News

Heptares plans Alzheimer's PhII; AstraZeneca ends I-O trial rollout; 4D buys microbiome firm

​In this week's EuroBiotech Report, the results from a Phase I trial of Heptares' muscarinic M1 receptor agonist have added to its belief that its pursuit of an Alzheimer's disease target that stumped Eli Lilly can pay off. And more.

After 2nd positive PhIII, AbbVie points endometriosis drug elagolix to a 2017 NDA

AbbVie says it has racked up a second set of positive Phase III data for its endometriosis drug elagolix, setting up a regulatory filing for sometime next year.

Shire's Ornskov signals a pause in dealmaking after a $50B buyout streak

Shire, awaiting the close of its $32 billion merger with Baxalta, is planning to move away from its penchant for acquisitions and focus on developing and launching products, CEO Flemming Ornskov said.

Intercept books a date with the FDA as buyout rumors simmer

After an FDA-mandated three-month delay, Intercept Pharmaceuticals is set for a meeting with agency advisers to discuss obeticholic acid, an in-development liver drug tabbed by analysts as a potential blockbuster.

JAK inhibition for solid tumors flops, forcing Incyte to pull the plug on a slate of trials

Jakafi has failed to help patients in a late-stage study for pancreatic cancer, and Incyte feels that it now has all the data it needs to prove that a JAK1 inhibitor is the wrong way to go in solid tumors.

AstraZeneca, Innate Pharma wrap up rollout of first wave of checkpoint inhibitor trials

AstraZeneca has kicked off another clinical trial of monalizumab, bringing to an end a rollout of studies it committed to when it struck its $1.3 billion (€1.1 billion) alliance with Innate Pharma. The fifth and final clinical trial in the first wave of studies is investigating the combination of monalizumab and AstraZeneca's big immuno-oncology hope durvalumab.

Pursuing new deals to grow the pipeline, Szela axes staffers in Aegerion reorg

Mary Szela, the new CEO at Cambridge, MA-based Aegerion, has reached for the budget ax to help compensate for the rising tide of competition that has challenged its cholesterol drug Juxtapid. The company announced today that it is chopping about 25% of its staff--roughly 80 workers--as it whittles its roster of employees down to 230.

4D pharma buys Tucana to add diagnostic capabilities to microbiome R&D toolkit

4D pharma has struck a deal to buy Tucana Health. The takeover, which is costing £3.1 million ($4.5 million) upfront with more tied to milestones, is intended to boost 4D pharma's ability to identify patients who may benefit from live biotherapeutics, starting with a treatment for irritable bowel syndrome.

AveXis and Proteostasis survive the market storm, IPOs raise $145M for R&D

These days there are two kinds of biotech IPOs that make it to the market: The select few solid successes in line with the range and some bargain selections that provide a haircut on the price, where the company ups the number of shares but sells at a significant discount to the range. Another group are just quietly leaving their IPOs on the shelves or pulling out altogether to wait out the storm.

FierceBiotech Radio on pharma's day on the Hill, biotech's paucity of M&A, and the gathering storm of biosimilars

FiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss a bizarre congressional hearing, how biotech's slump affects the buyout climate, and a major development in the world of biosimilars.

Ferring pits prostate cancer drug against AbbVie's Lupron in PhIIIb CV outcomes study

Ferring Pharmaceuticals is set to put its prostate cancer drug Firmagon up against AbbVie's Lupron in a Phase IIIb trial. The study is designed to assess the cardiovascular safety profile of the gonadotropin-releasing hormone receptor agonist and antagonist, potentially giving Ferring an edge over a product that generated $826 million (€744 million) for AbbVie last year.

ImmuPharma rounds up £8.3M for PhIII trial of fast-tracked lupus drug

ImmuPharma has raised £8.3 million ($12.0 million) to propel its lupus drug through a Phase III study. The cash will support ImmuPharma through to the data readout from its 200-person transatlantic trial, at which point management will weigh up commercialization options.

Just how well do you think biopharma is handling the gender diversity issue?

I hope you'll take a minute--just a minute--to provide a letter grade on just how well biopharma is doing on gender diversity. And take a second to let us know what you're thinking. I'll be following up.

Heptares plans PhII Alzheimer's, schizophrenia trials after M1 agonist clears first clinical test

Heptares is gearing up to advance a candidate from its muscarinic M1 receptor agonist program into Phase II in patients with Alzheimer's disease, schizophrenia or Lewy body dementia. While specifics of which drug to aim at which indication are still being decided, Heptares has seen enough in its first clinical data to continue pursuing a target that has shown more promise than most in Alzheimer's.

Pending Allergan merger stirs layoff fears among Pfizer scientists

Pfizer's planned $160 billion merger with Allergan has some researchers worried the company will embrace its counterpart's austere approach to R&D and mount major layoffs.

Astellas finally wraps up its $379M deal for Ocata

After months of agitating and activism from miffed shareholders, Astellas has finally convinced the majority of Ocata Therapeutics investors to accept its $8.50-a-share offer, ending a surprisingly protracted process for the Japanese drugmaker.

Celgene, Google ante up for Armo's next-gen IL-10/PD-1 immuno-oncology combos

Well along in the clinic with a mix of second-wave immuno-oncology programs in early-stage studies, Armo BioSciences has lined up $50 million in funding to pay for pivotal stage development.

AbbVie taps Synlogic to take a microbiomic approach to IBD

Cambridge, MA, startup Synlogic signed its first major pharma partnership, teaming up with AbbVie in a multiyear collaboration in hopes of developing new treatments for inflammatory bowel disease.

Biogen, Sanofi back Tony Coles' neurodegeneration player Yumanity

For much of 2015, Tony Coles funded his neurodegeneration-focused startup Yumanity out of his own pocket. Seed money followed. And today he's pulling the veils off a $45 million A round designed to get him through the preclinical stage of identifying his top programs and on the way to further enlivening a growing field.

Patient deaths force FDA to slam the brakes on PhIII program for CTI/Baxalta's pacritinib

After a follow-up review, the FDA has decided that the adverse events and deaths recorded in CTI BioPharma's pivotal program of the myelofibrosis drug pacritinib are so alarming that they've imposed a full clinical hold on the trial, halting dosing and persuading the biotech to yank its newly completed drug application.

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