Appointments
- Despite abolishing a rule that prevented CEOs running the company past the age of 65, Merck is now seeking a replacement for longstanding leader Ken Frazier, who is set to leave the company ahead of his 65th birthday in December. Frazier, who joined the company over 25 years ago, served as its CEO for 11 years. He oversaw a period of massive growth, with drugs, such as Keytruda, gaining reglatory approval and pushing sales past the $7 billion mark. Though there has been speculation as to who will fill Frazier’s shoes, no official statement has been issued by Merck.
- Sanofi has hired Paul Hudson to be the company’s new CEO. Hudson, a British pharma executive, will replace Olivier Brandicourt, who left the company for early retirement. Hudson was a former executive at Novartis and will take the reigns at Sanofi from September 1.
Pricing
- As US Congress calls for caps on the price of insulin, Eli Lilly has launched Lispro, a generic version of Humalog with a list price of $137.35 per vial. The drug is 50 percent cheaper than its counterpart.
- The UK’s Competition and Market Authority (CMA) has cast blame on four UK pharmaceutical companies (Alliance Pharma, Focus, Lexon and Medreich) for pushing up the cost of prochlorperazine, an anti-nausea drug often used for the treatment of patients undergoing chemotherapy. The price paid by the UK’s National Health Service for the anti-sickness drug shot up by 700 percent (from £2.7 million to £7.5 million between 2013 and 2018) when the companies allegedly made an agreement against competition. According to the CMA, the agreement prevented rivals to Alliance Pharma from entering the market, driving up the cost of the drug. If the CMA investigation unveils unlawful conduct, each company could face a 10 percent financial penalty on their worldwide turnovers.
- Novartis has set the price tag for Zolgensma ( a gene therapy for the treatment of pediatric spinal muscular atrophy) at a record-breaking $2.1 million. As a result, industry watchdogs and patients have asked whether companies are out of control in their attitudes toward drug pricing. Novartis claims that it used “value based pricing frameworks to price Zolgensma at around 50 percent less than multiple established benchmarks including the 10-year current cost of chronic SMA therapy.”
Regulation & Approvals
- The FDA has selected four industry partners to participate in its latest Drug Supply Chain Security Act (DSCSA) pilot program. IBM, Merck, KPMG and Walmart have been invited by the regulatory agency to help create a blockchain network for the US market. The collaborative project will see the industry develop a system capable of identifying and tracking prescription medicines and vaccines in real-time.
- Five months after receiving approval from US regulators, Lynparza, a PARP inhibitor for the treatment of ovarian cancer, has received approval in Europe. The EU approval was based on a study in which Lynparza showed a 70 percent reduction in the risk of disease progression or death in patients with BRCA-mutated advanced ovarian cancer.
Facilities
- Catalent is set to acquire Bristol-Myers Squibb's manufacturing and packaging facility in Anagni, Italy. The facility is used for the manufacture of oral solid dose forms, biologics and sterile products. Upon the acquisition of the facility, Catalent will continue to produce the products in Bristol-Myer Squibb’s current portfolio. The handover is anticipated to be completed by the end of the year, provided that regulatory approval is gained and other closing conditions are met.
- A former GSK facility based in Prussia, Pennsylvania, is being transformed into healthcare, life sciences and tech co-working community by The Discovery Labs, a platform company who acquires former R&D facilities. With a cash injection of $500 million, The Discovery Labs hope to develop the world’s largest co-working space. The campus is expected to have a 1.6 million square foot collaborative laboratory and a 100,000 square foot incubator, called IQ Connect, which will house researchers and entrepreneurs – and connect them with investors and other business services.
- LSNE has purchased its first European site for the manufacture of sterile drug products. The CDMO currently owns four stateside facilities, but chose to buy the Spanish facility to help manage its growing client base in Europe. The site, based in León, Spain, has been inspected by both the FDA and Spanish authorities and can serve both the US and EU markets. The newly acquired site will add prefilled syringe, ophthalmic and sterile bulk lyophilization capabilities to LSNE’s repertoire and help support commercial-scale lyophilization.
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