Industry news

Want to win on pricing? Take a closer look at the numbers

Emily Wasserman / FiercePharmaMarketing

Controversy surrounding drug pricing has reached an all-time high. Lawmakers and payers are pushing back at sky-high prices for new meds, and companies have been forced to discount their products to keep their market share. Increasing competition from generics and biosimilars only adds to the drama.

Direct-to-consumer company tests FDA's resolve on gene testing

Julie Steenhuysen / Reuters

Just as 23andMe has made peace with the U.S. Food and Drug Administration, another direct-to-consumer genetics company is testing the regulatory waters with the launch of a $249 DNA test designed to predict drug response.

China considers drug approval reforms to spur research

Matthew Driskill / FiercePharmaAsia

Saying the current drug approval process in China "does not suit the development of the drug making industry," the head of China's Food and Drug Administration said the mainland's government is considering reforms to the drug examination and approval process, according to a report by state-ownedXinhua and carried on the China.org.cn website.

Euro biotech IPOs smash through €1B barrier in just 9 months

Nick Paul Taylor / Fierce Biotech

European biotechs raised more than €1 billion ($1.1 billion) through IPOs in their home markets and overseas in the first 9 months of 2015, according to market analyst Biocom. But while the total represents an 18% increase over the same period of last year, a stuttering final quarter could cause 2015 to end with a whimper.

CMS biosimilar coverage is at odds with its own biologics policy

Mari Serebrov / BioWorld

In a move that could hamstring the U.S. biosimilars market before it has a chance to fully open its doors, the Centers for Medicare & Medicaid Services (CMS) is sticking to a Part B biosimilars payment policy that would create a bifurcated biologics scheme when older proteins such as insulin and growth hormone are brought under the Biologics Price Competition and Innovation Act (BPCIA) in 2020, Pfenex Inc. CEO Bert Liang told BioWorld Today.

06 November 2015

Marinus Pharmaceuticals Announces Public Offering of Common Stock

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) ("Marinus" or the "Company") today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Jefferies LLC and RBC Capital Markets, LLC are acting as joint bookrunning managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Biosimilar Development Continues to Challenge FDA and Industry

Jill Wechsler / BioPharm International

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process. Now with one approved biosimilar under its belt, and dozens more under review and in development, FDA’s biosimilar regulatory and approval program has moved “beyond the finish line,” says Steven Kozlowski, director of the Office of Biotechnology Products (OBP) in the Center for Drug Evaluation and Research (CDER).

Drug approval pilot plan formally launched in China

Matthew Driskill / FiercePharmaAsia

Following on from a presentation to the State Council earlier this week, China announced Thursday it will launch a three-year pilot plan to speed up approvals for new drugs. China's Food and Drug Administration (CFDA) said in a statement on its website that the pilot plan will take place in 10 regions and will allow research organizations and researchers themselves to seek approval for new drugs rather than forcing them to transfer their findings to drug manufacturers who then would be allowed to produce the drugs and reap most of the benefits.

Biotech sector roars back with strong October performance

Peter Winter / BioWorld

After suffering a 20 percent drop in value during August and September, the BioWorld Blue Chip Biotech Index, comprising 20 of the leading companies ranked by market cap, recovered over half of its losses with an 11.5 percent jump in October. Biotech benefited from a calmer, more positive period in the capital markets with the Nasdaq Composite index and the Dow Jones Industrial Average also recording strong growth of 10 percent and 9 percent, respectively. 

Pharma dealmaking and collaboration shine brightly through the fog

Cormac Sheridan / BioWorld

The value of up-front payments in global biopharma licensing agreements is still climbing, and global M&A spending on R&D-stage companies so far in 2015 is the best in more than a decade. Despite the gathering clouds on both the funding and reimbursement fronts – and despite the strictly nonmetaphorical fog that delayed the arrival of many delegates – those who made it to the introductory session of the 21st BIO-Europe Fall meeting Monday heard some upbeat messages from David Thomas, director of industry research and analysis, at the Washington-based Biotechnology Industry Organization (BIO).