Deadline Is Today: FDA Soon To Decide On Sickle Cell Treatment Using CRISPR
The treatment, called exa-cel, would be the first approved medicine in the U.S. to use the gene-editing tool to alter DNA. In other pharma news, an unusual surge in stock trading before Abbvie's big announcement Wednesday has raised eyebrows.
NBC News:
New Sickle Cell Treatment Sparks Feelings Of Hope And Some Hesitancy Among Black Patients
The Food and Drug Administration must decide by Friday whether to approve a new gene-editing therapy to treat sickle cell disease, a debilitating blood disorder that affects at least 100,000 Americans, most of whom are Black. The treatment, called exa-cel, would be the first approved medicine in the U.S. to use the groundbreaking gene-editing tool CRISPR to alter DNA. The new therapy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is, experts say, a stunning advancement in medicine. (Bellamy, 12/7)
In other pharmaceutical industry news —
Reuters:
Cerevel Options Trading Surge Before AbbVie Deal News Raises Eyebrows
Trading in the options of Cerevel Therapeutics Holdings Inc experienced an unusual surge along with its stock price in the days before Wednesday's announcement that AbbVie would buy the drug developer in a multi-billion dollar deal. AbbVie said after the market close on Wednesday it would buy Cerevel for about $8.7 billion in a bid to replace revenue as its huge-selling arthritis drug Humira faces a raft of new competitors. The announcement came minutes after Reuters reported a deal was near. (Ahmed, 12/8)
Stat:
Medtronic Cancels $738 Million Acquisition Of Diabetes Pump Maker
Medtronic is no longer buying EOFlow, a Korean maker of wearable insulin pumps. The news comes three months after Insulet, EOFlow’s rival, filed a lawsuit accusing the company of stealing trade secrets. (Lawrence, 12/7)
Bloomberg:
New Ajax Health Affiliate Raises $90 Million Led By KKR, Hellman
Ajax Health has established a new medical technology company to develop a treatment for the most common heart rhythm disorder. The new company, Cortex, has raised $90 million from KKR & Co. and Hellman & Friedman, according to a statement reviewed by Bloomberg News. Cortex is developing an integrated, comprehensive platform for evaluating and treating atrial fibrillation. (Davis, 12/7)
The Denver Post:
Cannabis Sleep Supplement Maker Faces Liver-Damage Accusations
A maker of cannabis and herb supplements in Adams County just outside Denver recently settled one lawsuit and faces other claims after some people who took its marijuana-infused sleep aids said they developed sudden liver problems. ... The drops, sold under the 1906 brand name, included cannabis and corydalis, a traditional Chinese herbal remedy. Corydalis contains tetrahydropalmatine, or THP, a chemical that can cause liver damage at high doses. The manufacturers recalled the products earlier this year. (Wingerter, 12/7)
Stat:
Research Misconduct: Proposed New Rules Face Resistance
Research universities are voicing concerns over some proposed changes to the process for reviewing scientific misconduct allegations, citing worries that new government requirements would hobble their own independent procedures and constitute a huge administrative burden. (Merelli, 12/8)
In global news —
CBS News:
CDC Reports "Alarming" Rise In Drug-Resistant Germs In Ukraine
Hospitals in Ukraine are now battling an "alarming increase" in germs with resistance to the last-ditch antibiotic medications used to treat the infections, a study published by the U.S. Centers for Disease Control and Prevention reported Thursday. Officials are now calling for the "urgent crisis" to be addressed, and warning that the drug-resistant germs are spreading beyond the war-torn country's borders. (Tin, 12/7)
Reuters:
WHO Says More Contaminated Medicinal Syrups Found In New Regions
The World Health Organization on Thursday said several contaminated syrups and suspension medicines had been identified in countries in the WHO regions of the Americas, the Eastern Mediterranean, South-East Asia and the Western Pacific. The affected products were manufactured by Pharmix Laboratories in Pakistan, the WHO said, and were first identified in the Maldives and Pakistan. Some of the tainted products have also been found in Belize, Fiji and Laos. Pharmix was not immediately available for comment. (Rigby and Deshmukh, 12/7)
