Thursday, December 20, 2018
Celgene multiple myeloma treatment granted FDA orphan designation
Celgene’s multiple myeloma treatment was granted FDA orphan designation, according to a post to the agency’s website.
https://thefly.com/landingPageNews.php?id=2840181
FDA, HHS Urge Co-Prescribing Naloxone to Patients at High Risk for Opioid Abuse
Patients prescribed opioids who are deemed to be at high risk for opioid overdose could also receive a prescription for naloxone, an opioid overdose reversal drug.
On Wednesday, a joint U.S. Food and Drug Administration (FDA) committee narrowly voted in favor of language that would encourage prescribers to think of adding naloxone when prescribing opioids. The Regulatory Affairs Professionals Society reported that the 12-11 vote in favor of adding naloxone was the result of questions raised by some committee members of whether or not adding the overdose reversal drug actually addressed the opioid crisis that has gripped much of the nation. Those who supported the additional language calling for the mandatory prescription argued that co-prescribing naloxone is already a standard of care and should be added to the labeling, RAPS reported.
According to the U.S. Department of Health and Human Services, 116 Americans die dailyfrom opioid overdoses. In October, the FDA announced that the agency was looking for ways to increase the availability of naloxone as a way to combat the crisis. Since Scott Gottlieb took over as FDA commissioner, his agency has been working to diminish the opioid crisis. The joint committee vote to add naloxone to prescribing guidelines was part of the efforts Gottlieb announced earlier this fall.
When releasing the new guidance, Adm. Brett P. Giroir, the assistant secretary for health at the Department of Health and Human Services and senior advisor for opioid policy, noted that naloxone can help save lives and should be prescribed to all patients who are at risk for opioid complications.
“Given the scope of the opioid crisis, it’s critically important that healthcare providers and patients discuss the risks of opioids and how naloxone should be used in the event of an overdose,” Giroir said in a statement on the HHS website. “We have begun to see some encouraging signs in our response to the opioid crisis, but we know that more work is required to fully reverse the decades-long epidemic. Co-prescribing naloxone when a patient is considered to be at high risk of an overdose is an essential element of our national effort to reduce overdose deaths and should be practiced widely.”
The new guidelines recommend that individuals who are prescribed relatively high doses of opioids, take medications that can enhance opioid complications or have underlying health conditions that could lead to overdose, be prescribed naloxone alongside the opioids. Adding naloxone to the prescribing requirements can better equip patients and their families in the case of an accidental (or intentional) overdose.
HHS Secretary Alex Azar said promoting the availability and distribution of overdose-reversing drugs is one of the five pillars of the department’s 2017, 5-Point Strategy to Combat the Opioids Crisis.
“This new guidance reflects our commitment to ensuring those who need overdose-reversing drugs have them and provides practical steps that clinicians, patients, and the public can take to reduce the risk of an overdose,” Azar said in a statement.
Orgenesis initiated at Dawson James
Orgenesis initiated with a Buy at Dawson James. Dawson James initiated Orgenesis with a Buy and $10 price target.
https://thefly.com/landingPageNews.php?id=2840085
Novartis announces offer to acquire CellforCure
Novartis announced an offer to acquire CellforCure from LFB. CellforCure, a French company, is one of the first and largest contract development and manufacturing organizations producing cell and gene therapies in Europe, Novartis stated. Under the proposed agreement, Novartis would acquire the share capital of CellforCure from LFB including the cell and gene manufacturing facility located in Les Ulis and the related adjacent land. If the offer is accepted, CellforCure would become a wholly owned Novartis manufacturing site, joining the network of cell and gene therapy sites including Morris Plains, New Jersey, USA and Stein, Switzerland, where construction continues to progress as planned. In July 2018, Novartis announced that it had signed an agreement with CellforCure to produce CAR-T cell therapies including Kymriah. The transaction is subject to usual and customary closing conditions, including employee consultation process and necessary regulatory approvals. If approved, the transaction is expected to be funded through available cash and close in the first half of 2019.
https://thefly.com/landingPageNews.php?id=2840129
Immunomedics drops 22% in pre-market trading
Immunomedics drops 22% in pre-market trading The pre-market weakness in shares of is being attributed to a cautious note published by Favus Research, according to contacts.
Acer Therapeutics initiated at Needham
Acer Therapeutics initiated with a Buy at Needham. Needham analyst Serge Belanger initiated Acer Therapeutics with a Buy rating and a price target of $48. The analyst sees the company as an “attractive under-the-radar orphan drug story with two late-stage derisked assets that have key transformational catalysts in 2019.” Belanger cites Acer’s lead product candidate currently under FDA review for the treatment of vascular Ehlers-Danlose syndrome that affects up to 5K people in the U.S. along with its ACER-001 drug candidate that is currently under development for Urea Cycle Disorders and on track for an NDA filing in late-2019.
Unum Therapeutics initiated at H.C. Wainwright
Unum Therapeutics initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Andrew Fein started Unum Therapeutics with a Buy rating and $18 price target. While most T-cell therapy players are focusing on tackling one or two aspects of the major challenges faced by CAR-T, the differentiating value of Unum resides in its potential to address all aspects especially its unique advantages in targeting solid tumors, where the largest commercial opportunities lie for new entrants in the space, says the analyst.
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