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Arqule Inc. CEO Paolo Pucci said the firm was “limited in what we can comment [on] for the time being” in connection with Merck & Co. Inc.’s deal to pay about $2.7 billion in cash for the company. “There is no better model for bringing a drug faster into the hands of patients and caregivers than the example of Keytruda. I will leave it at that.” Merck’s Keytruda (pembrolizumab), a human PD-1-blocking antibody was first approved in September 2014 for advanced melanoma. The label has been widely expanded since. Read More
BEIJING – Luye Pharma Group Ltd., of Yantai, Shandong Province of China, has proposed to acquire Shandong Boan Biological Technology Co. Ltd. for up to $205.8 million to expand and diversify its pipeline portfolio into biologics. The payment is to be in three parts: an initial amount of $102.9 million, followed by payments linked to China marketing approval for two of Boan’s candidates of $51.45 million each. Read More
DUBLIN – Sanofi SA is paying a hefty 172% premium to acquire Synthorx Inc. for $68 per share, or $2.5 billion in all, to add a clinical-stage immuno-oncology asset to its pipeline and a platform technology that will enable it to optimize cytokine-based drugs for cancer and autoimmune disease. Read More
LONDON – Janssen Biotech Inc. is buying Xbiotech Inc.’s interleukin-1a (IL-1a) inhibitor bermekimab for $750 million up front and will pay a further $600 million in potential milestones as the product advances in development for the treatment of atopic dermatitis and the chronic immune-mediated skin disease, hidradenitis suppurativa (HS). Read More
ORLANDO, Fla. – Data from two studies from Forty Seven Inc. announced at the American Society of Hematology (ASH) annual meeting moved the market in a major way Monday as the company stock (NASDAQ:FTSV) soared 111% to close at $30.43, up $15.99. Read More
ORLANDO, Fla. - Chimeric antigen receptor T (CAR T) cells have proved to be a major advance in treating patients with refractory B-cell malignancies so far. But, often, in approaching those issues "we solve one and we create another," Stephen Schuster, a doctor at the Abramson Cancer Center at the University of Pennsylvania in Philadelphia, told reporters at the 61st American Society of Hematology (ASH) annual meeting Saturday. Read More
ORLANDO, Fla. – “The Wright brothers showed that you could fly a plane, but it wasn’t very far and it wasn’t very safe,” Wendell Lim told his audience at the 61st American Society of Hematology (ASH) annual meeting this weekend. “That’s where cell therapy is now.” Read More
ORLANDO, Fla. – New phase I/II data from Autolus Therapeutics plc announced at the American Society of Hematology’s (ASH) annual conference show that AUTO-3, the first bicistronic CAR T targeting CD19 and CD22 followed by an anti-PD1, was well-tolerated in a phase I/II study. Read More
ORLANDO, Fla. – Preliminary data from a phase II test of Constellation Pharmaceuticals Inc.'s CPI-0610 in patients with myelofibrosis (MF), previewed to market adulation in November, got a full airing Monday at the American Society of Hematology (ASH) annual meeting. Read More
ORLANDO, Fla. – Kura Oncology Inc., encouraged by new data on tipifarnib and positive feedback from the FDA, said Sunday that next year it will initiate a single-arm, phase II registration-directed trial of the candidate in angioimmunoblastic T-cell lymphoma (AITL), a rare and often aggressive form of peripheral T-cell lymphoma (PTCL). Read More
ORLANDO, Fla. – Not long past the opening of the American Society of Hematology’s (ASH) massive annual conference, Janssen Biotech Inc. released upbeat follow-up survivability data on Imbruvica (ibrutinib) from two studies and an integrated analysis evaluating Imbruvica in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read More
ORLANDO, Fla. – While disparities remain in putting minority and older patients into clinical trials and being treated for blood cancers, there are successes in getting once-ignored patients into the mix so they can receive the same treatments as others. Read More
ORLANDO, Fla. – In an effort to get sickle cell disease (SCD) researchers, drug developers, patients and regulators all on the same page, the American Society of Hematology (ASH) and the FDA have released new recommendations aimed at establishing uniform global standards for clinical trial endpoints to evaluate new therapies. Read More
SAN DIEGO – Smaller companies looking to move their Alzheimer’s disease drugs into late-stage testing as quickly as possible are eschewing cognitive endpoints that can take years to readout for biomarkers and functional assays of brain activity. Read More
LONDON – GE Healthcare Life Sciences is bringing its heft to 3D bioprinting in an agreement with Advanced Solutions Life Science Inc. (ASLS), in which the partners aim to automate the production of quality-assured, vascularized tissues, for bone, soft tissue and organ replacements. Read More
Vancouver, British Columbia-based Correvio Pharma Corp. is hoping that it will receive a positive response from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which meets tomorrow to consider the U.S. approvability of Brinavess (vernakalant hydrochloride, I.V.), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF). Read More
New and updated preclinical and clinical data presented by biopharma firms at the 61st American Society of Hematology annual meeting in Orlando, Fla. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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