Industry news

India's drug regulator handcuffed by low funding, lack of trained personnel

Matthew Driskill / FiercePharmaAsia

The reputation of India's massive $15 billion drug industry is being threatened at the federal and state level by a lack of properly trained personnel and a shortage of funding that points out possible changes may be needed in how the country finances inspections and quality control work, according to a report in the Business Standard.

11 November 2015

Circulating tumor cells (CTCs) in patients' blood detected by Epic Sciences are an "accurate representation" of genetic aberrations found in fresh metastatic tumor samples

Most men with advanced prostate cancer, whether initially treated through surgical or chemical castration, eventually develop drug-resistant tumors. Monitoring for drug resistant genetic mutations could inform selection of the next line of therapy. Complicating this is that prostate cancer frequently metastasizes extensively in the bone, which means monitoring may require repeated and sometimes painful bone biopsies, some of which may fail to recover a tumor sample.

Google Life Sciences teams with AHA to target heart disease in $50M research initiative

Emily Wasserman / FierceMedicalDevices

Alphabet's ($GOOG) Google Life Sciences group is broadening its med tech cachet through a new research deal with the American Heart Association (AHA), teaming up with the organization to come up with new tools and resources to address heart disease.

US stillbirth rates unchanged after move to discourage elective deliveries before 39 weeks

U.S. National Institute of Health

The recommendation to delay delivery of otherwise healthy infants until at least the 39th week of pregnancy does not appear to have increased stillbirths in the United States, according to a study by researchers at the National Institutes of Health and other institutions. These findings contradict an earlier study that raised the concern that waiting until 39 weeks could lead to more stillbirths.

Drug industry bemoans Britain's lack of science skills

Ben Hirschler / Reuters

British pharmaceutical and biotechnology companies face a major skills shortage which threatens future investment and the long-term success of the life sciences sector, according to a new industry report.

Strengthening IP would significantly boost India’s economy

Mark Grayson / PhRMA

On the heels of the October 28 U.S.-India Trade Policy Forum, PhRMA Chairman and Merck Chief Executive Officer Ken Frazier traveled to New Delhi this week for meetings with top Indian government officials. Later today, he will join other U.S. and Indian thought leaders for a panel discussion organized by the Observer Research Foundation that asks a critical question – can Prime Minister Modi’s signature “Make in India” campaign make room for “Innovate in India”? The answer is a resounding “Yes.” 

10 November 2015

Tobira Therapeutics Reports Third Quarter 2015 Financial Results

Tobira Therapeutics, Inc.  ( NASDAQ : TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, today reported business highlights and financial results for the third quarter of 2015.

10 November 2015

FDA Accepts PMA Submission for ReVision Optics’ Raindrop Near Vision Inlay

ReVision Optics, Inc. (RVO®), a leader in implantable presbyopia-correcting corneal inlay technology, announces that the U.S. Food and Drug Administration (FDA) has accepted and deemed fileable the company’s premarket approval (PMA) submission for the Raindrop® Near Vision Inlay. The Raindrop is a microscopic hydrogel inlay designed to correct presbyopia, thus reducing or eliminating the need for reading glasses. Acceptance and filing of the submission means the FDA has made a threshold determination that the Raindrop PMA submission is sufficiently complete to move forward in the FDA review and approval process.

Europe Seeing Record Percentage of Bolt-ons, Boosted in Part by U.S. Firms

PitchBook Blog

The proportion of bolt-ons in European private equity activity has seen a noticeable jump in 2015, claiming 49.5% of the year's buyouts through last quarter—a new high point—as covered in our latest European Breakdown Report. For comparison, that percentage has grown to a record 62% in the U.S. through 3Q.

The Partnership for Prescription Assistance: A history of caring

PhRMA

America is a country of problem solvers, innovators and dreamers. In April 2005, professionals on the front lines of health care at America’s biopharmaceutical research companies, created the Partnership for Prescription Assistance (PPA) to connect uninsured and underinsured patients to programs that provide prescription medicines for free or nearly free. Since 2005, PPA has helped nearly 9.5 million patients get access to public and private assistance programs.