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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 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

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

The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.

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

Charlie Baker announced a plan to invest up to $500 million in the MA life-science industry.

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.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.

The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

UC Berkeley appealed the February 2017 decision that determined Harvard and MIT’s Broad Institute and Berkeley’s CRISPR-Cas9 technologies were separately patentable.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

The recall was issued because of a defective delivery system; the units affected had possible package leakage.

The mAb is the first approved treatment that targets the progressive form of the disease.

Human antibody for Zika virus could help in the treatment and prevention of the infection.

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing technology.

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.

Aggressive petitioning by ViroPharma kept a generic equivalent to Vancocin off the market for more than two years.

A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.