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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 approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

The dispute over who has the rights to key CRISPR-Cas9 patents continues. On April 12, 2017 the University of California, Berkeley, in conjunction with the University of Vienna and Emmanuelle Charpentier, filed an appeal to overturn an earlier decision by the United States Patent Trial and Appeal Board (PTAB).

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 company to keep patents for their CRISPR-Cas9 gene-editing technology.

Evaluate and BioPharm International highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

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.

Pfizer executives were not among the pharma representatives who met with Trump yesterday to discuss various issues affecting the industry, a circumstance that Pfizer attributed to a schedule conflict with its quarterly earnings call. Despite the company’s absence from the meeting, Pfizer’s CEO Ian C. Read commented on some of Trump’s policy suggestions, and also discussed sales trends and projections for Pfizer’s R&D pipeline.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

The Reproducibility Project: Cancer Biology has been working to confirm the results in five prominent cancer biology experiments, and just released the results of its preliminary findings on Jan. 19, 2017. The researchers were only able to validate the findings in two of the five initial studies. The researchers could not replicate the findings in one study, and deemed another two studies “uninterpretable” because the tumor cells under investigation either grew too quickly or too slowly to measure whether the cancer drug had the predicted effect.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

Industry experts identify the future focus of the biopharma industry in a new survey.

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

J&J’s Innovation Global announced the company has entered into 15 new collaborations.

Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.