Noah Higgins-Dunn

What was once considered the “Achilles heel” of lung cancer tumors, as Amgen puts it, now has an FDA-approved treatment in the company’s KRAS inhibitor, Lumakras.

Biohaven Pharmaceuticals’ oral Nurtec ODT is now the first FDA-approved treatment to treat and prevent migraines. With the agency’s latest go-ahead, the dual anti-CGRP drug is in “the next stage of being really disruptive,” CEO Vlad Coric said in an interview.

Eli Lilly said in an SEC filing that the Department of Justice subpoenaed the company this month, demanding documents that relate to its manufacturing site in Branchburg, New Jersey, which manufactures its widely-deployed COVID-19 antibody treatment.

The FDA on Wednesday approved Myovant Sciences’ relugolix to help women manage heavy menstrual bleeding linked to uterine fibroids, and pharma giant Pfizer will help sell the drug beginning in June.

As AbbVie comes under renewed scrutiny for its pricing and patenting strategies, the company is still working to build out the case for its next-gen immunology drugs Skyrizi and Rinvoq. The company posted data on 5 late-stage trials in Crohn’s disease and atopic dermatitis.

Less than two weeks after the FDA approved Apellis’ C3 inhibitor Empaveli for patients with a rare blood disorder known as paroxysmal nocturnal hemoglobinuria (PNH), the company is now touting late-stage data that shows its drug can help patients regardless of prior treatment with Alexion’s Soliris.

Biogen said Switzerland’s medicines surveillance authority issued its Solothurn manufacturing a Good Manufacturing Practice (GMP) license, paving the way for the facility to potentially make doses of its Alzheimer’s hopeful aducanumab.

Japan, which has fallen far behind other wealthy nations when it comes to its COVID-19 vaccine rollout, approved the emergency use of shots from AstraZeneca and Moderna. The move comes just months ahead of the already-postponed Olympic Games.

GlaxoSmithKline said it will sell its entire 32% stake in royalty management company Innoviva for roughly $392 million, although the pair’s collaborations on respiratory treatments will remain intact.

After two years of pushback, Takeda’s Baxalta unit has entered into a settlement agreement with Bayer over the $172 million it owed after losing a hemophilia patent infringement lawsuit in 2019, court documents show.

Exelixis’ oncology drug Cabometyx improved progression-free survival for a group of thyroid cancer patients and appeared to help with overall survival. But it did not significantly improve the response rate among some patients, according to data to be presented at the American Society of Clinical On…

AbbVie repeatedly raised the prices of its top-seller Humira and cancer blockbuster Imbruvica and exploited the U.S. patent system to build and maintain its market monopoly for the two drugs, the House Committee on Oversight and Reform said in a 48-page report released Tuesday.

AstraZeneca’s Farxiga may not have hit its marks in a COVID-19 trial, but it did well enough to keep trying, the study’s lead author said. On top of that, its performance on the safety side may help dispel doctors’ fears that SGLT2 drugs could cause serious side effects in COVID-19 patients.

The FDA handed a green light to Apellis’ C3 inhibitor, pegcetacoplan—now dubbed Empaveli—for patients with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), setting up a showdown with Alexion’s heavyweight Soliris.

The CDC is doing away with its suggestion that people wait two weeks before or after getting a COVID-19 shot before receiving another vaccine for a different condition, a rule that many Big Pharma players blamed for reducing sales during the first quarter of the year.

Roche CEO Severin Schwan has joined the list of pharma executives rejecting a U.S.-backed measure that would waive patent protections for COVID-19 products, saying in an interview with the Financial Times that the idea is “counterproductive.”

Exelixis’ tyrosine kinase inhibitor Cabometyx has produced “promising” late-stage trial results in thyroid cancer, inducing France’s Ipsen to join the company in the drug’s regulatory efforts.

AstraZeneca shareholders narrowly approved an enhanced 2021 pay package for CEO Pascal Soriot despite opposition from a number of investor groups. Meanwhile, the drugmaker now faces another legal challenge from the European Union over its COVID-19 vaccine deliveries to the bloc.

Eli Lilly has tapped three Indian generic drugmakers—Cipla, Lupin and Sun Pharma—through royalty-free, non-exclusive voluntary licensing agreements to manufacture and sell its COVID-19 drug baricitinib, which recently received emergency authorization for hospitalized patients when paired with Gilead…

The European Medicines Agency’s safety committee said on Friday that it’s evaluating an assortment of potential side effects following inoculation with most leading COVID-19 vaccines, including heart inflammation, facial swelling and a rare nerve-degenerating disorder.