Biopharma News
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.
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.
BMS Acquires Biotech Company in Billion-Dollar Deal
On August 3, 2017, Bristol-Myers Squibb (BMS) announced that it has agreed to acquire biotech firm, IFM Therapeutics, in a deal worth over $1 billion to develop BMS’ oncology pipeline.
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 Grants Approval of Treatment for cGVHD
FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.
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.
FDA advances biosimilars progress 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.
Takeda in Anti-Cancer Pact Worth Up to $340 Million
Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.
Eli Lilly, Incyte RA Drug Delayed to Beyond 2017
Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.
Boehringer Ingelheim Expands Fremont Manufacturing Facility with $217 Million Investment
Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.
GSK Plans Changes to UK Manufacturing Network
GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.
GSK Ships Seasonal Influenza Vaccines for US Market
GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.
GMP Issues Derail a Drug Approval for the Second Time
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
Novartis CAR-T Cell Therapy CTL019 Recommended for FDA Approval
FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.
Sanofi Acquires Protein Sciences
The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio
Endo Withdraws Opioid Drug from Market
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
SOBI003 Granted Orphan Drug Designation for MPS IIIA Treatment
SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.
Noninvasive NMR Imaging Could Open New Biotech Opportunities
A new probe developed by researchers at the University of Melbourne, Australia, would allow NMR to be used without the use of microwaves, and with smaller machines.
Pfizer Breaks Ground on New R&D Facility
The company has broken ground on a R&D and process development facility in Missouri.
