Bristol-Myers Squibb Co., of Princeton, N.J., and AstraZeneca plc, of London, said the FDA accepted for review and granted priority designation for the biologics license application for metreleptin in metabolic disorders associated with inherited or acquired lipodsytrophy...Under priority review, the FDA aims to complete its review within an eight-month review cycle

Bristol-Myers Squibb Co., of New York, said it has notified the New York Stock Exchange (NYSE) of its intention to voluntarily delist its $2 convertible preferred stock from the NYSE, a decision driven by the low number of shares outstanding, low daily trading volume, listing fees and compliance administration costs

Adaptive Biotechnologies, of Seattle, entered a collaboration with Bristol-Myers Squibb Co., of New York, for the discovery of immunological biomarkers in oncology...Under the terms, Adaptive will use its immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response

Bristol-Myers Squibb Co., of New York, said the FDA approved a supplemental new drug application for the HIV-1 therapy Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg

Inc., of Whitehouse Station, N.J., entered into a nonexclusive deal with Bristol-Myers Squibb Co., of New York, to conduct a Phase II trial of a once-daily oral combination regimen consisting of BMS' NS5A replication complex inhibitor daclatasvir and Merck's NS3/4A protease inhibitor MK-5172 to treat chronic hepatitis C virus infection genotype 1

Bristol-Myers Squibb Co., of New York, will invest $250 million to expand its large-scale biologics manufacturing facility in Devens, Mass., introducing biologics development and clinical trial manufacturing capabilities and adding about 350 employees

Amylin Pharmaceutical Inc., of San Diego, (later acquired by Bristol-Myers Squibb Co. with help from AstraZeneca plc) is the subject of a three-defendant lawsuit along with Merck & Co...Pradax is used to prevent clotting in patients who suffer from atrial fibrillation

The agreement allows the HPA to contribute to global polio eradication, while securing a commitment from a major pharma firm to develop use of its technology...Terms include certain milestones and tiered royalty payments to the HPA in return for technology transfer and other licensing rights

to develop, manufacture and supply commercial quantities of Ofirmev (acetaminophen) injection in flexible plastic bags...PolyTherics Ltd., of London, received an undisclosed milestone payment from Celtic Pharma Holdings LP, also of London, triggered by further progress on their hematology alliance to produce longer-acting versions of blood factor proteins...Sorrento Therapeutics Inc., of San Diego, signed an exclusive option to acquire Igdrasol Inc., of Fountain Valley, Calif., a private company

Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market...Under the terms, Bio-Link will work with Phylogica to monetize those assets through out-licensing or disposal of the Phylomer peptides to a pharma or biotech company...Protalix BioTherapeutics Inc., of Carmiel, Israel, said it engaged Citigroup to assist

BioCryst's chimpanzee study had been designed to determine if nontoxic doses of BCX5191 would have a potent antiviral effect...Cerulean Pharma Inc., of Cambridge, Mass., said preclinical data showed that CRLX101 in combination with Avastin (bevacizumab, Roche AG) inhibited tumor growth and improved survival vs...Lee's will have an option to negotiate for commercial rights in China

PharmaIN Corp., of Bothell, Wash., and LAT Pharma LLC, of Chicago, said the FDA granted orphan designation for terlipressin for the treatment of ascites due to all etiologies except for cancer...Tranzyme Pharma Inc., of Research Triangle Park, N.C., reported the successful completion of its chemistry-based drug discovery collaboration with New York-based Bristol-Myers Squibb Co., which will now further develop the transferred active macrocycles across multiple drug targets

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., of New York, said the FDA approved Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nanvalvular atrial fibrillation

The Japanese Ministry of Health, Labor, and Welfare approved Eliquis (apixaban) by Bristol-Myers Squibb Co., of Princeton, N.J., and Pfizer Inc., of New York, for prevention of stroke and embolism in patients with nonvalvular atrial fibrillation...The FDA acknowledged receipt of a new drug application for Eliquis in September and deemed it a complete response to its June 22 complete response letter requesting additional information on data management and verification from the ARISTOTLE trial

Bristol-Myers Squibb Co., of New York, joined the Multiple Myeloma Research Foundation pre-competitive consortium to discover and accelerate new approaches to treating multiple myeloma through the organization's Personalized Medicine Initiative

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, said the European Commission approved Eliquis (apixaban) for prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors...LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated

Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was

Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was

Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said the European Commission approved Forxiga (dapaglifozin) tablets for Type II diabetes in the European Union...Forxiga is the first SGLT2 inhibitor to gain approval in diabetes and is intended for use as an adjunct to diet and exercise in combination with other glucose-lowering products such as insulin or as a monotherapy in metformin-intolerant patients