Rise and shine, everyone, the middle of the week is already here. Hard to believe, yes? Meanwhile, a delightful and beautiful morning is unfolding here on the Pharmalot campus, where the official mascot is noisily snoozing and the short people are nowhere to be found, since they departed for gainful employment. As for us, we are downing yet another needed cup of stimulation. Feel free to join us, as always. And here are some tidbits to help you along. Have a wonderful day and keep in touch. …
A judge backed a push by U.S. cities and counties suing opioid makers to negotiate a settlement as a group, but he put off until August a final decision on the request, Bloomberg News tells us. U.S. District Judge Dan Polster, who is overseeing more than 1,900 lawsuits by U.S. municipalities, said the idea of creating a negotiating class of local governments to spur settlement talks was an innovative one. Normally, such classes are formed only after a tentative deal has been struck.
Nonetheless, tension is emerging between lawyers representing state and local governments over the path forward in a set of lawsuits seeking to hold the drug industry accountable for the toll of the nation’s opioid crisis, the Associated Press adds. Attorneys general for most states wrote in a pair of letters to Polster that such an arrangement could hurt their ability to reach a national settlement. One letter warned the deal would give communities elsewhere “functional veto power” over any settlement a state reached that is not acceptable for all.
For the first time in decades, drug-overdose deaths in the U.S. are on the precipice of declining, The Wall Street Journal says. Provisional data from the Centers for Disease Control and Prevention are pointing lower and predict there were nearly 69,100 drug deaths in the 12-month period ending last November, down from almost 72,300 predicted deaths for 12 months ending November 2017. If the trend holds through December, annual drug deaths will fall for the first time since 1990, when overdoses killed about 8,400 people.
Mylan (MYL) shareholders backed a proposal to strengthen a clawback policy that forces top executives to return incentive pay in the case of misconduct, The Pittsburgh Post-Gazette reports. The majority of proxies received from the June 21 annual shareholders meeting supported the non-binding proposal, which was submitted by the UAW Retiree Medical Benefits Trust. The pension fund argued Mylan’s clawback policy was weak because it allowed recoupment of incentive pay only if any misconduct caused a financial restatement.
Pfizer (PFE) is urging the U.S. Supreme Court to allow it to move from California state to federal court the lawsuits by about 4,800 women who claim they developed diabetes as a result of taking Lipitor, its blockbuster anti-cholesterol drug, Reuters writes. The drug maker petitioned the justices to consider whether a California court decision to coordinate the cases triggered the Class Action Fairness Act’s threshold for federal jurisdiction over mass actions involving more than 100 plaintiffs.
The U.S. patent office declared an interference between a dozen key patents awarded to the Broad Institute on the genome-editing technology CRISPR and 10 CRISPR patent applications submitted by the University of California and its partners, according to STAT. The declaration of an interference means that the patent office has determined that one or more patent applications describe inventions that are substantially the same as those for which patents have already been issued.
PatientsLikeMe is joining the research and development arm of UnitedHealth Group (UNH), according to STAT. Backed by Chinese capital, PatientsLikeMe was forced by the Trump administration to find a buyer following a review by the Committee on Foreign Investment in the United States. The news comes amid increasing U.S. government scrutiny of Chinese investments in tech startups as trade tensions between the U.S. and China drag on. PatientsLikeMe provides an online service that helps patients find people with similar health conditions.
The Food and Drug Administration declined to approve an Acer Therapeutics (ACER) drug for treating a severe, rare genetic disorder that can cause blood vessels to fatally rupture, sending its shares plunging as much as 78%, Reuters notes. The treatment, Edsivo, aims to treat vascular Ehlers-Danlos syndrome, or vEDS, which is the most severe type of a hereditary disorder of the connective tissue. The agency, in its complete response letter, has asked Acer to conduct a clinical trial to determine the efficiency of Edsivo in treating patients with vEDS.
Athersys (ATHX) is using the story of a stroke survivor to promote the development of an experimental stem cell therapy, but by doing so, the company has obscured a clinical trial failure, STAT explains. The clinical trial in which the patient participated showed the MultiStem treatment was no better than a placebo in helping patients recover from strokes, and a previous study involving patients with ulcerative colitis also failed, which are ignored in media and video stories.
Novartis (NVS) denied exporting dual-use chemicals to a Syrian partner amid scrutiny of shipments by German chemicals distributor Brenntag via a Swiss subsidiary in 2014, Reuters says. Reports in the Sueddeutsche Zeitung and other newspapers said Brenntag, the world’s largest chemicals distributor, sold chemical raw materials to a Syrian pharmaceutical company called Mediterranean Pharmaceutical Industries. Novartis has a contract manufacturing and distribution deal with MPI for some products.
A United Nations Human Rights Council draft resolution on access to medicines and vaccines calls for making public health needs more central to the research and development of new health products, and for the new products to be priced to ensure access, Health Policy Watch informs us. The draft resolution includes new language that decries the failures of market-driven R&D to address public health needs with respect to rare and neglected diseases, as well as antimicrobial resistance.
Akorn (AKRX) received a warning letter from the FDA over quality controls concerns found during an inspection last summer at its manufacturing facility in New Jersey, the latest in a string of setbacks for the generic drug maker, Reuters writes. The FDA warning is the second that Akorn has received this year and follows a warning letter for another manufacturing plant in Decatur, Ill., after the drug maker did not resolve previously highlighted violations, such as failure to follow procedures to prevent contamination of drugs produced at the plant.
The FDA issued warning letters to two privately held companies for illegally selling unapproved, misbranded drugs containing kratom claiming to cure opioid addiction and withdrawal symptoms, Reuters notes. Leaves of the kratom tree, native to southeast Asia, can be used as a stimulant or sedative and the Drug Enforcement Administration has listed it as a “drug and chemical of concern.” Advocates say kratom helps ease pain and reduce symptoms of opioid withdrawal, but the FDA has not approved it for any medical use.