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CEL-SCI expands work on current H1N1 virus vaccine

CEL-SCI Corporation has announced that it is expanding the scope of its work towards creating a novel treatment and vaccination against the current H1N1 virus, as well as a future mutated form in which the virus has acquired greater morbidity and mortality.

19 Aug 2009

Light-activated delivery system enhances anti-tumour drug potency

The effects of tumour-targeting drugs in mice are significantly enhanced by PCI Biotech's light-activated delivery system, a new study shows. Researchers say this dual therapy approach could be employed to increase the effect and lower the side effects of anti-cancer drugs in humans.

19 Aug 2009

Orient Pharma granted commercialization rights for a drug candidate by DURECT

DURECT Corporation today announced that it has signed a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which DURECT has granted to Orient Pharma development and commercialization rights in selected Asian and South Pacific countries to a drug candidate based on DURECT's ORADUR(R) Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD).

19 Aug 2009

BioAlliance Pharma's new drug application for oropharyngeal candidiasis treatment accepted by the FDA

BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad® (Loramyc®) Mucoadhesive Buccal Tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole Lauriad® delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.

19 Aug 2009

CSL Biotherapies to supply Afluria influenza vaccines from newly licensed packaging facility

CSL Biotherapies, a subsidiary of CSL Limited, one of the world's leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA) has licensed the company’s newest vaccine filling and packaging facility, located in Kankakee, Ill. The facility, part of an investment to expand CSL’s U.S. influenza vaccine production capabilities, includes a high-speed, single-dose vaccine syringe filling line.

19 Aug 2009

New production technology to develop vaccine for norovirus

Scientists have used a new vaccine production technology to develop a vaccine for norovirus, a dreaded cause of diarrhea and vomiting that may be the second most common viral infection in the United States after the flu. Sometimes called the "cruise ship virus," this microbe can spread like wildfire through passenger liners, schools, offices and military bases.

19 Aug 2009

SFDA approves China Pharma Holdings' generic Omeprazole Sodium injection

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that it has received approval from the Chinese State Food and Drug Administration ("SFDA) for the production of generic Omeprazole Sodium injections.

19 Aug 2009

FDA places Geron Corporation's IND for spinal cord injury on clinical hold

Geron Corporation (Nasdaq:GERN) today announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

19 Aug 2009

Amira Pharmaceuticals submits IND for inflammatory and allergic disease treatment candidate

Amira Pharmaceuticals, Inc. announced today the submission of an Investigational New Drug application (IND) of AM461, its internally-discovered, oral drug candidate for the treatment and control of inflammatory and allergic disease linked to the arachidonic acid pathway, to the U.S. Food and Drug Administration.

19 Aug 2009

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Gloucester Pharmaceuticals will discuss the New Drug Application for romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL) at the Oncologic Drugs Advisory Committee (ODAC) meeting on September 2, 2009.

18 Aug 2009

Labopharm comments on outcome of patent-infringement litigation initiated by Purdue Pharma

Labopharm Inc. today commented on the outcome of patent-infringement litigation initiated by Purdue Pharma Products L.P. against Par Pharmaceutical Companies, Inc. relating to Ultram(R) ER (tramadol hydrochloride extended-release tablets). The patents-in-suit are owned by Purdue and are licensed to Ortho-McNeil, Inc., the marketer of Ultram(R) ER.

18 Aug 2009

Par Pharmaceutical wins in Ultram ER litigation

Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of Delaware has ruled in favor of Par in its challenge of Purdue's patents relating to extended-release tramadol, which are listed in the Orange Book for Ortho-McNeil's Ultram(R) ER product.

18 Aug 2009

Synco Bio to manufacture Versartis type 2 diabetes drug candidate

SynCo Bio Partners, a Netherlands based biopharmaceutical contract manufacturer, and Versartis, Inc. today announced a strategic partnership to produce Versartis' lead drug candidate VRS-859, a novel GLP-1 analog for monthly dosing to treat type 2 diabetes Under the agreement, SynCo will further develop the Versartis existing production process for VRS-859 and optimize the manufacturing process to increase yields for the forthcoming cGMP production.

18 Aug 2009

Boehner blasts Phrma on deal with White House

The drug industry’s decision to agree to $80 billion in concessions to the White House was short-sighted, will hurt drug manufacturers and their customers, and "has all the markings of a deal gone sour," House Minority Leader John Boehner wrote Monday to his former colleague, Billy Tauzin, who now heads the Pharmaceutical Research and Manufacturers of America.

17 Aug 2009

FDA approves Helixate FS for routine prophylaxis in children with hemophilia A

CSL Behring announced today that Helixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage.

17 Aug 2009

Alpharx completes lyophilization process for Zysolin

AlphaRx Inc. has announced that it has completed the lyophilization process for Zysolin(TM), allowing the company to proceed to clinical batch material manufacturing for human trials. This process has been solely developed by AlphaRx's scientists and the resulting formulations have been successfully tested in animal studies conducted by the U.S. Army under a Material Transfer Agreement.

17 Aug 2009

GSK starts testing H1N1 vaccine; Opinion piece addresses U.S. role in helping developing countries procure vaccine

"GlaxoSmithKline has started testing its pandemic H1N1 swine flu vaccine in humans, and expects to start giving the results to government agencies next month, the drugmaker said on Friday," Reuters reports. The company "plans to conduct 16 different trials of the vaccine and to test 9,000 people in total across Europe, Canada and the United States," according to the news service (Deighton, 8/14).

17 Aug 2009

FDA approves Extavia for multiple sclerosis

The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

17 Aug 2009

Astronauts test nutritional supplement formulas in space

After nearly four years of joint research of Houston-based AmeriSciences and NASA / Johnson Space Center (JSC), a senior NASA medical officer has confirmed that two of the resulting nutritional supplement formulas were used and tested in space by the astronauts of mission STS-125 of May 11, 2009 and the mission STS-127 of July 15, 2009 and are now in use and testing aboard the International Space Station.

17 Aug 2009

Mylan Pharmaceuticals receives final FDA report on Morgantown, W.Va., manufacturing facility

Mylan Inc. (Nasdaq: MYL) today announced that the U.S. Food and Drug Administration (FDA) has released its official and final report regarding the agency's review of allegations made in a July newspaper article concerning the company's Morgantown, W.Va., manufacturing facility.

14 Aug 2009

Pharmaceutical News

CEL-SCI expands work on current H1N1 virus vaccine

Light-activated delivery system enhances anti-tumour drug potency

Orient Pharma granted commercialization rights for a drug candidate by DURECT

BioAlliance Pharma's new drug application for oropharyngeal candidiasis treatment accepted by the FDA

CSL Biotherapies to supply Afluria influenza vaccines from newly licensed packaging facility

New production technology to develop vaccine for norovirus

SFDA approves China Pharma Holdings' generic Omeprazole Sodium injection

FDA places Geron Corporation's IND for spinal cord injury on clinical hold

Amira Pharmaceuticals submits IND for inflammatory and allergic disease treatment candidate

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Labopharm comments on outcome of patent-infringement litigation initiated by Purdue Pharma

Par Pharmaceutical wins in Ultram ER litigation

Synco Bio to manufacture Versartis type 2 diabetes drug candidate

Boehner blasts Phrma on deal with White House

FDA approves Helixate FS for routine prophylaxis in children with hemophilia A

Alpharx completes lyophilization process for Zysolin

GSK starts testing H1N1 vaccine; Opinion piece addresses U.S. role in helping developing countries procure vaccine

FDA approves Extavia for multiple sclerosis

Astronauts test nutritional supplement formulas in space

Mylan Pharmaceuticals receives final FDA report on Morgantown, W.Va., manufacturing facility

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