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NGM Bio hits endpoint in Phase 2 NASH study

The biotech's engineered hormone drug rapidly reduced liver fat and fibrosis in patients with liver disease. The next step will be a Phase 2b study in NASH patients later this year.

Kineta, Roche's Genentech strike chronic pain deal

Kineta's first big pharma deal could speed development of a potential disease-modifying pain drug.

Q1 kicks off with J&J, Novartis, Glaxo results

J&J and Novartis have already turned in their score cards for the first quarter. Biogen, Eli Lilly, Amgen and GSK will report next Tuesday and Wednesday. 

FDA removes clinical hold on Bellicum's cell therapy

Bellicum's trials for BPX-501, which are investigating the candidate as an adjunctive therapy for stem cell transplantation in cancer, may now resume after the FDA OK’d protocol modifications.

Mylan bets future on complex generics

The drugmaker aims to move past hard times, highlighting its strength in biosimilars and other complex copycat drugs. 

ICER releases draft report on CGRP migraine drugs

The watchdog group's review says that Aimovig could only treat 16% of the population without affecting the healthcare budget.

GSK offloads gene therapy drugs to UK's Orchard

Included in the deal is GSK's Strimvelis, a one-off treatment for a rare immune deficiency that's shown the commercial challenges of gene therapy.

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Prescribed Reading: Novartis ups the ante in gene therapy, while GSK folds on the space

Big pharmas are placing their bets on the future of gene therapy, with one European company going all-in and another pulling out.

Hanmi scraps lung cancer drug due to AstraZeneca rival, reports say

Olita showed promise but fizzled amid partnership and safety setbacks, and ultimately failed to compete with AstraZeneca's Tagrisso.

PCSK9s appear to be meeting less payer resistance

A new report finds the nation's largest health plans ultimately denied 26% of claims for the cholesterol-lowering drugs in 2017 — a lower rate than before.

Lonza makes gene therapy ambitions clear with Texas plant

Banking on surging demand for the biologic components of gene therapy, Lonza has constructed what it claims is the world's largest dedicated facility for production of the complex treatments.

Sanofi boosts vaccine supply capabilities with Toronto investment

The Toronto site is the exclusive producer of the five-component pertussis, an antigen used to make pertussis combination vaccines.

Pfizer's Inlyta misses mark in Phase 3 kidney cancer study

Attention will now turn to a combination study testing the tyrosine kinase inhibitor together with Pfizer's immunotherapy Bavencio.

Alexion broadens pipeline with $855M Wilson Therapeutics buy

The deal hands Alexion WTX101, a candidate in Phase 3 testing for a rare genetic condition called Wilson's disease.

Roche pauses Tecentriq/Cotellic cancer trial after 4 patient deaths

The Swiss pharma called a temporary halt to recruitment in its PD-L1/MEK inhibitor Phase 2 study for metastatic colorectal cancer.

CVS hands pharmacists tool to compare drug prices

Aiming to tamp down on out-of-pocket costs, CVS will roll out a new program designed to help retail pharmacists find the cheapest drug option for patients.

Kadmon gets FDA go-ahead for ROCK2 inhibitor study

​Based on the regulator's feedback, Kadmon says a planned Phase 2 open-label study could potentially support registration of the drug in graft-versus-host disease.

Pfizer inks lease on new NYC headquarters

The pharma giant's new digs will house most of the 3,200 staff employed at the company's current location in the city. 

Latest Phase 3 failure underscores Alzheimer's indomitable nature

Shares of vTv Therapeutics fell nearly 70% on the news it is discontinuing clinical studies of its lead candidate following a late-stage miss.

Novartis buys AveXis for $8.7B, broadening gene therapy bet

Acquiring the U.S. biotech and its late-stage candidate for spinal muscular atrophy is new CEO Vas Narasimhan's first major deal as Novartis chief.

FDA to take closer look at liver data, delaying AbbVie's elagolix

The agency pushed back its decision date for the endometriosis-associated pain drug by three months in order to review liver function tests. 

AstraZeneca snaps up NASH candidate from Ionis

The British pharma will pay Ionis $30 million to take over development reins, the third time it has licensed a drug from Ionis under a 2015 deal. 

With study success, AbbVie's arthritis hopeful looks to be a safer bet

Upadacitinib hit on all trial endpoints in a large Phase 3 study, results that eased concerns about the experimental JAK inhibitor's safety profile.

Menlo's Phase 2 skin data disappoints, shares plummet

Though it could not scratch the Phase 2 itch, the company is still banking on the NK-1 receptor agonist's potential in other indications.