Biopharma News
Emerging Life-Sciences Markets: New Partnerships, New Competitors
Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.
New Study Reveals Immunotherapy More Effective Than Chemotherapy
The results from an international study on nivolumumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.
EMA Approves Blincyto, with Conditions
Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.
Roche's Ocrelizumab Reduces MS Progression in Phase III Trials
Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.
MedImmune and 3M Collaborate on TLR Agonist Cancer Therapies
MedImmune and 3M Drug Delivery Systems collaborate to develop toll-like receptor (TLR) agonists for immuno-oncology.
Avastin Biosimilar Demonstrates “Clinical Equivalence”
ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.
Innate Pharma Expects Data on Lirilumab by 2016
The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.
Amgen to Use Xencor’s Bispecific Antibody Platform
Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.
RSV Vaccine Shows Promise in Preclinical Studies
Novovax’s investigational vaccine targeting respiratory syncytial virus (RSV) demonstrated clinical effectiveness in animal models.
Nexvet Secures Biomanufacturing Facility for Veterinary Biologics
Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.
Daiichi Sankyo to Develop Thrombus Dissolving Agent
Daiichi Sankyo signed an exclusive licensing agreement with clinical-stage biopharmaceutical company Translational Sciences to develop and commercialize its novel thrombus (blood clot) dissolving agent, TS23.
AstraZeneca Buys Amgen's Biologics Manufacturing Facility
According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.
Aragen Bioscience Licenses Protein Production Technology
Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.
Valeant Licenses Brodalumab Candidate from AstraZeneca
The investigational monoclonal antibody targets interleukin-17 and is in clinical trials for the treatment of plaque psoriasis.
Sharing Project or Partnership Details
When should CMOs and their pharma clients share the details of their partnerships with outside parties?
FDA Approves Repatha, Amgen’s PCSK9 Inhibitor
The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.
GSK to Divest Ofatumumab to Novartis Pharma
GSK announces plan to divest its rights in ofatumumab for auto-immune indications for up to $1 billion.
Novo Nordisk to Start Phase IIIa Trials for Oral Biologic
The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.
Merus Obtains Financing and Progresses in Clinical Trials of Bispecific Antibodies
Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.
Pfizer to Divest Four Injectable Products in Hospira Acquisition
Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.
BeiGene Plans First cGMP Manufacturing Facility in Suzhou, China
Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.
Valeant Buys Sprout Pharmaceuticals
The acquisition occurs one day after FDA approval of Sprout’s Addyi, the first medication to treat hypoactive sexual desire disorder in women.
Novartis Licenses AVEO Oncology’s Antibody to Treat Metabolic Syndrome
Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.
Novo Nordisk Licenses Genmab's Bispecific Antibody Platform
Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments
Pluristem's PLX Cell Therapy Considered for Accelerated Development
The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
Medimmune and Inovio Pharmaceuticals Form Cancer Pact
Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.
Flexion Collaborates with Patheon to Manufacture Osteoarthritis Treatment
Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis injectable steroid drug product.
Avitide Secures Financing for Novel Affinity Purification Platform
The company’s purification platform is thought to reduce the number of purification steps that are currently required for the manufacture of complex therapeutics.
Amneal Purchases Manufacturing Site in Ireland
US generics manufacturer Amneal acquires a former J&J plant in Ireland.
Shire Takes Baxalta Proposal to Shareholders
Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.
