Company (Location) Product Description Indication Status Date AUTOIMMUNE Novan Therapeutics Inc. (Durham, N.C.) SB204 Nitric oxide-releasing compound Acne Reduced colonization of skin in a Phase I trial 5/31/13 Soligenix Inc. (Princeton, N.J.) SGX203 Oral beclomethasone 17, 21-diproprionate Pediatric Crohn's disease Began its first trial 5/16/13 Xenetic Biosciences plc (London) Myeloxen Vaccine based on the Imuxen liposomal technology Multiple sclerosis Completed the Phase I safety study 5/13
Johnson & Johnson has jumped into the early stage development pool with both feet. With the opening of its California Innovation Center based in Menlo Park earlier this month, the New Brunswick, N.J.-based company has established regional innovation centers, incubators, and entrepreneurs in residence to get J&J closer to early stage products that might be licensed or acquired by the health-care giant. Previously, J&J was interacting with the outside world through different channels, but now
By Brian Orelli | BioWorld Insight | Monday, June 17, 2013
Two initiatives from different ends of the drug development spectrum are shining a bright light on nagging weaknesses in translational medicine and the urgent need to improve speed and efficiency in moving early stage discoveries into therapeutic candidates. Glaxosmithkline plc's (GSK) Discovery Fast Track competition is designed to serve as a funnel, enabling the London-based pharma to quickly sift a large number of academic discoveries and identify 10 candidates for its Discovery Partnerships
By Marie Powers | BioWorld Insight | Monday, June 17, 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Sarilumab Fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex Moderate to severe rheumatoid arthritis Enrolled their first patients in Phase III trials 5/16/13 Xenoport Inc. (Santa Clara, Calif.) Arbaclofen placarbil A prodrug of the R-isomer of baclofen Spasticity due to multiple sclerosis Terminated the
Company (Location) Product Description Indication Status Date AUTOIMMUNE GW Pharmaceuticals plc (Porton Down, UK) Sativex Cannabinoid product Moderate to severe spasticity in multiple sclerosis Received commercial approval for Sativex in Italy 5/8/13 CANCER Aveo Pharmaceuticals Inc. (Cambridge, Mass.) and Astellas Pharma Inc. (Tokyo) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Astellas no longer intends to submit an MAA and will not fund any
It has been 10 years since the international human genome project (HGP) was officially declared completed two years ahead of schedule. This monumental undertaking has helped fuel the biopharmaceutical sector to its current lofty heights and one of the reasons that bioscience discoveries in overdrive can be traced back to the completion of the sequencing of the human genome. (See BioWorld Today, April 16, 2003.) This truly remarkable achievement has been the underpinning of a new wave of genomics
By Peter Winter | BioWorld Insight | Monday, June 17, 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) Plegridy Peginterferon beta-1a Multiple sclerosis Submitted a BLA 5/22/13 CANCER Algeta ASA (Oslo, Norway) and Bayer AG (Leverkusen, Germany) Xofigo Radium Ra 223 dichloride; an alpha particle-emitting radioactive therapeutic agent Castration-resistant prostate cancer FDA approved it 5/16/13 Aveo Oncology Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase
"There are a lot of situations where people use only an animal model and take a shot at a clinical trial and are disappointed after spending resources that could have been spent elsewhere." – Gene Williams, executive chairman and CEO of DART Therapeutics Inc., discussing its use of Biovista Inc.'s clinical outcomes search space technology to identify potential drug candidates for in-licensing in Duchenne's muscular dystrophy "I think the biggest challenge today for selling into BRIC for global
Company (Location) Product Description Indication Status Date AUTOIMMUNE Creabilis SA (Luxembourg) CT327 Topical TrkA kinase inhibitor Chronic pruritis caused by psoriasis Phase IIb data showed a statistically significant and clinically meaningful reduction in pruritus of 60 percent compared to 20 percent for those receiving placebo 5/13/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-3100 A selective antagonist of Toll-like receptors 7 and 9 Psoriasis Phase II data showed improvements
In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court ruled Thursday that naturally occurring, isolated DNA is not patent eligible. However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created. In striking down Myriad's isolated DNA claims to the BRCA1 and BRCA2 genes, the court said the Salt Lake
By Mari Serebrov | BioWorld Today | Friday, June 14, 2013
Apceth GmbH, of Munich, Germany, received approval to conduct a clinical cancer trial with its genetically modified adult mesenchymal stem cells. The multicenter, open-label trial will recruit patients suffering from advanced adenocarcinomas of the gastrointestinal tract. The therapy is based on mesenchymal stem cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient. Celgene Corp., of Summit, N.J., said oral
Astrazeneca plc, of London, the University of Manchester and Cancer Research Technology, the commercial arm of Cancer Research UK, inked two agreements to seek new cancer drugs. In the first agreement, scientists at the Cancer Research UK Paterson Institute for Cancer Research at the University of Manchester will develop potential drugs targeting a key protein involved in DNA damage response, with Astrazeneca providing the preliminary compounds. Astrazeneca will have first rights to the
Takeda California Inc., of San Diego, a subsidiary of Takeda Pharmaceutical Co. Ltd., partnered with Sea Lane Biotechnologies, of Mountain View, Calif., giving Takeda access to Sea Lane's Concirt human antibody libraries for its drug discovery program in exchange for an up-front payment and milestone option fees for projects initiated under the collaboration. Sea Lane also is eligible for downstream milestone option payments. The two-year agreement has a pre-negotiation option to extend. "We
By Catherine Shaffer | BioWorld Today | Friday, June 14, 2013
Predicting protein folding has made strides in recent years, mainly through unconventional approaches. Computer games like foldit have been able to apply crowdsourcing to proteins, and solve structures that had evaded traditional computing power. (See BioWorld Today, Aug. 13, 2010.) But George Rose, who is at Johns Hopkins University, said he thinks that the problem can, and perhaps should, be solved in a more fundamental way. Current methods for predicting a protein's shape when folded from
By Anette Breindl | BioWorld Today | Friday, June 14, 2013
Esperion Therapeutics Inc., of Plymouth, Mich., filed terms for its initial public offering, planning to raise $63 million by offering 4.5 million shares at a price range of $13 to $15. The company would list under the symbol "ESPR." Cytomedix Inc., of Gaithersburg, Md., amended its previous financing with Lincoln Park Capital, and said in paperwork filed with the SEC that it has registered and may sell up to about 10.3 million shares to Lincoln.
Amarantus Bioscience Holdings Inc., of Sunnyvale, Calif., said it signed a laboratory services agreement with BD Biosciences, a segment of BD (Becton, Dickinson and Co.), of Franklin Lakes, N.J, under which BD's Custom Technology Team will perform sample analysis on Amarantus' LymPro Test for Alzheimer's disease. Financial terms were not disclosed. Amgen Inc., of Thousand Oaks, Calif., said the FDA expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant
SAN DIEGO – At a Calbio session, Cambell Alliance, the business consulting segment of Inventiv Health Inc., presented its survey of business development professionals. In addition to the forward-looking examination of dealmaking expectations, a panel gave their experiences in the ever-changing business development. Most survey respondents – both primarily out-licensers and primarily in-licensers – expect the number of deals for early stage assets to increase. For Phase III assets, 59 percent
By Brian Orelli | BioWorld Today | Friday, June 14, 2013
For Celgene Corp., entering Japan proved a relatively brisk venture, said Jerome Zeldis, the company's chief medical officer, but China – where Celgene also has established itself, and is launching Revlimid (lenalidomide) this week – represents something more of a challenge for biotech and pharma firms. "I don't think any other company has ever walked into Japan, established a footprint and gotten to approval faster than we did," Zeldis said, noting that the Summit, N.J.-based firm gained
By Randy Osborne | BioWorld Today | Friday, June 14, 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Novan Therapeutics Inc. (Durham, N.C.) SB204 Nitric oxide-releasing compound Acne Reduced colonization of skin in a Phase I trial 5/31/13 Soligenix Inc. (Princeton, N.J.) SGX203 Oral beclomethasone 17, 21-diproprionate Pediatric Crohn's disease Began its first trial 5/16/13 Xenetic Biosciences plc (London) Myeloxen Vaccine based on the Imuxen liposomal technology Multiple sclerosis Completed the Phase I safety study 5/13