Bio/Pharma News
Oncurious to Buy VIB’s Immun-Oncology Portfolio
With this acquisition, Oncurious, a Belgium-based biotechnology company, will gain a pipeline of immune-oncology drug candidates.
Hospira Recalls One Lot of Injectable Vancomycin Hydrochloride
Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.
FDA Rejects Parkinson’s Disease Drug
FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.
FDA Expands Approval for Genentech’s Arthritis Drug
Genentech’s Actemra (tocilizumab), a rheumatoid arthritis drug, has been approved for a new indication, treating CAR T cell-induced cytokine release syndrome (CRS), a side effect of CAR T cell therapy.
Gilead to Buy Kite Pharma for $11.9 Billion
Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.
AstraZeneca and Takeda to Partner for PD Treatment
AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).
FDA Grants Priority Review to Genentech’s Anti-Cancer Drug
Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.
Sanofi Closes Acquisition of Protein Sciences
The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.
Alembic Sells Indian Formulations Plant
The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.
Genentech Gets Priority Review for Hemophilia A Biologic
FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.
Xellia Completes Budapest Facility Expansion
Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.
Samsung Bioepis Partners with Takeda to Develop Novel Biologics
The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.
Shire Announces Director and Senior Management Changes
Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.
Pfizer Gets FDA Approval for New Leukemia Drug
FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.
Biocon Withdraws Breast Cancer Biosimilar Filings in Europe
The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.
GSK Opens $57-Million Vaccines Facility in UK
GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.
Aslan Pharma Partners with Taiwan for Cancer Drug
A research collaboration joins Aslan with an academic research institute for studying small-molecule cancer drug candidates.
Alexion Gains Patent Protection Extension for Rare-Disease Drug
The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.
Regeneron Halts Development of RSV Biologic
The antibody therapeutic failed to meet its primary endpoint in a Phase III study.
SK Capital to Acquire Perrigo’s API Business
The private investment firm’s $110-million acquisition boosts its API and finished dosage form value chain.
Pfizer Plans Gene Therapy Manufacturing Investment in North Carolina
Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.
FDA Extends Dynavax’s Hep B Vaccine Review
FDA requests more detailed information on a post-marketing study for Dynavax’s hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.
Merck KGaA and Baylor Partner on Vaccines for Neglected Diseases
Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.
Galena Biopharma, SELLAS to Merge
Upon merging, the combined company will be named SELLAS Life Science Group and will focus on cancer treatments with a late-stage pipeline featuring immunotherapies targeting hematology and solid tumors.
Seattle Genetics Acquires Pharma Manufacturing Facility from BMS
The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.
FDA Grants Approval of Treatment for Hepatitis C
FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).
FDA Accepts Application for Teva’s Herceptin Biosimilar
FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Janssen, Bavarian Nordic Partner on Hep B and HIV Vaccines
Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.
AstraZeneca, Merck & Co. in $8.5-Billion Oncology Collaboration
Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.
GSK Plans Major R&D Overhaul
Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.
