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Pfizer announces top-line results from Phase 3 Trial of LYRICA® (pregabalin) in primary generalized tonic-clonic seizures

World Pharma News - Fri, 05/24/2019 - 10:00
Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the use of LYRICA® (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in a statistically significant reduction in seizure frequency versus placebo.

Novartis' SMA Gene Therapy Treatment Approved by FDA, Priced at $2.125 Million

Biospace news - Fri, 05/24/2019 - 02:00
The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.

Novocure Wins FDA Approval for First Mesothelioma Treatment in 15 Years

Biospace news - Fri, 05/24/2019 - 02:00
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.

White House to Issue Executive Order to Disclose Pricing Across the Health Care Industry

Biospace news - Fri, 05/24/2019 - 02:00
The administration sees the push for transparency as a tool to help consumers control the costs of their health care.

Daiichi Sankyo Denies Report That It's Selling Over-the-Counter Drug Unit

Biospace news - Fri, 05/24/2019 - 02:00
On Thursday, Nikkei Business reported that Japan’s Daiichi Sankyo was in negotiations with several companies to sell its over-the-counter drug unit. The final price, Nikkei Business suggested, would hit around $900 million.

Tonix Pharma In-Licenses Drug to Treat Cocaine Intoxication

Biospace news - Fri, 05/24/2019 - 02:00
New York City-based Tonix Pharmaceuticals announced it has in-licensed a Phase II drug, TNX-1300, from Columbia University. TNX-1300 is a recombinant enzyme that degrades and metabolizes cocaine in cocaine abusers.

Stoke Therapeutics Files for $86 Million IPO

Biospace news - Fri, 05/24/2019 - 02:00
Stoke focuses on treating genetic diseases by upregulating protein expression. Its lead compound, STK-001, is focused on Dravet syndrome, a rare form of epilepsy that starts in infancy.

Dynavax to Lay Off 37% of Staff, CEO to Retire as Company Restructures

Biospace news - Fri, 05/24/2019 - 02:00
Dynavax plans to step away from immuno-oncology development and will lay off 37% of its staff as a result.

Research Roundup: Dog Ownership, Diabetes, Alzheimer’s, HIV Vaccine and More

Biospace news - Fri, 05/24/2019 - 02:00
Research Roundup for Friday, May 24.

Researchers ID How Common Liver Cancer Mutation Changes Cells

Biospace news - Fri, 05/24/2019 - 02:00
Researchers with the Hubrecht Institute in Utrecht, Netherlands and Radboud University in Nijmegen, Netherlands, recently developed a human model using organoids to evaluate the function of specific genes commonly mutated in liver cancer.

BioSpace Movers and Shakers, May 24

Biospace news - Fri, 05/24/2019 - 02:00
Biopharma companies from across the globe strengthen their leadership teams with key executive appointments.

Aspirin green light for brain bleed stroke patients, study finds

World Pharma News - Thu, 05/23/2019 - 19:00
People who suffer a stroke caused by bleeding in the brain - known as brain haemorrhage - can take common medicines without raising their risk of another stroke, a major clinical trial has found. Researchers say the findings are reassuring for the thousands of people who take the medicines to reduce their risk of heart attack and another common type of stroke caused by blood clots in the brain.

APRINOIA Therapeutics awarded grant from The Michael J. Fox Foundation for Parkinson's Research

World Pharma News - Thu, 05/23/2019 - 18:00
APRINOIA Therapeutics, a clinical-stage biotechnology company with a pipeline of therapeutics and imaging diagnostics for neurodegenerative diseases, announces today that it has been awarded are search grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) for the development of alpha-synuclein PET imaging tracers.

Bayer Makes Global Impact Through World Federation of Hemophilia Humanitarian Aid Program

Biospace news - Thu, 05/23/2019 - 02:00
In addition to education and training, it will offer Bayer’s complete portfolio of recombinant Factor VIII treatments to healthcare providers in more than 60 countries.

Report Highlights Positive Progress on Global Access to Medications

Biospace news - Thu, 05/23/2019 - 02:00
Pharma and biotech companies have been developing cutting-edge treatments and medications for a myriad of diseases but, for some patients, getting those medications has become a herculean task.

Report: Biopharma Manufacturing is a Robust and Vital Part of the U.S. Economy

Biospace news - Thu, 05/23/2019 - 02:00
The study found at least seven significant economic contributions of biopharmaceutical manufacturing.

Eli Lilly’s Generic Insulin Hits Market at Half the Price of Branded Counterpart

Biospace news - Thu, 05/23/2019 - 02:00
Lispro Injection is a generic of Eli Lilly's Humalog that is now available to diabetes patients at a 50% lower list price.

House Appropriations Committee Proposes 6% Increase in FDA Funding

Biospace news - Thu, 05/23/2019 - 02:00
“Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks,” the House Committee said in a statement. “...

MIT Professor Passed Off the Work of Others as His Own, Paper Claims

Biospace news - Thu, 05/23/2019 - 02:00
A paper published by Tillman Gerngross, chief executive officer of Adimab LLC, alleges that an MIT professor's work is nearly identical to work published several years before his.

BioSpace Global Roundup, May 23

Biospace news - Thu, 05/23/2019 - 02:00
Biopharma companies from across Europe share pipeline and strategy updates.