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The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

Roche will acquire oncology-focused healthcare technology and services company Flatiron Health for $1.9 billion to further its personalized oncological healthcare strategy.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

The President described US drug costs as unfair and stated that prices will come down.

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

The acquisition would boost Sanofi's position in hematology and specialty medicines.

The latest continuing resolution funds the government for three weeks.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

New tax legislation may result in savings for biopharma companies.

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.

Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery

Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.

AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

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

The agency announced a plan to eliminate its existing orphan designation request backlog.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.