Industry News

The agency and the European Commission published updated guidance to answer questions about Brexit.

During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

Manufacturers and trading partners struggle to meet drug tracking requirements

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.

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.

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.

Two of the medicines recommended for approval are orphan drugs.

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

The voluntary recall is due to blister packages containing the incorrect product.

The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.

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.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

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.

The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.

Girish Malhorta, CPhI expert and president of EPCOT International, discussed world revenues for pharmaceuticals and how companies may improve cost and availability of drugs in CPhI’s 2017 Annual Report.

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

The agency has published educational material for physicians promoting the benefits of biosimilars.