With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs). The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.
HYDERABAD, India – Multinationals and domestic companies are stepping up research in India, including working to leverage the country’s digital and entrepreneurial capabilities, to boost India’s capabilities and market share in more innovative biologic drugs.
Five Prime Therapeutics Inc. said it's licensing a family of monoclonal antibodies (Mabs) to Seattle Genetics Inc. for inclusion in new early stage cancer-killing antibody-drug conjugate (ADC) candidates, all directed to a single target. The deal holds $5 million up front for Five Prime, plus up to $525 million in milestone payments for the first two candidates. South San Francisco-based Five Prime's shares (NASDAQ:FPRX) rose about 18% on the deal, which interim CEO William Ringo said allows the firm "to realize value from our preclinical pipeline while prioritizing our clinical investments based on upcoming data readouts."
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
What with the lawsuits, declining prescriptions and approval hurdles that seem to be the U.S. answer to a nationwide opioid epidemic, drug companies have to think long and hard before spending the resources to develop yet another opioid drug. And patients are paying the price.
HYDERABAD, India – India could play a key role in driving down the exorbitant cost of emerging cell and gene therapies, with a combination of comparatively cheap labor and efficient manufacturing, international experts said during the annual BioAsia conference.
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
BOGOTA, Colombia – As part of an effort to further control drug costs, Colombia set price caps on 770 drugs in late January. The move takes the total of price-regulated drugs in the Latin American country to 2,487. The new caps on drug prices apply to a broad range of products from generics to biosimilars and to biologics such as ranibizumab, trastuzumab, vedolizumab, secukinumab and pembrolizumab, among dozens of others.
BEIJING – Zhongshan-based Akeso Inc., which focuses on bispecific antibodies, is again seeking pre-revenue listing on the Hong Kong Stock Exchange (HKEX), after its first IPO attempt failed to go through in December. The move comes at a time when analysts believe the coronavirus outbreak is weighing on the city’s IPO market.
A high-profile test of two experimental medicines in people with autosomal dominant Alzheimer’s disease (ADAD), a rare inherited form of the disease, found that neither drug significantly slowed rates of cognitive decline vs. placebo, the primary endpoint.
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