Industry news

20 September 2016

Allergan to Acquire Tobira Therapeutics Expanding Global GI R&D Pipeline and Taking a Leading R&D Position in NASH

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, today announced that they have entered into a definitive agreement under which  Allergan  will acquire Tobira for an upfront payment of  $28.35  per share, in cash, and up to  $49.84  per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones, for a total potential consideration of up to  $1.695 billion . The Boards of Directors of both companies have unanimously approved the transaction.

EMA Recommends Breast Cancer Treatment

BioPharm International

The European Medicines Agency (EMA) announced on Sept. 16, 2016 that it was recommending that Ibrance, a treatment for locally advanced or metastatic breast cancer, be granted marketing authorization in the European Union. According to EMA, the drug has been used to treat cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.

The European Medicines Agency (EMA) announced on Sept. 16, 2016 that it was recommending that Ibrance, a treatment for locally advanced or metastatic breast cancer, be granted marketing authorization in the European Union. According to EMA, the drug has been used to treat cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.

EMA Stops Import of Products from US Company

BioPharm International

The European Medicines Agency (EMA) announced on Sept. 16, 2016 that the agency was recommending that non-critical drugs manufactured by Pharmaceutics International Inc. (Hunt Valley, MD) no longer be available in the European Union, except for Ammonaps (sodium phenylbutyrate), because of failures in good manufacturing practices (GMPs).

The European Medicines Agency (EMA) announced on Sept. 16, 2016 that the agency was recommending that non-critical drugs manufactured by Pharmaceutics International Inc. (Hunt Valley, MD) no longer be available in the European Union, except for Ammonaps (sodium phenylbutyrate), because of failures in good manufacturing practices (GMPs).

HHS takes steps to provide more information about clinical trials to the public

U.S. National Institute of Health

In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. 

Biopharmas bite back at UN’s scathing life science R&D report

Ben Adams / Fierce Biotech

A highly influential and long-awaited report from the United Nations has attacked the market-based R&D approach used by the biopharma industry, but an industry group has hit back at its “narrow focus.”

EMA Recommends Approval of 11 Drugs

BioPharm International

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of 11 drugs during their Sept. 12–15, 2016 meeting. The approved drugs treat a range of conditions including different forms of cancer, type 2 diabetes, secondary hyperparathyroidism, heart failure, and HIV.

Pitch dark? In funding bid, be open about challenges they'll find anyway: panel

Randy Osborne / BioWorld

Tweaks were made this year to the format of Biopharm America, which featured shorter, snappier sessions intended to stimulate exactly the kind of early partnering talks that the event is designed to foster.

U.K. biopharma sector delivers wish list for Brexit negotiations

Nuala Moran / BioWorld

After a summer of concerted effort to scope out and reach a unified view, the life sciences sector had its first meeting with the government's new Department for Exiting the EU, to put forward the industry's wish list and requirements once negotiations on U.K. withdrawal from the EU get underway.

Corporate Venture Groups Participated in 20.6 Percent of all Deals and 24.2 Percent of Investment in Biotechnology Sector

U.S. National Venture Capital Association

Biotechnology companies received the second largest amount of corporate venture dollars in the second quarter, attracting $407 million in 25 deals, representing 33 percent of corporate venture dollars invested and 12.6 percent of deals.  As a share of overall venture dollars invested in biotechnology companies, corporate venture groups accounted for 24.2 percent of total dollars invested, which was substantially over-weighted in the sector.

$15.3 Billion in Venture Capital Deployed to Startup Ecosystem in Second Quarter, According to the MoneyTree Report

U.S. National Venture Capital Association

Venture capitalists invested $15.3 billion in 961 deals in the second quarter of 2016, according to the MoneyTree™ Report from PricewaterhouseCoopers LLP (PwC) and the National Venture Capital Association (NVCA), based on data provided by Thomson Reuters. Total venture dollars deployed to startup companies for the quarter increased 20 percent and total deal count was down 5 percent, compared with the first quarter when $12.7 billion was invested in 1,011 deals. Compared with Q2 2015, dollars and deals are down 12 and 22 percent, respectively. This is the tenth consecutive quarter of more than $10 billion in venture capital invested in a single quarter.