Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and etanercept in Europe, for the same indications as the respective reference medicines.
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
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.
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.
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.
Cobra will increase capacity in response to customer demand for DNA and viral vector production.
The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).
BMS is licensing two investigational compounds in separate deals with Roche and Biogen for a total of $470 million in upfront payments.
Pharmaceutical Technology spoke with Ben Locwin and Tom Fox ahead of their CPhI North America presentation to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.
The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.
Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.
The company received priority review for its investigational CAR-T therapy to treat leukemia.
The mAb is the first approved treatment that targets the progressive form of the disease.
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 has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.
The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.
FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.
The company said it plans to expand diabetes manufacturing facilities in the United States.
Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.
The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.
The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.
Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.
Senator Chuck Grassley sent a letter to the Kaléo CEO questioning the drugs high listing price.
The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.
BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.
The companies have entered into an agreement to develop and commercialize a mAb for the prevention of lower respiratory tract illness in young children.
A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.
Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.
FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.
