Biopharma News

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.

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.

FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).

FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.

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.

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

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.

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 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 plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

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.

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.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

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.

The company has broken ground on a R&D and process development facility in Missouri.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

The companies expanded their alliance to develop plasmid DNA drugs.

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

Basilea Pharmaceutica International Ltd. entered into a distribution and license agreement with Pfizer and Avir Pharma Inc. to distribute Basilea’s antifungal treatments.

The company said it expects to transaction to close on June 16, 2017.

The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.

The company released an interim analysis from its JULIET study with CTL019.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.