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Mesoblast preps first filings for GVHD drug after phase 3 win

A late-stage study of Mesoblast’s off-the-shelf stem cell therapy for acute graft-versus-host disease (GVHD) has hit its main goal, setting up an imminent U.S. filing.

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Bristol-Myers chops clinical staff as site closure enters endgame

Bristol-Myers Squibb is set to lay off 107 staffers at its Wallingford, Connecticut, site as its planned closure of the facility gathers pace. Having earmarked the site for staff reductions in 2015, Bristol-Myers is now doling out pink slips at an accelerating rate as it gets closer to shuttering by the end of the year.

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Merck's ERK inhibitor shows promise in combo against resistant cancers

One-fifth of patients in a phase 1 study responded to Merck's ERK inhibitor, a comparable response rate to other cancer drugs, such as MEK inhibitors. The results suggest the drug could be used in tandem with another to fight cancers with a specific mutation.

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A personalized MS treatment built from skin stem cells

Scientists at the University of Cambridge believe they’ve found a new way to repair the damaged myelin around nerve cells that's characteristic of multiple sclerosis—and it involves reprogramming patients’ own skin cells.

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Deal-hungry Takeda forges another R&D alliance

Takeda has added another early-stage research partnership as it reboots its R&D operations, this time teaming up with two Seattle-based academic centers in a project focused on its key targets of cancer, gastrointestinal disease and neurological disorders.

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Gilead, Sangamo strike $3B off-the-shelf CAR-T deal

Gilead’s Kite has struck a $3 billion deal to access Sangamo Therapeutics’ zinc finger nuclease (ZFN) technology. Kite will use the ZFN gene editing platform to create next-generation, off-the-shelf CAR-T therapies to cement its position as a long-term front-runner in the growing cell therapy space.

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Santhera offers Raxone to U.S. DMD patients through expanded access program

Santhera has suffered several regulatory setbacks around Raxone (idebenone) in Duchenne muscular dystrophy (DMD). In the absence of official approvals, the company is offering the drug for patients in the U.S. through an expanded access program operated by Clinigen.

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GW cannabinoid drug fails midphase epilepsy trial

GW Pharmaceuticals’ GWP42006 has failed to outperform placebo in a phase 2a focal seizure trial. The setback wiped 5% off GW’s stock and dented the prospects of the cannabidivarin candidate.

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Arcus Biosciences eyes $100M IPO

Mere months after bagging $107 million in its series C round, Arcus Biosciences is teeing up for a $100 million IPO, which will drive the clinical development of its lead assets into 2020.

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Medigene gets OK for first trial of T-cell receptor therapy

Medigene has been given a green light by regulators in Germany to start human trials of MDG1011, the lead candidate to come out of its modified T-cell program.

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Ipsen joins Arix’s growing pool of pharma partners

Ipsen has become the latest drugmaker to start working with Arix Bioscience. The French biopharma follows Fosun, Takeda and UCB to become the fourth company to secure a connection to Arix’s stable of startups.

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Merck inks $394M takeover of oncolytic virus play Viralytics

Merck is set to pay $394 million to acquire Viralytics. The takeover will give Merck control of an oncolytic immunotherapy that Viralytics is testing in combination with Keytruda in early-phase trials.

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Ionis farms out antisense drug to AstraZeneca in deal worth up to $330M

Ionis Pharmaceuticals has licensed an antisense drug for the treatment of kidney disease to AstraZeneca, picking up a $30 million payment in the process.

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Aimmune aces peanut allergy phase 3, teeing up FDA filing

Aimmune has presented strong data from a phase 3 trial of its peanut allergy treatment AR101. The Brisbane, California-based biotech plans to file for FDA approval by the end of 2018 to give patients a way to protect themselves against accidental exposure to peanut protein.

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AbbVie doubles down on tau with Voyager Alzheimer's deal

AbbVie has teamed up with Voyager Therapeutics on a tau protein-targeting program, paying $69 million upfront for an option on the Alzheimer’s disease candidate.

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Takeda rides the neuro R&D Wave with latest biotech pact

Perennial biotech dealmaker Takeda is at it again, striking a new pact with Wave Life Sciences with a focus on a series of difficult-to-treat neurological disorders.

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Lilly scraps rheumatoid arthritis trial after interim review

Eli Lilly has halted a phase 2 rheumatoid arthritis trial after getting a midstudy glimpse at the data. The setback leaves Lilly and partner Hanmi Pharmaceutical to weigh whether it is worth moving the Bruton's TKI forward in other indications.

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Apricus craters as FDA rejects erectile dysfunction cream again

The FDA has issued a complete response letter for Apricus’ topical erectile dysfunction drug Vitaros for the second time, sparking a massive after-hours slump in its share price.

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Roche pens $1.9B deal to buy oncology data firm Flatiron

Roche has struck a $1.9 billion deal to acquire Flatiron Health. The takeover gives Roche ownership of the cancer software and real-world evidence that turned GV-backed Flatiron into a rising star.

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Using stem cells to generate an immune attack against cancer

Induced pluripotent stem cells have the power to transform into any cell in the body, making them a prime candidate for regenerative medicine. Scientists at Stanford University believe stem cells can also teach the immune system to recognize and attack cancer—and they tested the concept in mouse models of breast cancer.

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Celgene spinoff debuts with big names, big bucks and big hopes

A Celgene spinout known as Celularity with some of the biggest names across biotech and Silicon Valley has raised an eye-watering $250 million for its work in cancer.

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Vertex’s big week continues as nonopioid pain drug clears second phase 2 test

Vertex Pharma now has a pair of studies backing up its new drug VX-150, suggesting it can provide opioidlike pain relief without the addiction risks.

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Santhera, reeling from DMD blow, lands cystic fibrosis drug

Santhera Pharmaceuticals has licensed a clinical-phase cystic fibrosis asset from Polyphor. The Swiss biotech penned a CHF 127.5 million ($138 million) deal for the human neutrophil elastase inhibitor to expand its clinical pipeline.

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Biogen tweaks Alzheimer’s phase 3, sparking stock slide

Biogen has spooked investors by disclosing midstudy changes to its late-phase Alzheimer’s program. The biotech is adding 510 patients to the phase 3 aducanumab trials after seeing more “variability” than expected in a sample size re-estimation.

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Gradually eliminating BACE1 clears amyloid plaque from mice with Alzheimer’s

Cleveland Clinic researchers depleted BACE1 to reverse amyloid plaque formation in mice with Alzheimer's disease, buoying hopes that blocking the enzyme could become a viable treatment for humans.

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PASBION HEALTHCARE INC

1747 S. Douglass Road, Suite C

Anaheim, California 92806

714.231.9876