News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies.
On the same day that Merck & Co. Inc.'s Zerbaxa (ceftolozane/tazobactam) obtained a supplemental approval from the US FDA for hospital- and ventilator acquired pneumonia (HABP/VABP), the big pharma reaffirmed its commitment to the antibiotic space at the Biotechnology Innovation Organization’s annual convention in Philadelphia.
During a 3 June session on reimbursement reform for novel antibiotics in the US, Jenelle Krishnamoorthy, Merck & Co.’s associate...
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.
In this week's podcast edition of Five Must-Know Things: global CEO remuneration; another late-stage loss for Merch KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models.
The German major is kicking off Phase II trials for a cell therapy and a gene therapy that could be gamechangers for the progressive neurodegenerative disorder that affects more than 10 million people worldwide.
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
