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SFDA approves production license for Sinovac's H1N1 vaccine

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

4 Sep 2009

ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

ERT (Nasdaq: ERES) has celebrated a significant milestone by completing its 150th thorough QT clinical Trial (TET). ERT provides full TET support to the biopharmaceutical industry, including consultation, study design, and provision of ECG equipment to ECG analysis, data processing, management, reconciliation, reporting, quality control and regulatory support.

4 Sep 2009

Acurox's New Drug Application discussed with the FDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets CII (NDA).

4 Sep 2009

IND for Cytopia's CYT387 clears the FDA review

Cytopia Limited's Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.

4 Sep 2009

Two new antibodies for targeting HIV virus discovered

Researchers at and associated with the International AIDS Vaccine Initiative (IAVI), at The Scripps Research Institute, and at the biotechnology companies Theraclone Sciences and Monogram Biosciences have discovered two powerful new antibodies to HIV that reveal what may be an Achilles heel on the virus. They published their work in Science this week.

3 Sep 2009

H1N1 vaccine to cost countries $2.50 - $20 per dose

The H1N1 (swine) flu vaccine will cost countries between $2.50 and $20 per dose, based on their ability to pay, according to the director of the Initiative for Vaccine Research at the WHO, Marie-Paule Kieny, Agence France-Presse/Khaleej Times reports. During an interview published in the September issue of the WHO Bulletin, Kieny "also warned that there would not be enough vaccines for the world's population and that people should not rely entirely on the vaccine," the news service writes (9/2).

3 Sep 2009

Updated Blue Spoon Consulting briefing note available for web download

Blue Spoon Consulting Group, LLC, today updated its briefing note examining the degrading trends in pharmaceutical marketing, and what can be done about it. Available for download through the Blue Spoon Consulting website (www.bluespoonconsulting.com), ‘Pharmaceutical Promotion At Its Productivity Frontier’ is currently the only piece of strategic writing that looks at a total context of change shaping how pharmaceutical companies market and measure performance.

3 Sep 2009

Endo Pharmaceuticals launches VALSTAR for treating recurrent carcinoma in situ bladder tumors

Endo Pharmaceuticals (Nasdaq: ENDP) today announced the availability of VALSTAR(TM) (valrubicin) for the treatment of a distinct form of bladder cancer. VALSTAR is the only FDA-approved intravesical therapy for patients with Bacille Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks.

3 Sep 2009

China Aoxing submits an NDA to the China SFDA for its Codeine Phosphate

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, today announced that it has submitted a new drug application (NDA) to the China State Food and Drug Administration (SFDA) for its Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough.

3 Sep 2009

China Sky One Medical submits application to perform clinical trials for two new generic drugs

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that the Company has finished the required research for two new generic drugs for eye treatment and submitted application to the State Food and Drug Administration (SFDA) in China to perform clinical trials.

3 Sep 2009

Criminal pricing of Merck’s HIV/AIDS drug Isentress challenged by the AIDS Healthcare Foundation

As part of its ongoing campaign to lower drug prices and increase access, AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress (raltegravir). The first phase of the public awareness campaign includes a postcard mailer, scheduled to arrive this week in the mailboxes of residents of Whitehouse Station, New Jersey, where Merck is headquartered.

3 Sep 2009

Ethical Alternative Products launches the OmniFlex joint support formula

Ethical Alternative Products has launched OmniFlex, a unique joint support formula combining five highly researched ingredients shown specifically to positively impact joint structure and function in easy-to-swallow soft-gel capsules.

3 Sep 2009

SAFLUTAN launched in United Kingdom and Spain

Merck Sharp & Dohme (MSD) has launched SAFLUTAN (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today.

3 Sep 2009

Sheller, P.C helps to settle the largest whistleblower complaint

Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise. The drug giant also defrauded federal and state taxpayers by marketing Zyvox off-label, according to a qui tam whistleblower complaint filed by Philadelphia law firm Sheller, P.C. and other documents unsealed with today's $2.3 billion Pfizer settlement.

3 Sep 2009

Ten of ChemBridge's screening libraries available through CDD database

ChemBridge Corporation, a leading discovery chemistry company offering an extensive portfolio of discovery chemistry products and contract research services, has now made ten of their most popular screening libraries available to researchers via the Collaborative Drug Discovery (CDD) Public Access database.

3 Sep 2009

Celgene to collaborate with PTC on advancing drug discovery efforts

PTC Therapeutics, Inc. (PTC) today announced that Celgene Corporation has exercised its option to collaborate on advancing drug discovery efforts on an oncology target addressed through the application of PTC's GEMS(TM) (Gene Expression Modulation by Small-molecules) technology.

3 Sep 2009

Pfizer finalizes settlement agreement with U.S. DOJ regarding past promotional practices

Pfizer Inc today announced that it has finalized a previously reported agreement in principle with the U.S. Department of Justice (DOJ) to settle an investigation regarding past off-label promotional practices related to Bextra, which Pfizer voluntarily withdrew from the market in 2005.

3 Sep 2009

P2Y2 to be included in the intellectual property sale auction

Joseph F. Finn, Jr., C.P.A. ("Finn"), announced today that the P2Y2 Gastrointestinal Early Development Candidate Program will be part of the intellectual property offered for sale at the September 30, 2009 auction.

3 Sep 2009

Pfizer pleads guilty of defrauding Medicare, Medicaid and other government-funded health care programs

Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

3 Sep 2009

Two 2008 drug approval reports highlight Ceplene benefits

EpiCept Corporation today announced that Ceplene (histamine dihydrochloride) has been highlighted in two separate reports issued recently reviewing 2008 drug approvals in the European Union.

3 Sep 2009