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Merck KGaA and Pfizer get their fifth-place immunotherapy on the FDA fast track

CommentsPharmacodia.com2015-10-08 00:00 Read   297

Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.

New Analysis Suggests Aubagio® (teriflunomide) Slows Brain Atrophy in People with Relapsing Multiple Sclerosis

R&DPharmacodia.com2015-10-08 00:00 Read   322

Sanofi and its subsidiary Genzyme announced today that magnetic resonance imaging (MRI) data from the Phase III TEMSO study demonstrate that Aubagio® (teriflunomide) significantly slowed brain volume loss (or atrophy) vs. placebo over two years in people with relapsing multiple sclerosis (RMS). In this analysis, MRI data from TEMSO were analyzed utilizing SIENA (structural image evaluation using normalization of atrophy), an alternative methodology than originally used.

Roche's investigational combination of Cotellic and Zelboraf helped people with advanced melanoma live significantly longer than Zelboraf alone

R&DPharmacodia.com2015-10-08 00:00 Read   178

Roche today announced final survival data from the Phase III coBRIM study showing that Cotellic (cobimetinib), when used with Zelboraf (vemurafenib), helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer (overall survival, OS) compared to Zelboraf alone. Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year.

Genocea Announces Positive Durability Data from 6-Month Analysis of Phase 2 Clinical Trial of Genital Herpes Immunotherapy GEN-003

R&DPharmacodia.com2015-10-08 00:00 Read   180

Genocea Biosciences, Inc., a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study.

Seattle Genetics Announces Initiation of Phase 1/2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo® (Nivolumab) in Second-line Hodgkin Lymphoma

R&DPharmacodia.com2015-10-08 00:00 Read   230

Seattle Genetics, Inc.today announced that it has initiated a phase 1/2 clinical trial of ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) for patients with relapsed or refractory Hodgkin lymphoma (HL) after failure of frontline treatment.

Proteros signs new oncology collaboration with Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA on epigenetic target

TrendPharmacodia.com2015-10-08 00:00 Read   383

Proteros biostructures GmbH today announced that it has signed an agreement with Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA ("MSD") to discover and develop small molecule compounds against an epigenetic target for the potential treatment of various types of cancer.

Lion Biotechnologies Obtains Exclusive License From NIH to Develop and Commercialize TIL in Bladder, Lung, Breast and HPV-Associated Cancers

TrendPharmacodia.com2015-10-08 00:00 Read   520

Lion Biotechnologies (LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that it has obtained an exclusive, worldwide license from the National Institutes of Health (NIH) to develop and commercialize TIL therapy in four additional tumor indications. Under the agreement, the NIH has granted Lion exclusive rights to certain patents to develop TIL in the treatment of bladder, lung, breast and HPV-associated cancers, including cervical and head and neck.

Chinese scientist YouYou Tu was awarded the 2015 Nobel Prize in Physiology or Medicine

CommentsPharmacodia.com2015-10-06 00:00 Read   642

the 2015 Nobel Prize in Physiology or Medicine

Analyst sees big things for Allergan, Amgen despite slow growth in China and biosimilar pressures

CommentsPharmacodia.com2015-10-05 00:00 Read   314

The media blitz over jacked-up drug prices and concerns over slowing growth in China may have temporarily kicked the breath out of pharma valuations, but some analysts think the concerns will be short-lived and a return to growth is inevitable.

FTC weighs in on Mylan case, saying generics tweaking may be anticompetitive

CommentsPharmacodia.com2015-10-05 00:00 Read   333

Generics makers have had just about enough with branded drugmakers tweaking aging meds to hold on to sales, with some arguing in court that the move is inherently anticompetitive. Now the FTC is wading into the debate, saying that pharma companies that make small changes to brand-name products to ward off competition from cheaper copycats may be violating antitrust laws.

Ackman's Pershing Square off 12.6 pct for year after Valeant tumble

CommentsPharmacodia.com2015-10-05 00:00 Read   259

Billionaire hedge fund manager William Ackman's Pershing Square Holdings fund is nursing a 12.6 percent loss for 2015, an investor who received Ackman's letter on Thursday said, marking a dramatic reversal of fortune for one of last year's best performing managers.

Astellas and Chromocell Announce License and Collaboration Agreement to Develop and Commercialize New Therapies to Treat Neuropathic Pain

TrendPharmacodia.com2015-10-01 00:00 Read   985

Astellas Pharma Inc. and Chromocell Corporation today announced that they have entered into a license and collaboration agreement for the development and commercialization of therapeutics to treat neuropathic and other pain conditions.