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First Edition: May 2, 2014

Today's headlines include coverage of the latest round of health insurance enrollment data released by the Obama administration.

2 May 2014

Biotech to the rescue

MIT professor Ram Sasisekharan's three biotech companies — Momenta Pharmaceuticals, Cerulean Pharma, and Visterra — share a similar goal.

1 May 2014

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Teva Pharmaceutical Industries Ltd. today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237).

30 Apr 2014

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Purdue Pharma L.P. announced that it has filed a New Drug Application (NDA) with the U.S. Food & Drug Administration seeking authorization to market a once-daily, single-entity hydrocodone bitartrate tablet (HYD).

30 Apr 2014

Hospira’s net sales increase 6.3% to $1.1B in first quarter 2014

Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, today reported results for the first quarter ended March 31, 2014.

30 Apr 2014

Otonomy secures $49M in oversubscribed Series D round of financing

Otonomy, Inc., a biopharmaceutical company developing and commercializing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced it has secured $49 million in an oversubscribed Series D round of financing.

30 Apr 2014

Actavis’ net revenue increases 40% to $2.66B in Q1 2014

Actavis plc today reported net revenue increased 40 percent to $2.66 billion for the first quarter ended March 31, 2014, compared to $1.90 billion in the first quarter 2013.

30 Apr 2014

Alkermes reports financial results for first quarter of 2014

Alkermes plc today reported financial results for the first quarter of 2014. "During the quarter, we continued to generate positive cash flow, reflecting the strength of our commercial business and enabling us to invest in our advancing late-stage pipeline and prepare for the launch of aripiprazole lauroxil," commented James Frates, Chief Financial Officer of Alkermes.

30 Apr 2014

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Braeburn Pharmaceuticals announced today the initiation of a new clinical trial for Probuphine® based on clear guidance from the U.S. Food and Drug Administration (FDA). The study, which was submitted for FDA review in mid-March, is expected to begin enrollment by mid-year and to be completed by the middle of 2015.

30 Apr 2014

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

Synergy Pharmaceuticals Inc. today announced positive top-line results from a phase 2b dose-ranging study assessing plecanatide's safety and efficacy in 424 patients with irritable bowel syndrome with constipation (IBS-C).

30 Apr 2014

ICON Q1 2014 net revenue increases 10% to $349.6 million

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the first quarter ended March 31, 2014.

30 Apr 2014

RDT receives FDA approval for new liquid form of treatment for patients with ALL

Rare Disease Therapeutics, Inc. (RDT), the producer of orphan pharmaceuticals for the treatment of rare diseases, announced today that they have received FDA approval for PURIXAN™ (mercaptopurine) 20 mg/mL oral suspension---a new, easier-to-dose, liquid form of an established treatment for patients with Acute Lymphoblastic Leukemia (ALL).

30 Apr 2014

Scientific data confirms therapeutic potential of Anavex's S1R agonist against Parkinson’s disease

Anavex Life Sciences Corp., a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer’s, other diseases of the central nervous system (CNS) and various types of cancer, today announced the findings of a research study published in the current issue of peer-reviewed scientific journal Brain.

30 Apr 2014

Vertex: Conditions of PBAC recommendation may limit Australians who could benefit from KALYDECO

The Pharmaceutical Benefits Advisory Committee has again recommended KALYDECO (ivacaftor) for listing on the Pharmaceutical Benefits Scheme (PBS). However, Vertex is deeply disappointed in the conditions the PBAC has attached to the recommendation. These conditions fail to reflect the substantial clinical benefits recognised by the PBAC, and would result in limiting the number of eligible Australians who would be able to receive KALYDECO.

30 Apr 2014

New study explores methods for improving resilience of health system

According to a new study by the American Meteorological Society Policy Program, a risk management framework can improve the resilience of healthcare facilities and services to high-impact weather such as tornadoes and hurricanes. The report is based on a recent AMS Policy Program workshop, A Prescription for the 21st Century: Improving Resilience to High-Impact Weather for Healthcare Facilities and Services, held in Washington, DC in October 2013.

30 Apr 2014

Viewpoints: New poll points out inconsistencies among health law's opponents; protecting vets; Calif. restaurant nutrition info missing

The case against the Affordable Care Act rests on the premise that the free market can better provide health insurance to the nation's 54 million uninsured than a government program can. But what does it mean if many of the same people who oppose Obamacare also object to the cost of covering more people through the market? A telephone survey by Bankrate.com asked 3,496 people how they would react if a business tacked on an extra 25 cents to every bill to help cover the cost of health insurance for its employees. Among Democrats, 70 percent said they would approve.

30 Apr 2014

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Otsuka Pharmaceutical Co., Ltd. today announced that the European Commission has granted a marketing authorization for Deltyba (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

30 Apr 2014

Cerus, Nipro partner to develop key component of INTERCEPT red cell disposable set

Cerus Corporation announced today that it has entered into a collaboration agreement with the Nipro Corporation's pharmaceutical division to develop technology to support commercial implementation of the INTERCEPT System for Red Blood Cells (RBCs).

29 Apr 2014

Endo enters into definitive agreement to acquire Grupo Farmaceutico Somar

Endo International plc today announced it has entered into a definitive agreement under which Endo will acquire Grupo Farmaceutico Somar, a leading privately-owned specialty pharmaceuticals company based in Mexico City, Mexico, for cash consideration. Endo expects the transaction to be immediately accretive to adjusted earnings per share.

29 Apr 2014

YourEncore announces partnership extension with Roche to provide expert solutions

YourEncore, a leading provider of expert solutions to the life sciences, consumer health and nutrition industries, today announced a partnership extension with Roche to provide expert solutions and services to support enhancing productivity and strengthening regulatory compliance.

29 Apr 2014

Pharmaceuticals News and Research

First Edition: May 2, 2014

Biotech to the rescue

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Hospira’s net sales increase 6.3% to $1.1B in first quarter 2014

Otonomy secures $49M in oversubscribed Series D round of financing

Actavis’ net revenue increases 40% to $2.66B in Q1 2014

Alkermes reports financial results for first quarter of 2014

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

ICON Q1 2014 net revenue increases 10% to $349.6 million

RDT receives FDA approval for new liquid form of treatment for patients with ALL

Scientific data confirms therapeutic potential of Anavex's S1R agonist against Parkinson’s disease

Vertex: Conditions of PBAC recommendation may limit Australians who could benefit from KALYDECO

New study explores methods for improving resilience of health system

Viewpoints: New poll points out inconsistencies among health law's opponents; protecting vets; Calif. restaurant nutrition info missing

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Cerus, Nipro partner to develop key component of INTERCEPT red cell disposable set

Endo enters into definitive agreement to acquire Grupo Farmaceutico Somar

YourEncore announces partnership extension with Roche to provide expert solutions

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