Bio/Pharma News
Cell Medica Begins Commercial Manufacturing of Cell Therapies
The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.
First Hospira Biosimilar mAb Approved in West Europe
Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.
Genzyme Announces $845-Million Gene Therapy Deal
Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.
Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.
Amgen Announces Humira Biosimilar Clinical Studies Success
Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.
AstraZeneca Reaches an Agreement to Acquire Actavis’ Respiratory Portfolio
AstraZeneca announced that it would strengthen its respiratory pipeline with the acquisition of Actavis’ branded respiratory business in the US and Canada.
FDA Accelerates Approval to Pfizer's Palbociclib
The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.
First Inhalable Insulin Comes to the US
Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.
EMD Serono Announces Product Marketing Change
Merck announced that the responsibility for its diabetes and thyroid brands will be shifted back to EMD Serono in Russia, removing the responsibility from its marketing partner, Takeda.
Shantha Constructs Insulin Facility in India
The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.
Precision Biologics Enlists EMD Millipore for Help with Upstream Process Development
EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.
FDA Approves HIV Treatments from BMS and J&J
Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.
AstraZeneca Partners with MD Anderson on Cancer Therapy Development
AstraZeneca and the University of Texas MD Anderson Cancer Center announced a plan to collaborate for the improvement of patient outcomes in clinical trials with investigational therapies.
Piramal Invests $30.6 Million in Coldstream Acquisition
Giovanni Caforio Named BMS CEO
Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.
Catalent and MGC Pharma Partner for Production of Cell Lines
Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.
Boehringer Ingelheim Partners with Vanderbilt University to Develop Ras Inhibitors
Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.
Sanofi Forms Strategic Pact with Boehringer Ingelheim for Biologics Manufacture
Sanofi has entered into a strategic manufacturing collaboration with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies (mAbs).
Catalent and Sanofi to Collaborate on ADC Development
Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.
EFPIA and IMI Announce New Projects to Fight Ebola
Eight new projects will focus on the diverse needs of the Ebola epidemic, such as new vaccine development, production and distribution, and new diagnostic methods.
Shire Acquires NPS Pharma for $5.2 billion
Shire adds rare-disease portfolio with acquisition of NPS Pharma.
Bristol-Myers Squibb Celebrates Superior Overall Survival for Opdivo
Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.
Argos and Saint-Gobain Partner on Single-Use Components for Immunotherapy Manufacturing
Single-use components aid efficiency in automated personalized therapy manufacturing.
Cardio3 BioSciences Acquires OnCyte CAR T-Cell Portfolio for $180 million
Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.
CVS Health Announces Hepatitis C Drug Exclusivity Deal with Gilead
The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.
Protein Sciences Considers Sourcing Flublok From Japan
Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.
Janssen Beefs Up Antibody Discovery Capabilities through Agreement with Sevion
The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.
Merck Acquires Biotechnology Company, OncoEthix
Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.
Fujifilm Completes Acquisition of Kalon Biotherapeutics
Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.
Actavis Announces Senior Leadership Team
Actavis announced a senior leadership team comprised of both Actavis and Allergan leaders designed to facilitate dynamic company growth.