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Omeros plans to file patent infringement lawsuit against Par

Omeros Corporation today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

17 Aug 2015

NanoViricides speeds up HerpeCide drug development program

NanoViricides, Inc., a nanomedicine company developing anti-viral drugs, reports that it is accelerating its HerpeCide drug development program.

17 Aug 2015

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Chiasma, Inc., a U.S. late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application (NDA) for the marketing and sale of octreotide capsules, an oral drug proposed for the maintenance therapy of adult patients with acromegaly.

17 Aug 2015

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

United Therapeutics Corporation announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).

17 Aug 2015

Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

Veloxis Pharmaceuticals A/S, today announced that Envarsus XR was granted Orphan Drug status by the U.S. Food and Drug Administration for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus XR received marketing authorization from the FDA on July 10, 2015.

14 Aug 2015

Risk for endophthalmitis no higher with Avastin, finds study

Eye injections of the drug Avastin, used to treat retinal diseases, bring no greater risk of endophthalmitis, a potentially blinding eye infection, than injections with the much more expensive drug Lucentis made by the same company, according to new research from the Perelman School of Medicine at the University of Pennsylvania. Their findings are published today in JAMA Ophthalmology.

14 Aug 2015

Centenary Institute researchers take lead on promising new class of drugs for melanoma treatment

Researchers at Sydney’s Centenary Institute have taken the lead on a promising new class of drugs that may prove to be highly effective for the treatment of certain cases of melanoma.

14 Aug 2015

Opioids produced by yeast; revealing the potential for cheaper pain relief

Researchers at Stanford University have genetically engineered yeast so it produces hydrocodone, a semi-synthetic opioid analgesic used in the United States for relief of moderate to severe pain.

14 Aug 2015

New study focuses on dental screenings for drug misuse

A visit to the dentist has the potential to be more than a checkup of our teeth as patients are increasingly screened for medical conditions like heart disease and diabetes.

14 Aug 2015

PHIV children may lack immunity against measles, mumps, and rubella despite vaccination

Between one-third and one-half of individuals in the United States who were infected with HIV around the time of birth may not have sufficient immunity to ward off measles, mumps, and rubella--even though they may have been vaccinated against these diseases.

14 Aug 2015

CPhI reports positive outlook on the Chinese pharmaceutical market

CPhI – a division of UBM EMEA – alongside UBM Sinexpo, announces the findings of the Pharma Insights China 2015 report.

13 Aug 2015

RealTime Dynamix: New monthly service launched for pharmaceutical markets

Spherix Global Insights announces the launch of RealTime Dynamix, its new monthly service developed to keep clients on the pulse in highly dynamic specialty markets.

13 Aug 2015

Combination of chemotherapy and immune-blocking drug could prevent cancer recurrence

Giving patients a drug that blocks part of the immune system from going into overdrive might help prevent cancer coming back in some people, according to research published today in Cancer Research.

13 Aug 2015

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

New study explains why statins are more beneficial than others in some cases

Statins' success in reducing atherosclerosis-related events has elevated the medications to wonder-drug status, with some researchers advocating for their wider use as a preemptive therapy for cardiovascular disease.

13 Aug 2015

Increasing vaccination coverage in the US protects against chickenpox

Since the chickenpox vaccine became available in the U.S. in 1995, there has been a large reduction in chickenpox cases. Hospitalizations and outpatient visits for chickenpox have continued their decline after a second dose of the vaccine was recommended to improve protection against the disease, according to a new study published in the Journal of the Pediatric Infectious Diseases Society.

13 Aug 2015

Abortions performed with Mifepristone result in shorter waiting time, earlier abortions

Nearly all abortions in Norway today are performed with the abortion pill Mifepristone. This has resulted in shorter waiting time, earlier abortions, and the possibility to have abortions at home.

13 Aug 2015

CrystalGenomics signs agreement with Dong-A ST for commercialization of Acelex (polmacoxib) in Korea

CrystalGenomics, Inc. has announced that it has signed a Sales and Marketing Agreement with Dong-A ST Co., Ltd. for the commercialization of Acelex (polmacoxib) in Korea.

13 Aug 2015

CMC Biologics, PATH Malaria Vaccine Initiative sign agreement for development of specific monoclonal antibodies

CMC Biologics, a global leader in clinical and commercial development and contract manufacture of therapeutic proteins, announced today it has entered into an agreement with the PATH Malaria Vaccine Initiative (MVI) for process development and manufacture of specific monoclonal antibodies to test for their capacity to protect humans from malaria infection.

12 Aug 2015

Postmenopausal women more likely to use vaginal estrogen to achieve significantly higher sexual quality of life

Local vaginal estrogen (VE) appears to have escaped the shroud of doubt cast upon hormone therapy as a result of the Women's Health Initiative Study by providing numerous medical benefits without systemic effects. That's according to a new study reported online today in Menopause, the journal of The North American Menopause Society.

12 Aug 2015

Pharmaceutical News

Omeros plans to file patent infringement lawsuit against Par

NanoViricides speeds up HerpeCide drug development program

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

Risk for endophthalmitis no higher with Avastin, finds study

Centenary Institute researchers take lead on promising new class of drugs for melanoma treatment

Opioids produced by yeast; revealing the potential for cheaper pain relief

New study focuses on dental screenings for drug misuse

PHIV children may lack immunity against measles, mumps, and rubella despite vaccination

CPhI reports positive outlook on the Chinese pharmaceutical market

RealTime Dynamix: New monthly service launched for pharmaceutical markets

Combination of chemotherapy and immune-blocking drug could prevent cancer recurrence

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

New study explains why statins are more beneficial than others in some cases

Increasing vaccination coverage in the US protects against chickenpox

Abortions performed with Mifepristone result in shorter waiting time, earlier abortions

CrystalGenomics signs agreement with Dong-A ST for commercialization of Acelex (polmacoxib) in Korea

CMC Biologics, PATH Malaria Vaccine Initiative sign agreement for development of specific monoclonal antibodies

Postmenopausal women more likely to use vaginal estrogen to achieve significantly higher sexual quality of life

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