HTC Says Its Crypto-Friendly Smartphone Will Support Litecoin

Litecoin creator Charlie Lee revealed Monday he will serve as an advisor to HTC’s Exodus, the blockchain-powered smartphone.

Fierce Biotech

UCB's bispecific outshines AbbVie's Humira in phase 3 psoriasis test

UCB’s bispecific antibody recently beat Johnson & Johnson’s Stelara at clearing psoriasis symptoms in a phase 3 study, and now it has bested AbbVie’s Humira, too. After 16 weeks of treatment, more patients who received UCB’s drug achieved a 90% reduction of psoriasis area and severity and clear or almost clear skin.

Amirah Al Idrus

Foundation Medicine nets 19th companion Dx approval, for Novartis’ aspiring breast cancer blockbuster Piqray

Foundation Medicine received a new companion diagnostic approval from the FDA for its FoundationOne CDx test, now for selecting breast cancer patients for treatment with Novartis’ Piqray targeted therapy.

Conor Hale

FDA hits Ipsen's $1B drug with clinical hold over safety signal

The FDA has placed two trials of palovarotene on partial clinical hold eight months after Ipsen gained the drug in its $1 billion (€900 million) takeover of Clementia Pharmaceuticals. FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist.

Nick Paul

Biogen's Rorschach readout continues as detailed Alzheimer's data divide experts

Biogen has shared the detailed data on aducanumab that it hopes will secure FDA approval in Alzheimer’s disease. The Clinical Trials on Alzheimer's Disease presentation cleared up some questions about the data set without delivering a telling blow for either side of the debate.

Nick Paul

FDA knocks down Enzyvant candidate on manufacturing concerns after plant inspection

Privately held biotech Enzyvant was hoping its first shot at an FDA approval with a rare immunodeficiency disease candidate would come up in its favor. But the FDA has dashed those hopes, citing manufacturing concerns in a response letter—at least, for now.

Kyle Blankenship

Biospace.com

BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4) - Dec. 05, 2019

BridgeBio Pharma, Inc. announced that on November 22, 2019, the compensation committee of BridgeBio’s board of directors granted eight new employees options to purchase an aggregate of 62,745 shares of the Company’s common stock with a per share exercise price of $31.14 and restricted stock units for an aggregate of 23,980 shares of the Company’s […]

CooperCompanies Announces Fourth Quarter and Full Year 2019 Results

CooperCompanies announced financial results for the fiscal fourth quarter and full year ended October 31, 2019.

Latham & Watkins Advises Ardelyx in Upsized Public Offering of Common Stock

Ardelyx, Inc. has announced the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.25 per share, before underwriting discounts and commissions, for gross proceeds of $125,000,000.

Alpha Holdings Comments on OncoSec’s Inability to Defend China Grand Takeover

Alpha Holdings, Inc., the largest stockholder of OncoSec Medical Incorporated, with an approximate 15.1% ownership stake, issued the following response to OncoSec’s most recent announcements.

Biotech Startup 4TEEN4 Pharmaceuticals Closes EUR 7 Million Series A Financing

4TEEN4 Pharmaceuticals GmbH announced the closing of a EUR 6.9 million Series A financing round.

Feedity.com/biospace

Meitheal Pharmaceuticals Announces FDA Approval of Enoxaparin Sodium Injection, USP in the United States

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox®.

FDA approves first generics of Gilenya

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer

Results of Phase 1 and 2 studies in BCG Unresponsive Non-Muscle Invasive Bladder Cancer in High Risk Carcinoma in Situ Disease Earn FDA Breakthrough Status for ImmunityBio’s IL-15 Superagonist Complex

Personal Genome Diagnostics Receives Investigational Device Exemption Approval from the FDA to Support Merck’s Precision Oncology Trial

Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for the use of the company’s elio™ tissue complete assay in a Merck trial of pembrolizumab-based combination therapy.

Technology

Adobe is acquiring Oculus Medium, a virtual reality sculpting tool launched in 2015, from Facebook (Adi Robertson/The Verge)

Adi Robertson / The Verge: Adobe is acquiring Oculus Medium, a virtual reality sculpting tool launched in 2015, from Facebook — New updates will be coming in 2020 — Adobe is acquiring Oculus Medium, a virtual reality sculpting tool originally revealed by the Facebook-owned VR company in 2015.

SEC has rejected NYSE's proposal to allow companies going public through a direct listing to raise capital at the same time (Ari Levy/CNBC)

Ari Levy / CNBC: SEC has rejected NYSE's proposal to allow companies going public through a direct listing to raise capital at the same time — - Last week, the New York Stock Exchange filed for a rule change that would allow companies in a direct listing to raise capital.

Facebook says its AI bot achieved high scores playing Hanabi, a card game requiring teamwork, showing how AI can work with other bots or people to reach a goal (Queenie Wong/CNET)

Queenie Wong / CNET: Facebook says its AI bot achieved high scores playing Hanabi, a card game requiring teamwork, showing how AI can work with other bots or people to reach a goal — The bot got a nearly perfect average score playing the card game Hanabi. — Facebook has already built artificial intelligence-powered bots […]

Report: Magic Leap sold ~6,000 headsets in six months after release, compared to a goal of 100,000 in the first year, and recently laid off dozens of employees (Adi Robertson/The Verge)

Adi Robertson / The Verge: Report: Magic Leap sold ~6,000 headsets in six months after release, compared to a goal of 100,000 in the first year, and recently laid off dozens of employees — And Google CEO Sundar Pichai reportedly left its board — Magic Leap's sales numbers reportedly haven't matched CEO Rony …

Foursquare CEO Jeff Glueck is leaving at the end of the year, to be replaced by David Shim, who joined Foursquare as president in June (David Cohen/Adweek)

David Cohen / Adweek: Foursquare CEO Jeff Glueck is leaving at the end of the year, to be replaced by David Shim, who joined Foursquare as president in June — Jeff Glueck is leaving after leading the company for 4 years — David Shim, who joined the location-based recommendation platform Foursquare as president in June […]