FDA pushes pharma to continue efforts in Alzheimer's

In new guidance to industry, the regulator signaled greater flexibility around the use of biomarkers in studying the neurodegenerative disease.

By Suzanne Elvidge • Feb. 16, 2018

J&J gets first-of-its-kind prostate cancer approval

The FDA greenlighted apalutamide for non-metastatic CRPC based on a new endpoint: metastasis-free survival. 

By Lisa LaMotta • Feb. 14, 2018

BIO: Pain pipeline lacking as opioid crisis continues

The analysis comes as a new Senate report calls into question drugmaker ties to advocacy groups in fighting the epidemic.

By Suzanne Elvidge • Feb. 14, 2018

Trump pitches changes to 180-day generic exclusivity

The administration's budget includes a proposal to prevent generic drugmakers from abusing the current system.

By David Lim • Feb. 13, 2018

Fewer regs could lower drug costs: White House council

The Council of Economic Advisers also suggested creating an independent agency to oversee the 340B prescription drug program.  

By Les Masterson • Feb. 12, 2018

Pharma to pay more under 2-year budget deal

Staving off an extended government shutdown, the pact includes higher payments from drugmakers for Medicare recipients and more funds to fight the opioid crisis.

By David Lim • Feb. 9, 2018

Prescribed Reading: Earnings point to restructuring, not M&A

As pharma companies continued to report full-year earnings, the M&A spree has stopped and the focus has shifted to fixing up the pipeline. 

By Lisa LaMotta • Feb. 9, 2018

FDA warning letter details violations at Celltrion plant

Issuance of the warning letter to Celltrion is causing a headache for Teva, which uses the Korean drugmaker to produce API for its biosimilar candidates and fremanezumab. 

By Ned Pagliarulo • Feb. 8, 2018

Isotope manufacturing headed back to US following new FDA approval

The agency OK'd the RadioGenix System, which produces a radioisotope used in more than 80% of nuclear medicine imaging in the U.S.

By Jacob Bell • Feb. 8, 2018

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