Biopharma News
Sanofi and Boehringer Ingelheim Sign on Business Unit Swaps
The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.
Kalytera Appoints Robert Langer to Scientific Advisory Board
Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.
Adaptimmune and Thermo Fisher Collaborate on Manufacture of Cell Therapies
The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.
Sandoz Plans to Launch Five Biosimilars by 2020
Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.
FDA Accepts Emergent’s sBLA for Manufacturing of its Anthrax Vaccine
Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.
Janssen Alleges HyClone Lab Infringed its Cell-Culture Media Patent
In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.
Anthrax Vaccine Nabs Orphan Drug Status
A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.
Keytruda Proves Superior to Chemotherapy in Phase III Trials
Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.
Pfizer Builds Biologics Clinical Manufacturing Facility in Massachusetts
Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.
Merck to Acquire Afferent Pharmaceuticals
Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.
Results Released from Ixekizumab Phase III Trials
In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.
Alvotech Opens mAbs Biosimilar Facility in Iceland
Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.
Darzalex Should Be a New Standard of Care, Say Study Authors
J&J’s Darzalex, in combination with two older drugs, was found to significantly extend progression-free survival in patients with relapsed refractory multiple myeloma.
Fujifilm Diosynth Announces Collaboration With MSD on Large-Scale Biologics Facility
A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.
Atezolizumab: Soon to Be a Monotherapy?
New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.
Mylan and Biocon’s Biosimilar to Herceptin Demonstrates Comparable Efficacy
Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.
Amyris and Janssen Collaborate on Biosynthetic Drug Discovery
Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.
EU Grants Approval to Remicade Biosimilar Flixabi
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
Jazz Pharmaceuticals Acquires Celator
Jazz will acquire Celator for approximately $1.5 billion.
FDA Accepts Samsung Bioepis' BLA for Remicade Biosimilar
FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).
Sanofi Makes Changes to Executive Committee
Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.
FDA Approves Atezolizumab
Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.
Celgene and Agios Collaborate on Metabolic Immuno-Oncology
Celgene will pay Agios $200 million to lead exploratory, research, drug discovery, and early development work for metabolic immuno-oncology.
Pfizer to Acquire Anacor
Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.
Caribou Biosciences Completes Series B Financing Round
Caribou announced the completion of a $30-million Series B financing round, which included the participation of new and current investors.
AXIM Begins Clinical Trials with CBG Ointment
The Phase I trials will examine AX-1602’s clinical efficacy for the treatment of psoriasis and eczema.
Takeda Receives Grant from Bill & Melinda Gates Foundation
Takeda received a $38 million grant from the Bill & Melinda Gates Foundation to develop, license, and supply Sabin-strain inactivated poliovirus to more than 70 developing countries.
WAVE and Pfizer to Collaborate on the Development of Nucleic Acid Therapies
Under the terms of an agreement with Pfizer, WAVE will advance up to five programs from discovery through the selection of clinical candidates.
MilliporeSigma Expands California GMP Facility
MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.
Sanofi Collaborates with Duke University and Massachusetts General Hospital
The collaborations have the goal of creating new tools that will help predict how people with Type 2 diabetes adhere to their medication.