Caroline Hroncich

A sampling of new laboratory equipment showcases streamlined operations.

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.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.

Valeant’s Siliq (brodalumab) injection will be listed for $3500 a month in the United States, the company said on April 21, 2017. In a statement, Valeant said this makes Siliq the lowest-priced injectable biologic to treat psoriasis on the US market.

Amgen is once again asking the court to weigh in on a patent infringement case. In March 2017, Sanofi and Regeneron asked a federal court to issue a declaratory judgment of non-infringement indicating that their drug Dupixent (dupilumab) does not infringe on Amgen’s ‘487 patent covering IL-4 inhibitors. Although the court has not yet responded to this request, in early April 2017 Amgen issued a complaint of patent infringement against Sanofi/Regeneron involving the same ‘487 patent.

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

On April 20, 2017 UniQure announced that it will not pursue marketing authorization renewal in the European Union for Glybera (alipogene tiparvovec), the first gene-therapy approved by EMA. Glybera’s marketing authorization is set to expire on Oct. 25, 2017.

Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

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

Pharmaceutical Technology spoke with CPhI North America presenters Ben Locwin, PhD, MBA, MBB, president at Healthcare Science Advisors, and Tom Fox, principal at Advanced Compliance Solutions, to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

The company received priority review for its investigational CAR-T therapy to treat leukemia.

FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

The company said it plans to expand diabetes manufacturing facilities in the United States.

Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.

Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.

An influx of millennial workers may have an impact on whether pharma manufacturers choose to implement IIoT technology.

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

Senator Chuck Grassley sent a letter to the Kaléo CEO questioning the drugs high listing price.

A new software technology, CRISPETa, is designed to assist in the deletion of non-protein coding sections of DNA.

Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.

Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.

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.