FDA grants full approval to Amgen’s Blincyto
SILVER SPRING, Md. — Patients with a certain type of acute lymphoblastic leukemia have a new treatment option. The Food and Drug Administration has granted Amgen’s Blincyto (blinatumomab) full approval for the treatment of Philadelphia Chromosome-positive relaped or refractory B-cell precursor ALL.
“We are pleased that the FDA has granted full approval for Blincyto, marking a significant milestone for certain patients with relapsed or refractory ALL,” Amgen EVP research and development Dr. Sean Harper said. “This approval supports the use of Blincyto in a broader spectrum of patients, including those with few options to date, such as Philadelphia chromosome-positive patients, and reinforces the potential of the [bispeciic T cell engager] platform as a novel approach to immuno-oncology.”
The drug had previously been granted breakthrough therapy designation and accelerated approval.
“Relapsed or refractory ALL is often a lethal disease, with a median overall survival of just four months on standard-of-care chemotherapy,” Moffitt Cancer Center oncologist Dr. Bijal Shah said. “As a physician, my goal is to identify treatments that improve response rates in patients with aggressive hematologic malignancies. Blincyto is an option that has been shown to help these high-risk patients fight their disease."
Astellas names 2 regional sales execs
NORTHBROOK, Ill. — Astellas has named the heads of two regional sales leads The company on Wednesday promoted David Musselman to be area VP sales, primary care and specialty care-east, and named Lynn Gerber area VP sales, primary care and specialty care-west.
“These changes will further support our efforts to ensure we’re providing valuable therapies to patients who need them,” Astellas VP sales, primary care/specialty and hospital, Steve Sabus said. “Both David and Lynn’s demonstrated ability to lead and develop high-performance teams will build on the important relationships and communication that we’ve established with our customers and accounts in key US geographies.”
Musselman’s pharmaceutical sales experience spans 20 years, most recently at Astellas as its director of regional accounts east. In that role, he led a team of regional account managers in the company’s oncology, urology, transplant and antifungal franchises. He joined the company as a Georgia regional sales manager in 2007, followed by his time as area sales director for the southeastern United States. His career began at Pfizer, where he served in various roles, including district manager. In his new role, Musselman will be based in South Carolina, overseeing a team of five sales directors and reporting to Sabus.
Musselman takes over his new role from Gerber, who has been with Astellas since 2003 and has more than 25 years of pharmaceutical industry experience. Before joining Astellas, she worked in sales, marketing and operations roles of increasing responsibility at GSK. Gerber is a member of the Healthcare Businesswomen’s Association and was the winner of its 2015 BA Luminary Award. In her new role she will be based in Illinois, overseeing a team of five sales directors.
Sanofi to acquire Protein Sciences
PARIS — Sanofi on Tuesday announced that it would be acquiring vaccine company Protein Sciences for $650 million upfront. The acquisition also would see Sanofi paying an additional $100 million based on certain milestones.
“Protein Sciences was actively looking for an opportunity to grow its business, particularly in the United States,” Protein Sciences president and CEO Manon M.J. Cox said. “As part of Sanofi Pasteur, we expect our Flublok influenza vaccine to benefit from Sanofi Pasteur’s expertise in the field of influenza vaccines.”
The deal would bring Protein Sciences’ recently approved Flublok quadrivalent flu vaccine to its portfolio — bringing the company a non-egg-based flu vaccine.
"The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg based vaccine," Sanofi EVP and head of the company’s vaccine arm Sanofi Pasteur David Loew said.
Sanofi and Protein Sciences expect the deal to close by the end of the third quarter