vivero, CEO of digital health startup Amino.

By Shannon Muchmore, Daphne Howland & Jeff Byers • Jan. 31, 2018

Patient death, clinical hold sink Bellicum shares

Three patients treated with the biotech's BPX-501 developed encephalopathy, causing the FDA to halt all U.S.-based trials of the drug.

By Jacob Bell • Jan. 31, 2018

CutisPharma wins FDA approval of oral liquid vancomycin

The company's version of the antibiotic is designed to reduce the burden on pharmacists who compound the drug into liquid formulations.

By Suzanne Elvidge • Jan. 30, 2018

Industry awaits FDA on rules for real-world evidence

Top FDA officials talk up data from outside the clinic, but the agency has yet to give the industry concrete guidance for best practices.

By Lisa LaMotta • Jan. 29, 2018

Aradigm stung by FDA rejection of inhaled antibiotic

In a Complete Response Letter to the biotech, the regulator asked for another costly Phase 3 study to further prove Linhaliq's efficacy. 

By Ned Pagliarulo • Jan. 29, 2018

FDA approves Novartis-acquired Lutathera for certain gut cancers

Novartis' new acquisition won an FDA OK for gastroenteropancreatic neuroendocrine tumors.

By Suzanne Elvidge • Jan. 29, 2018

FDA changes biologics inspections from biennial to risk-based

"While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase," FDA chief Scott Gottlieb said.

By David Lim • Jan. 26, 2018

Prescribed Reading: Art of the deal, pharma dines with Trump

Just a few weeks into the year, M&A showed signs of life. Meanwhile, pharma execs schmoozed in Davos and Q4 earnings were all about the art of the deal. 

By Lisa LaMotta • Jan. 26, 2018

Azar confirmed as HHS secretary in bipartisan vote

The former Eli Lilly executive, attacked by some critics as too cozy with the pharmaceutical industry, has said he will make drug prices a top priority.

By David Lim • Jan. 24, 2018

EMA frets drug shortages ahead of Brexit

The European regulatory agency is surveying U.K. manufacturers to prepare for drug shortages after the U.K.'s departure from the EU. 

By Lisa LaMotta • Jan. 24, 2018

FDA debuts paper on quality standards, aiming to decrease review times

The Office of Pharmaceutical Quality is aiming to give manufacturers clarity on standards, in line with other FDA initiatives to increase efficiency. 

By David Lim • Jan. 24, 2018

UPDATED: Shutdown ends after half of HHS furloughed

With government agencies operating at a diminished capacity, the FDA had been set to stop routine establishment inspections, as well as certain compliance and enforcement activities.

By David Lim • Jan. 22, 2018

Braeburn hits setback with CRL for opioid disorder

One analyst says the delay could push back approval by four to eight months.

By Suzanne Elvidge • Jan. 22, 2018

FDA to speed public notification of product recalls

The move is part of the FDA's efforts to strengthen its enforcement of potentially unsafe food and medical products.

By Ned Pagliarulo • Jan. 19, 2018

Prescribed Reading: Murmurs of M&A, backlash over CRLs

Celgene may make another acquisition, while the FDA Commissioner gets his first negative marks for reneging on a promise. 

By Lisa LaMotta • Jan. 19, 2018

FDA issues PRV guidance for medical countermeasures

A new PRV program looks to reward drugmakers for developing products that address diseases tied to biological, nuclear and other threats, as well as emerging infectious diseases.

By Suzanne Elvidge • Jan. 19, 2018

Pharma, payers clash over CMS Part D drug rebate plan

The drug, PBM and insurance industries differ on a CMS proposal to require Part D sponsors to pass on a percentage of rebates to consumers.

By David Lim • Jan. 18, 2018

Shire's latest approval won't save it from Hemlibra

The EC thumbs up for Adynovi should bolster Shire's hemophilia business, yet Roche's new drug still threatens bottom lines. 

By Jacob Bell • Jan. 17, 2018