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Home » Newsletters » BioWorld

BioWorld

Nov. 8, 2016

View Archived Issues

A cure that's not affordable is like the proverbial falling tree

Recognizing that the fevered finger-pointing and congressional calls for investigations into escalating drug prices won't subside after Tuesday's election, the U.S. biopharma industry is ramping up social media campaigns and lobbying efforts to demonstrate the need for a systemic cure to a broken health care system rather than dusted-off bandages that could make the problem worse. Read More

Other news to note

Upsher-Smith Laboratories Inc., of Maple Grove, Minn., inked an exclusive agreement for a generic product developed by Bluepharma SA, of Coimbra, Portugal, in an undisclosed market category with U.S. sales exceeding $75 million. Read More

In the clinic

Exelixis Inc., of South San Francisco, reported that, based on data from a phase Ib dose escalation study of cobimetinib and atezolizumab in patients with metastatic melanoma, Basel, Switzerland-based Roche AG subsidiary Genentech Inc. plans to initiate a phase III pivotal trial of the combination vs. a PD-1 inhibitor in patients with previously untreated BRAF wild-type advanced melanoma next year. Read More

Biopharma deal-making holds up during investor exodus, price disputes

COLOGNE, Germany – There are few countries to rival Germany for supplying gloomy gray weather in November. It's always a danger to rely too heavily on pathetic fallacy to describe the state of the biopharma industry, but to delegates arriving at the Koeln Messe Congress Centre for the 22nd annual BIO-Europe Fall meeting, the heavy clouds hanging over the cold waters of the Rhine seemed an apt metaphor for its current prospects. Read More

China's low level of reimbursement drives biopharma markets west

SHANGHAI – During the ChinaTrials meeting in Shanghai last week it was clear that many China biopharmas view entering the U.S. market as necessary for long-term success. When looking ahead, they lack confidence the China market will sufficiently reward investments in new drugs. Even after sweeping regulatory reforms have been made in biopharma's favor, reimbursement remains an issue. Read More

India cracks down on unapproved fixed-dose combination drugs

NEW DELHI – With pharmaceutical sector regulations in urgent need of reforms, India has taken the first step, tightening rules for fixed-dose combination (FDC) drugs. Read More

Pfizer's vaccine business makes a comeback in China with Prevenar

HONG KONG – With the approval of blockbuster vaccine Prevenar 13, Pfizer Inc. is making a comeback into China's vaccine market after being forced to shut down operations last year. Read More

Biogen and Ionis 'CHERISH' phase III nusinersen findings in later-onset SMA

Biogen Inc. looked for a broader label in connection with potential approval of the spinal muscular atrophy (SMA) candidate, nusinersen, after reporting with Ionis Pharmaceuticals Inc. that the phase III CHERISH trial in children with later-onset disease met the primary endpoint at interim analysis and was stopped early. Read More

Financings

Therapix BioSciences, of Tel-Aviv, Israel, which is developing cannabinoid-based therapies, filed its form F-1 with the SEC in order to raise up to $12 million in an IPO. It has applied to list its American depositary shares on Nasdaq under the symbol TRPX. Read More

Regulatory front

The U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) declined to institute an inter partes review (IPR) petition submitted by Coherus Biosciences Inc., of Redwood City, Calif. Read More

Earnings

Horizon Pharma plc, of Dublin, reported third-quarter 2016 net sales, which included a $65 million litigation settlement with Express Scripts as a one-time reduction, were $208.7 million, a decrease of 8 percent compared to the third quarter of 2015, primarily attributable to the settlement. Read More

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