Industry news

What's Up Next? Biotech And Pharma Predictions For 2016

Matthew Herper / Forbes

Almost every year, I’ve tried to make some predictions about what will happen over the next 12 months in healthcare. This year, I’m going back to a format proposed by former Forbes.com editor Paul Maidment. Here are some thoughts on drug pricing, Obamacare and more.

06 January 2016

Tobira: Undervalued With A Fast-Tracked NASH Compound

Seeking Alpha

TBRA has one drug candidate that shows promising results for treating NASH and HIV patients, with potential for other clinical applications due to the unique mechanism of action. TBRA faces moderate regulatory and management risks, and a higher financial risk which may exacerbate if more clinical trials take place with the current cash reserves. Overall, we think that TBRA is a moderately undervalued company, which will face a pivotal stage when the primary data from the lead trials come out in 2016.

The Biotech IPO Floodgates Start to Open

Max Nisen / Bloomberg

On the first trading day of 2016, even as the Nasdaq tumbled 2 percent, five biotechs filed S-1s in the U.S. That's more biotech IPO announcements in one day than in any week in the past couple of years, and more than in all but four months in 2015. 

05 January 2016

Clearside Biomedical, Inc. Announces Positive Topline Data from Phase 2 Clinical Trial for the Treatment of Macular Edema Associated with Non-Infectious Uveitis

Clearside Biomedical, Inc., a late-stage clinical biopharmaceutical company developing innovative first-in-class drug therapies to treat blinding diseases of the eye, today announced positive results from the company’s Phase 2 clinical trial of CLS-TA, Clearside’s proprietary form of triamcinolone acetonide, using suprachoroidal space (SCS™) drug administration for the treatment of macular edema associated with non-infectious uveitis.

04 January 2016

Circulating Tumor Cells Linked with Treatment Resistance and Response in Prostate Cancer Patients

Research teams at Memorial Sloan Kettering Cancer Center and Epic Sciences have found that greater diversity among circulating tumor cells (CTCs) in the blood of advanced prostate cancer patients predicts not only shorter overall survival, but also the development of resistance to key anti-androgen therapies. Furthermore, high diversity among CTCs was not associated with resistance to taxane-based chemotherapy.  This suggests that patients likely to fail anti-androgen therapies but potentially benefit from chemotherapy can be identified.

04 January 2016

Breast cancer biotech Syndax Pharmaceuticals refiles for an $86 million IPO

Renaissance Capital IPO Center

Syndax Pharmaceuticals, a late-stage biotech developing a novel therapy for treatment-resistant breast cancer, refiled on Monday with the SEC to raise up to $86 million in an initial public offering.

04 January 2016

Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Announce Collaboration to Evaluate Combination of Avelumab and Entinostat in Ovarian Cancer

Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals, Inc. announced today that they have entered into a collaboration agreement to evaluate avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory T-cells), in patients with heavily pre-treated, recurrent ovarian cancer. 

Germany's Bionorica looks to Russia for expansion

Eric Sagonowsky / FiercePharmaManufacturing

While recent economic instability has deterred some pharma plans in Russia, Germany's Bionorica says it's unfazed and will expand with a new plant there. The herbal-drug producer, led by CEO Michael Popp, will build its first Russian plant in Voronezh, about 320 miles south of Moscow, Bloomberg reports. 

The top 5 trends for med tech in 2016

Stacy Lawrence / Fierce Medical Devices

Next year promises to be a contradictory, almost bipolar one for medical devices and diagnostics. Somehow, the industry is likely to both remain mired in unremitting, long-standing regulatory and financial pressures at the same time that it benefits from an influx of major new innovation-focused players.

M&A: Buckle your seat belts for another big round of deals

John Carroll / FierceBiotech

With valuations down, buyouts and licensing deals become even more attractive. They're already a requirement. Anyone with a casual acquaintance with the state of Big Pharma R&D knows the giants in this business badly need promising mid- and late-stage assets to feed into their pipelines.