New Drug For Lung Cancer Approved

Axios: FDA Approves Amgen Drug That Targets Lung Cancer With Specific Mutation 
The Food and Drug Administration approved Amgen's Lumakras drug as the first treatment for adult patients with a common form of lung cancer. Non-small cell lung cancer with a specific mutation in a gene known as KRAS has been considered to be resistant to any sort of drug treatment, per the FDA. Lumakras was able to shrink the tumors of between 36% and 58% of patients studied. (Gonzalez, 5/29)

Fox News: Diabetes Vaccine Shows Promise For Some Patients In Early Trial
In a small, early study, a vaccine for type 1 diabetes helped preserve the body's natural production of insulin, at least in a subset of newly diagnosed patients. In patients with type 1 diabetes, the body's immune system attacks the beta cells in the pancreas that produce insulin, a hormone that's necessary for cells to absorb glucose from the bloodstream. These patients need lifelong insulin injections to stay alive. And because so many hidden factors inside the body can affect how much insulin a person needs, people who are insulin-dependent often have high and low blood sugar. High blood sugar, or hyperglycemia, damages the organs over the long term, while low blood sugar, or hypoglycemia, can lead to seizures or death in the short term. (Saplakoglu, 5/29)

The Washington Post: Alzheimer’s Drug Aducanumab Sparks Emotional Battle As FDA Nears Deadline On Whether To Approve 
When Phil Gutis was diagnosed with early-stage Alzheimer’s disease at 54, he immediately enrolled in a clinical trial for an experimental drug but had little hope of being helped. Over time, though, he started feeling better, his brain less cloudy. “There was just a fogginess I remember having a couple of years ago that I don’t really feel I have now,” said Gutis, who has received monthly infusions of a medication called aducanumab for five years, except for a short interruption. (McGinley, 5/31)

The New York Times: A Vaccine Side Effect Leaves Women Wondering: Why Isn’t The Pill Safer? 
Last month, as the Food and Drug Administration paused use of Johnson & Johnson’s Covid-19 vaccine to evaluate the risk of blood clots in women under 50, many scientists noted that clots associated with birth control pills were much more common. The comparison was intended to reassure women of the vaccine’s safety. Instead, it has stoked anger in some quarters — not about the pause, but about the fact that most contraceptives available to women are hundreds of times riskier, and yet safer alternatives are not in sight. (Mandavilli, 5/30)

Reuters: EU To Decide On Astrazeneca's $39 Bln Alexion Deal By July 5 
EU antitrust regulators will decide by July 5 whether to clear Anglo-Swedish drugmaker AstraZeneca's (AZN.L) $39 billion bid for U.S.-based Alexion (ALXN.O), a European Commission filing showed on Tuesday. AstraZeneca sought EU approval on Monday for the deal, its largest ever in a bet on rare-disease immunology and to boost its business, which includes a fast-growing cancer medicines unit and a major COVID-19 vaccine. (6/1)

In updates on the opioid trial in West Virginia —

Charleston Gazette-Mail: Email Shows Drug Firm Employees Applauded Customers’ Shift To Illicit Drugs
An email released Friday in the federal trial pitting Huntington and Cabell County against three drug distributors showed McKesson Corp. employees cheering trends that showed Appalachians were shifting away from opioid pills to illicit drugs in 2012. The email was sent among McKesson employees — first by Tracy Jonas, director of regulatory processes, who shared a February 2012 article that said the DEA was seeing a sharp drop in oxycodone sales in Florida. “We are showing trends in other states where the addicts are moving to heroin and Meth. Ohio and Ky. for instance. I spoke to Jeff Conners of the DEA and he called it ‘Whack a Mole,’” Dave Gustin, a director of regulatory affairs, responded. (Hessler, 5/28)