Top News

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.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

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.

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

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

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.

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.

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.

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.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.