Industry news

Gottlieb: Don’t take away FDA’s drug/device approval remit for soldiers

Ben Adams / FierceBiotech

FDA Commissioner Scott Gottlieb, M.D., has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for soldiers. A new policy from the Senate’s National Defense Authorization Act, which is going through committee, would allow the Pentagon to approve devices and drugs not green-lit by FDA to be used on military personnel “for emergency use.” The plans were first published this week by Politico.

Russian government proposed to increase funding for pharmaceutical industry

GMP News

The government has proposed to increase funding for the state program “Development of Pharmaceutical and Medical Industry” by 6.38 million rubles in 2018-2020. This results from the amendments to the draft budget prepared for the second reading in the State Duma.

Scientists developing a new approach to antibiotic resistance

GMP News

Antibiotic resistance to serious wound and systemic infections is a growing concern, particularly among those injured in combat. Researchers at the University of Maryland School of Medicine (UM SOM) are studying how to fend off deadly infections by targeting the body’s immune response to harmful bacteria.

FDA loosens rules on consumer genetic health tests

Nick Paul Taylor / FierceBiotech

The FDA has cleared the way for more direct-to-consumer genetic health tests to come to market. If finalized, the approach will allow certain manufacturers to bring genetic tests to market without undergoing premarket review.

ARPM and others review medicines advertising in Russia

Remedium

At a special session of Russia’s National Advertising Forum-2017, titled “Those who must not be named: advertising of pharmaceutical products, prohibitions and opportunities,” the principles of inter-industry self-regulation in the field of medicine advertising were discussed.

Pfizer renews 'Know Pneumonia' campaign with myth-busting creative

Beth Snyder Bulik / FiercePharma

The new TV commercial shows healthy older people asking myth-type questions, including, “Isn’t it like a bad cold or flu?” and, “Can I catch it from a pneumococcal vaccination?” A doctor—portrayed by an actor—responds to the inquisitors, telling them that it’s actually a potentially serious bacteria, and that vaccines do not contain live bacteria so no, you can’t catch it from the shot.

08 November 2017

Clearside Biomedical, Inc. Announces Third Quarter 2017 Financial Results and Provides Corporate Update

Clearside Biomedical, Inc.  (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today reported financial results for the quarter and nine months ended  September 30, 2017  and provided an update on its key development programs.

08 November 2017

Neothetics Provides Business Update and Reports Third Quarter 2017 Financial Results

Neothetics , Inc. (NASDAQ:NEOT) provided a business update and reported financial results for the third quarter 2017. Research and development expenses for the third quarter of 2017 were approximately  $0.5 million , compared to  $1.0 million  for the same quarter in 2016. Research and development expenses for the nine months ended  September 30, 2017  were  $3.6 million , compared to  $5.7 million  for the same period in 2016. 

Russian manufacturers of antibiotics strengthen their market positions

GMP News

The volume of antibiotics market in Russia reached 19.7 billion rubles in prices of final consumption or 120 million packages. Compared to the same period of 2016, this segment grew by 3.9% in monetary terms and remained virtually unchanged in physical terms. This was revealed by the retail audit of QuintilesIMS for 8 months of 2017.

07 November 2017

Syndax Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Clinical and Business Update

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today announced that it has agreed to sell 2,021,018 shares of its common stock to Biotechnology Value Fund, L.P. and certain of its affiliates ("BVF") in a registered direct offering.