Drug Production News and Research

RSS

CPhI Russia Pharma Expo to be held at St. Petersburg from 16 to 17 April, 2014

Leading events organizer, UBM Live, along with partner RESTEC, announces that CPhI Russia @ IPhEB is returning for a second year to St. Petersburg, from 16th to 17th April 2014. The event will co-locate with ICSE, P-MEC and InnoPack, creating Russia's most comprehensive meeting point for the pharmaceutical industry.

9 Apr 2014

BioAlliance Pharma, Daewoong sign new licensing agreement for commercialization of Sitavig in South Korea

BioAlliance Pharma SA, an innovative Company specialized in the development of drugs in orphan oncology diseases, today announces an exclusive supply and license agreement for Sitavig® (Acyclovir Lauriad®) with Daewoong Pharmaceutical Co., Ltd. for commercialization rights in South Korea.

2 Apr 2014

Tetraphase Pharmaceuticals reports net loss of $11.3 million for Q4 2013

Tetraphase Pharmaceuticals, Inc. today reported financial results for the quarter and full year ended December 31, 2013.

6 Mar 2014

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV).

19 Feb 2014

Researchers create promising compound for cancer treatment

A promising compound for cancer treatment has been syntesised in a laboratory by an RMIT University researcher during his PhD research.

9 Feb 2014

TSRI scientists discover unusual protein that probably helps some bacteria evade immune response

A team led by scientists at The Scripps Research Institute (TSRI) has discovered an unusual bacterial protein that attaches to virtually any antibody and prevents it from binding to its target. Protein M, as it is called, probably helps some bacteria evade the immune response and establish long-term infections.

7 Feb 2014

ScinoPharm constructs Changshu plant in China

ScinoPharm today announced that the company has completed construction of its Changshu plant on a 16-acre (6.5-hectare) site.

12 Dec 2013

Rensselaer professors team up to develop innovative biomanufacturing technology

Two chemical engineering professors at Rensselaer Polytechnic Institute are contributing to a collaboration among academia, industry, and the federal government to develop a method for rapidly manufacturing biologic drugs.

4 Dec 2013

FDA proposes rule to speed dissemination of new safety information about generic drugs

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.

11 Nov 2013

First generic versions of Aciphex delayed-release tablets get FDA approval for GERD treatment

The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease in adults and adolescents (ages 12 and up).

10 Nov 2013

MIT investigators receive DARPA grant to develop new technologies for BioMOD program

Investigators from MIT's Biomanufacturing Research Program (BioMAN) have received a $10.4 million grant from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies for DARPA's Biologically-derived Medicines On Demand (BioMOD) program.

5 Oct 2013

Metabolic enzymes in opium poppy are used to produce valuable painkilling drugs

University of Calgary scientists have discovered metabolic enzymes in the opium poppy that play "widespread roles" in enabling the plant to make painkilling morphine and codeine, and other important compounds.

5 Oct 2013

Federal judge passes consent order against Shamrock Medical for distributing mislabeled drugs

The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.

19 Sep 2013

FDA issues import alert on drug products manufactured at Ranbaxy's facility in Mohali, India

The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.'s facility in Mohali, India.

17 Sep 2013

First generic version of Xeloda gets FDA approval for breast and colorectal cancers

The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.

17 Sep 2013

Dakota Laboratories banned from manufacturing and distributing drugs

Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws.

4 Sep 2013

Arrays of nanoscale sensors detect flaws in drugs and help improve production

MIT chemical engineers have discovered that arrays of billions of nanoscale sensors have unique properties that could help pharmaceutical companies produce drugs - especially those based on antibodies - more safely and efficiently.

17 Aug 2013

Renaissance in drug development for rare diseases

Once famously described as "orphan diseases, too small to be noticed, too small to be funded" in the Hollywood drama Lorenzo's Oil, rare diseases are getting unprecedented attention today among drug manufacturers, who are ramping up research efforts and marketing new medicines that promise fuller lives for children and other patients with these heartbreaking conditions.

14 May 2013

BD receives FDA approval for second prefilled injectable drug

BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD, announced today that the U.S. Food and Drug Administration has approved the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injectables.

From BD (Becton, Dickinson and Company) 24 Apr 2013

FDA finds violations at 28 drug compounding pharmacies

The FDA has found safety violations at 28 of 29 compounding pharmacies that are supposed to be producing sterile drugs.

16 Apr 2013