Sanofi, Merck get Vaxelis approval
Sanofi and Merck have received the Food and Drug Administration’s blessing for Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age, or prior to the 5th birthday.
Vaxelis was developed as part of a joint partnership between Sanofi and Merck.
Commercial supply will not be available in the United States prior to 2020.
Vaxelils is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).
Hikma, Sciecure Pharma ink deal for niche injectable anti-viral medicines
Hikma Pharmaceuticals has reached a license, supply and distribution agreement between its wholly-owned subsidiary Hikma Pharmaceuticals International and Beijing Sciecure Pharmaceutical, a leading Chinese company that researches, develops and manufactures pharmaceutical products for global markets.
The agreement provides Hikma with exclusive rights to sell one of Sciecure’s niche injectable anti-viral medicines across the U.S. for a minimum of eight years, with an option to extend this partnership for an additional two years.
Sciecure expects to file this product for approval with the US Food and Drug Administration in early 2019.
“We are thrilled to partner with Sciecure, an innovative and vertically integrated company capable of producing high-quality products across the pharmaceutical spectrum from API to finished doses,” Hikma executive vice president of commercial and business development Daniel Motto said. “Our partnership with Sciecure is another example of how Hikma is continuing to expand its pipeline, targeting both niche products and high-volume opportunities, in order to offer a broad portfolio of high-quality medicines to US patients, physicians and hospitals.”
Lupin, AbbVie partner to develop cancer drugs
Through a new partnership, AbbVie has licensed Lupin’s MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program.
“Delivering on new drugs was a key element of Dr. Deshbandhu Gupta’s vision. We are extremely proud of being able to realize his vision to bring new treatments to patients in need. We are very pleased to partner with AbbVie who share a commitment to deliver high quality medicines in areas that lack approved treatment and have a dire medical need. Their proven success in rapidly commercializing new targeted oncology treatments made them our partner of choice for this program,” Lupin’s managing director, Nilesh Gupta said.
AbbVie has gained exclusive global rights to develop and commercialize Lupin’s MALT1 inhibitors. MALT-1 is a protein involved in T-cell and B-cell lymphocyte activation and AbbVie intends to pursue development across a range of hematological cancers, many with limited current treatment options.
“Lupin’s MALT1 program is exploring a new and innovative approach in difficult-to-treat cancers. AbbVie is committed to pursuing advanced treatment options for patients and we look forward to partnering our expertise in hematological oncology with Lupin’s discovery program to offer new hope to patients.” AbbVie Discovery vice president, Tom Hudson said.