News

Almirall spares 9 jobs as ax falls on Spanish R&D operation

Almirall has confirmed it is to cut back its Spanish R&D operation as part of a move toward becoming a specialty dermatology company. But the ax-wielding is less severe than first expected, with Almirall retaining 9 of the 68 positions that were originally on the block.

Astellas dives into immuno-oncology with a sweeping biotech deal

Japanese pharma giant Astellas is entering the booming field of immuno-oncology, pairing up with Cambridge, MA's Potenza Therapeutics to work on a wide variety of treatments that use the body's natural defenses to combat cancer.

Allied Minds' SciFluor banks $30M to get into the clinic

SciFluor Life Sciences, a graduate of the Allied Minds startup factory, raised $30 million to get its fluorine-based candidates into clinical development.

Biogen gives Roche 'renewed confidence' in its own failed Alzheimer's drugs

Biogen turned heads around the industry last month with early data in which its plaque-destroying Alzheimer's treatment had a significant effect on patients' cognition, bucking a vexing trend for such antibodies. Among those paying close attention was Roche, which is now re-examining a pair of once-failed treatments.

Amgen, AstraZeneca prep a brodalumab pitch--after scuttling asthma program

Amgen and its partner AstraZeneca are winding up to deliver U.S. and European applications for their big blockbuster hopeful brodalumab for plaque psoriasis by midyear. But their last shot to push ahead with the drug in asthma ran into defeat, with Amgen announcing Tuesday afternoon that it pulled the plug on a Phase IIb following a futility assessment.

Juno's CAR-T contender comes through in another Phase I leukemia study

Juno Therapeutics' in-development cancer immunotherapy notched a 91% complete remission rate in a small trial on children with a form of leukemia, an incremental victory for the company as it rolls into late-stage trials.

Does a $45B Vertex buyout make sense for Gilead? Porges says heck yes

Bernstein's Geoffrey Porges has run the numbers on what a Gilead takeover of Vertex would look like. And he loves what he sees.

Gene therapy player Dimension stirs IPO buzz with $65M venture round

Demonstrating once again that gene therapy research has emerged as one of the hottest fields in biotech, Cambridge, MA-based Dimension Therapeutics has rounded up a $65 million B round from a slate of new and existing investors. Adding in Bayer's $20 million upfront for signing on as a partner last summer along with its A round, Dimension has now banked more than $100 million for its R&D activities. The only question now is whether it will wait long to file an IPO.

Alnylam's star RNAi drug keeps the pace on the way to Phase III

Alnylam's lead RNAi treatment continued to prevent nerve damage tied to a rare disease in an ongoing Phase II study, paving the path for late-stage development.

Following a setback, Pfizer gets a win in Phase III cancer drug study

Two years after going down in flames in a Phase III study for CD22-positive non-Hodgkin's lymphoma, Pfizer has helped resurrect hopes for top drug prospect inotuzumab ozogamicin, saying the drug hit its first primary endpoint for spurring hematologic remission in patients with CD22-positive acute lymphoblastic leukemia.

Surging Actelion is on the hunt for buyouts amid 'M&A frenzy'

Fueled by strong sales for its latest cardio drug and a promising pipeline, Switzerland's Actelion says it's on the lookout for acquisitions but remains wary of paying the big premiums that have become commonplace in pharma.

Shifting positions, Genervon now admits it has yet to file for ALS drug OK

The Wall Street Journal has caught up with the Genervon controversy, recapping a series of events from the last few days that followed the big social media campaign to gain an instant approval for a new ALS drug based on the results of a 12-patient study. FierceBiotech readers will know already that the data were questioned by Steve Perrin, president and chief scientific officer of the ALS Therapy Development Institute, and that the FDA followed up a day later with an extraordinary challenge to Genervon to publish the data on a drug that the biotech has touted as a major advance for patients.

Data in hand, Merck shoots for Keytruda approval for lung cancer

Hot on the heels of Bristol-Myers Squibb, Merck announced over the weekend that it has filed for FDA approval to market its PD-1 star Keytruda for non-small cell lung cancer.

Biotech guru Neil Woodford lands $1.2B for new tech fund

U.K. investment guru Neil Woodford has landed his $1.2 billion tech fund, making it a record debut for an investment trust in the country.

Lilly's psoriatic arthritis drug aces Phase III with a crowded market ahead

Eli Lilly's closely watched autoimmune treatment met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.

Ampio routed as lead osteoarthritis drug flunks a PhIII test

Shares of Ampio Pharmaceuticals were crushed this morning after the biotech acknowledged that its lead drug flunked a Phase III test for osteoarthritis. And the news comes just days after one of its drug subsidiaries was absorbed into a new biotech that will be called Aytu.

Novartis' new CAR-T hopeful looks safe in an early solid tumor study

A novel immuno-oncology treatment from Novartis and the University of Pennsylvania came through in an early safety study on patients with solid tumors, encouraging investigators and burnishing its potential.

Roche bets $555M on an Indian biotech's immuno-oncology drug

Roche inked a deal worth up to $555 million to work with India's Curadev Pharma on cancer treatments that use the body's immune system to combat tumors, expanding its trove of assets in one of the industry's hottest fields.

What's driving the massive social media campaign for Genervon's ALS drug?

Genervon CEO Winston Ko has repeatedly prodded a desperate ALS patient population and their families to demand that the FDA provide an accelerated approval to allow sales of its controversial drug based on the data from 8 patients in one tiny study.

Sanofi and Innate Pharma team up on anticancer ADCs

Sanofi has reached out to its French neighbor Innate Pharma to collaborate on armed antibody treatments, borrowing the biotech's technology to craft new treatments for cancer and inflammatory disease.