SEC Filings Reveal GlaxoSmithKline's 13% Stake in This Massachusetts Biotech
A filing with the SEC indicates that Glaxo now has a 13 percent stake in Spero Therapeutics. Source: BioSpace
On a Roll: FDA OKs Genentech's Gazyva for Untreated Follicular Lymphoma
Genentech scored two approvals from the FDA this week. Source: BioSpace
Pfizer Wins Expanded FDA Nod for Cancer Drug Sutent
The approval was based on results from a trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event for patients at high risk of RCC…
Takeda CEO Actively Hunts for Deals, Looks to Shed Non-Core Businesses
Bloomberg noted that Takeda's CEO is looking at making Takeda a nimble company, but one with a deeply entrenched R&D focus. Source: BioSpace
Eli Lilly Insulin Drug Price Tripled While Trump's HHS Nominee Was President of the U.S. Unit
Azar, the new HHS nominee, is being pitched as someone who will help lower the price of prescription drugs. Source: BioSpace
Arbutus' LNP Licensee Alnylam Initiates Rolling Submission of NDA to U.S. FDA for Patisiran
This submission allows the FDA to review completed portions of the NDA on an ongoing basis. Alnylam expects to submit final clinical data by year end. Source: BioSpace
scPharmaceuticals Nabs $89.6M in IPO
The company's common stock will begin trading on the Nasdaq under the ticker symbol "SCPH" today. Source: BioSpace
FDA Extends Review for Lipocine's TLANDO; Advisory Committee Meeting Date of January 10, 2018 Rem…
The FDA has assigned a new Prescription Drug User Fee Act goal date of May 8, 2018. Source: BioSpace
FDA Committee Votes Against Bayer’s Cipro Inhalation Powder
An FDA advisory committee voted Thursday to not recommend two regimens for Bayer’s inhalation-powder formulation of ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis, citing inconsistent data from clinical trials.…
Bill on Use of New Drugs for Soldiers Heads to White House
The Senate gave final congressional approval to a bill designed to resolve a dispute involving FDA and the Department of Defense, preserving FDA’s authority over authorizing innovative medical treatments for…
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