Keep a close eye on Achaogen, Inc. (AKAO). The company will host a conference call and webcast on Tuesday, March 31st at 4:30PM Eastern Time to update investors on its lead program, plazomicin.
During the fourth quarter, AKAO remained focused on advancing the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial for plazomicin, AKAO's lead product for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae.
AKAO said that it has been exploring strategies to improve patient recruitment and remains in discussions with the US Food and Drug Administration (FDA) regarding potential modifications to the study design as well as additional clinical trials that could support and, possibly, facilitate regulatory filings for plazomicin.
AKAO's plazomicin recently received Qualified Infectious Disease Product designation from the FDA, which also granted fast track status for the product in 2012.
Shares of AKAO climbed slightly $0.15 (or +1.55%) to $9.85 on Monday's trading session
AKAO is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections.
More about Achaogen, Inc. (AKAO) at www.achaogen.com
**
Novartis AG (NVS) said that the FDA has approved Jadenu(TM) (deferasirox) tablets, a new oral formulation of Exjade(R) (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients 10 years of age and older.
Jadenu is the only once-daily oral iron chelator that can be swallowed whole. In the United States, it is available by prescription only.
NVS has submitted additional regulatory applications for Jadenu in other countries worldwide.
NVS surged $0.91 (or +0.91%) to $101.31 per share on Monday.
NVS researches, develops, manufactures, and markets a range of healthcare products worldwide. It offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals.
More about Novartis AG (NVS) at www.novartis.com
**
Shares of VIVUS, Inc. (VVUS) closed at $2.52, down $0.05 (or -1.95%) on Monday's market activity. After the closing bell, VVUS provided an operational update.
VVUS said that it plans to discuss with U.S. regulatory authorities and key consultants potential cost-saving alternatives with respect to the Qsymia CVOT, known as AQCLAIM. VVUS is also in the process of pursuing approval for Qsymia in the EU and other key countries, as well as new indications in other chronic diseases such as obstructive sleep apnea and type 2 diabetes.
VVUS plans to optimize spending while pursuing these potential objectives.
Qsymia is an FDA-approved prescription medicine that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off. Qsymia should be used with a reduced-calorie diet and increased physical activity.
According to VVUS, its confidence in and commitment to its avanafil franchise remains unchanged. The company will continue to work closely with its worldwide commercial alliance partners in the erectile dysfunction market as part of VVUS' effort to ensure that it maximizes the potential value of this important asset.
VVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health.
More about VIVUS, Inc. (VVUS) at www.vivus.com.
**
Crown Equity Holdings Inc. (CRWE) provides marketing solutions that boost customer awareness and merchant visibility on the Internet. The company is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included the City of Lakewood, CA ( www.lakewood.crwe-pr.com ) into the CRWE Network.
Lakewood is a residential suburb located in southern Los Angeles County, California, about 23 miles southeast of Los Angeles. Lakewood is predominantly owner-occupied, with the large majority of its housing comprised of single-family detached units.
The City of Lakewood had an estimated population in 2013 (U.S. Census Bureau) of 81,121, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
The CRWE Network has reached the 1487th community website in the U.S. and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
The company’s CRWE Press Release ( www.crwepressrelease.com ) offers increased visibility with cost effective solutions through the distribution of information to the entire CRWE Network for both public and private companies.
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: CRWE-PR Finance is not a registered investment adviser. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
During the fourth quarter, AKAO remained focused on advancing the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial for plazomicin, AKAO's lead product for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae.
AKAO said that it has been exploring strategies to improve patient recruitment and remains in discussions with the US Food and Drug Administration (FDA) regarding potential modifications to the study design as well as additional clinical trials that could support and, possibly, facilitate regulatory filings for plazomicin.
AKAO's plazomicin recently received Qualified Infectious Disease Product designation from the FDA, which also granted fast track status for the product in 2012.
Shares of AKAO climbed slightly $0.15 (or +1.55%) to $9.85 on Monday's trading session
AKAO is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections.
More about Achaogen, Inc. (AKAO) at www.achaogen.com
**
Novartis AG (NVS) said that the FDA has approved Jadenu(TM) (deferasirox) tablets, a new oral formulation of Exjade(R) (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients 10 years of age and older.
Jadenu is the only once-daily oral iron chelator that can be swallowed whole. In the United States, it is available by prescription only.
NVS has submitted additional regulatory applications for Jadenu in other countries worldwide.
NVS surged $0.91 (or +0.91%) to $101.31 per share on Monday.
NVS researches, develops, manufactures, and markets a range of healthcare products worldwide. It offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals.
More about Novartis AG (NVS) at www.novartis.com
**
Shares of VIVUS, Inc. (VVUS) closed at $2.52, down $0.05 (or -1.95%) on Monday's market activity. After the closing bell, VVUS provided an operational update.
VVUS said that it plans to discuss with U.S. regulatory authorities and key consultants potential cost-saving alternatives with respect to the Qsymia CVOT, known as AQCLAIM. VVUS is also in the process of pursuing approval for Qsymia in the EU and other key countries, as well as new indications in other chronic diseases such as obstructive sleep apnea and type 2 diabetes.
VVUS plans to optimize spending while pursuing these potential objectives.
Qsymia is an FDA-approved prescription medicine that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off. Qsymia should be used with a reduced-calorie diet and increased physical activity.
According to VVUS, its confidence in and commitment to its avanafil franchise remains unchanged. The company will continue to work closely with its worldwide commercial alliance partners in the erectile dysfunction market as part of VVUS' effort to ensure that it maximizes the potential value of this important asset.
VVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health.
More about VIVUS, Inc. (VVUS) at www.vivus.com.
**
Crown Equity Holdings Inc. (CRWE) provides marketing solutions that boost customer awareness and merchant visibility on the Internet. The company is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included the City of Lakewood, CA ( www.lakewood.crwe-pr.com ) into the CRWE Network.
Lakewood is a residential suburb located in southern Los Angeles County, California, about 23 miles southeast of Los Angeles. Lakewood is predominantly owner-occupied, with the large majority of its housing comprised of single-family detached units.
The City of Lakewood had an estimated population in 2013 (U.S. Census Bureau) of 81,121, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
The CRWE Network has reached the 1487th community website in the U.S. and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
The company’s CRWE Press Release ( www.crwepressrelease.com ) offers increased visibility with cost effective solutions through the distribution of information to the entire CRWE Network for both public and private companies.
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: CRWE-PR Finance is not a registered investment adviser. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
