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Updated: 28 min 51 sec ago

More bad Alzheimer’s news as FDA device panel is not persuaded by Neuronix’s TMS study

Fri, 03/22/2019 - 13:35
An agency advisory panel voted against recommending clearance for Neuronix's transcranial magnetic stimulation device, which targets the memory and learning centers of the brain during cognitive therapy sessions.

A smart toilet seat to detect heart failure?

Fri, 03/22/2019 - 07:54
A new toilet seat-based monitoring system aims to spot the signs of congestive heart failure in the privacy of the home, with the noble goal of lowering hospital readmission rates. Developed by researchers at RIT, the sensors in the high-tech seats will be privy to a person’s heart rate, blood pressure and more.

Turning Point Therapeutics eyes $100M IPO to propel treatment for drug-resistant tumors

Fri, 03/22/2019 - 07:49
Turning Point Therapeutics has filed to raise up to $100 million in its Nasdaq debut. The proceeds will push its lead asset, repotrectinib, into phase 2 studies and to advance a pair of earlier-stage programs in advanced solid tumors.

Impulse Dynamics wins FDA approval for breakthrough heart implant

Fri, 03/22/2019 - 06:50
The FDA has approved another one of its breakthrough devices: an implant from Impulse Dynamics designed for patients with chronic heart failure who aren’t able to use a pacemaker or standard cardiac resynchronization therapy.

CRISPR diagnostic maker Sherlock Biosciences says the game’s afoot with $35M launch

Fri, 03/22/2019 - 04:53
Sherlock Biosciences is launching with $35 million and a two-pronged approach to improving the current state of diagnostics, with the goal of creating new tools that “reach further out, where testing isn’t being done today, but should be."

Conatus and Novartis suffer another midphase NASH flop

Fri, 03/22/2019 - 03:22
Conatus Pharmaceuticals’ emricasan has failed another midphase clinical trial. The latest setback saw the Novartis-partnered liver disease drug fail to beat placebo in NASH patients, wiping another 50% off Conatus’ stock price.

One day after aducanumab disaster, Eisai kick-starts backup Alzheimer’s drug trial

Fri, 03/22/2019 - 02:31
Albert Einstein is often attributed as saying: “The definition of insanity is doing the same thing over and over again, but expecting different results.” He likely didn’t actually say this, but regardless of its origins, this witticism comes sharply into focus when you read Eisai’s PR about starting new trials for BAN2401.

J&J dumps Alios RSV drug, wiping remaining $900M off value

Fri, 03/22/2019 - 00:29
Johnson & Johnson has abandoned development of anti-RSV drug AL-8176, wiping another $900 million off the value of the assets it acquired from Alios Biopharma. The writedown comes months after J&J took a $630 million hit tied to the suspension of clinical development of AL-8176.

GSK’s anti-BCMA multiple myeloma drug shows durability in updated data

Thu, 03/21/2019 - 14:47
Patients taking GlaxoSmithKline’s anti-BCMA treatment for multiple myeloma had an overall response rate of 60% and median progression-free survival of one year, new phase 1 data show. The Big Pharma expects pivotal data for the candidate by the end of the year.

Fresenius forms new global medical office to coordinate R&D and practice sharing

Thu, 03/21/2019 - 12:48
Dialysis provider Fresenius Medical Care has created a new global medical office that will head up its work in clinical science and coordinate knowledge and practice sharing across the company’s global network of clinics.

Chutes & Ladders—Two senior Genentech executives make the leap to smaller biotechs

Thu, 03/21/2019 - 11:08
NGM Bio gains a Genentech and Lilly vet as new R&D chief, as Forma nabs a longtime Genentech commercial executive as CEO. Meanwhile, Nimbus builds out its team with new heads of biology and preclinical development. Those moves plus more hirings, firings and retirings throughout the industry.

EuroBiotech Report—Alexion's Euro deals, Biogen-Nightstar, Genfit IPO and Allergy flop

Thu, 03/21/2019 - 06:58
In this week's EuroBiotech Report, Alexion strikes deals with European biotechs, Nightstar discusses a Biogen deal and Genfit sets IPO terms.

Forma Therapeutics nabs long-time Genentech commercial executive as CEO

Thu, 03/21/2019 - 06:42
Forma Therapeutics has poached a Genentech senior vice president, Frank Lee, to be its new CEO, effective March 27.

EuroBiotech: More articles of note

Thu, 03/21/2019 - 06:41
In our EuroBiotech roundup this week, Enterone forms a cancer pact, Motif soars on an FDA update and Affimed receives a Genentech payment. 

Ely Benaim to leave Rexahn, take CMO role at Novocure

Thu, 03/21/2019 - 06:36
Ely Benaim is set to leave Rexahn Pharmaceuticals to take up the CMO position at Novocure. The move comes as Rexahn closes in on data from a phase 2a trial of its pancreatic cancer prospect. 

Biotech builder Cydan boosts R&D leadership with 2 new hires

Thu, 03/21/2019 - 06:28
Drug accelerator Cydan is building out its R&D leadership, hiring on Yongchang Qiu, Ph.D., as vice president of preclinical development and Ryan Tyler, Ph.D., as senior director of preclinical research.

Alexion strikes Zealand deal to further pipeline rebuild

Thu, 03/21/2019 - 05:46
Alexion and Zealand Pharma have teamed up to develop peptide therapies for complement-mediated diseases. The deal will see Alexion pay $25 million (€22 million) upfront to work with Zealand on the subcutaneously delivered therapies.

Bypassing the anti-cancer p53 gene for better CRISPR editing in blood disorders

Thu, 03/21/2019 - 05:00
Stem cells' natural response to damage could limit use of the CRISPR gene editing tool in certain inherited immune and blood disorders. But a team led by scientists in Italy has managed to keep the complication under control by bypassing the well-known anti-cancer gene p53.

Biogen hit by 'transformative failure' as it cans aducanumab tests

Thu, 03/21/2019 - 04:54
Biogen and partner Eisai are throwing in the towel on late-stage tests for their key Alzheimer’s drug as independent experts reveal that it just won't make the grade.

WIRB-Copernicus launches product aimed at institutions and research sites

Wed, 03/20/2019 - 21:26
Clinical trial specialist WIRB-Copernicus Group launched a new product aimed at upping the efficiency and profitability of clinical research operators at institutions and independent research sites.